Blood and lymphatic system disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Blood and lymphatic system disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Anemia
Hemoglobin (Hgb) <LLN - 10.0 g/dL; <LLN - 6.2 mmol/L; <LLN - 100 g/LHgb <10.0 - 8.0 g/dL; <6.2 - 4.9 mmol/L; <100 - 80 g/LHgb <8.0 g/dL; <4.9 mmol/L; <80 g/L; transfusion indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a reduction in the amount of hemoglobin in 100 ml of blood. Signs and symptoms of anemia may include pallor of the skin and mucous membranes, shortness of breath, palpitations of the heart, soft systolic murmurs, lethargy, and fatigability.
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Aplastic anemia
 -Use of growth factor indicated; transfusion indicatedSevere or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by the inability of the bone marrow to make enough new blood cells.
Navigational Note: Do not report individual cell count decreases in addition to this term.
Bone marrow hypocellular
Mildly hypocellular or <=25% reduction from normal cellularity for ageModerately hypocellular or >25 - <50% reduction from normal cellularity for ageSeverely hypocellular or >50 - <=75% reduction cellularity from normal for ageAplastic persistent for longer than 2 weeksDeath
Definition: A disorder characterized by the inability of the bone marrow to produce hematopoietic elements.
Navigational Note: Consider Blood and lymphatic system disorders: Anemia, Thrombocytopenia, and/or Investigations: Neutrophil count decreased if bone marrow hypocellularity is not seen.
Disseminated intravascular coagulation
 -Laboratory findings with no bleedingLaboratory findings and bleedingLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by systemic pathological activation of blood clotting mechanisms which results in clot formation throughout the body. There is an increase in the risk of hemorrhage as the body is depleted of platelets and coagulation factors.
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Eosinophilia
>ULN and >Baseline -Steroids initiated - -
Definition: A disorder characterized by laboratory test results that indicate an increased number of eosinophils in the blood.
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Febrile neutropenia
 - -ANC <1000/mm³ with a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees F) for more than one hourLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an ANC <1000/mm³ and a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees F) for more than one hour.
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Hemolysis
Laboratory evidence of hemolysis only (e.g., direct antiglobulin test; DAT; Coombs'; schistocytes; decreased haptoglobin)Evidence of hemolysis and >=2 g decrease in hemoglobinTransfusion or medical intervention indicated (e.g., steroids)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by laboratory test results that indicate widespread erythrocyte cell membrane destruction.
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Hemolytic anemia
<10% drop in Hgb from last assessment; intervention not indicated<=2 units of PRBCs transfused per day>2 units of PRBCs per day indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: Anemia resulting from hemolysis.
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Hemolytic uremic syndrome
 - -Laboratory findings with clinical consequences (e.g., renal insufficiency, petechiae)Life-threatening consequences, (e.g., CNS hemorrhage or thrombosis/embolism or renal failure)Death
Definition: A disorder characterized by a form of thrombotic microangiopathy with renal failure, hemolytic anemia, and severe thrombocytopenia when the etiology is due to infections with shiga-toxin producing bacteria, such as E coli O157:H7.
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Leukocytosis
 - ->100,000/mm³Clinical manifestations of leucostasis; urgent intervention indicatedDeath
Definition: A disorder characterized by laboratory test results that indicate an increased number of white blood cells in the blood.
Navigational Note: Do not use for increases due to growth factors, steroids, or leukemias.
Lymph node pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in a lymph node.
Navigational Note: Record final diagnosis/cause once determined.
Lymphopenia
Present - - - -
Definition: A finding based on laboratory test results that indicate a decrease in number of lymphocytes in a blood specimen.
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Methemoglobinemia
 ->ULNRequiring urgent interventionLife-threatening consequencesDeath
Definition: A disorder characterized by laboratory test results that indicate increased methemoglobin in the blood.
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Thrombocytopenia
<LLN - 75,000/mm³; <LLN - 75.0 x 10⁹/L<75,000 - 50,000/mm³; <75.0 - 50.0 x 10⁹/L<50,000 - 10,000/mm³; <50.0 - 10.0 x 10⁹/L; transfusion indicated<10,000/mm³; 10.0 x 10⁹/L; life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a decrease in number of platelets in a blood specimen.
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Thrombocytosis
Present - - - -
Definition: A finding based on laboratory test results that indicate an increase in number of platelets in a blood specimen.
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Thrombotic microangiopathy
 -Outpatient intervention indicated (e.g., modification of immunosuppression)Transfusion or IV intervention indicatedLife-threatening consequencesDeath
Definition: A disorder characterized by a form of thrombotic microangiopathy with laboratory findings that indicate hemolytic anemia, severe thrombocytopenia, and renal insufficiency/failure.
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Thrombotic thrombocytopenic purpura
 - -Laboratory findings with clinical consequences (e.g., renal insufficiency, petechiae)Life-threatening consequences, (e.g., CNS hemorrhage or thrombosis/embolism or renal failure)Death
Definition: A disorder characterized by a deficiency of ADAMTS13 and the presence of microangiopathic hemolytic anemia, thrombocytopenic purpura, fever, renal abnormalities and neurological abnormalities such as seizures, hemiplegia, and visual disturbances. It is an acute or subacute condition.
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Blood and lymphatic system disorders - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
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Cardiac disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Cardiac disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Aortic valve disease
Asymptomatic valvular thickening with or without mild valvular regurgitation or stenosis by imagingAsymptomatic; moderate regurgitation or stenosis by imagingSymptomatic; severe regurgitation or stenosis by imaging; symptoms controlled with medical interventionLife-threatening consequences; urgent intervention indicated (e.g., valve replacement, valvuloplasty)Death
Definition: A disorder characterized by a defect in aortic valve function or structure.
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Asystole
 - -Intervention indicated; device (e.g., pacemaker)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a dysrhythmia without cardiac electrical activity. Typically, this is accompanied by cessation of the pumping function of the heart.
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Atrial fibrillation
Asymptomatic, intervention not indicatedNon-urgent medical intervention indicated; electrical cardioversionSymptomatic, urgent intervention indicated; device (e.g., pacemaker); ablation; new onsetLife-threatening consequencesDeath
Definition: A disorder characterized by a dysrhythmia without discernible P waves and an irregular ventricular response due to multiple reentry circuits. The rhythm disturbance originates above the ventricles.
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Atrial flutter
Asymptomatic, intervention not indicatedNon-urgent medical intervention indicatedSymptomatic, urgent intervention indicated; device (e.g., pacemaker); ablationLife-threatening consequencesDeath
Definition: A disorder characterized by a dysrhythmia with organized rhythmic atrial contractions with a rate of 200-300 beats per minute. The rhythm disturbance originates in the atria.
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Atrioventricular block complete
 -Non-urgent intervention indicatedSymptomatic and incompletely controlled medically, or controlled with device (e.g., pacemaker); new onsetLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a dysrhythmia with complete failure of atrial electrical impulse conduction through the AV node to the ventricles.
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Atrioventricular block first degree
Asymptomatic, intervention not indicatedNon-urgent intervention indicated - - -
Definition: A disorder characterized by a dysrhythmia with a delay in the time required for the conduction of an electrical impulse through the atrioventricular (AV) node beyond 0.2 seconds; prolongation of the PR interval greater than 200 milliseconds.
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Cardiac arrest
 - - -Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by cessation of the pumping function of the heart.
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Chest pain - cardiac
Mild painModerate pain; pain on exertion; hemodynamically stable; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Pain at rest; cardiac catheterization; new onset cardiac chest pain; unstable angina; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by substernal discomfort due to insufficient myocardial oxygenation e.g., angina pectoris.
Navigational Note: Consider Cardiac disorders: Myocardial infarction. Record final diagnosis/cause once determined.
Heart failure
Mild symptoms; no initiation or intensification of treatmentOutpatient initiation or intensification of treatmentHospitalization indicatedRequiring inotropic support, mechanical circulatory support, or consideration of cardiac transplantationDeath
Definition: A disorder characterized by the inability of the heart to pump blood at an adequate volume to meet tissue metabolic requirements, or, the ability to do so only at an elevation in the filling pressure.
Navigational Note: If asymptomatic, consider Cardiac disorders: Left ventricular dysfunction.
Left ventricular dysfunction
Left ventricular ejection fraction (LVEF) ≥50% AND one or more of the following: 1) New relative decline in Global Longitudinal Strain (GLS) >15% from baseline 2) New rise in cardiac biomarkersLVEF 40 - 49% AND one or more of the following: 1) LVEF reduction by ≥10% 2) New relative decline in GLS >15% from baseline 3) New rise in cardiac biomarkersNew LVEF reduction to <40% - -
Definition: A disorder characterized by an ASYMPTOMATIC abnormality of cardiac function.
Navigational Note: If symptomatic, consider Cardiac disorders: Heart failure.
Mitral valve disease
Asymptomatic valvular thickening with or without mild valvular regurgitation or stenosis by imagingAsymptomatic; moderate regurgitation or stenosis by imagingSymptomatic; severe regurgitation or stenosis by imaging; symptoms controlled with medical interventionLife-threatening consequences; urgent intervention indicated (e.g., valve replacement, valvuloplasty)Death
Definition: A disorder characterized by a defect in mitral valve function or structure.
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Mobitz (type) II atrioventricular block
Asymptomatic, intervention not indicatedSymptomatic; medical intervention indicatedSymptomatic and incompletely controlled medically, or require a device (e.g., pacemaker)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a dysrhythmia with relatively constant PR interval prior to the block of an atrial impulse. This is the result of intermittent failure of atrial electrical impulse conduction through the atrioventricular (AV) node to the ventricles.
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Mobitz type I
Asymptomatic, intervention not indicatedSymptomatic; medical intervention indicatedSymptomatic and incompletely controlled medically, or controlled with device (e.g., pacemaker)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a dysrhythmia with a progressively lengthening PR interval prior to the blocking of an atrial impulse. This is the result of intermittent failure of atrial electrical impulse conduction through the atrioventricular (AV) node to the ventricles.
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Myocardial infarction
 -Asymptomatic; imaging or ECG features consistent with myocardial infarction which may be of uncertain age Hemodynamically stable AND detection of a rise and/or fall of Cardiac troponin values with at least 1 value above the 99th percentile URL AND at least 1 of the following: 1) Symptoms of myocardial ischemia; 2) New ischemic ECG changes; 3) Development of pathological Q waves; 4) Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology; 5) Identification of a coronary thrombus by angiographyLife-threatening consequences; hemodynamically UNstable AND detection of a rise and/or fall of Cardiac troponin values with at least 1 value above the 99th percentile URL AND at least 1 of the following: 1) Symptoms of myocardial ischemia; 2) New ischemic ECG changes; 3) Development of pathological Q waves; 4) Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology; 5) Identification of a coronary thrombus by angiographyDeath
Definition: A disorder characterized by gross necrosis of the myocardium; this is due to an interruption of blood supply to the area.
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Myocarditis
Asymptomatic with Lab or ECG findings onlySymptoms with moderate activity or exertionSevere with symptoms at rest or with minimal activity or exertion; intervention indicated; new onset of symptomsLife-threatening consequences; urgent intervention indicated (e.g., continuous IV therapy or mechanical hemodynamic support); hemodynamically unstable requiring non-invasive or invasive ventilation; complete or high grade AV block; significant ventricular arrhythmiaDeath
Definition: A disorder characterized by inflammation of the muscle tissue of the heart.
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Palpitations
Mild symptoms; intervention not indicatedIntervention indicated - - -
Definition: A disorder characterized by an unpleasant sensation of irregular and/or forceful beating of the heart.
Navigational Note: Record final diagnosis/cause once determined.
Paroxysmal atrial tachycardia
Asymptomatic, intervention not indicatedNon-urgent medical intervention indicatedSymptomatic, urgent intervention indicated; ablationLife-threatening consequences; incompletely controlled medically; cardioversion indicatedDeath
Definition: A disorder characterized by a dysrhythmia with abrupt onset and sudden termination of atrial contractions with a rate of 150-250 beats per minute. The rhythm disturbance originates in the atria.
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Pericardial effusion
 -Asymptomatic effusion size small to moderateEffusion with physiologic consequencesLife-threatening consequences; hospitalizationDeath
Definition: A disorder characterized by fluid collection within the pericardial sac, usually due to inflammation.
Navigational Note: Consider Cardiac disorders: Pericardial tamponade, Pericarditis.
Pericardial tamponade
 - - -Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an increase in intrapericardial pressure due to the collection of blood or fluid in the pericardium.
Navigational Note: Consider Cardiac disorders: Pericarditis.
Pericarditis
Asymptomatic, ECG or physical findings (e.g., rub) consistent with pericarditisSymptomatic pericarditis (e.g., chest pain)Pericarditis with physiologic consequences (e.g., pericardial constriction)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by irritation to the layers of the pericardium (the protective sac around the heart).
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Pulmonary valve disease
Asymptomatic valvular thickening with or without mild valvular regurgitation or stenosis by imagingAsymptomatic; moderate regurgitation or stenosis by imagingSymptomatic; severe regurgitation or stenosis by imaging; symptoms controlled with medical interventionLife-threatening consequences; urgent intervention indicated (e.g., valve replacement, valvuloplasty)Death
Definition: A disorder characterized by a defect in pulmonary valve function or structure.
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Sick sinus syndrome
Asymptomatic, intervention not indicatedSymptomatic, intervention not indicated; change in medication initiatedSymptomatic, intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a dysrhythmia with alternating periods of bradycardia and atrial tachycardia accompanied by syncope, fatigue and dizziness.
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Sinus bradycardia
Asymptomatic, intervention not indicatedSymptomatic, intervention not indicated; change in medication initiatedSymptomatic, intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a dysrhythmia with a heart rate less than 60 beats per minute that originates in the sinus node.
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Sinus tachycardia
Asymptomatic, intervention not indicatedSymptomatic; non-urgent medical intervention indicatedUrgent medical intervention indicated - -
Definition: A disorder characterized by a dysrhythmia with a heart rate greater than 100 beats per minute that originates in the sinus node.
Navigational Note: Record final diagnosis/cause once determined.
Supraventricular tachycardia
Asymptomatic, intervention not indicatedNon-urgent medical intervention indicatedSymptomatic, urgent intervention indicatedLife-threatening consequencesDeath
Definition: A disorder characterized by a dysrhythmia with a heart rate greater than 100 beats per minute that originates above the ventricles.
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Tricuspid valve disease
Asymptomatic valvular thickening with or without mild valvular regurgitation or stenosisAsymptomatic; moderate regurgitation or stenosis by imagingSymptomatic; severe regurgitation or stenosis; symptoms controlled with medical interventionLife-threatening consequences; urgent intervention indicated (e.g., valve replacement, valvuloplasty)Death
Definition: A disorder characterized by a defect in tricuspid valve function or structure.
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Ventricular arrhythmia
Asymptomatic, intervention not indicatedNon-urgent medical intervention indicatedUrgent intervention indicatedLife-threatening consequences; hemodynamic compromiseDeath
Definition: A disorder characterized by a dysrhythmia that originates in the ventricles.
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Ventricular fibrillation
 - - -Life-threatening consequences; hemodynamic compromiseDeath
Definition: A disorder characterized by a dysrhythmia without discernible QRS complexes due to rapid repetitive excitation of myocardial fibers without coordinated contraction of the ventricles.
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Ventricular tachycardia
 -Non-urgent medical intervention indicatedSymptomatic, urgent intervention indicatedLife-threatening consequences; hemodynamic compromiseDeath
Definition: A disorder characterized by a dysrhythmia with a heart rate greater than 100 beats per minute that originates distal to the bundle of His.
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Cardiac disorders - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
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Congenital, familial and genetic disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Congenital, familial and genetic disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Congenital, familial and genetic disorders - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
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Ear and labyrinth disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Ear and labyrinth disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Ear pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the ear.
Navigational Note: Record final diagnosis/cause once determined.
External ear pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the external ear region.
Navigational Note: Record final diagnosis/cause once determined.
Hearing impaired
Adult: Subjective change in hearing in the absence of documented hearing loss; threshold shift of 15 - 25 dB averaged at 2 contiguous test frequencies in at least one ear (on a 1, 2, 4, 3, 6, and 8 kHz audiogram); Pediatric (on a 1, 2, 3, 4, 6, and 8 kHz audiogram): Threshold shift >20 dB hearing loss (HL) (i.e., 25 dB HL or greater); sensorineural hearing loss (SNHL) above 4 kHz (i.e., 6 or 8 kHz) in at least one earAdult: Hearing loss not requiring hearing aid; intervention not indicated; limiting instrumental ADL; threshold shift of >25 dB averaged at 2 contiguous test frequencies in at least one ear (on a 1, 2, 3, 4, 6, and 8 kHz audiogram); Pediatric (on a 1, 2, 3, 4, 6, and 8 kHz audiogram): Threshold shift >20 dB at 4 kHz in at least one ear; mild/moderate impact on age-appropriate normal daily activityAdult: Hearing loss requiring hearing aid; intervention indicated; limiting self-care ADL; threshold shift of >25 dB averaged at 3 contiguous test frequencies in at least one ear(on a 1, 2, 3, 4, 6, and 8 kHz audiogram); Pediatric (on a 1, 2, 3, 4, 6, and 8 kHz audiogram): Hearing loss sufficient to indicate therapeutic intervention, including hearing aids; threshold shift >20 dB at 2 to <4 kHz in at least one ear; severe impact on age-appropriate normal daily activityAdult: Nonservicable hearing; decrease in hearing to profound bilateral loss (absolute threshold >80 dB HL at 2 kHz and above); Pediatric: Audiologic indication for cochlear implant; >40 dB HL (i.e., 45 dB HL or more); SNHL at 2 kHz and above -
Definition: A disorder characterized by partial or complete loss of the ability to detect or understand sounds resulting from damage to ear structures.
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Middle ear inflammation
Serous otitisSerous otitis, medical intervention indicatedMastoiditis; necrosis of canal soft tissue or boneLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by inflammation (physiologic response to irritation), swelling and redness to the middle ear.
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Tinnitus
Mild symptoms; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by noise in the ears, such as ringing, buzzing, roaring or clicking.
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Vertigo
Mild symptomsModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation as if the external world were revolving around the patient (objective vertigo) or as if he himself were revolving in space (subjective vertigo).
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Vestibular disorder
 -Symptomatic; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by dizziness, imbalance, nausea, and vision problems.
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Ear and labyrinth disorders - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
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Endocrine disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Endocrine disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Adrenal insufficiency
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; medical intervention indicatedSevere symptoms; hospitalization indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by the adrenal cortex not producing enough of the hormone cortisol and in some cases, the hormone aldosterone. It may be due to a disorder of the adrenal cortex as in Addison's disease or primary adrenal insufficiency.
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Cushingoid
Mild symptoms; intervention not indicatedModerate symptoms; medical intervention indicatedSevere symptoms, medical intervention or hospitalization indicated - -
Definition: A disorder characterized by signs and symptoms that resemble Cushing's disease or syndrome: buffalo hump obesity, striations, adiposity, hypertension, diabetes, and osteoporosis, usually due to exogenous corticosteroids.
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Delayed puberty
 -No breast development by age 13 yrs for females; testes volume of <3 cc or no Tanner Stage 2 development by age 14.5 yrs for malesNo breast development by age 14 yrs for females; no increase in testes volume or no Tanner Stage 2 by age 16 yrs for males; hormone replacement indicated - -
Definition: A disorder characterized by unusually late sexual maturity.
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Hyperparathyroidism
Mild symptoms; intervention not indicatedModerate symptoms; medical intervention indicated - - -
Definition: A disorder characterized by an increase in production of parathyroid hormone by the parathyroid glands. This results in hypercalcemia (abnormally high levels of calcium in the blood).
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Hyperthyroidism
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; thyroid suppression therapy indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by excessive levels of thyroid hormone in the body. Common causes include an overactive thyroid gland or thyroid hormone overdose.
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Hypogonadism
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a decrease in production of sex hormones from the gonads.
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Hypoparathyroidism
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; medical intervention indicatedSevere symptoms; medical intervention or hospitalization indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a decrease in production of parathyroid hormone by the parathyroid glands.
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Hypophysitis
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by inflammation and cellular infiltration of the pituitary gland.
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Hypopituitarism
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a decrease in production of hormones from the pituitary gland.
Navigational Note: Consider Endocrine disorders: Hypophysitis.
Hypothyroidism
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; thyroid replacement initiated; increase in current thyroid replacement therapy; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a decrease in production of thyroid hormone by the thyroid gland.
Navigational Note: Consider Endocrine disorders: Hypophysitis.
Precocious puberty
Physical signs of puberty with no biochemical markers for females <8 years and males <9 yearsPhysical signs and biochemical markers of puberty for females <8 years and males <9 years - - -
Definition: A disorder characterized by unusually early development of secondary sexual features; the onset of sexual maturation begins usually before age 8 for girls and before age 9 for boys.
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Testosterone deficiency
Asymptomatic; mild symptoms with no intervention indicatedReplacement therapy initiated - - -
Definition: A disorder characterized by low testosterone.
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Thyroiditis
AsymptomaticMedical intervention indicatedHospitalization indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by inflammation or destruction of the thyroid gland.
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Virilization
Mild symptoms; intervention not indicatedModerate symptoms; medical intervention indicated - - -
Definition: A disorder characterized by inappropriate masculinization occurring in a female or prepubertal male.
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Endocrine disorders - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
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Eye disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Eye disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Blurred vision
Intervention not indicatedSymptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Best corrected visual acuity of 20/200 or worse in the affected eye -
Definition: A disorder characterized by visual perception of unclear or fuzzy images.
Navigational Note: Consider: Eye disorders: Uveitis.
Cataract
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline); glare symptoms affecting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Best corrected visual acuity of 20/200 or worse in the affected eye -
Definition: A disorder characterized by partial or complete opacity of the crystalline lens of one or both eyes. This results in a decrease in visual acuity and eventual blindness if untreated.
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Corneal ulcer
 - -Corneal ulcer without perforation in the affected eyePerforation in the affected eye -
Definition: A disorder characterized by an area of epithelial tissue loss on the surface of the cornea. It is associated with inflammatory cells in the cornea and anterior chamber.
Navigational Note: -
Decreased night vision
Symptomatic but not limiting ADLModerate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Best corrected visual acuity of 20/200 or worse in the affected eye -
Definition: A disorder characterized by an inability to see clearly in dim light.
Navigational Note: -
Dry eye
Clinical or diagnostic observations only; symptoms relieved by lubricantsSymptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by dryness of the cornea and conjunctiva.
Navigational Note: If corneal ulcer is present, grade under Eye disorders: Corneal ulcer. If related to syndromes not present in CTCAE (ex. Sjogren's syndrome, etc.), report as Other, specify in the most representative SOC.
Extraocular muscle paresis
Asymptomatic; clinical or diagnostic observations onlyUnilateral paresis without double visionBilateral paresis or unilateral paresis causing double vision in peripheral gaze, but not in central gazeBilateral paresis requiring head turning to see beyond central 60 degrees or double vision in central gaze -
Definition: A disorder characterized by incomplete paralysis of an extraocular muscle.
Navigational Note: -
Eye pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the eye.
Navigational Note: Record final diagnosis/cause once determined.
Eyelid function disorder
Clinical or diagnostic observations only; intervention not indicatedSymptomatic; nonoperative intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Operative intervention indicated requiring hospitalization; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by impaired eyelid function.
Navigational Note: -
Flashing lights
SymptomaticLimiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sudden or brief burst of light.
Navigational Note: Consider Eye disorders: Retinal tear, Retinal detachment.
Floaters
SymptomaticLimiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by an individual seeing spots before their eyes. The spots are shadows of opaque cell fragments in the vitreous humor or lens.
Navigational Note: Consider Eye disorders: Retinal tear, Retinal detachment.
Glaucoma
Less than 8 mmHg of elevated intraocular pressure (EIOP); no visual field deficitTopical medication indicatedEIOP causing visual field deficitsVisual field deficit within the central 10 degrees of the visual field in the affected eye -
Definition: A disorder characterized by an increase in pressure in the eyeball due to obstruction of the aqueous humor outflow.
Navigational Note: -
Keratitis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); corneal ulcer; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Perforation; best corrected visual acuity of 20/200 or worse in the affected eye -
Definition: A disorder characterized by inflammation to the cornea of the eye.
Navigational Note: Consider Eye disorders: Corneal ulcer.
Optic nerve disorder
Asymptomatic; clinical or diagnostic observations onlyModerate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)Marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200)Best corrected visual acuity of 20/200 or worse in the affected eye -
Definition: A disorder characterized by involvement of the optic nerve (second cranial nerve).
Navigational Note: -
Papilledema
Asymptomatic; no visual field deficitSymptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200)Best corrected visual acuity of 20/200 or worse in the affected eye -
Definition: A disorder characterized by swelling around the optic disc.
Navigational Note: Record final diagnosis/cause once determined.
Periorbital edema
Soft or non-pittingIndurated or pitting edema; topical intervention indicatedEdema associated with visual disturbance; increased intraocular pressure, glaucoma or retinal hemorrhage; diuretics indicated; operative intervention indicated - -
Definition: A disorder characterized by swelling due to an excessive accumulation of fluid around the orbits of the face.
Navigational Note: Record final diagnosis/cause once determined.
Photophobia
SymptomaticLimiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by fear and avoidance of light.
Navigational Note: -
Retinal detachment
 - -Macular sparing rhegmatogenous detachmentMacula-off rhegmatogenous retinal detachment -
Definition: A disorder characterized by the separation of the inner retina layers from the underlying pigment epithelium.
Navigational Note: -
Retinal tear
No retinal detachment and treatment not indicatedNo retinal detachment and treatment indicated - - -
Definition: A disorder characterized by a small laceration of the retina. Symptoms include flashes and floaters.
Navigational Note: If retinal detachment is present, grade under Eye disorders: Retinal detachment.
Retinal vascular disorder
 -Retinal vascular disorder without neovascularizationRetinal vascular disorder with neovascularization - -
Definition: A disorder characterized by pathological retinal blood vessels that adversely affects vision.
Navigational Note: If vitreous hemorrhage is present, report under Eye disorders: Vitreous hemorrhage.
Retinopathy
Asymptomatic; clinical or diagnostic observations onlySymptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Best corrected visual acuity of 20/200 or worse in the affected eye -
Definition: A disorder involving the retina.
Navigational Note: If vitreous hemorrhage is present, report under Eye disorders: Vitreous hemorrhage.
Scleral disorder
No change in vision from baselineSymptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Best corrected visual acuity of 20/200 or worse in the affected eye -
Definition: A disorder characterized by involvement of the sclera of the eye.
Navigational Note: -
Uveitis
Anterior uveitis with trace cellsAnterior uveitis with 1+ or 2+ cellsAnterior uveitis with 3+ or greater cells; intermediate posterior or pan-uveitisBest corrected visual acuity of 20/200 or worse in the affected eye -
Definition: A disorder characterized by inflammation to the uvea of the eye.
Navigational Note: -
Vision decreased
 -Moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)Marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200)Best corrected visual acuity of 20/200 or worse in the affected eye -
Definition: A disorder characterized by a decrease in visual acuity.
Navigational Note: If etiology is known, use a more specific CTCAE term. Consider: Eye disorders: Uveitis
Vitreous hemorrhage
Intervention not indicatedSymptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); vitrectomy indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Best corrected visual acuity of 20/200 or worse in the affected eye -
Definition: A disorder characterized by bleeding into the vitreous humor.
Navigational Note: -
Watering eyes
Intervention not indicatedSymptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)Marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200)Best corrected visual acuity of 20/200 or worse in the affected eye -
Definition: A disorder characterized by excessive tearing in the eyes; it can be caused by overproduction of tears or impaired drainage of the tear duct.
Navigational Note: -
Eye disorders - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; no change in visionModerate; minimal, local or noninvasive intervention indicated; best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately sight-threatening; decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Sight-threatening consequences; urgent intervention indicated; best corrected visual acuity of 20/200 or worse in the affected eye -
Definition: -
Navigational Note: -
Gastrointestinal disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Gastrointestinal disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Abdominal distension
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe discomfort; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by swelling of the abdomen.
Navigational Note: -
Abdominal pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the abdominal region.
Navigational Note: Record final diagnosis/cause once determined.
Anal fissure
AsymptomaticSymptomaticInvasive intervention indicated - -
Definition: A disorder characterized by a tear in the lining of the anus.
Navigational Note: -
Anal fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the opening in the anal canal to the perianal skin.
Navigational Note: -
Anal mucositis
Asymptomatic or mild symptoms; intervention not indicatedModerate symptoms; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by ulceration or inflammation of the mucous membrane of the anus.
Navigational Note: Report Grade 4 and 5 as Gastrointestinal disorders: Anal ulcer.
Anal necrosis
 - -TPN or hospitalization indicated; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a necrotic process occurring in the anal region.
Navigational Note: -
Anal pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the anal region.
Navigational Note: Record final diagnosis/cause once determined.
Anal stenosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI functionSymptomatic and severely altered GI function; non-emergent operative intervention indicated; TPN or hospitalization indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a narrowing of the lumen of the anal canal.
Navigational Note: -
Anal ulcer
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI functionSeverely altered GI function; TPN indicated; elective invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the anal canal.
Navigational Note: -
Ascites
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; medical intervention or paracentesis indicatedSevere symptoms; catheter placement indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by accumulation of serous or hemorrhagic fluid in the peritoneal cavity.
Navigational Note: Record final diagnosis/cause once determined.
Belching
Increase from baselineIntervention initiated (including over the counter medications) - - -
Definition: To expel gas noisily from the mouth.
Navigational Note: Synonym: Burping
Bloating
No change in bowel function or oral intakeSymptomatic, decreased oral intake; change in bowel function - - -
Definition: A disorder characterized by subject-reported feeling of uncomfortable fullness of the abdomen.
Navigational Note: -
Cecal hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the cecum.
Navigational Note: -
Cheilitis
Clinical or diagnostic observations only; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by inflammation of the lip.
Navigational Note: -
Chylous ascites
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; medical intervention indicated (e.g., fat-restricted diet); paracentesis or tube drainage indicatedSevere symptoms; elective operative intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by accumulation of milky fluid in the peritoneal cavity.
Navigational Note: -
Colitis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedAbdominal pain; mucus or blood in stoolSevere abdominal pain; peritoneal signsLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by inflammation of the colon.
Navigational Note: -
Colonic fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the large intestine and another organ or anatomic site.
Navigational Note: -
Colonic obstruction
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI functionHospitalization indicated; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by blockage of the normal flow of the intestinal contents in the colon.
Navigational Note: -
Colonic perforation
 -Invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a rupture in the colonic wall.
Navigational Note: Consider Gastrointestinal disorders: Colitis.
Colonic stenosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI functionSeverely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a narrowing of the lumen of the colon.
Navigational Note: -
Colonic ulcer
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI functionSeverely altered GI function; TPN indicated; elective invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the colon.
Navigational Note: -
Constipation
Occasional or intermittent symptoms; occasional use of stool softeners, laxatives, dietary modification, or enemaPersistent symptoms with regular use of laxatives or enemas; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Obstipation with manual evacuation indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by irregular and infrequent or difficult evacuation of the bowels.
Navigational Note: -
Dental caries
One or more dental caries, not involving the rootDental caries involving the rootDental caries resulting in pulpitis or periapical abscess or resulting in tooth loss - -
Definition: A disorder characterized by the decay of a tooth, in which it becomes softened, discolored and/or porous.
Navigational Note: -
Diarrhea
Change in consistency or frequencyIncrease of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric); change in consistency or frequency AND limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Increase of >=7 stools per day over baseline; hospitalization indicated; severe increase in ostomy output compared to baseline; requires IV intervention; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an increase in frequency and/or loose or watery bowel movements.
Navigational Note: Consider Gastrointestinal disorders: Colitis, Enterocolitis.
Dry mouth
Symptomatic (e.g., dry or thick saliva) without significant dietary alteration; unstimulated saliva flow >0.2 ml/minModerate symptoms; oral intake alterations (e.g., copious water, other lubricants, diet limited to purees and/or soft, moist foods); unstimulated saliva 0.1 to 0.2 ml/minInability to adequately aliment orally; tube feeding or TPN indicated; unstimulated saliva <0.1 ml/min - -
Definition: A disorder characterized by reduced salivary flow in the oral cavity.
Navigational Note: If related to syndromes not present in CTCAE (ex. Sjogren's syndrome, etc.), report as Other, specify in the most representative SOC.
Duodenal fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the duodenum and another organ or anatomic site.
Navigational Note: -
Duodenal hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the duodenum.
Navigational Note: Consider Gastrointestinal disorders: Enterocolitis.
Duodenal obstruction
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI functionHospitalization indicated; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by blockage of the normal flow of stomach contents through the duodenum.
Navigational Note: -
Duodenal perforation
 -Invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a rupture in the duodenal wall.
Navigational Note: Consider Gastrointestinal disorders: Enterocolitis.
Duodenal stenosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI functionSeverely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a narrowing of the lumen of the duodenum.
Navigational Note: -
Duodenal ulcer
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severely altered GI function; TPN indicated; elective invasive intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the duodenal wall.
Navigational Note: -
Dyspepsia
Mild symptoms; intervention not indicatedModerate symptoms; medical intervention indicatedSevere symptoms; operative intervention indicated - -
Definition: A disorder characterized by an uncomfortable, often painful feeling in the stomach, resulting from impaired digestion. Symptoms include burning stomach, bloating, heartburn, nausea and vomiting.
Navigational Note: Consider Gastrointestinal disorders: Gastritis, Gastroparesis.
Dysphagia
Symptomatic, able to eat regular dietSymptomatic and altered eating/swallowingSeverely altered eating/swallowing; tube feeding, TPN, or hospitalization indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by difficulty in swallowing.
Navigational Note: -
Enterocolitis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedAbdominal pain; mucus or blood in stoolSevere or persistent abdominal pain; fever; ileus; peritoneal signsLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by inflammation of the small and large intestines.
Navigational Note: If reporting a known abnormality of the colon, use Gastrointestinal disorders: Colitis. If reporting a documented infection, use Infections and infestations: Enterocolitis infectious.
Enterovesical fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the urinary bladder and the intestine.
Navigational Note: -
Esophageal fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the esophagus and another organ or anatomic site.
Navigational Note: -
Esophageal hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the esophagus.
Navigational Note: -
Esophageal necrosis
 - -Inability to aliment adequately by GI tract; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a necrotic process occurring in the esophageal wall.
Navigational Note: -
Esophageal obstruction
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Hospitalization indicated; invasive intervention indicated; limiting self care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by blockage of the normal flow of the contents in the esophagus.
Navigational Note: -
Esophageal pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the esophageal region.
Navigational Note: Record final diagnosis/cause once determined.
Esophageal perforation
 -Invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a rupture in the wall of the esophagus.
Navigational Note: -
Esophageal stenosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI functionSeverely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a narrowing of the lumen of the esophagus.
Navigational Note: -
Esophageal ulcer
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severely altered GI function; TPN indicated; elective invasive intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the esophageal wall.
Navigational Note: -
Esophageal varices hemorrhage
 -Self-limited; intervention not indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from esophageal varices.
Navigational Note: -
Esophagitis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered eating/swallowing; oral supplements indicatedSeverely altered eating/swallowing; tube feeding, TPN, or hospitalization indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by inflammation of the esophageal wall.
Navigational Note: -
Fecal incontinence
Occasional use of pads requiredDaily use of pads requiredSevere symptoms; elective operative intervention indicated - -
Definition: A disorder characterized by inability to control the escape of stool from the rectum.
Navigational Note: -
Flatulence
Mild symptoms; intervention not indicatedModerate; persistent; psychosocial sequelae - - -
Definition: A disorder characterized by a discharge of excessive gas from the lower GI tract.
Navigational Note: -
Gastric fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the stomach and another organ or anatomic site.
Navigational Note: -
Gastric hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the gastric wall.
Navigational Note: -
Gastric necrosis
 - -Inability to aliment adequately by GI tract; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a necrotic process occurring in the gastric wall.
Navigational Note: -
Gastric perforation
 -Invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a rupture in the stomach wall.
Navigational Note: -
Gastric stenosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI functionSeverely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a narrowing of the lumen of the stomach.
Navigational Note: -
Gastric ulcer
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI function; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severely altered GI function; TPN indicated; elective invasive intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the stomach.
Navigational Note: -
Gastritis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI function; medical intervention indicatedSeverely altered eating or gastric function; TPN or hospitalization indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by inflammation of the stomach.
Navigational Note: -
Gastroesophageal reflux disease
Mild symptoms; intervention not indicatedModerate symptoms; medical intervention indicatedSevere symptoms; operative intervention indicated - -
Definition: A disorder characterized by reflux of the gastric and/or duodenal contents into the distal esophagus. It is chronic in nature and usually caused by incompetence of the lower esophageal sphincter, and may result in injury to the esophageal mucosal. Symptoms include heartburn and acid indigestion.
Navigational Note: -
Gastrointestinal fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between any part of the gastrointestinal system and another organ or anatomic site.
Navigational Note: -
Gastrointestinal pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the gastrointestinal region.
Navigational Note: Consider Gastrointestinal disorders: Colitis, Enterocolitis. Record final diagnosis/cause once determined.
Gastroparesis
Mild nausea, early satiety and bloating, able to maintain caloric intake on regular dietModerate symptoms; able to maintain nutrition with dietary and lifestyle modifications; may need pharmacologic interventionWeight loss >=20% from baseline; tube feeding or TPN indicated; elective operative intervention indicatedLife-threatening consequences; urgent intervention indicated -
Definition: A disorder characterized by an incomplete paralysis of the muscles of the stomach wall resulting in delayed emptying of the gastric contents into the small intestine.
Navigational Note: -
Gingival pain
Mild painModerate pain interfering with oral intakeSevere pain; inability to aliment orally - -
Definition: A disorder characterized by a sensation of marked discomfort in the gingival region.
Navigational Note: Record final diagnosis/cause once determined.
Hematemesis
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by the vomiting of blood.
Navigational Note: Record final diagnosis/cause once determined.
Hematochezia
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by the passage of fresh blood per anus, usually in or with stools.
Navigational Note: Consider Gastrointestinal disorders: Colitis, Enterocolitis, Proctitis; Record final diagnosis/cause once determined.
Hemorrhoidal hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the hemorrhoids.
Navigational Note: -
Hemorrhoids
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; banding or medical intervention indicatedSevere symptoms; invasive intervention indicated - -
Definition: A disorder characterized by the presence of dilated veins in the rectum and surrounding area.
Navigational Note: -
Ileal fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the ileum and another organ or anatomic site.
Navigational Note: -
Ileal hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the ileal wall.
Navigational Note: Consider Gastrointestinal disorders: Enterocolitis.
Ileal obstruction
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI function; naso-gastric tube indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Hospitalization indicated; invasive intervention indicated; long intestinal tube indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by blockage of the normal flow of the intestinal contents in the ileum.
Navigational Note: -
Ileal perforation
 -Invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a rupture in the ileal wall.
Navigational Note: Consider Gastrointestinal disorders: Enterocolitis.
Ileal stenosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI functionSeverely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a narrowing of the lumen of the ileum.
Navigational Note: -
Ileal ulcer
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI functionSeverely altered GI function; TPN indicated; elective invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the ileum.
Navigational Note: -
Ileus
Asymptomatic and radiologic observations onlySymptomatic; altered GI function; bowel rest indicatedSeverely altered GI function; TPN indicated; tube placement indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by failure of the ileum to transport intestinal contents.
Navigational Note: -
Intra-abdominal hemorrhage
 -Moderate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding in the abdominal cavity.
Navigational Note: -
Jejunal fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the jejunum and another organ or anatomic site.
Navigational Note: -
Jejunal hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the jejunal wall.
Navigational Note: Consider Gastrointestinal disorders: Enterocolitis.
Jejunal obstruction
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Hospitalization indicated; invasive intervention indicated; limiting self care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by blockage of the normal flow of the intestinal contents in the jejunum.
Navigational Note: -
Jejunal perforation
 -Invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a rupture in the jejunal wall.
Navigational Note: Consider Gastrointestinal disorders: Enterocolitis.
Jejunal stenosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI functionSeverely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a narrowing of the lumen of the jejunum.
Navigational Note: -
Jejunal ulcer
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI functionSeverely altered GI function; TPN indicated; elective invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the jejunum.
Navigational Note: -
Lip pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort of the lip.
Navigational Note: Record final diagnosis/cause once determined.
Malabsorption
 -Altered diet; oral intervention indicatedInability to aliment adequately; TPN indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by inadequate absorption of nutrients in the small intestine. Symptoms include abdominal marked discomfort, bloating and diarrhea.
Navigational Note: -
Melena
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by black, tarry stools.
Navigational Note: Record final diagnosis/cause once determined.
Mucositis oral
Asymptomatic or mild symptoms; intervention not indicatedModerate pain or ulcer that does not interfere with oral intake; modified diet indicatedSevere pain; interfering with oral intakeLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by ulceration or inflammation of the oral mucosal.
Navigational Note: -
Nausea
Loss of appetite without alteration in eating habitsOral intake decreased without significant weight loss, dehydration or malnutrition; IV intervention indicatedInadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated - -
Definition: A disorder characterized by a queasy sensation and/or the urge to vomit.
Navigational Note: Consider Gastrointestinal disorders: Enterocolitis, Gastritis and/or Endocrine disorders: Adrenal insufficiency, Hypophysitis.
Obstruction gastric
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Hospitalization indicated; invasive intervention indicated; limiting self care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by blockage of the normal flow of the contents in the stomach.
Navigational Note: -
Oral cavity fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the oral cavity and another organ or anatomic site.
Navigational Note: -
Oral dysesthesia
Mild discomfort; not interfering with oral intakeModerate pain; interfering with oral intakeDisabling pain; tube feeding or TPN indicated - -
Definition: A disorder characterized by a burning or tingling sensation on the lips, tongue or entire mouth.
Navigational Note: -
Oral hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the mouth.
Navigational Note: -
Oral pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the mouth, tongue or lips.
Navigational Note: Record final diagnosis/cause once determined.
Pancreatic duct stenosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI functionSeverely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a narrowing of the lumen of the pancreatic duct.
Navigational Note: -
Pancreatic fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the pancreas and another organ or anatomic site.
Navigational Note: -
Pancreatic hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the pancreas.
Navigational Note: -
Pancreatic insufficiency
Asymptomatic and pancreatic enzymes <LLNIncrease in stool frequency, bulk, or odor; steatorrheaSequelae of absorption deficiency - -
Definition: A disorder characterized by impaired exocrine pancreatic function usually associated with decreased pancreatic exocrine enzymes production.
Navigational Note: -
Pancreatic necrosis
 - -Tube feeding or TPN indicated; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a necrotic process occurring in the pancreas.
Navigational Note: -
Pancreatitis
 -Radiologic findings onlySevere pain; vomiting; medical intervention indicated (e.g., analgesia, nutritional support)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by inflammation of the pancreas with no documented pancreas infection.
Navigational Note: -
Periodontal disease
Gingival recession or gingivitis; limited bleeding on probing; mild local bone lossModerate gingival recession or gingivitis; multiple sites of bleeding on probing; moderate bone lossSpontaneous bleeding; severe bone loss with or without tooth loss; osteonecrosis of maxilla or mandible - -
Definition: A disorder in the gingival tissue around the teeth.
Navigational Note: -
Peritoneal necrosis
 - -Tube feeding or TPN indicated; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a necrotic process occurring in the peritoneum.
Navigational Note: -
Proctitis
Rectal discomfort, intervention not indicatedSymptomatic (e.g., rectal discomfort, passing blood or mucus); fecal urgency or stool incontinence; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by inflammation of the rectum.
Navigational Note: Consider Gastrointestinal disorders: Fecal incontinence.
Rectal fissure
AsymptomaticSymptomaticInvasive intervention indicated - -
Definition: A disorder characterized by a tear in the lining of the rectum.
Navigational Note: -
Rectal fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the rectum and another organ or anatomic site.
Navigational Note: -
Rectal mucositis
Asymptomatic or mild symptoms; intervention not indicatedModerate symptoms; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by ulceration or inflammation of the mucous membrane of the rectum.
Navigational Note: -
Rectal necrosis
 - -Tube feeding or TPN indicated; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a necrotic process occurring in the rectal wall.
Navigational Note: -
Rectal obstruction
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Hospitalization indicated; invasive intervention indicated; limiting self care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by blockage of the normal flow of the intestinal contents in the rectum.
Navigational Note: -
Rectal pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the rectal region.
Navigational Note: Record final diagnosis/cause once determined.
Rectal perforation
 -Invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a rupture in the rectal wall.
Navigational Note: -
Rectal stenosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI functionSeverely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a narrowing of the lumen of the rectum.
Navigational Note: -
Rectal ulcer
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI function (e.g., altered dietary habits, vomiting, diarrhea)Severely altered GI function; TPN indicated; elective invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the rectum.
Navigational Note: -
Retroperitoneal hemorrhage
 -Self-limited; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the retroperitoneal area.
Navigational Note: -
Salivary duct inflammation
Slightly thickened saliva; slightly altered taste (e.g., metallic)Thick, ropy, sticky saliva; markedly altered taste; alteration in diet indicated; secretion-induced symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Acute salivary gland necrosis; severe secretion-induced symptoms (e.g., thick saliva/oral secretions or gagging); tube feeding or TPN indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by inflammation of the salivary duct.
Navigational Note: -
Salivary gland fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between a salivary gland and another organ or anatomic site.
Navigational Note: -
Small intestinal mucositis
Asymptomatic or mild symptoms; intervention not indicatedModerate symptoms; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; interfering with oral intake; tube feeding, TPN or hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by ulceration or inflammation of the mucous membrane of the small intestine.
Navigational Note: -
Small intestinal obstruction
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Hospitalization indicated; invasive intervention indicated; limiting self care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by blockage of the normal flow of the intestinal contents of the small intestine.
Navigational Note: -
Small intestinal perforation
 -Invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a rupture in the small intestine wall.
Navigational Note: Consider Gastrointestinal disorders: Enterocolitis.
Small intestinal stenosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI functionSymptomatic and severely altered GI function; tube feeding, TPN or hospitalization indicated; non-emergent operative intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a narrowing of the lumen of the small intestine.
Navigational Note: -
Small intestine ulcer
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severely altered GI function; TPN indicated; elective invasive intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the small intestine.
Navigational Note: -
Stomach pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the stomach.
Navigational Note: Record final diagnosis/cause once determined.
Tooth development disorder
Asymptomatic; hypoplasia of tooth or enamelImpairment correctable with oral surgeryMaldevelopment with impairment not surgically correctable; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a pathological process of the teeth occurring during tooth development.
Navigational Note: -
Tooth discoloration
Surface stains - - - -
Definition: A disorder characterized by a change in tooth hue or tint.
Navigational Note: -
Toothache
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the tooth.
Navigational Note: -
Typhlitis
 - -Symptomatic (e.g., abdominal pain, fever, change in bowel habits with ileus); peritoneal signsLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by necrotizing enterocolitis in neutropenic patients. Also referred to as neutropenic enterocolitis, ileocecal syndrome, or cecitis.
Navigational Note: Includes Clostridioides difficile (c. diff, c. difficile). Also report Investigations: Neutrophil count decreased; Also consider Infections and infestations: Cecal infection.
Upper gastrointestinal hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the upper gastrointestinal tract (oral cavity, pharynx, esophagus, and stomach).
Navigational Note: -
Visceral arterial ischemia
 -Brief (<24 hrs) episode of ischemia managed medically and without permanent deficitProlonged (>=24 hrs) or recurring symptoms and/or invasive intervention indicatedLife-threatening consequences; evidence of end organ damage; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a decrease in blood supply due to narrowing or blockage of a visceral (mesenteric) artery.
Navigational Note: -
Vomiting
Intervention not indicatedInitiation of outpatient IV hydration; medical intervention indicatedInitiation of tube feeding, or TPN; hospitalization indicatedLife-threatening consequencesDeath
Definition: A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth.
Navigational Note: Consider Gastrointestinal disorders: Enterocolitis, Gastritis and/or Endocrine disorders: Adrenal insufficiency, Hypophysitis.
Gastrointestinal disorders - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
Navigational Note: -
General disorders and administration site conditions
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
General disorders and administration site conditions
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Chills
Mild sensation of cold; shivering; chattering of teethModerate tremor of the entire body; narcotics indicatedSevere or prolonged, not responsive to narcotics - -
Definition: A disorder characterized by a sensation of cold that often marks a physiologic response to sweating after a fever.
Navigational Note: Consider Injury, poisoning and procedural complications: Infusion related reaction.
Death neonatal
 - - -Neonatal loss of life -
Definition: Newborn death occurring during the first 28 days after birth.
Navigational Note: -
Death NOS
 - - - -Death
Definition: Death that cannot be attributed to a CTCAE term associated with Grade 5.
Navigational Note: If death is due to an AE (ex., Cardiac disorders: Cardiac arrest), report as a Grade 5 event under that AE.
Disease progression
 - - - -Death
Definition: Death due to disease progression that cannot be attributed to a CTCAE term associated with Grade 5.
Navigational Note: If death is due to an AE (ex., Cardiac disorders: Cardiac arrest), report as a Grade 5 event under that AE.
Edema face
Localized edemaModerate localized edema; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe swelling; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by swelling due to excessive fluid accumulation in facial area tissues.
Navigational Note: Record final diagnosis/cause once determined.
Facial pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the face.
Navigational Note: Record final diagnosis/cause once determined.
Fatigue
Fatigue relieved by restFatigue not relieved by rest; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Fatigue not relieved by rest, limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities.
Navigational Note: Record final diagnosis/cause once determined.
Fever
38.0 - 39.0 degrees C (100.4 - 102.2 degrees F)>39.0 - 40.0 degrees C (102.3 - 104.0 degrees F)>40.0 degrees C (>104.0 degrees F) for <=24 hrs>40.0 degrees C (>104.0 degrees F) for >24 hrsDeath
Definition: A disorder characterized by elevation of the body's temperature above the upper limit of normal.
Navigational Note: Consider Injury, poisoning and procedural complications: Infusion related reaction.
Flu like symptoms
Mild flu-like symptoms presentModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a group of symptoms similar to those observed in patients with the flu. It includes fever, chills, body aches, malaise, loss of appetite and dry cough.
Navigational Note: Synonym: Flu, Influenza; Consider Injury, poisoning and procedural complications: Infusion related reaction.
Gait disturbance
Mild change in gait (e.g., wide-based, limping or hobbling)Moderate change in gait (e.g., wide-based, limping or hobbling); assistive device indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by walking difficulties.
Navigational Note: -
Generalized edema
Noted on exam; 1+ pitting edemaOral therapy initiated; interfering with instrumental ADLs or mild/moderate impact on age-appropriate normal daily activity (pediatric)Interferes with self-care ADL or severe impact on age-appropriate normal daily activity (pediatric); intravenous IV therapy indicated; skin breakdownLife-threatening consequences -
Definition: A disorder characterized by fluid accumulation in the tissues of the body including the skin.
Navigational Note: Record final diagnosis/cause once determined.
Hypothermia
 -35 - >32 degrees C; 95 - >89.6 degrees F32 - >28 degrees C; 89.6 - >82.4 degrees F<=28 degrees C; 82.4 degrees F; life-threatening consequences (e.g., coma, hypotension, pulmonary edema, acidemia, ventricular fibrillation)Death
Definition: A disorder characterized by an abnormally low body temperature. Treatment is required when the body temperature is 35C (95F) or below.
Navigational Note: -
Infusion site extravasation
Painless edemaErythema with associated symptoms (e.g., edema, pain, induration, phlebitis)Ulceration or necrosis; severe tissue damage; operative intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by leakage of the infusion into the surrounding tissue. Signs and symptoms may include induration, erythema, swelling, burning sensation and marked discomfort at the infusion site.
Navigational Note: -
Injection site reaction
Tenderness with or without associated symptoms (e.g., warmth, erythema, itching)Pain; lipodystrophy; edema; phlebitisUlceration or necrosis; severe tissue damage; operative intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an intense adverse reaction (usually immunologic) developing at the site of an injection.
Navigational Note: -
Localized edema
Localized to dependent areas, no disability or functional impairmentModerate localized edema and intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe localized edema and intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by swelling due to excessive fluid accumulation at a specific anatomic site.
Navigational Note: Prior to using this term consider specific edema areas and/or causes: Cardiac disorders: Heart failure; General disorders and administration site conditions: Edema face, Peripheral edema; Nervous system disorders: Edema cerebral; Respiratory, thoracic and mediastinal disorders: Laryngeal edema, Pulmonary edema; Eye disorders: Periorbital edema; Vascular disorders: Lymphedema. Record final diagnosis/cause once determined.
Malaise
Uneasiness or lack of well beingUneasiness or lack of well being limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Uneasiness or lack of well being limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a feeling of general discomfort or uneasiness, an out-of-sorts feeling.
Navigational Note: -
Multi-organ failure
 - -Shock with azotemia and acid-base disturbances; significant coagulation abnormalitiesLife-threatening consequences (e.g., vasopressor dependent and oliguric or anuric or ischemic colitis or lactic acidosis)Death
Definition: A disorder characterized by progressive deterioration of the lungs, liver, kidney and clotting mechanisms.
Navigational Note: -
Non-cardiac chest pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the chest unrelated to a heart disorder.
Navigational Note: Record final diagnosis/cause once determined.
Pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by the sensation of marked discomfort, distress or agony.
Navigational Note: Prior to using this term consider using a specific body part pain term found throughout the CTCAE (over 40 different pain terms). Record final diagnosis/cause once determined.
Peripheral edema
Swelling or obscuration of anatomic architecture on close inspectionReadily apparent obscuration of anatomic architecture; obliteration of skin folds; readily apparent deviation from normal anatomic contour; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Gross deviation from normal anatomic contour; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by swelling due to excessive fluid accumulation in the body periphery.
Navigational Note: Consider Cardiac disorders: Heart failure; Record final diagnosis/cause once determined.
Pneumatosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; medical intervention indicatedSevere symptoms; operative intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of gas in the bowel wall.
Navigational Note: -
Sudden death NOS
 - - - -Death
Definition: An unexpected death that cannot be attributed to a CTCAE term associated with Grade 5.
Navigational Note: If death is due to an AE (ex., Cardiac disorders: Cardiac arrest), report as a Grade 5 event under that AE.
Vaccination site lymphadenopathy
Local lymph node enlargementLocalized ulceration; generalized lymph node enlargement - - -
Definition: A disorder characterized by lymph node enlargement after vaccination.
Navigational Note: -
General disorders and administration site conditions - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
Navigational Note: -
Hepatobiliary disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Hepatobiliary disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Bile duct stenosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI function; IV fluids indicated <24 hrsSeverely altered GI function; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a narrowing of the lumen of the bile duct.
Navigational Note: -
Biliary fistula
 -Symptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the bile ducts and another organ or anatomic site.
Navigational Note: -
Biliary obstruction
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI function; IV fluids indicated <24 hrsSymptomatic and severely altered GI function; hospitalization indicated; non-emergent operative intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by blockage of the normal flow of the normal flow of bile.
Navigational Note: -
Budd-Chiari syndrome
 -Medical management indicatedSevere or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; asterixis; mild encephalopathyLife-threatening consequences; moderate to severe encephalopathy; comaDeath
Definition: A disorder characterized by occlusion of the hepatic veins and typically presents with abdominal pain, ascites and hepatomegaly.
Navigational Note: -
Cholecystitis
 -Symptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by inflammation involving the gallbladder. It may be associated with the presence of gallstones.
Navigational Note: -
Gallbladder fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the gallbladder and another organ or anatomic site.
Navigational Note: -
Gallbladder necrosis
 - - -Life-threatening consequences; urgent invasive intervention indicatedDeath
Definition: A disorder characterized by a necrotic process occurring in the gallbladder.
Navigational Note: -
Gallbladder obstruction
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; altered GI function; IV fluids indicated <24 hrsSymptomatic and severely altered GI function; hospitalization indicated; non-emergent operative intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by blockage of the normal flow of the contents of the gallbladder.
Navigational Note: -
Gallbladder pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the gallbladder region.
Navigational Note: Record final diagnosis/cause once determined.
Gallbladder perforation
 - - -Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a rupture in the gallbladder wall.
Navigational Note: -
Hepatic failure
 - -Asterixis; mild encephalopathy; drug-induced liver injury (DILI); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; moderate to severe encephalopathy; comaDeath
Definition: A disorder characterized by the inability of the liver to metabolize chemicals in the body. Laboratory test results reveal abnormal plasma levels of ammonia, bilirubin, lactic dehydrogenase, alkaline phosphatase, aminotransferase, and/or prolongation of prothrombin time (INR.) Drug-induced liver injury (DILI) as defined by Hy's Law.
Navigational Note: -
Hepatic hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the liver.
Navigational Note: -
Hepatic necrosis
 - - -Life-threatening consequences; urgent invasive intervention indicatedDeath
Definition: A disorder characterized by a necrotic process occurring in the hepatic parenchyma.
Navigational Note: -
Hepatic pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the liver region.
Navigational Note: Record final diagnosis/cause once determined.
Hepatitis
 -Moderate symptoms; medical intervention indicatedSymptomatic liver dysfunction; compensated cirrhosis; hospitalization or prolongation of existing hospitalization indicatedLife-threatening consequences; severe decompensated liver function (e.g., coagulopathy, encephalopathy, coma)Death
Definition: A disorder characterized by inflammation of the liver.
Navigational Note: Consider Infections and infestations: Hepatitis viral, Hepatobiliary disorders: Hepatic failure. Report Autoimmune hepatitis under Hepatobiliary disorders: Other, specify.
Perforation bile duct
 - -Invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a rupture in the wall of the extrahepatic or intrahepatic bile duct.
Navigational Note: -
Portal hypertension
 -Decreased portal vein flowReversal/retrograde portal vein flow; associated with varices and/or ascitesLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an increase in blood pressure in the portal venous system.
Navigational Note: -
Portal vein thrombosis
 -Intervention not indicatedMedical intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by the formation of a thrombus (blood clot) in the portal vein.
Navigational Note: -
Sinusoidal obstruction syndrome
 -Blood bilirubin 2 - 5 mg/dL; minor interventions required (i.e., blood product, diuretic, oxygen)Blood bilirubin >5 mg/dL; coagulation modifier indicated (e.g., defibrotide); reversal of flow on ultrasoundLife-threatening consequences (e.g., ventilatory support, dialysis, plasmapheresis, peritoneal drainage)Death
Definition: A disorder characterized by severe hepatic injury as a result of the blood vessels of the liver becoming inflamed and/or blocked.
Navigational Note: -
Hepatobiliary disorders - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
Navigational Note: -
Immune system disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Immune system disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Allergic reaction
Systemic intervention not indicatedOral intervention indicatedBronchospasm; hospitalization indicated for clinical sequelae; IV intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an adverse general response from exposure to an allergen.
Navigational Note: If related to infusion, consider Injury, poisoning and procedural complications: Infusion related reaction. If related to immunization, consider Injury, poisoning and procedural complications: Systemic post-immunization reaction. Do not report both.
Anaphylaxis
 - -Symptomatic bronchospasm, with or without urticaria; parenteral intervention indicated; allergy-related edema/angioedema; hypotensionLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an acute inflammatory reaction resulting from the release of histamine and histamine-like substances from mast cells, causing a hypersensitivity immune response. Clinically, it presents with breathing difficulty, dizziness, hypotension, cyanosis and loss of consciousness and may lead to death.
Navigational Note: If related to infusion, consider Injury, poisoning and procedural complications: Infusion related reaction. Do not report both.
Autoimmune disorder
Asymptomatic; serologic or other evidence of autoimmune reaction, with normal organ function; intervention not indicatedEvidence of autoimmune reaction involving a non-essential organ or function (e.g., hypothyroidism)Autoimmune reactions involving major organ (e.g., colitis, anemia, myocarditis, kidney)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by loss of function or tissue destruction of an organ or multiple organs, arising from humoral or cellular immune responses of the individual to his own tissue constituents.
Navigational Note: Prior to using this term consider specific autoimmune AEs.
Cytokine release syndrome
Fever with or without constitutional symptomsHypotension responding to fluids; hypoxia requiring low-flow nasal cannula or blow-byHypotension managed with one pressor; hypoxia requiring high-flow nasal cannula, facemask, nonrebreather mask, or Venturi maskLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by fever, tachypnea, headache, tachycardia, hypotension, rash, and/or hypoxia caused by the release of cytokines.
Navigational Note: Consider reporting other organ dysfunctions including neurological toxicities such as: Psychiatric disorders: Confusion, Hallucinations; Nervous system disorders: Dysphasia, Headache, Seizure, Tremor.
Graft versus host disease
 -Oral intervention indicatedIV intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by donor cells attacking the recipient's organs.
Navigational Note: -
Secondary hemophagocytic lymphohistiocytosis
Asymptomatic or mild symptoms; requiring clinical and/or diagnostic evaluation; intervention not indicatedModerate symptoms; intervention indicated (e.g., immunosuppressive agents)Severe or medically significant but not immediately life threatening; hospitalization or prolongation of existing hospitalization indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by the development of a pathological and biochemical hyperinflammatory syndrome characterized by fever, cytopenias, hyperferritinemia, coagulopathy, hypofibrinogenemia and/or transaminitis and is attributable to therapy.
Navigational Note: -
Serum sickness
Clinical or diagnostic observations only; intervention not indicatedModerate arthralgia; fever, rash, urticaria, antihistamines indicatedSevere arthralgia or arthritis; extensive rash; steroids or IV fluids indicatedLife-threatening consequences; pressor or ventilatory support indicatedDeath
Definition: A disorder characterized by a delayed-type hypersensitivity reaction to foreign proteins derived from an animal serum. It occurs approximately six to twenty-one days following the administration of the foreign antigen. Symptoms include fever, arthralgias, myalgias, skin eruptions, lymphadenopathy, chest marked discomfort and dyspnea.
Navigational Note: -
Immune system disorders - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
Navigational Note: Use for diagnoses not present in CTCAE (ex. Sjogren's syndrome, etc.).
Infections and infestations
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Infections and infestations
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Abdominal infection
 -Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the abdominal cavity.
Navigational Note: -
Anorectal infection
Localized, local intervention indicatedOral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the anal area and the rectum.
Navigational Note: -
Appendicitis
 - -IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by acute inflammation to the vermiform appendix caused by a pathogenic agent.
Navigational Note: -
Appendicitis perforated
 - -Medical intervention indicated; operative intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by acute inflammation to the vermiform appendix caused by a pathogenic agent with gangrenous changes resulting in the rupture of the appendiceal wall. The appendiceal wall rupture causes the release of inflammatory and bacterial contents from the appendiceal lumen into the abdominal cavity.
Navigational Note: -
Arteritis infective
 - -IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving an artery.
Navigational Note: -
Aseptic meningitis
 - -Steroid therapy indicated; severe changes in mental status; self-limited seizure activity; neurologic abnormalitiesLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an inflammatory process of the meninges of the brain and/or spinal cord.
Navigational Note: Consider Infections and infestations: Meningitis.
Bacteremia
 -Blood culture positive with no signs or symptoms - - -
Definition: A disorder characterized by the presence of bacteria in the blood stream.
Navigational Note: Grade 2 with hospitalization is acceptable; Consider Infections and infestations: Sepsis (Grades 3, 4 & 5).
Biliary tract infection
 -Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the biliary tract.
Navigational Note: -
Bladder infection
 -Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the bladder.
Navigational Note: -
Bone infection
 -Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the bones.
Navigational Note: -
Breast infection
 -Local infection with moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; severe infection; axillary adenitisLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the breast.
Navigational Note: -
Bronchial infection
 -Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the bronchi.
Navigational Note: -
Candidiasis
Asymptomatic; local symptom management indicatedOral intervention indicated (e.g., antifungal)IV antifungal intervention indicatedLife-threatening consequencesDeath
Definition: A disorder characterized by a fungal infection caused by candida.
Navigational Note: If recovered in bloodstream report as Infections and infestations: Fungemia.
Catheter related infection
 -Localized; local intervention indicated; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process that involves a catheter or port.
Navigational Note: If related to a device other than a catheter or port, use Infections and infestations: Device related infection.
Cecal infection
 -Localized; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the cecum.
Navigational Note: -
Cervicitis infection
 -Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the uterine cervix.
Navigational Note: -
Conjunctivitis
Asymptomatic or mild symptoms; intervention not indicatedSymptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Best corrected visual acuity of 20/200 or worse in the affected eye -
Definition: A disorder characterized by inflammation, swelling and redness to the conjunctiva of the eye.
Navigational Note: Consider Infections and infestations: Conjunctivitis infective if caused by infection.
Conjunctivitis infective
 -Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicated -
Definition: A disorder characterized by an infectious process involving the conjunctiva. Clinical manifestations include pink or red color in the eyes.
Navigational Note: -
Corneal infection
 -Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the cornea.
Navigational Note: -
Cranial nerve infection
 - -IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving a cranial nerve.
Navigational Note: -
Cytomegalovirus infection reactivation
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; medical intervention indicatedSevere or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; IV intervention indicatedLife-threatening consequences; urgent intervention indicated; blindnessDeath
Definition: A disorder characterized by the reactivation of cytomegalovirus (CMV).
Navigational Note: Synonym: CMV
Device related infection
 -Oral intervention indicated (e.g., antibiotic, antifungal)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the use of a medical device.
Navigational Note: If related to a catheter or port, use Infections and infestations: Catheter related infection.
Duodenal infection
 -Moderate symptoms; medical intervention indicated (e.g., oral antibiotics)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the duodenum.
Navigational Note: -
Encephalitis
 - -IV antibiotic, antifungal, or antiviral intervention indicated; steroid therapy indicated; severe changes in mental status; self-limited seizure activity; neurologic abnormalitiesLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious or inflammatory process involving the brain tissue.
Navigational Note: -
Encephalomyelitis
 - -IV antibiotic, antifungal, or antiviral intervention indicated; steroid therapy indicated; severe changes in mental status; self-limited seizure activity; neurologic abnormalitiesLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious or inflammatory process involving the brain and spinal cord tissues.
Navigational Note: -
Endocarditis infective
 - -IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the endocardial layer of the heart.
Navigational Note: -
Endophthalmitis
 -Local intervention indicatedSystemic intervention; hospitalization indicatedBest corrected visual acuity of 20/200 or worse in the affected eye -
Definition: A disorder characterized by an infectious process involving the internal structures of the eye.
Navigational Note: -
Enterocolitis infectious
 -Passage of >3 unformed stools per 24 hrs or duration of illness >48 hrs; moderate abdominal pain; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated; profuse watery diarrhea with signs of hypovolemia; bloody diarrhea; fever; severe abdominal pain; hospitalization indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the small and/or large intestines.
Navigational Note: Includes Clostridioides difficile (c. diff, c. difficile). Consider Gastrointestinal disorders: Typhlitis, Infections and infestations: Cecal infection.
Epstein-Barr virus infection reactivation
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; medical intervention indicatedSevere or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; IV intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by the reactivation of Epstein-Barr virus (EBV).
Navigational Note: Synonym: EBV
Esophageal infection
 -Local intervention indicated (e.g., oral antibiotic, antifungal, antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the esophagus.
Navigational Note: -
Eye infection
 -Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicated; enucleationDeath
Definition: A disorder characterized by an infectious process involving the eye.
Navigational Note: -
Folliculitis
No intervention indicatedTopical intervention initiatedSystemic intervention indicated - -
Definition: A disorder characterized by inflammation or infection of the hair follicles.
Navigational Note: -
Fungemia
 -Moderate symptoms; medical intervention indicatedSevere or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated - -
Definition: A disorder characterized by the presence of fungus in the blood stream.
Navigational Note: -
Gallbladder infection
 -Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the gallbladder.
Navigational Note: -
Gum infection
Local therapy indicated (swish and swallow)Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the gums.
Navigational Note: -
Hepatic infection
 -Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the liver.
Navigational Note: -
Hepatitis B reactivation
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; medical intervention indicatedSevere or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; IV intervention indicatedLife-threatening consequences; urgent intervention indicated; severe decompensated liver function (e.g., coagulopathy, encephalopathy, coma)Death
Definition: A disorder characterized by the reactivation of hepatitis B virus.
Navigational Note: -
Hepatitis viral
Asymptomatic, intervention not indicatedModerate symptoms; medical intervention indicatedSymptomatic liver dysfunction; fibrosis by biopsy; compensated cirrhosis; hospitalization or prolongation of existing hospitalization indicatedLife-threatening consequences; severe decompensated liver function (e.g., coagulopathy, encephalopathy, coma)Death
Definition: A disorder characterized by a viral pathologic process involving the liver parenchyma.
Navigational Note: -
Herpes simplex reactivation
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; medical intervention indicatedSevere or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; IV intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by the reactivation of Herpes simplex virus.
Navigational Note: -
Infective myositis
 -Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the skeletal muscles.
Navigational Note: -
Joint infection
 -Localized; local intervention indicated; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral); needle aspiration indicated (single or multiple)Arthroscopic intervention indicated (e.g., drainage) or arthrotomy (e.g., open surgical drainage)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving a joint.
Navigational Note: -
Kidney infection
 -Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the kidney.
Navigational Note: -
Laryngitis
 -Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an inflammatory process involving the larynx.
Navigational Note: For symptoms and no intervention, consider Respiratory, thoracic and mediastinal disorders: Hoarseness, Sore throat.
Lip infection
Localized, local intervention indicatedOral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated - -
Definition: A disorder characterized by an infectious process involving the lips.
Navigational Note: -
Lymph gland infection
 -Localized; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the lymph nodes.
Navigational Note: -
Mediastinal infection
 - -IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the mediastinum.
Navigational Note: -
Meningitis
 - -IV antibiotic, antifungal, or antiviral intervention indicated; steroid therapy indicated; severe changes in mental status; self-limited seizure activity; neurologic abnormalitiesLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious or inflammatory process of the meninges of the brain and/or spinal cord.
Navigational Note: Consider Infections and infestations: Aseptic meningitis.
Meningoencephalitis
 - -IV antibiotic, antifungal, or antiviral intervention indicated; steroid therapy indicated; severe changes in mental status; self-limited seizure activity; neurologic abnormalitiesLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious or inflammatory process involving the meninges and the brain tissue.
Navigational Note: -
Mucosal infection
Localized, local intervention indicatedOral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving a mucosal surface.
Navigational Note: -
Myelitis
Asymptomatic; mild signs (e.g., Babinski's reflex or Lhermitte's sign)Moderate weakness or sensory loss; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe weakness or sensory loss; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by inflammation involving the spinal cord. Symptoms include weakness, paresthesia, sensory loss, marked discomfort and incontinence.
Navigational Note: -
Nail infection
Localized, local intervention indicatedOral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated - -
Definition: A disorder characterized by an infectious process involving the nail.
Navigational Note: -
Otitis externa
Localized, local intervention indicatedOral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the outer ear and ear canal. Contributory factors include excessive water exposure (swimmer's ear infection) and cuts in the ear canal. Symptoms include fullness, itching, swelling and marked discomfort in the ear and ear drainage.
Navigational Note: Changes associated with radiation to external ear (pinnae) are graded under Injury, poisoning and procedural complications: Dermatitis radiation.
Otitis media
 -Localized; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the middle ear.
Navigational Note: -
Ovarian infection
 -Localized; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the ovary.
Navigational Note: -
Pancreas infection
 - -IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the pancreas.
Navigational Note: -
Paronychia
Nail fold edema or erythema; disruption of the cuticleLocal intervention indicated; oral intervention indicated (e.g., antibiotic, antifungal, antiviral); nail fold edema or erythema with pain; associated with discharge or nail plate separation; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Operative intervention indicated; IV antibiotics indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by an infectious process involving the soft tissues around the nail.
Navigational Note: -
Pelvic infection
 -Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the pelvic cavity.
Navigational Note: -
Penile infection
Localized, local intervention indicatedOral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the penis.
Navigational Note: -
Periorbital infection
 -Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process near or around the orbit of the eye.
Navigational Note: -
Peripheral nerve infection
 -Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the peripheral nerves.
Navigational Note: -
Peritoneal infection
 - -IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the peritoneum.
Navigational Note: -
Pharyngitis
 -Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by inflammation of the throat.
Navigational Note: For Grade 1 Consider Respiratory, thoracic and mediastinal disorders: Sore throat.
Phlebitis infective
Localized, local intervention indicatedOral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the vein. Clinical manifestations include erythema, marked discomfort, swelling, and induration along the course of the infected vein.
Navigational Note: -
Pleural infection
 -Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the pleura.
Navigational Note: -
Pneumonia
 -Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the lungs, including pneumonia.
Navigational Note: Replaces Lung infection as this term is more commonly used. If due to aspiration, consider reporting Respiratory, thoracic and mediastinal disorders: Aspiration
Prostate infection
 -Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the prostate gland.
Navigational Note: -
Rash pustular
 -Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated - -
Definition: A disorder characterized by a circumscribed and elevated skin lesion filled with pus.
Navigational Note: Consider Skin and subcutaneous tissue disorders: Pustular drug eruption.
Rhinitis infective
 -Localized; local intervention indicated - - -
Definition: A disorder characterized by an infectious process involving the nasal mucosal.
Navigational Note: -
Salivary gland infection
 -Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the salivary gland.
Navigational Note: -
Scrotal infection
Localized, local intervention indicatedOral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the scrotum.
Navigational Note: -
Sepsis
 - -IV intervention indicatedLife-threatening consequencesDeath
Definition: A disorder characterized by the presence of pathogenic microorganisms in the blood stream that cause varying degrees of organ dysfunction due to a dysregulated host response to infection.
Navigational Note: Consider Infections and infestations: Bacteremia (Grade 2).
Shingles
Localized, local intervention indicatedLocal infection with moderate symptoms; oral intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; IV intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by the reactivation of herpes zoster virus.
Navigational Note: Synonym: Herpes zoster
Sinusitis
 -Localized; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the mucous membranes of the paranasal sinuses.
Navigational Note: -
Skin infection
Localized, local intervention indicatedOral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the skin such as cellulitis.
Navigational Note: -
Small intestine infection
 -Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the small intestine.
Navigational Note: -
Soft tissue infection
 -Localized; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving soft tissues.
Navigational Note: -
Splenic infection
 - -IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the spleen.
Navigational Note: -
Stoma site infection
Localized, local intervention indicatedOral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving a stoma (surgically created opening on the surface of the body).
Navigational Note: -
Tooth infection
 -Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving a tooth.
Navigational Note: Record final diagnosis/cause once determined.
Tracheitis
 -Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the trachea.
Navigational Note: -
Upper respiratory infection
 -Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the upper respiratory tract (nose, paranasal sinuses, pharynx, larynx, or trachea).
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Urethral infection
 -Localized; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the urethra.
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Urinary tract infection
 -Localized; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the urinary tract, most commonly the bladder and the urethra.
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Uterine infection
 -Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the endometrium. It may extend to the myometrium and parametrial tissues.
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Vaginal infection
Localized, local intervention indicatedOral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the vagina.
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Viremia
 -Moderate symptoms; medical intervention indicatedSevere or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated - -
Definition: A disorder characterized by the presence of a virus in the blood stream.
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Vulval infection
Localized, local intervention indicatedOral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the vulva.
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Wound infection
Localized, local intervention indicatedOral intervention indicated (e.g., antibiotic, antifungal, or antiviral)IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an infectious process involving the wound.
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Infections and infestations - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
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Injury, poisoning and procedural complications
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Injury, poisoning and procedural complications
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Anesthetic complication
 -Any anesthesia effects requiring medical intervention for reversal of symptomatic effects and requiring unplanned hospitalization of <24 hours.Any anesthesia effects requiring medical intervention for reversal of symptomatic effects and requiring unplanned hospitalization of >=24 hours.Anesthesia effects with life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by reactions related to the administration of local or moderate sedation given for a procedure.
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Aortic injury
 -Operative intervention not indicatedSevere symptoms; repair or revision indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; evidence of end organ damage; urgent operative intervention indicatedDeath
Definition: A finding of damage to the aorta.
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Arterial injury
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; repair or revision not indicatedSevere symptoms; repair or revision indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; evidence of end organ damage; urgent operative intervention indicatedDeath
Definition: A finding of damage to an artery.
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Biliary anastomotic leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage of bile due to breakdown of a biliary anastomosis (surgical connection of two separate anatomic structures).
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Bladder anastomotic leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage of urine due to breakdown of a bladder anastomosis (surgical connection of two separate anatomic structures).
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Bruising
Localized or in a dependent areaGeneralized - - -
Definition: A finding of injury of the soft tissues or bone characterized by leakage of blood into surrounding tissues.
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Burn
Minimal symptoms; intervention not indicatedMedical intervention; minimal debridement indicatedModerate to major debridement or reconstruction indicatedLife-threatening consequencesDeath
Definition: A finding of impaired integrity to the anatomic site of an adverse thermal reaction. Burns can be caused by exposure to chemicals, direct heat, electricity, flames and radiation. The extent of damage depends on the length and intensity of exposure and time until provision of treatment.
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Dermatitis radiation
Faint erythema or dry desquamationModerate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edemaMoist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasionLife-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicatedDeath
Definition: A finding of cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of ionizing radiation.
Navigational Note: Synonym: Radiation induced skin toxicities (CTCAE v3.0 )
Esophageal anastomotic leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage due to breakdown of an esophageal anastomosis (surgical connection of two separate anatomic structures).
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Fall
Minor with no resultant injuries; intervention not indicatedSymptomatic; noninvasive intervention indicatedHospitalization indicated; invasive intervention indicated - -
Definition: A finding of sudden movement downward, usually resulting in injury.
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Fallopian tube anastomotic leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage due to breakdown of a fallopian tube anastomosis (surgical connection of two separate anatomic structures).
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Fallopian tube perforation
 -Invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent operative intervention indicated (e.g., organ resection)Death
Definition: A disorder characterized by a rupture of the fallopian tube wall.
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Fracture
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic but non-displaced; immobilization indicatedSevere symptoms; displaced or open wound with bone exposure; operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A state in which the continuity of the bone is broken.
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Gastric anastomotic leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage due to breakdown of a gastric anastomosis (surgical connection of two separate anatomic structures).
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Gastrointestinal anastomotic leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage due to breakdown of a gastrointestinal anastomosis (surgical connection of two separate anatomic structures).
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Gastrointestinal stoma necrosis
 -Superficial necrosis; intervention not indicatedSevere symptoms; hospitalization indicated; elective operative intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a necrotic process occurring in the gastrointestinal tract stoma.
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Infusion related reaction
Mild transient reaction; infusion interruption not indicated; intervention not indicatedTherapy or infusion interruption indicated but responds promptly to symptomatic treatment (e.g., antihistamines, NSAIDS, narcotics, IV fluids); prophylactic medications indicated for <=24 hrsProlonged (e.g., not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelaeLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by adverse reaction to the infusion of pharmacological or biological substances.
Navigational Note: If the reaction is an allergic reaction related to an agent, consider reporting as Immune system disorders: Allergic reaction. Do not report both.
Injury to carotid artery
 -Repair or revision not indicatedSevere symptoms (e.g., transient cerebral ischemia); repair or revision indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to the carotid artery.
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Injury to inferior vena cava
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; repair or revision not indicatedSevere symptoms; repair or revision indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to the inferior vena cava.
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Injury to jugular vein
 -Repair or revision not indicatedSymptomatic; repair or revision indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to the jugular vein.
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Injury to superior vena cava
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; repair or revision not indicatedSevere symptoms; repair or revision indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to the superior vena cava.
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Intestinal stoma leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage of contents from an intestinal stoma (surgically created opening on the surface of the body).
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Intestinal stoma obstruction
 -Self-limited; intervention not indicatedSevere symptoms; IV fluids, tube feeding, or TPN indicated >=24 hrs; elective operative intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by blockage of the normal flow of the contents of the intestinal stoma.
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Intestinal stoma site bleeding
Minimal bleeding identified on clinical exam; intervention not indicatedModerate bleeding; medical intervention indicatedInvasive intervention indicated; hospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the intestinal stoma.
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Intraoperative arterial injury
Primary repair of injured organ/structure indicatedPartial resection of injured organ/structure indicatedComplete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to an artery during a surgical procedure.
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Intraoperative breast injury
Primary repair of injured organ/structure indicatedPartial resection of injured organ/structure indicatedComplete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to the breast parenchyma during a surgical procedure.
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Intraoperative cardiac injury
 - -Primary repair of injured organ/structure indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to the heart during a surgical procedure.
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Intraoperative ear injury
Primary repair of injured organ/structure indicatedPartial resection of injured organ/structure indicatedComplete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL (e.g., impaired hearing; impaired balance) or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to the ear during a surgical procedure.
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Intraoperative endocrine injury
Primary repair of injured organ/structure indicatedPartial resection of injured organ/structure indicatedComplete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to the endocrine gland during a surgical procedure.
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Intraoperative gastrointestinal injury
Primary repair of injured organ/structure indicatedPartial resection of injured organ/structure indicatedComplete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to the gastrointestinal system during a surgical procedure.
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Intraoperative head and neck injury
Primary repair of injured organ/structure indicatedPartial resection of injured organ/structure indicatedComplete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to the head and neck during a surgical procedure.
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Intraoperative hemorrhage
 - -Postoperative invasive intervention indicated; hospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of uncontrolled bleeding during a surgical procedure.
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Intraoperative hepatobiliary injury
Primary repair of injured organ/structure indicatedPartial resection of injured organ/structure indicatedComplete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to the hepatic parenchyma and/or biliary tract during a surgical procedure.
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Intraoperative musculoskeletal injury
Primary repair of injured organ/structure indicatedPartial resection of injured organ/structure indicatedComplete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to the musculoskeletal system during a surgical procedure.
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Intraoperative neurological injury
Primary repair of injured organ/structure indicatedPartial resection of injured organ/structure indicatedComplete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to the nervous system during a surgical procedure.
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Intraoperative ocular injury
Primary repair of injured organ/structure indicatedPartial resection of injured organ/structure indicatedComplete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to the eye during a surgical procedure.
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Intraoperative renal injury
Primary repair of injured organ/structure indicatedPartial resection of injured organ/structure indicatedComplete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to the kidney during a surgical procedure.
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Intraoperative reproductive tract injury
Primary repair of injured organ/structure indicatedPartial resection of injured organ/structure indicatedComplete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to the reproductive organs during a surgical procedure.
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Intraoperative respiratory injury
Primary repair of injured organ/structure indicatedPartial resection of injured organ/structure indicatedComplete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to the respiratory system during a surgical procedure.
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Intraoperative splenic injury
 -Primary repair of injured organ/structure indicatedResection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to the spleen during a surgical procedure.
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Intraoperative urinary injury
Primary repair of injured organ/structure indicatedPartial resection of injured organ/structure indicatedComplete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to the urinary system during a surgical procedure.
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Intraoperative venous injury
Primary repair of injured organ/structure indicatedPartial resection of injured organ/structure indicatedComplete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to a vein during a surgical procedure.
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Kidney anastomotic leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage of urine due to breakdown of a kidney anastomosis (surgical connection of two separate anatomic structures).
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Large intestinal anastomotic leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage due to breakdown of an anastomosis (surgical connection of two separate anatomic structures) in the large intestine.
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Nerve injury
 -Limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Invasive intervention indicated; hospitalization; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to a nerve.
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Pancreatic anastomotic leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage due to breakdown of a pancreatic anastomosis (surgical connection of two separate anatomic structures).
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Pharyngeal anastomotic leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage due to breakdown of a pharyngeal anastomosis (surgical connection of two separate anatomic structures).
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Post biopsy bleeding
 -Requiring additional observationTransfusion indicated; invasive intervention indicated; hospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding as a result of a biopsy procedure.
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Postoperative hemorrhage
Mild symptoms; intervention not indicatedModerate bleeding requiring transfusion <2 units (10 cc/kg for pediatrics) of pRBCsTransfusion indicated of >=2 units (10 cc/kg for pediatrics) pRBCs; invasive intervention indicated; hospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding occurring after a surgical procedure.
Navigational Note: Consider Injury, poisoning and procedural complications: Post biopsy bleeding.
Postoperative thoracic procedure complication
 -Extubated within 24 - 72 hrs postoperativelyExtubated >72 hrs postoperatively, but before tracheostomy indicatedLife-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)Death
Definition: A finding of a previously undocumented problem that occurs after a thoracic procedure.
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Prolapse of intestinal stoma
Asymptomatic; reducibleRecurrent after manual reduction; local irritation or stool leakage; difficulty to fit appliance; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; elective operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of protrusion of the intestinal stoma (surgically created opening on the surface of the body) above the abdominal surface.
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Prolapse of urostomy
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedLocal care or maintenance; minor revision indicatedDysfunctional stoma; elective operative intervention or major stomal revision indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of displacement of the urostomy.
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Radiation recall reaction (dermatologic)
Faint erythema or dry desquamationModerate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edemaMoist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasionLife-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicatedDeath
Definition: A finding of acute skin inflammatory reaction caused by drugs, especially chemotherapeutic agents, for weeks or months following radiotherapy. The inflammatory reaction is confined to the previously irradiated skin and the symptoms disappear after the removal of the pharmaceutical agent.
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Rectal anastomotic leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage due to breakdown of a rectal anastomosis (surgical connection of two separate anatomic structures).
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Seroma
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; simple aspiration indicatedSymptomatic, elective invasive intervention indicated - -
Definition: A finding of tumor-like collection of serum in the tissues.
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Small intestinal anastomotic leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage due to breakdown of an anastomosis (surgical connection of two separate anatomic structures) in the small bowel.
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Spermatic cord anastomotic leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage due to breakdown of a spermatic cord anastomosis (surgical connection of two separate anatomic structures).
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Stenosis of gastrointestinal stoma
 -Symptomatic; IV fluids indicated <24 hrs; manual dilation at bedsideSeverely altered GI function; tube feeding, TPN or hospitalization indicated; elective operative intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of narrowing of the gastrointestinal stoma (surgically created opening on the surface of the body).
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Stomal ulcer
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; elective operative intervention indicated - -
Definition: A disorder characterized by a circumscribed, erosive lesion on the jejunal mucosal surface close to the anastomosis site following a gastroenterostomy procedure.
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Systemic post-immunization reaction
Mild pain; erythema 2.5 - 5 cm; induration/swelling 2.5 - 5 cm; does not interfere with activityModerate pain; erythema >5 - 10 cm; Induration/swelling >5 - 10 cm; lipodystrophy; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; erythema >10 cm; Induration/swelling >10 cm; necrosis; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicated -
Definition: A disorder characterized by a systemic manifestation that occurs after the injection of a substance with antigenic properties, administered to activate the immune system.
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Tissue injury
 -Limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Invasive intervention indicated; hospitalization; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A finding of damage to an organ or tissue as a result of a procedure.
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Tracheal hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the trachea.
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Tracheal obstruction
Partial asymptomatic obstruction on examination (e.g., visual, radiologic or endoscopic)Symptomatic (e.g., noisy airway breathing), no respiratory distress; medical intervention indicated (e.g., steroids); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Stridor or respiratory distress; invasive intervention indicated (e.g., stent, laser); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)Death
Definition: A disorder characterized by blockage of the lumen of the trachea.
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Tracheostomy site bleeding
Minimal bleeding identified on clinical exam; intervention not indicatedModerate bleeding; medical intervention indicatedInvasive intervention indicated; hospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the tracheostomy site.
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Ureteric anastomotic leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage due to breakdown of a ureteral anastomosis (surgical connection of two separate anatomic structures).
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Urethral anastomotic leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage due to breakdown of a urethral anastomosis (surgical connection of two separate anatomic structures).
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Urostomy leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage of contents from a urostomy.
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Urostomy obstruction
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; dilation or endoscopic repair or stent placement indicatedAltered organ function (e.g., sepsis or hydronephrosis, or renal dysfunction); elective operative intervention indicatedLife-threatening consequences; organ failure; urgent operative intervention indicatedDeath
Definition: A disorder characterized by blockage of the urostomy.
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Urostomy site bleeding
Minimal bleeding identified on clinical exam; intervention not indicatedModerate bleeding; medical intervention indicatedInvasive intervention indicated; hospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the urostomy site.
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Urostomy stenosis
 -Symptomatic but no hydronephrosis, sepsis, or renal dysfunction; dilation or endoscopic repair or stent placement indicatedSymptomatic (e.g., hydronephrosis, or renal dysfunction); elective operative intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of narrowing of the opening of a urostomy.
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Uterine anastomotic leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage due to breakdown of a uterine anastomosis (surgical connection of two separate anatomic structures).
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Uterine perforation
 -Invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a rupture in the uterine wall.
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Vaginal anastomotic leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage due to breakdown of a vaginal anastomosis (surgical connection of two separate anatomic structures).
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Vas deferens anastomotic leak
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A finding of leakage due to breakdown of a vas deferens anastomosis (surgical connection of two separate anatomic structures).
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Vascular access complication
TPA administration into line with no intent for systemic therapy indicatedDevice dislodgement, blockage, leak, or malposition; device replacement indicatedPulmonary embolism, deep vein or cardiac thrombosis; intervention indicatedLife-threatening consequences with hemodynamic or neurologic instabilityDeath
Definition: A finding of a previously undocumented problem related to the vascular access site.
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Venous injury
Asymptomatic diagnostic finding; intervention not indicatedSymptomatic (e.g., claudication); repair or revision not indicatedSevere symptoms; repair or revision indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; evidence of end organ damage; urgent operative intervention indicatedDeath
Definition: A finding of damage to a vein.
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Wound complication
Observation only; topical intervention indicatedBedside local care indicatedOperative intervention indicatedLife-threatening consequencesDeath
Definition: A finding of development of a new problem at the site of an existing wound.
Navigational Note: Prior to using this term consider Injury, poisoning and procedural complications: Wound dehiscence or Infections and infestations: Wound infection.
Wound dehiscence
Incisional separation, intervention not indicatedIncisional separation, local care (e.g., suturing) or medical intervention indicated (e.g., analgesic)Fascial disruption or dehiscence without evisceration; revision by operative intervention indicatedLife-threatening consequences; symptomatic hernia with evidence of strangulation; fascial disruption with evisceration; major reconstruction flap, grafting, resection, or amputation indicatedDeath
Definition: A finding of separation of the approximated margins of a surgical wound.
Navigational Note: Consider Infections and infestations: Wound infection.
Injury, poisoning and procedural complications - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
Navigational Note: -
Investigations
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Investigations
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Activated partial thromboplastin time prolonged
>ULN - 1.5 x ULN>1.5 - 2.5 x ULN>2.5 x ULN; bleeding - -
Definition: A finding based on laboratory test results in which the partial thromboplastin time is found to be greater than the control value. As a possible indicator of coagulopathy, a prolonged partial thromboplastin time (PTT) may occur in a variety of diseases and disorders, both primary and related to treatment.
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Alanine aminotransferase increased
>ULN - 3.0 x ULN if baseline was normal or less than normal; 1.0 - 1.5 x baseline if baseline was >ULN>3.0 - 5.0 x ULN if baseline was normal or less than normal; >1.5 - 2.0 x baseline if baseline was >ULN>5.0 - 20.0 x ULN if baseline was normal or less than normal; >2.0 - 4.0 x baseline if baseline was >ULN up to 5 x ULN>20.0 x ULN if baseline was normal or less than normal; >4.0 x baseline if baseline was >ULN -
Definition: A finding based on laboratory test results that indicate an increase in the level of alanine aminotransferase (ALT or SGPT) in the blood specimen.
Navigational Note: Consider Hepatobiliary disorders: Hepatic failure. Report Autoimmune hepatitis under Hepatobiliary disorders: Other, specify.
Alkaline phosphatase increased
>Baseline and ULN - - - -
Definition: A finding based on laboratory test results that indicate an increase in the level of alkaline phosphatase (ALP) in a blood specimen.
Navigational Note: -
Aspartate aminotransferase increased
>ULN - 3.0 x ULN if baseline was normal or less than normal; 1.0 - 1.5 x baseline if baseline was >ULN>3.0 - 5.0 x ULN if baseline was normal or less than normal; >1.5 - 2.0 x baseline if baseline was >ULN>5.0 - 20.0 x ULN if baseline was normal or less than normal; >2.0 - 4.0 x baseline if baseline was >ULN up to 5 x ULN>20.0 x ULN if baseline was normal or less than normal; >4.0 x baseline if baseline was >ULN -
Definition: A finding based on laboratory test results that indicate an increase in the level of aspartate aminotransferase (AST or SGOT) in a blood specimen.
Navigational Note: Consider Hepatobiliary disorders: Hepatic failure. Report Autoimmune hepatitis under Hepatobiliary disorders: Other, specify.
Blood antidiuretic hormone abnormal
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; medical intervention indicatedHospitalization indicated - -
Definition: A finding based on laboratory test results that indicate abnormal levels of antidiuretic hormone (ADH) in the blood specimen.
Navigational Note: -
Blood bicarbonate decreased
<LLN and no intervention initiated - - - -
Definition: A finding based on laboratory test results that indicate a decrease in levels of bicarbonate in a venous blood specimen.
Navigational Note: Consider Metabolism and nutrition disorders: Acidosis, Alkalosis.
Blood bilirubin increased
>ULN - 1.5 x ULN if baseline was normal or less than normal; 1.0 - 1.5 x baseline if baseline was >ULN>1.5 - 3.0 x ULN if baseline was normal or less than normal; >1.5 - 2.5 x baseline if baseline was >ULN>3.0 - 10.0 x ULN if baseline was normal or less than normal; >2.5 - 10.0 x baseline if baseline was >ULN>10.0 x ULN if baseline was normal or less than normal; >10.0 x baseline if baseline was >ULN -
Definition: A finding based on laboratory test results that indicate an abnormally high level of total bilirubin in the blood. Excess bilirubin is associated with jaundice.
Navigational Note: Consider Hepatobiliary disorders: Hepatic failure. Report Autoimmune hepatitis under Hepatobiliary disorders: Other, specify.
Blood corticotrophin decreased
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; medical intervention indicatedHospitalization indicated - -
Definition: A finding based on laboratory test results that indicate a decrease in the expected levels of corticotrophin (ACTH) in a blood specimen.
Navigational Note: -
Blood gonadotrophin abnormal
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; medical intervention indicated - - -
Definition: A finding based on laboratory test results that indicate abnormal levels of gonadotrophin hormone in a blood specimen.
Navigational Note: -
Blood lactate dehydrogenase increased
>ULN - - - -
Definition: A finding based on laboratory test results that indicate increased levels of lactate dehydrogenase (LDH) in the blood specimen.
Navigational Note: -
Blood prolactin abnormal
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric) - - -
Definition: A finding based on laboratory test results that indicate abnormal levels of prolactin hormone in a blood specimen.
Navigational Note: -
Carbon monoxide diffusing capacity decreased
3 - 5 units below LLN if no baseline available; for follow-up, a decrease of 3 - 5 units (ml/min/mmHg) below the baseline value; asymptomatic and intervention not indicated6 - 8 units below LLN if no baseline available; for follow-up, an asymptomatic decrease of >5 - 8 units (ml/min/mmHg) below the baseline value; symptomatic and intervention not indicatedAsymptomatic decrease of >8 units drop; >5 units drop along with the presence of pulmonary symptoms (e.g., >Grade 2 hypoxia or >Grade 2 dyspnea); intervention indicated - -
Definition: A finding based on lung function test results that indicate a decrease in the lung capacity to absorb carbon monoxide (DLCO or TLCO).
Navigational Note: Consider Respiratory, thoracic and mediastinal disorders: Dyspnea, Respiratory failure.
CD4 lymphocytes decreased
<LLN - 500/mm³; <LLN - 0.5 x 10⁹/L<500 - 200/mm³; <0.5 - 0.2 x 10⁹/L<200 - 50/mm³; <0.2 - 0.05 x 10⁹/L<50/mm³; <0.05 x 10⁹/L -
Definition: A finding based on laboratory test results that indicate a decrease in levels of CD4 lymphocytes in a blood specimen.
Navigational Note: -
Cholesterol high
>ULN - 300 mg/dL; >ULN - 7.75 mmol/L>300 - 400 mg/dL; >7.75 - 10.34 mmol/L>400 - 500 mg/dL; >10.34 - 12.92 mmol/L>500 mg/dL; >12.92 mmol/L -
Definition: A finding based on laboratory test results that indicate higher than normal levels of cholesterol in a blood specimen.
Navigational Note: -
Creatinine clearance decreased
 -26 - 49 ml/min10 - 25 ml/min - -
Definition: A finding based on laboratory test results that indicate a decrease in creatinine clearance (CrCl) in a 24-hour urine collection.
Navigational Note: Report Grade 4 and 5 as Renal and urinary disorders: Acute kidney injury or Chronic kidney disease.
Creatinine increased
>ULN - 1.5 x ULN>1.5 - 3.0 x if baseline is below LLN; >1.5 - 3.0 x ULN>3.0 x if baseline is below LLN; >3.0 - 6.0 x ULN>6.0 x ULN -
Definition: A finding based on laboratory test results that indicate increased levels of creatinine in a biological specimen.
Navigational Note: Consider Renal and urinary disorders: Acute kidney injury, Glomerulonephritis, Tubulointerstitial nephritis.
Electrocardiogram QT corrected interval prolonged
Average QTc 450 - 480 msAverage QTc 481 - 500 msAverage QTc >500 ms; >60 ms change from baselineLife-threatening consequences; Torsade de pointes; polymorphic ventricular tachycardia -
Definition: A finding of a cardiac dysrhythmia characterized by an abnormally long corrected QT interval.
Navigational Note: Consider Cardiac disorders: Ventricular arrhythmia, Ventricular fibrillation, Ventricular tachycardia.
Fibrinogen decreased
<1.0 - 0.75 x LLN; if abnormal, <25% decrease from baseline<0.75 - 0.5 x LLN; if abnormal, 25 - <50% decrease from baseline<0.5 - 0.25 x LLN; if abnormal, 50 - <75% decrease from baseline<0.25 x LLN; if abnormal, 75% decrease from baseline; absolute value <50 mg/dL -
Definition: A finding based on laboratory test results that indicate an decrease in levels of fibrinogen in a blood specimen.
Navigational Note: -
Forced expiratory volume decreased
FEV1% (percentages of observed FEV1 and FVC related to their respective predicted values) 99 - 70% predicted; Global Lung Function Initiative (GLI) Z-score -1.65 to -2.5FEV1% 60 - 69%; GLI Z-score <-2.5 to -4FEV1% 50 - 59%; GLI Z-score <-4 - -
Definition: A finding based on test results that indicate a relative decrease in the fraction of the forced vital capacity that is exhaled in a specific number of seconds.
Navigational Note: Consider Respiratory, thoracic and mediastinal disorders: Dyspnea, Respiratory failure.
GGT increased
>ULN - 2.5 x ULN if baseline was normal or less than normal; 1.0 - 1.5 x baseline if baseline was >ULN>2.5 - 5.0 x ULN if baseline was normal or less than normal; >1.5 - 3.0 x baseline if baseline was >ULN>5.0 - 20.0 x ULN if baseline was normal or less than normal; >3.0 - 10.0 x baseline if baseline was >ULN>20.0 x ULN if baseline was normal or less than normal; >10.0 x baseline if baseline was >ULN -
Definition: A finding based on laboratory test results that indicate higher than normal levels of the enzyme gamma-glutamyltransferase in the blood specimen. GGT (gamma-glutamyltransferase ) catalyzes the transfer of a gamma glutamyl group from a gamma glutamyl peptide to another peptide, amino acids or water.
Navigational Note: -
Growth hormone abnormal
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric) - - -
Definition: A finding based on laboratory test results that indicate abnormal levels of growth hormone (GH) in a biological specimen.
Navigational Note: -
Haptoglobin decreased
<LLN - - - -
Definition: A finding based on laboratory test results that indicate an decrease in levels of haptoglobin (HP) in a blood specimen.
Navigational Note: -
HDL decreased
<LLN - - - -
Definition: A finding based on laboratory test results that indicate a decrease in HDL in a blood specimen.
Navigational Note: -
Hemoglobin increased
Increase in >0 - 2 g/dL above ULNIncrease in >2 - 4 g/dL above ULNIncrease in >4 g/dL above ULN - -
Definition: A finding based on laboratory test results that indicate increased levels of hemoglobin (Hgb) above normal.
Navigational Note: -
INR increased
>1.2 - 1.5; >1 - 1.5 x baseline if on anticoagulation; monitoring only indicated>1.5 - 2.5; >1.5 - 2.5 x baseline if on anticoagulation; dose adjustment indicated>2.5; >2.5 x baseline if on anticoagulation; bleeding - -
Definition: A finding based on laboratory test results that indicate an increase in the ratio of the patient's prothrombin time (PT) to a control sample in the blood.
Navigational Note: -
LDL increased
>ULN - - - -
Definition: A finding based on laboratory test results that indicate an increase in LDL in a blood specimen.
Navigational Note: -
Lipase increased
>ULN - 1.5 x ULN>1.5 - 3.0 x ULN; >3.0 - 5.0 x ULN and asymptomatic>3.0 - 5.0 x ULN with signs or symptoms; >5.0 x ULN and asymptomatic>5.0 x ULN and with signs or symptoms -
Definition: A finding based on laboratory test results that indicate an increase in the level of lipase in a biological specimen.
Navigational Note: Consider Gastrointestinal disorders: Pancreatitis.
Lymphocyte count increased
 ->4000/mm³ - 20,000/mm³>20,000/mm³ - -
Definition: A finding based on laboratory test results that indicate an abnormal increase in the number of lymphocytes in the blood, effusions or bone marrow.
Navigational Note: -
Neutrophil count decreased
<1500 - 1000/mm³; <1.5 - 1.0 x 10⁹/L<1000 - 500/mm³; <1.0 - 0.5 x 10⁹/L<500 - 100/mm³; <0.5 - 0.1 x 10⁹/L<100/mm³; <0.1 x 10⁹/L -
Definition: A finding based on laboratory test results that indicate a decrease in number of neutrophils (ANC) in a blood specimen.
Navigational Note: -
Neutrophil count increased
Present - - - -
Definition: A finding based on laboratory test results that indicate an increase in number of neutrophils (ANC) in a blood specimen.
Navigational Note: -
Serum amylase increased
>ULN - 1.5 x ULN>1.5 - 2.0 x ULN; >2.0 - 5.0 x ULN and asymptomatic or with mild signs or symptoms>2.0 - 5.0 x ULN with moderate or severe signs or symptoms; >5.0 x ULN and asymptomatic>5.0 x ULN and with signs or symptoms -
Definition: A finding based on laboratory test results that indicate an increase in the levels of amylase in a serum specimen.
Navigational Note: Consider Gastrointestinal disorders: Pancreatitis.
Thyroid stimulating hormone increased
TSH increased and no intervention indicated - - - -
Definition: A disorder characterized by an increase in thyroid stimulating hormone (TSH).
Navigational Note: If intervention initiated or symptomatic, report as Endocrine disorders: Hypothyroidism.
Urinary protein increased
Adult: 1+ proteinuria; urinary protein ≥ULN - <1.0 g/24 hrs; P/C <1; Pediatric: 1 + proteinuriaAdult: 2+ and 3+ proteinuria; urinary protein 1.0 - <3.5 g/24 hrs; P/C 1 - 3.5; Pediatric: Urine P/C (Protein/Creatinine) ratio 0.5 - 1.9; 2 - 3+ proteinuriaAdult: Urinary protein >=3.5 g/24 hrs; 4+ proteinuria; P/C >3.5; Pediatric: Urine P/C (Protein/Creatinine) ratio >1.9, 4+ proteinuria - -
Definition: A finding based on laboratory test results that indicate the presence of excessive protein in the urine. It is predominantly albumin, but also globulin.
Navigational Note: 24-hour urine collection takes precedence over dipstick.
Urine output decreased
 - -Adult: Oliguria (<80 ml in 8 hr); Infants: <1 ml/kg/hour; Children: <0.5 ml/kg/hourAdult: Anuria (<240 ml in 24 hr); Pediatric: No urine output over 12 hours -
Definition: A finding based on test results that indicate urine production is less relative to previous output.
Navigational Note: -
Vital capacity abnormal
90 - 75% of predicted value<75 - 50% of predicted value; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)<50% of predicted value; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A finding based on pulmonary function test results that indicate an abnormal vital capacity (VC) (amount of exhaled after a maximum inhalation) when compared to the predicted value.
Navigational Note: Consider Investigations: Forced expiratory volume decreased; Respiratory, thoracic and mediastinal disorders: Dyspnea, Respiratory failure.
Vitamin D decreased
Vitamin D decreased <LLN - - - -
Definition: A finding based on laboratory test results that indicate a low concentration of Vitamin D in the blood.
Navigational Note: -
Weight gain
5 - <10% from baseline10 - <20% from baseline>=20% from baseline - -
Definition: A finding characterized by an unexpected or abnormal increase in overall body weight; for pediatrics, percentages represent the absolute increase above that expected from the baseline growth curve (not change in growth percentiles).
Navigational Note: -
Weight loss
5 - <10% from baseline; intervention not indicated10 - <20% from baseline; nutritional support indicated>=20% from baseline; tube feeding or TPN indicated - -
Definition: A finding characterized by a decrease in overall body weight; for pediatrics, less than the baseline growth curve.
Navigational Note: -
White blood cell decreased
<LLN - 3000/mm³; <LLN - 3.0 x 10⁹/L<3000 - 2000/mm³; <3.0 - 2.0 x 10⁹/L<2000 - 1000/mm³; <2.0 - 1.0 x 10⁹/L<1000/mm³; <1.0 x 10⁹/L -
Definition: A finding based on laboratory test results that indicate an decrease in number of white blood cells (WBC) in a blood specimen.
Navigational Note: -
Investigations - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
Navigational Note: -
Metabolism and nutrition disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Metabolism and nutrition disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Acidosis
pH <normal, but >=7.3 -pH <7.3Life-threatening consequencesDeath
Definition: A disorder characterized by abnormally high acidity (high hydrogen-ion concentration) of the blood and other body tissues.
Navigational Note: -
Alcohol intolerance
 -PresentSevere symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an increase in sensitivity to the adverse effects of alcohol, which can include nasal congestion, skin flushes, heart dysrhythmias, nausea, vomiting, indigestion and headaches.
Navigational Note: -
Alkalosis
pH >normal, but <=7.5 -pH >7.5Life-threatening consequencesDeath
Definition: A disorder characterized by abnormally high alkalinity (low hydrogen-ion concentration) of the blood and other body tissues.
Navigational Note: -
Anorexia
Loss of appetite without alteration in eating habitsOral intake altered without significant weight loss or malnutrition; oral nutritional supplements indicatedAssociated with significant weight loss or malnutrition (e.g., inadequate oral caloric and/or fluid intake); tube feeding or TPN indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a loss of appetite.
Navigational Note: -
Dehydration
Increased oral fluids indicated; dry mucous membranes; diminished skin turgorIV fluids indicatedHospitalization indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by excessive loss of water from the body. It is usually caused by severe diarrhea, vomiting or diaphoresis.
Navigational Note: -
Diabetes mellitus
Abnormal glucose above baseline; diet changes only; no change in baseline diabetic managementOral antiglycemic agent initiated; insulin sliding scale initiatedInsulin therapy initiated or increased; hospitalization indicatedLife-threatening consequences; urgent intervention indicated; diabetic ketoacidosisDeath
Definition: A disorder characterized by increased Hgb A1C that may result in organ damage.
Navigational Note: Consider Metabolism and nutrition disorders: Hyperglycemia.
Failure to thrive
 -Limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A condition characterized by global decline with weight loss, decreased appetite, poor intake, and/or inactivity.
Navigational Note: -
Hypercalcemia
Corrected serum calcium of >ULN - 11.5 mg/dL; >ULN - 2.9 mmol/L; Ionized calcium >ULN - 1.5 mmol/LCorrected serum calcium of >11.5 - 12.5 mg/dL; >2.9 - 3.1 mmol/L; Ionized calcium >1.5 - 1.6 mmol/L; symptomaticCorrected serum calcium of >12.5 - 13.5 mg/dL; >3.1 - 3.4 mmol/L; Ionized calcium >1.6 - 1.8 mmol/L; hospitalization indicatedCorrected serum calcium of >13.5 mg/dL; >3.4 mmol/L; Ionized calcium >1.8 mmol/L; life-threatening consequencesDeath
Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of calcium (corrected for albumin) in blood.
Navigational Note: -
Hyperglycemia
Fasting glucose value >ULN - 160 mg/dL; Fasting glucose value >ULN - 8.9 mmol/LFasting glucose value >160 - 250 mg/dL; Fasting glucose value >8.9 - 13.9 mmol/L>250 - 500 mg/dL; >13.9 - 27.8 mmol/L; hospitalization indicated>500 mg/dL; >27.8 mmol/L; life-threatening consequences -
Definition: A condition characterized by laboratory test results that indicate a confirmed, short lasting and unexpected elevation in the concentration of blood sugar (glycemia).
Navigational Note: Consider Metabolism and nutrition disorders: Diabetes mellitus.
Hyperkalemia
>ULN - 5.5 mmol/L>5.5 - 6.0 mmol/L; intervention initiated>6.0 - 7.0 mmol/L; hospitalization indicated>7.0 mmol/L; life-threatening consequencesDeath
Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of potassium in the blood; associated with kidney failure or sometimes with the use of diuretic drugs.
Navigational Note: -
Hyperlipidemia
Requiring diet changesRequiring pharmaceutical interventionHospitalizationLife-threatening consequences -
Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of lipids in blood.
Navigational Note: Consider Gastrointestinal disorders: Pancreatitis.
Hypermagnesemia
>ULN - 3.0 mg/dL; >ULN - 1.23 mmol/L ->3.0 - 8.0 mg/dL; >1.23 - 3.30 mmol/L>8.0 mg/dL; >3.30 mmol/L; life-threatening consequencesDeath
Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of magnesium in the blood.
Navigational Note: -
Hypernatremia
>ULN - 150 mmol/L>150 - 155 mmol/L; intervention initiated>155 - 160 mmol/L; hospitalization indicated>160 mmol/L; life-threatening consequencesDeath
Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of sodium in the blood.
Navigational Note: -
Hyperphosphatemia
Laboratory finding only and intervention not indicatedNoninvasive intervention indicatedSevere or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicatedLife-threatening consequences; urgent intervention indicated (e.g., dialysis)Death
Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of phosphate in a blood.
Navigational Note: -
Hypertriglyceridemia
150 mg/dL - 300 mg/dL; 1.71 mmol/L - 3.42 mmol/L>300 mg/dL - 500 mg/dL; >3.42 mmol/L - 5.7 mmol/L>500 mg/dL - 1000 mg/dL; >5.7 mmol/L - 11.4 mmol/L>1000 mg/dL; >11.4 mmol/L; life-threatening consequencesDeath
Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of triglyceride concentration in the blood.
Navigational Note: -
Hyperuricemia
>ULN without physiologic consequences ->ULN with physiologic consequencesLife-threatening consequencesDeath
Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of uric acid.
Navigational Note: -
Hypoalbuminemia
<LLN - 3 g/dL; <LLN - 30 g/L<3 - 2 g/dL; <30 - 20 g/L<2 g/dL; <20 g/LLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by laboratory test results that indicate a low concentration of albumin in the blood.
Navigational Note: -
Hypocalcemia
Corrected serum calcium of <LLN - 8.0 mg/dL; <LLN - 2.0 mmol/L; Ionized calcium <LLN - 1.0 mmol/LCorrected serum calcium of <8.0 - 7.0 mg/dL; <2.0 - 1.75 mmol/L; Ionized calcium <1.0 - 0.9 mmol/L; symptomaticCorrected serum calcium of <7.0 - 6.0 mg/dL; <1.75 - 1.5 mmol/L; Ionized calcium <0.9 - 0.8 mmol/L; hospitalization indicatedCorrected serum calcium of <6.0 mg/dL; <1.5 mmol/L; Ionized calcium <0.8 mmol/L; life-threatening consequencesDeath
Definition: A disorder characterized by laboratory test results that indicate a low concentration of calcium (corrected for albumin) in the blood.
Navigational Note: -
Hypoglycemia
<LLN - 55 mg/dL; <LLN - 3.0 mmol/L<55 - 40 mg/dL; <3.0 - 2.2 mmol/L<40 - 30 mg/dL; <2.2 - 1.7 mmol/L<30 mg/dL; <1.7 mmol/L; life-threatening consequences; seizuresDeath
Definition: A condition characterized by laboratory test results that indicate a low concentration of glucose in the blood.
Navigational Note: -
Hypokalemia
<LLN - 3.0 mmol/LSymptomatic with <LLN - 3.0 mmol/L; intervention indicated<3.0 - 2.5 mmol/L; hospitalization indicated<2.5 mmol/L; life-threatening consequencesDeath
Definition: A disorder characterized by laboratory test results that indicate a low concentration of potassium in the blood.
Navigational Note: -
Hypomagnesemia
<LLN - 1.2 mg/dL; <LLN - 0.5 mmol/L<1.2 - 0.9 mg/dL; <0.5 - 0.4 mmol/L<0.9 - 0.7 mg/dL; <0.4 - 0.3 mmol/L<0.7 mg/dL; <0.3 mmol/L; life-threatening consequencesDeath
Definition: A disorder characterized by laboratory test results that indicate a low concentration of magnesium in the blood.
Navigational Note: -
Hyponatremia
<LLN - 130 mmol/L125 - <130 mmol/L and asymptomatic125 - <130 mmol/L symptomatic; 120 - <125 mmol/L regardless of symptoms<120 mmol/L; life-threatening consequencesDeath
Definition: A disorder characterized by laboratory test results that indicate a low concentration of sodium in the blood.
Navigational Note: -
Hypophosphatemia
Laboratory finding only and intervention not indicatedOral replacement therapy indicatedSevere or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicatedLife-threatening consequencesDeath
Definition: A disorder characterized by laboratory test results that indicate a low concentration of phosphates in the blood.
Navigational Note: -
Iron overload
 -Moderate symptoms; intervention not indicatedSevere symptoms; intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by accumulation of iron in the tissues.
Navigational Note: -
Tumor lysis syndrome
Laboratory tumor lysis syndrome (LTLS) AND creatinine >ULN - 1.5 × ULNLTLS AND creatinine >1.5 – 3.0 × ULN; cardiac arrhythmia managed medically; one brief generalized seizure; seizure(s) well controlled by anticonvulsants; infrequent focal motor seizures not limiting age-appropriate instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)LTLS AND creatinine >3.0 – 6.0 × ULN; cardiac arrhythmia controlled with device (e.g. defibrillator); seizure in which consciousness is altered; poorly controlled seizure disorder; breakthrough generalized seizures despite medical interventionLTLS AND creatinine >6.0 x ULN; life-threatening cardiac arrhythmia or seizureDeath
Definition: A disorder characterized by metabolic abnormalities that result from a spontaneous or therapy-related cytolysis of tumor cells. Clinical tumor lysis syndrome (CTLS) requires one or more clinical manifestations along with criteria for laboratory tumor lysis syndrome (LTLS). LTLS is defined by two or more of the following laboratory abnormalities within 3 days before or 7 days after the initiation of chemotherapy: Uric acid ≥ 476 mcmol/L or 25% increase from baseline, Potassium ≥ 6.0 mmol/L or 25% increase from baseline, Phosphorous ≥ 2.1 mmol/L (children), ≥1.45 mmol/L (adults) or 25% increase from baseline, Calcium ≤ 1.75 mmol/L or 25% decrease from baseline.
Navigational Note: -
Metabolism and nutrition disorders - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
Navigational Note: -
Musculoskeletal and connective tissue disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Musculoskeletal and connective tissue disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Abdominal soft tissue necrosis
 -Local wound care; medical intervention indicated (e.g., dressings or topical medications)Operative debridement or other invasive intervention indicated (e.g., tissue reconstruction, flap, or grafting)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the abdominal wall.
Navigational Note: -
Arthralgia
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in a joint.
Navigational Note: Report Inflammatory arthritis as Musculoskeletal and connective tissue disorder - Other, specify (Inflammatory arthritis).
Arthritis
Mild pain with inflammation, erythema, or joint swellingModerate pain associated with signs of inflammation, erythema, or joint swelling; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain associated with signs of inflammation, erythema, or joint swelling; irreversible joint damage; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by inflammation involving a joint.
Navigational Note: Report Inflammatory arthritis as Musculoskeletal and connective tissue disorder - Other, specify (Inflammatory arthritis).
Back pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the back region.
Navigational Note: Consider Injury, poisoning and procedural complications: Infusion related reaction; Record final diagnosis/cause once determined.
Bone pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the bones.
Navigational Note: Record final diagnosis/cause once determined.
Buttock pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the buttocks.
Navigational Note: Record final diagnosis/cause once determined.
Chest wall necrosis
 -Local wound care; medical intervention indicated (e.g., dressings or topical medications)Operative debridement or other invasive intervention indicated (e.g., tissue reconstruction, flap, or grafting)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the chest wall including breast.
Navigational Note: -
Chest wall pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the chest wall.
Navigational Note: Report Inflammatory costochondritis as Musculoskeletal and connective tissue disorder - Other, specify (Inflammatory costochondritis). Record final diagnosis/cause once determined.
Exostosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; elective operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by non-neoplastic overgrowth of bone.
Navigational Note: -
Fibrosis deep connective tissue
Mild induration, able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up)Moderate induration, able to slide skin, unable to pinch skin; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe induration; unable to slide or pinch skin; limiting joint or orifice movement (e.g., mouth, anus); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Generalized; associated with signs or symptoms of impaired breathing or feedingDeath
Definition: A disorder characterized by fibrotic degeneration of the deep connective tissues.
Navigational Note: -
Flank pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort on the lateral side of the body in the region below the ribs and above the hip.
Navigational Note: Record final diagnosis/cause once determined.
Generalized muscle weakness
Symptomatic; perceived by patient but not evident on physical examSymptomatic; evident on physical exam; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a reduction in the strength of muscles in multiple anatomic sites.
Navigational Note: Record final diagnosis/cause once determined.
Growth accelerated
 ->=+2 SD (standard deviation) above mid parental height or target height - - -
Definition: A disorder characterized by greater growth than expected for age.
Navigational Note: -
Growth suppression
Reduction in growth velocity by 10 - 29% ideally measured over the period of a yearReduction in growth velocity by 30 - 49% ideally measured over the period of a year or 0 - 49% reduction in growth from the baseline growth curveReduction in growth velocity of >=50% ideally measured over the period of a year - -
Definition: A disorder characterized by stature that is smaller than normal as expected for age.
Navigational Note: -
Head soft tissue necrosis
 -Local wound care; medical intervention indicated (e.g., dressings or topical medications)Operative debridement or other invasive intervention indicated (e.g., tissue reconstruction, flap, or grafting)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the head.
Navigational Note: Consider Respiratory, thoracic and mediastinal disorders: Sinus disorder, Grade 4.
Joint effusion
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; invasive intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by excessive fluid in a joint, usually as a result of joint inflammation.
Navigational Note: -
Joint range of motion decreased
<=25% loss of ROM (range of motion); decreased ROM limiting athletic activity>25 - 50% decrease in ROM; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)>50% decrease in ROM; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a decrease in joint flexibility of any joint.
Navigational Note: Report Inflammatory arthritis as Musculoskeletal and connective tissue disorder - Other, specify (Inflammatory arthritis).
Joint range of motion decreased cervical spine
Mild restriction of rotation or flexion between 60 - 70 degreesRotation <60 degrees to right or left; <60 degrees of flexionAnkylosed/fused over multiple segments with no C-spine rotation - -
Definition: A disorder characterized by a decrease in flexibility of a cervical spine joint.
Navigational Note: Report Inflammatory arthritis as Musculoskeletal and connective tissue disorder - Other, specify (Inflammatory arthritis).
Joint range of motion decreased lumbar spine
Stiffness; difficulty bending to the floor to pick up a very light object but able to do athletic activityPain with range of motion (ROM) in lumbar spine; requires a reaching aid to pick up a very light object from the floor<50% lumbar spine flexion; associated with symptoms of ankylosis or fused over multiple segments with no L-spine flexion (e.g., unable to reach to floor to pick up a very light object) - -
Definition: A disorder characterized by a decrease in flexibility of a lumbar spine joint.
Navigational Note: Report Inflammatory arthritis as Musculoskeletal and connective tissue disorder - Other, specify (Inflammatory arthritis).
Kyphosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedModerate accentuation; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe accentuation; operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by an abnormal increase in the curvature of the thoracic portion of the spine.
Navigational Note: -
Lordosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedModerate accentuation; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe accentuation; operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by an abnormal increase in the curvature of the lumbar portion of the spine.
Navigational Note: -
Muscle cramp
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by marked cramping sensation originating from a muscle or group of muscles.
Navigational Note: Synonym: Muscle spasm
Muscle weakness lower limb
Symptomatic; perceived by patient but not evident on physical examSymptomatic; evident on physical exam; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a reduction in the strength of the lower limb muscles.
Navigational Note: Consider Musculoskeletal and connective tissue disorders: Myositis; Immune system disorders: Immune system disorders - Other, specify; Injury, poisoning and procedural complications: Fall.
Muscle weakness trunk
Symptomatic; perceived by patient but not evident on physical examSymptomatic; evident on physical exam; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a reduction in the strength of the trunk muscles.
Navigational Note: Consider Musculoskeletal and connective tissue disorders: Myositis; Immune system disorders: Immune system disorders - Other, specify; Injury, poisoning and procedural complications: Fall.
Muscle weakness upper limb
Symptomatic; perceived by patient but not evident on physical examSymptomatic; evident on physical exam; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a reduction in the strength of the upper limb muscles.
Navigational Note: Consider Musculoskeletal and connective tissue disorders: Myositis; Immune system disorders: Immune system disorders - Other, specify; Injury, poisoning and procedural complications: Fall.
Musculoskeletal deformity
Cosmetically and functionally insignificant hypoplasiaDeformity, hypoplasia, or asymmetry able to be remediated by prosthesis (e.g., shoe insert) or covered by clothingSignificant deformity, hypoplasia, or asymmetry, unable to be remediated by prosthesis or covered by clothing; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by an abnormality of the musculoskeletal system.
Navigational Note: -
Myalgia
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by marked discomfort sensation originating from a muscle or group of muscles.
Navigational Note: Record final diagnosis/cause once determined.
Myositis
Mild painModerate pain associated with weakness; pain limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Pain associated with severe weakness; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicated -
Definition: A disorder characterized by inflammation involving the skeletal muscles.
Navigational Note: Record final diagnosis/cause once determined.
Neck pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the neck area.
Navigational Note: Record final diagnosis/cause once determined.
Neck soft tissue necrosis
 -Local wound care; medical intervention indicated (e.g., dressings or topical medications)Operative debridement or other invasive intervention indicated (e.g., tissue reconstruction, flap, or grafting)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the neck.
Navigational Note: -
Osteonecrosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; medical intervention indicated (e.g., analgesics or bisphosphonates); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; elective operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by necrotic changes in the bone tissue due to interruption of blood supply. Most often affecting the epiphysis of the long bones, the necrotic changes result in the collapse and the destruction of the bone structure.
Navigational Note: -
Osteonecrosis of jaw
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; medical intervention indicated (e.g., topical agents); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; elective operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a necrotic process occurring in the bone of the mandible.
Navigational Note: -
Osteoporosis
Adult: Radiologic evidence of osteoporosis or Bone Mineral Density (BMD) t-score -1 to -2.5 (osteopenia); Pediatric: BMD z score of <=-2.0 and no history of significant fracturesAdult: BMD t-score <-2.5; loss of height <2 cm; therapy to improve BMD indicated; limiting instrumental ADL; Pediatric: BMD z-score <=-2.0 and significant fracture history (defined as a long bone fracture of the lower extremity, vertebral compression, 2 or more long bone fractures of the upper extremities); mild/moderate impact on age-appropriate normal daily activityAdult: Loss of height >=2 cm; hospitalization indicated; limiting self-care ADL; Pediatric: Severe impact on age-appropriate normal daily activity - -
Definition: A disorder characterized by reduced bone mass, with a decrease in cortical thickness and in the number and size of the trabeculae of cancellous bone (but normal chemical composition), resulting in increased fracture incidence.
Navigational Note: -
Pain in extremity
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the upper or lower extremities.
Navigational Note: Record final diagnosis/cause once determined.
Pelvic soft tissue necrosis
 -Local wound care; medical intervention indicated (e.g., dressings or topical medications)Operative debridement or other invasive intervention indicated (e.g., tissue reconstruction, flap, or grafting)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the pelvis.
Navigational Note: -
Rhabdomyolysis
Asymptomatic, intervention not indicated; laboratory findings onlyNon-urgent intervention indicatedSymptomatic, urgent intervention indicatedLife-threatening consequences; dialysisDeath
Definition: A disorder characterized by the breakdown of muscle tissue resulting in the release of muscle fiber contents into the bloodstream.
Navigational Note: Record final diagnosis/cause once determined.
Rotator cuff injury
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental AD or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by an injury of the rotator cuff.
Navigational Note: -
Scoliosis
<20 degrees; clinically undetectable>20 - 45 degrees; visible by forward flexion; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)>45 degrees; scapular prominence in forward flexion; operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a lateral curvature of the spine.
Navigational Note: -
Soft tissue necrosis lower limb
 -Local wound care; medical intervention indicated (e.g., dressings or topical medications)Operative debridement or other invasive intervention indicated (e.g., tissue reconstruction, flap, or grafting)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the lower extremity.
Navigational Note: -
Soft tissue necrosis upper limb
 -Local wound care; medical intervention indicated (e.g., dressings or topical medications)Operative debridement or other invasive intervention indicated (e.g., tissue reconstruction, flap, or grafting)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the upper extremity.
Navigational Note: -
Superficial soft tissue fibrosis
Mild induration, able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up)Moderate induration, able to slide skin, unable to pinch skin; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe induration; unable to slide or pinch skin; limiting joint or orifice movement (e.g., mouth, anus); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Generalized; associated with signs or symptoms of impaired breathing or feedingDeath
Definition: A disorder characterized by fibrotic degeneration of the superficial soft tissues.
Navigational Note: -
Trismus
Decreased ROM (range of motion) without impaired eatingDecreased ROM requiring small bites, soft foods or pureesDecreased ROM with inability to adequately aliment or hydrate orally - -
Definition: A disorder characterized by lack of ability to open the mouth fully due to a decrease in the range of motion of the muscles of mastication.
Navigational Note: -
Unequal limb length
Mild length discrepancy <2 cmModerate length discrepancy 2 - 5 cm; shoe lift indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe length discrepancy >5 cm; operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a discrepancy between the lengths of the lower or upper extremities.
Navigational Note: -
Musculoskeletal and connective tissue disorder - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
Navigational Note: -
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Differentiation syndrome
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local, or noninvasive intervention indicated; limiting age appropriate instrumental ADLSevere or medically significant but not immediately life-threatening; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A potentially fatal complication of treatment in certain molecular subgroups of leukemia characterized by fever, rash, dyspnea and/or hypoxia, pulmonary infiltrates, peripheral edema with rapid weight gain, pleuropericardial effusion, acute renal failure, disseminated intravascular coagulation (DIC), bone pain and/or hypotension.
Navigational Note: -
Keratoacanthoma
 -Present - - -
Definition: A disorder characterized by a cutaneous tumor that most commonly presents a dome-shaped nodule with a central keratin-filled crater.
Navigational Note: -
Leukemia secondary to oncology chemotherapy
 - - -PresentDeath
Definition: A disorder characterized by leukemia arising as a result of the mutagenic effect of chemotherapy agents.
Navigational Note: -
Myelodysplastic syndrome
 - - -Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by insufficiently healthy hematapoietic cell production by the bone marrow.
Navigational Note: -
Retinoic acid syndrome
Fluid retention; <3 kg of weight gain; intervention with fluid restriction and/or diuretics indicatedModerate signs or symptoms; steroids indicatedSevere symptoms; hospitalization indicatedLife-threatening consequences; ventilatory support indicatedDeath
Definition: A disorder characterized by weight gain, dyspnea, pleural and pericardial effusions, leukocytosis and/or renal failure originally described in patients treated with all-trans retinoic acid.
Navigational Note: -
Skin papilloma
Asymptomatic; intervention not indicatedIntervention initiated - - -
Definition: A disorder characterized by the presence of one or more warts.
Navigational Note: -
Treatment related secondary malignancy
 - -Non life-threatening secondary malignancyAcute life-threatening secondary malignancy; blast crisis in leukemiaDeath
Definition: A disorder characterized by development of a malignancy most probably as a result of treatment for a previously existing malignancy.
Navigational Note: -
Tumor hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding in a tumor.
Navigational Note: -
Tumor pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort from a neoplasm that may be pressing on a nerve, blocking blood vessels, inflamed or fractured from metastasis.
Navigational Note: Record final diagnosis/cause once determined.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
Navigational Note: -
Nervous system disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Nervous system disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Abducens nerve disorder
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by dysfunction of the abducens nerve (sixth cranial nerve).
Navigational Note: Consider Nervous system disorders: Peripheral motor neuropathy, Peripheral sensory neuropathy.
Accessory nerve disorder
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by dysfunction of the accessory nerve (eleventh cranial nerve).
Navigational Note: Consider Nervous system disorders: Peripheral motor neuropathy, Peripheral sensory neuropathy.
Acoustic nerve disorder NOS
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by dysfunction of the acoustic nerve (eighth cranial nerve).
Navigational Note: Consider Nervous system disorders: Peripheral motor neuropathy, Peripheral sensory neuropathy.
Akathisia
Mild restlessness or increased motor activityModerate restlessness or increased motor activity; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe restlessness or increased motor activity; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by an uncomfortable feeling of inner restlessness and inability to stay still; this is a side effect of some psychotropic drugs.
Navigational Note: -
Amnesia
Mild; transient memory lossModerate; short term memory loss; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe; long term memory loss; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by systematic and extensive loss of memory.
Navigational Note: -
Anosmia
Present - - - -
Definition: A disorder characterized by a change in the sense of smell.
Navigational Note: Consider Nervous system disorders: Olfactory nerve disorder.
Arachnoiditis
Mild symptomsModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by inflammation of the arachnoid membrane and adjacent subarachnoid space.
Navigational Note: -
Ataxia
Mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; mechanical assistance indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by lack of coordination of muscle movements resulting in the impairment or inability to perform voluntary activities.
Navigational Note: Record final diagnosis/cause once determined.
Autonomic neuropathy
Mild symptomsModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by damage to nerves that control your internal organs.
Navigational Note: -
Brachial plexopathy
Mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by regional paresthesia of the brachial plexus, marked discomfort and muscle weakness, and limited movement in the arm or hand.
Navigational Note: -
Brain fog
PresentLimiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric) - - -
Definition: A disorder characterized by thinking and memory problems that a patient with cancer may have during or after cancer treatment.
Navigational Note: -
Central nervous system necrosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; corticosteroids indicatedSevere symptoms; medical intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a necrotic process occurring in the brain and/or spinal cord.
Navigational Note: -
Cerebral venous sinus thrombosis
 -Intervention not indicatedMedical intervention indicated (e.g., anticoagulants)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a thrombus (blood clot) in the brain’s venous sinuses leading to swelling and bleeding.
Navigational Note: -
Cerebrospinal fluid leakage
Post-craniotomy: asymptomatic; post-lumbar puncture: transient headache; postural care indicatedPost-craniotomy: moderate symptoms; medical intervention indicated; post-lumbar puncture: persistent moderate symptoms; blood patch indicatedSevere symptoms; medical intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by loss of cerebrospinal fluid into the surrounding tissues.
Navigational Note: -
Cognitive disturbance
Mild cognitive disability; not interfering with work/school/life performance; specialized educational services/devices not indicatedModerate cognitive disability; interfering with work/school/life performance but capable of independent living; specialized resources on part time basis indicatedSevere cognitive disability; significant impairment of work/school/life performance - -
Definition: A disorder characterized by a conspicuous change in cognitive function.
Navigational Note: Record final diagnosis/cause once determined.
Concentration impairment
Mild inattention or decreased level of concentrationModerate impairment in attention or decreased level of concentration; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe impairment in attention or decreased level of concentration; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a deterioration in the ability to concentrate.
Navigational Note: -
Depressed level of consciousness
Decreased level of alertnessSedation; slow response to stimuli; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Difficult to arouseLife-threatening consequences; coma; urgent intervention indicatedDeath
Definition: A disorder characterized by a decrease in ability to perceive and respond.
Navigational Note: Record final diagnosis/cause once determined.
Dizziness
Mild unsteadiness or sensation of movementModerate unsteadiness or sensation of movement; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe unsteadiness or sensation of movement; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a disturbing sensation of lightheadedness, unsteadiness, giddiness, spinning or rocking.
Navigational Note: Record final diagnosis/cause once determined.
Dysarthria
Mild slurred speechModerate impairment of articulation or slurred speechSevere impairment of articulation or slurred speech - -
Definition: A disorder characterized by slow and slurred speech resulting from an inability to coordinate the muscles used in speech.
Navigational Note: Record final diagnosis/cause once determined.
Dysesthesia
Mild sensory alterationModerate sensory alteration; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe sensory alteration; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by distortion of sensory perception, resulting in an abnormal and unpleasant sensation.
Navigational Note: Record final diagnosis/cause once determined.
Dysgeusia
Altered taste but no change in dietAltered taste with change in diet (e.g., oral supplements); noxious or unpleasant taste; loss of taste - - -
Definition: A disorder characterized by abnormal sensual experience with the taste of foodstuffs; it can be related to a decrease in the sense of smell.
Navigational Note: -
Dysphasia
Awareness of receptive or expressive characteristics; not impairing ability to communicateModerate receptive or expressive characteristics; impairing ability to communicate spontaneouslySevere receptive or expressive characteristics; impairing ability to read, write or communicate intelligiblyTotal loss of the ability to read, write, or communicate intelligibly -
Definition: A disorder characterized by impairment of verbal communication skills, often resulting from brain damage.
Navigational Note: Record final diagnosis/cause once determined.
Edema cerebral
Radiographic finding only and no medical management initiated -New onset; worsening from baseline; initiation of steroid therapyLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by swelling due to an excessive accumulation of fluid in the brain.
Navigational Note: Record final diagnosis/cause once determined.
Encephalopathy
Mild symptomsModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a pathologic process involving the brain.
Navigational Note: -
Extrapyramidal disorder
Mild involuntary movementsModerate involuntary movements; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe involuntary movements or torticollis; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by abnormal, repetitive, involuntary muscle movements, frenzied speech and extreme restlessness.
Navigational Note: -
Facial muscle weakness
Mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a reduction in the strength of the facial muscles.
Navigational Note: Record final diagnosis/cause once determined.
Facial nerve disorder
Mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by dysfunction of the facial nerve (seventh cranial nerve).
Navigational Note: -
Glossopharyngeal nerve disorder
Mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by dysfunction of the glossopharyngeal nerve (ninth cranial nerve).
Navigational Note: -
Guillain-Barre syndrome
Mild symptomsModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicated; intubationDeath
Definition: A disorder characterized by the body's immune system attacking the peripheral nervous system causing ascending paralysis.
Navigational Note: -
Headache
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in various parts of the head, not confined to the area of distribution of any nerve.
Navigational Note: -
Hemiparesis
Symptomatic; perceived by patient but not evident on physical examSymptomatic; evident on physical exam; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a reduction in the strength of the muscles on one side of the body.
Navigational Note: -
Hydrocephalus
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; intervention not indicatedSevere symptoms or neurological deficit; intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal increase of cerebrospinal fluid in the ventricles of the brain.
Navigational Note: -
Hypersomnia
Mild increased need for sleepModerate increased need for sleepSevere increased need for sleep - -
Definition: A disorder characterized by excessive sleepiness during the daytime.
Navigational Note: -
Hypoglossal nerve disorder
Mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by dysfunction of the hypoglossal nerve (twelfth cranial nerve).
Navigational Note: -
Immune effector cell-associated neurotoxicity syndrome
Mild symptoms; Immune Effector Cell-Associated Encephalopathy (ICE) score 7 - 9; Cornell Assessment of Pediatric Delirium (CAPD) score 1 - 8 AND awakens spontaneouslyModerate symptoms; ICE score 3 - 6; CAPD score 1 - 8 AND awakens to voice; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; ICE score 0 - 2; CAPD score >=9 AND awakens only to tactile stimulus; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a pathologic process involving the central nervous system following any immune therapy that results in the activation or engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms or signs can be progressive and may include aphasia, altered level of consciousness, impairment of cognitive skills, motor weakness, seizures, and cerebral edema.
Navigational Note: -
Intracranial hemorrhage
Mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; intervention indicatedVentriculostomy, ICP monitoring, intraventricular thrombolysis, or invasive intervention indicated; hospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from within the cranium.
Navigational Note: -
Lethargy
Mild symptoms; reduced alertness and awarenessModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric) - - -
Definition: A disorder characterized by a decrease in consciousness characterized by mental and physical inertness.
Navigational Note: Record final diagnosis/cause once determined.
Leukoencephalopathy
Asymptomatic; small focal T2/FLAIR hyperintensities; involving periventricular white matter or <1/3 of susceptible areas of cerebrum +/- mild increase in subarachnoid space (SAS) and/or mild ventriculomegalyModerate symptoms; focal T2/FLAIR hyperintensities, involving periventricular white matter extending into centrum semiovale or involving 1/3 to 2/3 of susceptible areas of cerebrum +/- moderate increase in SAS and/or moderate ventriculomegalySevere symptoms; extensive T2/FLAIR hyperintensities, involving periventricular white matter involving 2/3 or more of susceptible areas of cerebrum +/- moderate to severe increase in SAS and/or moderate to severe ventriculomegalyLife-threatening consequences; extensive T2/FLAIR hyperintensities, involving periventricular white matter involving most of susceptible areas of cerebrum +/- moderate to severe increase in SAS and/or moderate to severe ventriculomegalyDeath
Definition: A disorder characterized by diffuse reactive astrocytosis with multiple areas of necrotic foci without inflammation.
Navigational Note: -
Memory impairment
Mild memory impairmentModerate memory impairment; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe memory impairment; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a deterioration in memory function.
Navigational Note: -
Meningismus
Mild symptomsModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by neck stiffness, headache, and photophobia resulting from irritation of the cerebral meninges.
Navigational Note: -
Movements involuntary
Mild symptomsModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by uncontrolled and purposeless movements.
Navigational Note: -
Myasthenia gravis
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by weakness and rapid fatigue of any of the skeletal muscles.
Navigational Note: -
Neuralgia
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by intense painful sensation along a nerve or group of nerves.
Navigational Note: -
Nystagmus
 -Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by involuntary movements of the eyeballs.
Navigational Note: -
Oculomotor nerve disorder
Mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by dysfunction of the oculomotor nerve (third cranial nerve).
Navigational Note: -
Olfactory nerve disorder
 -Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by dysfunction of the olfactory nerve (first cranial nerve).
Navigational Note: -
Optic neuritis
Asymptomatic or mild symptoms; only enhancement on MRI scan with no change in visionTreatment indicated; best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline in the affected eye; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately sight-threatening; decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200) in the affected eye; oral steroids indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Sight-threatening consequences; urgent intervention indicated; best corrected visual acuity of 20/200 or worse in the affected eye: significant visual field loss; marked optic disc edema or enhancement on MRI scan; intravenous steroids indicated; blindness -
Definition: A disorder characterized by inflammation and demyelination of the optic nerve that causes acute, usually monocular, visual loss.
Navigational Note: -
Paresthesia
Mild symptomsModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by functional disturbances of sensory neurons resulting in abnormal cutaneous sensations of tingling, numbness, pressure, cold, and/or warmth.
Navigational Note: Consider Nervous system disorders: Peripheral motor neuropathy, Peripheral sensory neuropathy.
Peripheral motor neuropathy
Mild symptoms; clinical or diagnostic observations onlyModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by damage or dysfunction of the peripheral motor nerves.
Navigational Note: Consider Nervous system disorders: Peripheral sensory neuropathy.
Peripheral sensory neuropathy
Mild symptomsModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicated -
Definition: A disorder characterized by damage or dysfunction of the peripheral sensory nerves.
Navigational Note: -
Phantom pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort related to a limb or an organ that is removed from or is not physically part of the body.
Navigational Note: Record final diagnosis/cause once determined.
Presyncope
 -Present (e.g., near fainting) - - -
Definition: A disorder characterized by an episode of lightheadedness and dizziness which may precede an episode of syncope.
Navigational Note: Record final diagnosis/cause once determined.
Pyramidal tract syndrome
Mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by dysfunction of the corticospinal (pyramidal) tracts of the spinal cord. Symptoms include an increase in the muscle tone in the lower extremities, hyperreflexia, positive Babinski and a decrease in fine motor coordination.
Navigational Note: -
Radiculitis
Mild symptomsModerate symptoms; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by inflammation involving a nerve root. Patients experience marked discomfort radiating along a nerve path because of spinal pressure on the connecting nerve root.
Navigational Note: -
Recurrent laryngeal nerve palsy
Mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate symptomsSevere symptoms; medical intervention indicated (e.g., thyroplasty, vocal cord injection)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by paralysis of the recurrent laryngeal nerve.
Navigational Note: -
Reversible posterior leukoencephalopathy syndrome
 -Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; hospitalization; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequencesDeath
Definition: A disorder characterized by headaches, mental status changes, visual disturbances, and/or seizures associated with imaging findings of posterior leukoencephalopathy. It has been observed in association with hypertensive encephalopathy, eclampsia, and immunosuppressive and cytotoxic drug treatment. It is an acute or subacute reversible condition. Also known as posterior reversible encephalopathy syndrome (PRES).
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Seizure
Brief partial/focal seizure and no loss of consciousnessBrief generalized seizure; seizure(s) well controlled by anticonvulsants; infrequent partial/focal motor seizuresNew onset seizures (partial/focal or generalized); multiple seizures despite medical interventionLife-threatening consequences; prolonged repetitive generalized seizuresDeath
Definition: A disorder characterized by a sudden, involuntary skeletal muscular contractions of cerebral or brain stem origin.
Navigational Note: -
Somnolence
Mild but more than usual drowsiness or sleepinessModerate sedation; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Obtundation or stuporLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by characterized by excessive sleepiness and drowsiness.
Navigational Note: -
Spasticity
Mild or slight increase in muscle toneModerate increase in muscle tone and increase in resistance through range of motionSevere increase in muscle tone and increase in resistance through range of motionLife-threatening consequences; unable to move active or passive range of motionDeath
Definition: A disorder characterized by increased involuntary muscle tone that affects the regions interfering with voluntary movement. It results in gait, movement, and speech disturbances.
Navigational Note: -
Spinal cord compression
Radiologic findings onlyMild or moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by pressure on the spinal cord.
Navigational Note: -
Stroke
Incidental radiographic findings onlyMild to moderate neurologic deficit; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe neurologic deficit; hospitalization; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an interruption of blood supply to parts of the brain resulting in neurological damage.
Navigational Note: -
Syncope
 - -Fainting; orthostatic collapse - -
Definition: A disorder characterized by spontaneous loss of consciousness caused by insufficient blood supply to the brain.
Navigational Note: Record final diagnosis/cause once determined.
Tendon reflex decreased
Ankle reflex reducedAnkle reflex absent; other reflexes reducedAbsence of all reflexes - -
Definition: A disorder characterized by less than normal deep tendon reflexes.
Navigational Note: Consider Nervous system disorders: Peripheral motor neuropathy, Peripheral sensory neuropathy.
Transient ischemic attacks
Mild neurologic deficit with or without imaging confirmationModerate neurologic deficit with or without imaging confirmation - - -
Definition: A disorder characterized by a brief attack (less than 24 hours) of cerebral dysfunction of vascular origin, with no persistent neurological deficit.
Navigational Note: If >24 hours, Consider Nervous system disorders: Stroke.
Tremor
Mild symptomsModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by the uncontrolled shaking movement of the whole body or individual parts.
Navigational Note: -
Trigeminal nerve disorder
Mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by dysfunction of the trigeminal nerve (fifth cranial nerve).
Navigational Note: -
Trochlear nerve disorder
Mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by dysfunction of the trochlear nerve (fourth cranial nerve).
Navigational Note: -
Tumor inflammation-associated neurotoxicity
Headaches associated with fevers; mild worsening of existing neurological clinical signs and symptoms from baseline, resulting in minor functional deficits for which only observation or symptomatic management is neededModerate changes in the neurological exam from baseline that substantially affect functionSevere neurological clinical signs and symptoms that may affect critical cardiorespiratory functions; clinical signs and symptoms of increased intracranial pressure (>20 mmHg) that are responsive to interventionLife-threatening, clinically significant elevated ICP (>20 mmHg) refractory to CSF drainage with no improvement in clinical symptoms in response to CSF drainage, possibly warranting urgent escalation of neurosurgical intervention; clinical signs and symptoms of impending/early herniation; severe medullary dysfunction requiring endotracheal intubation for airway protection and/or mechanical ventilationDeath
Definition: A disorder characterized by localized neurotoxicity related to cellular therapies or other immunotherapies for CNS tumors (TIAN).
Navigational Note: -
Vagus nerve disorder
Mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by dysfunction of the vagus nerve (tenth cranial nerve).
Navigational Note: Record final diagnosis/cause once determined.
Vasovagal reaction
 -No management indicatedRequires active managementLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a sudden drop of the blood pressure, bradycardia, and peripheral vasodilation that may lead to loss of consciousness. It results from an increase in the stimulation of the vagus nerve.
Navigational Note: -
Nervous system disorders - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
Navigational Note: -
Pregnancy, puerperium and perinatal conditions
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Pregnancy, puerperium and perinatal conditions
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Fetal growth retardation
 -5 - <10% percentile of weight for gestational age1 - <5% percentile of weight for gestational age<1% percentile of weight for gestational age -
Definition: A disorder characterized by inhibition of fetal growth resulting in the inability of the fetus to achieve its potential weight.
Navigational Note: -
Pregnancy loss
 - - -Fetal loss at any gestational age -
Definition: Death in utero.
Navigational Note: -
Premature delivery
Delivery of a liveborn infant at >34 to 37 weeks gestationDelivery of a liveborn infant at >28 to 34 weeks gestationDelivery of a liveborn infant at 24 to 28 weeks gestationDelivery of a liveborn infant at 24 weeks of gestation or less -
Definition: A disorder characterized by delivery of a viable infant before the normal end of gestation. Typically, viability is achievable between the twentieth and thirty-seventh week of gestation.
Navigational Note: -
Pregnancy, puerperium and perinatal conditions - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
Navigational Note: -
Psychiatric disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Psychiatric disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Agitation
Mild mood alterationModerate mood alterationSevere agitation; hospitalization not indicatedLife-threatening consequences; urgent intervention indicated -
Definition: A disorder characterized by a state of restlessness associated with unpleasant feelings of irritability and tension.
Navigational Note: -
Anorgasmia
Inability to achieve orgasm not adversely affecting relationshipInability to achieve orgasm adversely affecting relationship - - -
Definition: A disorder characterized by an inability to achieve orgasm.
Navigational Note: -
Anxiety
Mild symptoms; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicated -
Definition: A disorder characterized by apprehension of danger and dread accompanied by restlessness, tension, tachycardia, and dyspnea unattached to a clearly identifiable stimulus.
Navigational Note: -
Confusion
Mild disorientationModerate disorientation; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe disorientation; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicated -
Definition: A disorder characterized by a lack of clear and orderly thought and behavior.
Navigational Note: -
Delayed orgasm
Delay in achieving orgasm not adversely affecting relationshipDelay in achieving orgasm adversely affecting relationship - - -
Definition: A disorder characterized by sexual dysfunction characterized by a delay in climax.
Navigational Note: -
Delirium
Mild acute confusional stateModerate and acute confusional state; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe and acute confusional state; hospitalization indicated; urgent intervention indicated; new onset; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences, threats of harm to self or others; urgent intervention indicatedDeath
Definition: A disorder characterized by the acute and sudden development of confusion, illusions, movement changes, inattentiveness, agitation, and hallucinations. Usually, it is a reversible condition.
Navigational Note: -
Delusions
 -Moderate delusional symptomsSevere delusional symptoms; outpatient management; new onsetLife-threatening consequences, threats of harm to self or others; hospitalization indicatedDeath
Definition: A disorder characterized by false personal beliefs held contrary to reality, despite contradictory evidence and common sense.
Navigational Note: -
Depression
Mild depressive symptomsModerate depressive symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe depressive symptoms; hospitalization not indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences, threats of harm to self or others; hospitalization indicatedDeath
Definition: A disorder characterized by melancholic feelings of grief or unhappiness.
Navigational Note: -
Euphoria
Mild mood elevationModerate mood elevationSevere mood elevation (e.g., hypomania) - -
Definition: A disorder characterized by an exaggerated feeling of well-being which is disproportionate to events and stimuli.
Navigational Note: -
Hallucinations
Mild hallucinations (e.g., perceptual distortions)Moderate hallucinationsSevere hallucinations; hospitalization not indicatedLife-threatening consequences, threats of harm to self or others; hospitalization indicatedDeath
Definition: A disorder characterized by a false sensory perception in the absence of an external stimulus.
Navigational Note: -
Insomnia
Mild difficulty falling asleep, staying asleep or waking up earlyModerate difficulty falling asleep, staying asleep or waking up earlySevere difficulty in falling asleep, staying asleep or waking up early - -
Definition: A disorder characterized by difficulty in falling asleep and/or remaining asleep.
Navigational Note: -
Irritability
Mild; easily consolableModerate; increased attention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe abnormal or excessive response; inconsolable; medical or psychiatric intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by an abnormal responsiveness to stimuli or physiological arousal; may be in response to pain, fright, a drug, an emotional situation or a medical condition.
Navigational Note: -
Libido decreased
Decrease in sexual interest not adversely affecting relationshipDecrease in sexual interest adversely affecting relationship - - -
Definition: A disorder characterized by a decrease in sexual desire.
Navigational Note: -
Libido increased
Present - - - -
Definition: A disorder characterized by an increase in sexual desire.
Navigational Note: -
Mania
Mild manic symptoms (e.g., elevated mood, rapid thoughts, rapid speech, decreased need for sleep)Moderate manic symptoms (e.g., relationship and work difficulties; poor hygiene)Severe manic symptoms (e.g., hypomania; major sexual or financial indiscretions); hospitalization not indicated; new onsetLife-threatening consequences, threats of harm to self or others; hospitalization indicatedDeath
Definition: A disorder characterized by excitement of psychotic proportions manifested by mental and physical hyperactivity, disorganization of behavior and elevation of mood.
Navigational Note: -
Personality change
Mild personality changeModerate personality changeSevere personality change; hospitalization not indicatedLife-threatening consequences, threats of harm to self or others; hospitalization indicated -
Definition: A disorder characterized by a conspicuous change in a person's behavior and thinking.
Navigational Note: -
Psychosis
Mild psychotic symptomsModerate psychotic symptoms (e.g., disorganized speech; impaired reality testing)Severe psychotic symptoms (e.g., paranoid, extreme disorganization); hospitalization not indicated; new onsetLife-threatening consequences, threats of harm to self or others; hospitalization indicatedDeath
Definition: A disorder characterized by personality change, impaired functioning, and loss of touch with reality. It may be a manifestation of schizophrenia, bipolar disorder or brain tumor.
Navigational Note: -
Restlessness
Mild symptoms; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by an inability to rest, relax or be still.
Navigational Note: -
Suicidal ideation
Increased thoughts of death but no wish to kill oneselfSuicidal ideation with no specific plan or intentSpecific plan to commit suicide without serious intent to die which may not require hospitalizationSpecific plan to commit suicide with serious intent to die which requires hospitalization -
Definition: A disorder characterized by thoughts of taking one's own life.
Navigational Note: -
Suicide attempt
 - -Suicide attempt or gesture without intent to dieSuicide attempt with intent to die which requires hospitalizationDeath
Definition: A disorder characterized by self-inflicted harm in an attempt to end one's own life.
Navigational Note: -
Psychiatric disorders - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; hospitalization or urgent intervention indicatedDeath
Definition: -
Navigational Note: -
Renal and urinary disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Renal and urinary disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Acute kidney injury
 - -Hospitalization indicatedLife-threatening consequences; dialysis indicatedDeath
Definition: A disorder characterized by the acute loss of renal function (within 2 weeks).
Navigational Note: Consider Investigations: Creatinine increased; Renal and urinary disorders: Tubulointerstitial nephritis.
Bladder perforation
 -Invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; organ failure; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a rupture in the bladder wall.
Navigational Note: -
Bladder spasm
Intervention not indicatedAntispasmodics indicatedHospitalization indicated - -
Definition: A disorder characterized by a sudden and involuntary contraction of the bladder wall.
Navigational Note: -
Chronic kidney disease
eGFR (estimated Glomerular Filtration Rate) or CrCl (creatinine clearance) <LLN - 60 ml/min/1.73 m2 or proteinuria 2+ present; urine protein/creatinine >0.5eGFR or CrCl <60 - 30 ml/min/1.73 m2eGFR or CrCl <30 - 15 ml/min/1.73 m2eGFR or CrCl <15 ml/min/1.73 m2; dialysis or renal transplant indicatedDeath
Definition: A disorder characterized by loss of kidney function greater than three months duration.
Navigational Note: -
Cystitis noninfective
Microscopic hematuria; minimal increase in frequency, urgency, dysuria, or nocturia; new onset of incontinenceModerate hematuria; moderate increase in frequency, urgency, dysuria, nocturia or incontinence; urinary catheter placement or bladder irrigation indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Gross hematuria; transfusion, IV medications, or hospitalization indicated; elective invasive intervention indicatedLife-threatening consequences; urgent invasive intervention indicatedDeath
Definition: A disorder characterized by inflammation of the bladder which is not caused by an infection of the urinary tract.
Navigational Note: -
Dysuria
Present - - - -
Definition: A disorder characterized by painful urination.
Navigational Note: If associated with an infection, report the infection. For grades higher than Grade 1, consider Renal and urinary disorders: Bladder spasm, Cystitis noninfective; Infections and infestations: Urinary tract infection.
Glomerulonephritis
Asymptomatic; laboratory findings onlyDeclining glomerular filtration rate (GFR); edema; hypertension; oral management indicatedIV therapy indicated; immunosuppressant indicated; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicated; renal replacement therapyDeath
Definition: A disorder characterized by inflammation of the glomerulus, usually based on renal biopsy.
Navigational Note: -
Glucosuria
Present - - - -
Definition: A disorder characterized by laboratory test results that indicate glucose in the urine.
Navigational Note: -
Hematuria
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; urinary catheter or bladder irrigation indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Gross hematuria; transfusion, IV medications, or hospitalization indicated; elective invasive intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent invasive intervention indicatedDeath
Definition: A disorder characterized by laboratory test results that indicate blood in the urine.
Navigational Note: -
Hemoglobinuria
Asymptomatic; clinical or diagnostic observations only; intervention not indicated - - - -
Definition: A disorder characterized by laboratory test results that indicate the presence of free hemoglobin in the urine.
Navigational Note: Report underlying AE if > Grade 1.
Nephrotic syndrome
 - -IV therapy indicated; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicated; renal replacement therapy; anasarcaDeath
Definition: A disorder characterized by symptoms that include severe edema, proteinuria, and hypoalbuminemia; it is indicative of renal dysfunction.
Navigational Note: -
Nocturia
Present - - - -
Definition: A disorder characterized by the need to get up at night on a regular basis to urinate.
Navigational Note: -
Renal calculi
Asymptomatic or mild symptoms; occasional use of nonprescription analgesics indicatedSymptomatic; oral antiemetics indicated; around the clock nonprescription analgesics or any oral narcotic analgesics indicatedHospitalization indicated; IV intervention (e.g., analgesics, antiemetics); elective invasive intervention indicatedLife-threatening consequences; urgent invasive intervention indicatedDeath
Definition: A disorder characterized by the formation of crystals/kidney stones in the pelvis of the kidney.
Navigational Note: -
Renal colic
Mild pain not interfering with activity; nonprescription medication indicatedModerate pain; prescription medication indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by paroxysmal and severe flank marked discomfort radiating to the inguinal area. Often, the cause is the passage of crystals/kidney stones.
Navigational Note: -
Renal hemorrhage
Mild symptoms; intervention not indicatedAnalgesics and hematocrit monitoring indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the kidney.
Navigational Note: -
Tubulointerstitial nephritis
Laboratory findings without increase in creatinineIncrease in creatinine; oral management indicated with steroidIV therapy indicated; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by inflammation of the renal tubule and surrounding tissues.
Navigational Note: -
Urinary fistula
 -Symptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent invasive intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between any part of the urinary system and another organ or anatomic site.
Navigational Note: -
Urinary frequency
PresentMedical management indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric) - - -
Definition: A disorder characterized by urination at short intervals.
Navigational Note: -
Urinary incontinence
Occasional (e.g., with coughing, sneezing, etc.), pads not indicatedSpontaneous; pads indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Intervention indicated (e.g., clamp, collagen injections); operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by inability to control the flow of urine from the bladder.
Navigational Note: -
Urinary retention
Urinary, suprapubic or intermittent catheter placement not indicated; able to void with some residualPlacement of urinary, suprapubic or intermittent catheter placement indicated; medication indicatedElective invasive intervention indicated; substantial loss of affected kidney function or massLife-threatening consequences; organ failure; urgent operative intervention indicatedDeath
Definition: A disorder characterized by accumulation of urine within the bladder because of the inability to urinate.
Navigational Note: -
Urinary tract obstruction
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic but no hydronephrosis, sepsis, or renal dysfunction; urethral dilation, urinary or suprapubic catheter indicatedAltered organ function (e.g., hydronephrosis or renal dysfunction); invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by blockage of the normal flow of contents of the urinary tract.
Navigational Note: -
Urinary tract pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the urinary tract.
Navigational Note: Record final diagnosis/cause once determined.
Urinary urgency
PresentMedical management indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric) - - -
Definition: A disorder characterized by a sudden compelling urge to urinate.
Navigational Note: -
Urine discoloration
Present - - - -
Definition: A disorder characterized by a change in the color of the urine.
Navigational Note: -
Renal and urinary disorders - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
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Reproductive system and breast disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Reproductive system and breast disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Amenorrhea
 -Present - - -
Definition: A disorder characterized by the abnormal absence of menses for at least three consecutive menstrual cycles.
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Azoospermia
 -Absence of sperm in ejaculate - - -
Definition: A disorder characterized by laboratory test results that indicate complete absence of spermatozoa in the semen.
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Breast pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the breast region.
Navigational Note: Record final diagnosis/cause once determined.
Dysmenorrhea
Mild symptoms; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by abnormally painful abdominal cramps during menses.
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Dyspareunia
Mild discomfort or pain associated with vaginal penetration; discomfort relieved with use of vaginal lubricants or estrogenModerate discomfort or pain associated with vaginal penetration; discomfort or pain partially relieved with use of vaginal lubricants or estrogenSevere discomfort or pain associated with vaginal penetration; discomfort or pain unrelieved by vaginal lubricants or estrogen - -
Definition: A disorder characterized by painful or difficult coitus.
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Ejaculation disorder
Diminished ejaculationAnejaculation or retrograde ejaculation - - -
Definition: A disorder characterized by problems related to ejaculation. This category includes premature, delayed, retrograde and painful ejaculation.
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Erectile dysfunction
Decrease in erectile function (frequency or rigidity of erections) but intervention not indicated (e.g., medication or use of mechanical device, penile pump)Decrease in erectile function (frequency/rigidity of erections), erectile intervention indicated, (e.g., medication or mechanical devices such as penile pump)Decrease in erectile function (frequency/rigidity of erections) but erectile intervention not helpful (e.g., medication or mechanical devices such as penile pump); placement of a permanent penile prosthesis indicated (not previously present) - -
Definition: A disorder characterized by the persistent or recurrent inability to achieve or to maintain an erection during sexual activity.
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Fallopian tube obstruction
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; elective intervention indicatedSevere symptoms; invasive intervention indicated - -
Definition: A disorder characterized by blockage of the normal flow of the contents in the fallopian tube.
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Feminization acquired
Mild symptoms; intervention not indicatedModerate symptoms; medical intervention indicated - - -
Definition: A disorder characterized by the development of secondary female sex characteristics in males due to extrinsic factors.
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Gynecomastia
AsymptomaticSymptomatic (e.g., pain or psychosocial impact)Severe symptoms; elective operative intervention indicated - -
Definition: A disorder characterized by excessive development of the breasts in males.
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Hematosalpinx
Minimal bleeding identified on imaging study or laparoscopy; intervention not indicatedModerate bleeding; medical intervention indicatedInvasive intervention indicated; hospitalizationLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by the presence of blood in a fallopian tube.
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Irregular menstruation
Intermittent/irregular menses for <=3 consecutive menstrual cyclesIntermittent/irregular menses for >3 consecutive menstrual cycles - - -
Definition: A disorder characterized by a change in cycle or duration of menses from baseline.
Navigational Note: Consider Reproductive system and breast disorders: Amenorrhea.
Lactation disorder
Mild changes in lactation, not significantly affecting production or expression of breast milkChanges in lactation, significantly affecting breast production or expression of breast milk - - -
Definition: A disorder characterized by disturbances of milk secretion. It is not necessarily related to pregnancy that is observed in females and can be observed in males.
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Menorrhagia
Mild; iron supplements indicatedModerate symptoms; medical intervention indicated (e.g., hormones)Hospitalization; operative intervention indicated (e.g., hysterectomy)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by abnormally heavy vaginal bleeding during menses.
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Nipple deformity
Asymptomatic; asymmetry with slight retraction and/or thickening of the nipple areolar complexSymptomatic; asymmetry of nipple areolar complex with moderate retraction and/or thickening of the nipple areolar complex - - -
Definition: A disorder characterized by an abnormality of the nipple.
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Oligospermia
Sperm concentration >0 to <15 million/ml - - - -
Definition: A disorder characterized by a decrease in the number of spermatozoa in the semen.
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Ovarian function insufficiency
Intermittent/irregular menses for 3 consecutive months with basal FSH levels >25 IU/L but less than postmenopausal rangeAmenorrhea for 3 consecutive months with basal FSH levels >40 IU/L or in the postmenopausal range - - -
Definition: A disorder characterized by the development of oligomenorrhea or amenorrhea for at least 3 consecutive months and serum follicle-stimulating hormone (FSH) levels in the menopausal range before age 40. Symptoms of estrogen deficiency may include hot flashes, night sweats, mood swings, and vaginal dryness. Laboratory findings include elevated serum FSH. Other supportive laboratory findings include decreased serum estradiol and anti-Mullerian hormone (AMH) levels.
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Ovarian hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the ovary.
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Ovarian rupture
Asymptomatic clinical or diagnostic observations only; intervention not indicatedSymptomatic and intervention not indicatedTransfusion; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by tearing or disruption of the ovarian tissue.
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Ovulation pain
 -Present - - -
Definition: A disorder characterized by a sensation of marked discomfort in one side of the abdomen between menstrual cycles, around the time of the discharge of the ovum from the ovarian follicle.
Navigational Note: Record final diagnosis/cause once determined.
Pelvic floor muscle weakness
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic, not interfering with bladder, bowel, or vaginal function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a reduction in the strength of the muscles of the pelvic floor.
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Pelvic pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the pelvis.
Navigational Note: Record final diagnosis/cause once determined.
Penile pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the penis.
Navigational Note: Record final diagnosis/cause once determined.
Perineal pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the area between the genital organs and the anus.
Navigational Note: Record final diagnosis/cause once determined.
Prostatic hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the prostate gland.
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Prostatic obstruction
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; elective intervention indicatedSevere symptoms; invasive intervention indicated - -
Definition: A disorder characterized by compression of the urethra secondary to enlargement of the prostate gland. This results in voiding difficulties (straining to void, slow urine stream, and incomplete emptying of the bladder).
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Prostatic pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the prostate gland.
Navigational Note: Record final diagnosis/cause once determined.
Scrotal pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the scrotal area.
Navigational Note: Record final diagnosis/cause once determined.
Spermatic cord hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the spermatic cord.
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Spermatic cord obstruction
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; elective intervention indicatedSevere symptoms; invasive intervention indicated - -
Definition: A disorder characterized by blockage of the normal flow of the contents of the spermatic cord.
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Testicular disorder
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic but not interfering with sexual function; intervention not indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; interfering with sexual function; intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicated -
Definition: A disorder characterized by abnormal function or appearance of the testis.
Navigational Note: Consider other AE terms in the Renal and urinary disorders SOC or Reproductive system and breast disorders SOC.
Testicular hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the testis.
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Testicular pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the testis.
Navigational Note: Record final diagnosis/cause once determined.
Uterine fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the uterus and another organ or anatomic site.
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Uterine hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the uterus.
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Uterine obstruction
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; elective intervention indicatedSevere symptoms; invasive intervention indicated - -
Definition: A disorder characterized by blockage of the uterine outlet.
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Uterine pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the uterus.
Navigational Note: Record final diagnosis/cause once determined.
Vaginal discharge
Mild vaginal discharge (greater than baseline for patient)Moderate to heavy vaginal discharge; use of perineal pad or tampon indicated - - -
Definition: A disorder characterized by vaginal secretions. Mucus produced by the cervical glands is discharged from the vagina naturally, especially during the childbearing years.
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Vaginal dryness
Mild vaginal dryness not interfering with sexual functionModerate vaginal dryness interfering with sexual function or causing frequent discomfortSevere vaginal dryness resulting in dyspareunia or severe discomfort - -
Definition: A disorder characterized by an uncomfortable feeling of itching and burning in the vagina.
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Vaginal fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the vagina and another organ or anatomic site.
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Vaginal hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the vagina.
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Vaginal inflammation
Mild discomfort or pain, edema, or rednessModerate discomfort or pain, edema, or redness; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe discomfort or pain, edema, or redness; small areas of mucosal ulceration; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; widespread areas of mucosal ulceration; urgent intervention indicated -
Definition: A disorder characterized by inflammation involving the vagina. Symptoms may include redness, edema, marked discomfort and an increase in vaginal discharge.
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Vaginal obstruction
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; elective intervention indicatedSevere symptoms; invasive intervention indicated - -
Definition: A disorder characterized by blockage of vaginal canal.
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Vaginal pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the vagina.
Navigational Note: Record final diagnosis/cause once determined.
Vaginal perforation
 -Invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a rupture in the vaginal wall.
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Vaginal stricture
Asymptomatic; mild vaginal shortening or narrowingVaginal narrowing and/or shortening not interfering with physical examinationVaginal narrowing and/or shortening interfering with the use of tampons, sexual activity or physical examination -Death
Definition: A disorder characterized by a narrowing of the vaginal canal.
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Reproductive system and breast disorders - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
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Respiratory, thoracic and mediastinal disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Respiratory, thoracic and mediastinal disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Adult respiratory distress syndrome
 - -Present with radiologic findings; intubation not indicatedLife-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicatedDeath
Definition: A disorder characterized by progressive and life-threatening pulmonary distress in the absence of an underlying pulmonary condition, usually following major trauma or surgery.
Navigational Note: Consider Respiratory, thoracic and mediastinal disorders: Pneumonitis.
Allergic rhinitis
Mild symptoms; intervention not indicatedModerate symptoms; medical intervention indicated - - -
Definition: A disorder characterized by an inflammation of the nasal mucous membranes caused by an IgE-mediated response to external allergens. The inflammation may also involve the mucous membranes of the sinuses, eyes, middle ear, and pharynx. Symptoms include sneezing, nasal congestion, rhinorrhea and itching.
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Aphonia
 - -Voicelessness; unable to speak - -
Definition: A disorder characterized by the inability to speak. It may result from injuries to the vocal cords or may be functional (psychogenic).
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Apnea
 - -Present; medical intervention indicatedLife-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicatedDeath
Definition: A disorder characterized by cessation of breathing.
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Aspiration
Clinical or diagnostic observations only; intervention not indicatedAltered eating habits; coughing or choking episodes after eating or swallowing; medical intervention indicated (e.g., suction or oxygen)Dyspnea and pneumonia symptoms (e.g., aspiration pneumonia); hospitalization indicated; unable to aliment orallyLife-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicatedDeath
Definition: A disorder characterized by inhalation of solids or liquids into the lungs.
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Atelectasis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic (e.g., dyspnea, cough); medical intervention indicated (e.g., chest physiotherapy, suctioning); bronchoscopic suctioningSupplemental oxygen indicated; hospitalization or elective operative intervention indicated (e.g., stent, laser)Life-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicatedDeath
Definition: A disorder characterized by the collapse of part or the entire lung.
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Bronchial fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the bronchus and another organ or anatomic site.
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Bronchial obstruction
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic (e.g., mild wheezing); endoscopic evaluation indicated; radiographic evidence of atelectasis/lobar collapse; medical management indicated (e.g., steroids, bronchodilators)Shortness of breath with stridor; endoscopic intervention indicated (e.g., laser, stent placement)Life-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicatedDeath
Definition: A disorder characterized by blockage of a bronchus passage, most often by bronchial secretions and exudates.
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Bronchial stricture
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic (e.g., rhonchi or wheezing) but without respiratory distress; medical intervention indicated (e.g., steroids, bronchodilators)Shortness of breath with stridor; endoscopic intervention indicated (e.g., laser, stent placement)Life-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicatedDeath
Definition: A disorder characterized by a narrowing of the bronchial tube.
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Bronchopleural fistula
AsymptomaticSymptomatic, invasive intervention not indicatedHospitalization; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between a bronchus and the pleural cavity.
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Bronchopulmonary hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; invasive intervention not indicatedHospitalizationLife-threatening consequences; intubation or urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the bronchial wall and/or lung parenchyma.
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Bronchospasm
Mild symptoms; intervention not indicatedSymptomatic; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Supplemental oxygen indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicatedDeath
Definition: A disorder characterized by a sudden contraction of the smooth muscles of the bronchial wall or narrowing of the airway. May be manifested as wheezing.
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Chylothorax
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; medical intervention indicated (e.g., fat-restricted diet); thoracentesis or tube drainage indicatedSevere symptoms; elective operative intervention indicatedLife-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicatedDeath
Definition: A disorder characterized by milky pleural effusion (abnormal collection of fluid) resulting from accumulation of lymph fluid in the pleural cavity.
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Cough
Mild symptoms; nonprescription intervention indicatedModerate symptoms, medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by sudden, often repetitive, spasmodic contraction of the thoracic cavity, resulting in violent release of air from the lungs and usually accompanied by a distinctive sound.
Navigational Note: Record final diagnosis/cause once determined.
Dyspnea
Shortness of breath with moderate exertionShortness of breath with minimal exertion; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Shortness of breath at rest; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an uncomfortable sensation of difficulty breathing.
Navigational Note: Consider Cardiac disorders: Heart failure; Record final diagnosis/cause once determined.
Epistaxis
Mild symptoms; intervention not indicatedModerate symptoms; medical intervention indicated (e.g., nasal packing, cauterization; topical vasoconstrictors)Transfusion; invasive intervention indicated (e.g., hemostasis of bleeding site)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the nose.
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Hiccups
Mild symptoms; intervention not indicatedModerate symptoms; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; interfering with sleep; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by repeated gulp sounds that result from an involuntary opening and closing of the glottis. This is attributed to a spasm of the diaphragm.
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Hoarseness
Mild or intermittent voice change; fully understandable; self-resolvesModerate or persistent voice changes; may require occasional repetition but understandable on telephone; medical evaluation indicatedSevere voice changes including predominantly whispered speech - -
Definition: A disorder characterized by harsh and raspy voice arising from or spreading to the larynx.
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Hypoxia
Asymptomatic decrease in oxygen saturation <LLNDecreased oxygen saturation with exercise (e.g., pulse oximeter <88%); intermittent supplemental oxygenDecreased oxygen saturation at rest (e.g., pulse oximeter <88% or PaO2 <=55 mmHg); continuous supplemental oxygenLife-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)Death
Definition: A disorder characterized by a decrease in the level of oxygen in the body.
Navigational Note: Consider Respiratory, thoracic and mediastinal disorders: Dyspnea, Pneumonitis; Record final diagnosis/cause once determined.
Laryngeal edema
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; medical intervention indicated (e.g., dexamethasone, epinephrine, antihistamines)Stridor; respiratory distress; hospitalization indicatedLife-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)Death
Definition: A disorder characterized by swelling due to an excessive accumulation of fluid in the larynx.
Navigational Note: Record final diagnosis/cause once determined.
Laryngeal fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the larynx and another organ or anatomic site.
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Laryngeal hemorrhage
Mild cough or trace hemoptysis; laryngoscopic findingsModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicated (e.g., tracheotomy or intubation)Death
Definition: A disorder characterized by bleeding from the larynx.
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Laryngeal inflammation
Mild sore throat; raspy voiceModerate sore throat; analgesics indicatedSevere throat pain; endoscopic intervention indicated - -
Definition: A disorder characterized by an inflammation involving the larynx.
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Laryngeal mucositis
Endoscopic findings only; mild discomfort with normal intakeModerate pain, analgesics indicated; altered oral intake; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; severely altered eating/swallowing; medical intervention indicatedLife-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)Death
Definition: A disorder characterized by ulceration or inflammation involving the mucous membrane of the larynx.
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Laryngeal obstruction
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic (e.g., noisy airway breathing), no respiratory distress; medical intervention indicated (e.g., steroids); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Stridor; endoscopic intervention indicated (e.g., stent, laser); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by blockage of the laryngeal airway.
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Laryngeal stenosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic (e.g., noisy airway breathing), no respiratory distress; medical intervention indicated (e.g., steroids); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Stridor; endoscopic intervention indicated (e.g., stent, laser); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a narrowing of the laryngeal airway.
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Laryngopharyngeal dysesthesia
Mild symptoms; no anxiety; intervention not indicatedModerate symptoms; mild anxiety, but no dyspnea; short duration of observation and/or anxiolytic indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; dyspnea and swallowing difficulty; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequencesDeath
Definition: A disorder characterized by an uncomfortable persistent sensation in the area of the laryngopharynx.
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Laryngospasm
 -Transient episode; intervention not indicatedRecurrent episodes; noninvasive intervention indicated (e.g., breathing technique, pressure point massage)Persistent or severe episodes associated with syncope; urgent intervention indicated (e.g., fiberoptic laryngoscopy, intubation, botox injection)Death
Definition: A disorder characterized by paroxysmal spasmodic muscular contraction of the vocal cords.
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Mediastinal hemorrhage
Mild symptoms; intervention not indicated; radiologic evidence onlyModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the mediastinum.
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Nasal congestion
Mild symptoms; intervention not indicatedModerate symptoms; medical intervention indicatedAssociated with bloody nasal discharge or epistaxis - -
Definition: A disorder characterized by obstruction of the nasal passage due to mucosal edema.
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Oropharyngeal pain
Mild painModerate pain; altered oral intake; non-narcotics initiated; topical analgesics initiatedSevere pain; severely altered eating/swallowing; narcotics initiated; requires parenteral nutrition - -
Definition: A disorder characterized by a sensation of marked discomfort in the oropharynx or pain on swallowing.
Navigational Note: Record final diagnosis/cause once determined.
Pharyngeal fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the pharynx and another organ or anatomic site.
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Pharyngeal hemorrhage
Mild symptoms; intervention not indicatedModerate symptoms; intervention indicatedHospitalizationLife-threatening consequences; intubation or urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the pharynx.
Navigational Note: -
Pharyngeal mucositis
Endoscopic findings only; minimal symptoms with normal oral intake; mild pain but analgesics not indicatedModerate pain, analgesics indicated; altered oral intake; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; unable to adequately aliment or hydrate orally; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by ulceration or inflammation involving the mucous membrane of the pharynx.
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Pharyngeal necrosis
 - -Inability to aliment adequately by GI tract; invasive intervention indicated; tube feeding or TPN indicatedLife-threatening consequences; urgent operative intervention indicatedDeath
Definition: A disorder characterized by a necrotic process occurring in the pharynx.
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Pharyngeal stenosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic (e.g., noisy airway breathing), no respiratory distress; medical intervention indicated (e.g., steroids); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Stridor; endoscopic intervention indicated (e.g., stent, laser); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)Death
Definition: A disorder characterized by a narrowing of the pharyngeal airway.
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Pharyngolaryngeal pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the pharyngolaryngeal region.
Navigational Note: Record final diagnosis/cause once determined.
Pleural effusion
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; intervention indicated (e.g., diuretics or therapeutic thoracentesis)Symptomatic with respiratory distress and hypoxia; operative intervention including chest tube or pleurodesis indicatedLife-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicatedDeath
Definition: A disorder characterized by an increase in amounts of fluid within the pleural cavity. Symptoms include shortness of breath, cough and marked chest discomfort.
Navigational Note: Record final diagnosis/cause once determined.
Pleural hemorrhage
Asymptomatic; mild hemorrhage confirmed by thoracentesisSymptomatic or associated with pneumothorax; chest tube drainage indicated>1000 ml of blood evacuated; persistent bleeding (150-200 ml/hr for 2 - 4 hr); persistent transfusion indicated; elective operative intervention indicated; hospitalizationLife-threatening consequences; intubation or urgent intervention indicatedDeath
Definition: A disorder characterized by bleeding from the pleural cavity.
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Pleuritic pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the pleura.
Navigational Note: Record final diagnosis/cause once determined.
Pneumonitis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; oxygen indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening respiratory compromise; urgent intervention indicated (e.g., tracheotomy or intubation)Death
Definition: A disorder characterized by inflammation focally or diffusely affecting the lung parenchyma.
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Pneumothorax
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; intervention indicatedSclerosis and/or operative intervention indicated; hospitalization indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by abnormal presence of air in the pleural cavity resulting in the collapse of the lung.
Navigational Note: -
Postnasal drip
Mild symptoms; intervention not indicatedModerate symptoms; medical intervention indicated - - -
Definition: A disorder characterized by excessive mucous secretion in the back of the nasal cavity or throat, causing sore throat and/or coughing.
Navigational Note: -
Productive cough
Occasional/minimal production of sputum with coughModerate sputum production; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Persistent or copious production of sputum; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by expectorated secretions upon coughing.
Navigational Note: Record final diagnosis/cause once determined.
Pulmonary edema
Radiologic findings only; minimal dyspnea on exertionModerate dyspnea on exertion; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe dyspnea or dyspnea at rest; oxygen indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening respiratory compromise; urgent intervention or intubation with ventilatory support indicatedDeath
Definition: A disorder characterized by accumulation of fluid in the lung tissues that causes a disturbance of the gas exchange that may lead to respiratory failure.
Navigational Note: Unless there is a clear non-cardiac cause, please record this event as Cardiac disorders: Heart failure. Record final diagnosis/cause once determined.
Pulmonary fibrosis
Radiologic pulmonary fibrosis <25% of lung volume associated with hypoxiaEvidence of pulmonary hypertension; radiographic pulmonary fibrosis 25 - 50% associated with hypoxiaSevere hypoxia; evidence of right-sided heart failure; radiographic pulmonary fibrosis >50 - 75%Life-threatening consequences (e.g., hemodynamic/pulmonary complications); intubation with ventilatory support indicated; radiographic pulmonary fibrosis >75% with severe honeycombingDeath
Definition: A disorder characterized by the replacement of the lung tissue by connective tissue, leading to progressive dyspnea, respiratory failure or right heart failure.
Navigational Note: -
Pulmonary fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the lung and another organ or anatomic site.
Navigational Note: -
Pulmonary hypertension
Asymptomatic; radiographic, physical, or diagnostic findingsSymptomatic; requiring medical interventionSevere symptoms, associated with hypoxia, right heart failure; oxygen indicatedLife-threatening airway consequences; urgent intervention indicated (e.g., tracheotomy or intubation)Death
Definition: A disorder characterized by an increase in pressure within the pulmonary circulation due to lung or heart disorder.
Navigational Note: -
Respiratory failure
 - - -Life-threatening consequences; urgent intervention, intubation, or ventilatory support indicatedDeath
Definition: A disorder characterized by impaired gas exchange by the respiratory system resulting in hypoxia and a decrease in oxygenation of the tissues that may be associated with an increase in arterial levels of carbon dioxide.
Navigational Note: Consider Respiratory, thoracic and mediastinal disorders: Pneumonitis.
Rhinorrhea
Present - - - -
Definition: A disorder characterized by excessive mucous secretions draining from the nose.
Navigational Note: -
Sinus disorder
Asymptomatic mucosal crusting; blood-tinged secretionsSymptomatic stenosis or edema/narrowing interfering with airflow; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Stenosis with significant nasal obstruction; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Necrosis of soft tissue or bone; urgent operative intervention indicatedDeath
Definition: A disorder characterized by involvement of the paranasal sinuses.
Navigational Note: -
Sinus pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the face, between the eyes, or upper teeth originating from the sinuses.
Navigational Note: Record final diagnosis/cause once determined.
Sleep apnea
Snoring and nocturnal sleep arousal without apneic periodsModerate apnea and oxygen desaturation; excessive daytime sleepiness; medical evaluation indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Oxygen desaturation; associated with pulmonary hypertension; medical intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Cardiovascular or neuropsychiatric symptoms; urgent operative intervention indicatedDeath
Definition: A disorder characterized by cessation of breathing for short periods during sleep.
Navigational Note: -
Sneezing
Mild symptoms; intervention not indicatedModerate symptoms; medical intervention indicated - - -
Definition: A disorder characterized by the involuntary expulsion of air from the nose.
Navigational Note: -
Sore throat
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting ability to swallow; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by marked discomfort in the throat.
Navigational Note: -
Stridor
 - -Respiratory distress; medical intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)Death
Definition: A disorder characterized by a high pitched breathing sound due to laryngeal or upper airway obstruction.
Navigational Note: -
Tracheal fistula
AsymptomaticSymptomatic, invasive intervention not indicatedInvasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an abnormal communication between the trachea and another organ or anatomic site.
Navigational Note: -
Tracheal mucositis
Endoscopic findings only; minimal hemoptysis, pain, or respiratory symptomsModerate symptoms; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; hemorrhage or respiratory symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an inflammation or ulceration involving the mucous membrane of the trachea.
Navigational Note: -
Tracheal stenosis
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic (e.g., noisy airway breathing), no respiratory distress; medical intervention indicated (e.g., steroids); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Stridor or respiratory distress; invasive intervention indicated (e.g., stent, laser); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)Death
Definition: A disorder characterized by a narrowing of the trachea.
Navigational Note: -
Voice alteration
Mild or intermittent change from normal voiceModerate or persistent change from normal voice; still understandableSevere voice changes including predominantly whispered speech; may require frequent repetition or face-to-face contact for understandability; may require assistive technology - -
Definition: A disorder characterized by a change in the sound and/or speed of the voice.
Navigational Note: -
Respiratory, thoracic and mediastinal disorders - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
Navigational Note: -
Skin and subcutaneous tissue disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Skin and subcutaneous tissue disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Alopecia
Hair loss of <50% of normal for that individual that is not obvious from a distance but only on close inspection; a different hair style may be required to cover the hair loss but it does not require a wig or hair piece to camouflageHair loss of >=50% normal for that individual that is readily apparent to others; a wig or hair piece is necessary if the patient desires to completely camouflage the hair loss; associated with psychosocial impact - - -
Definition: A disorder characterized by a decrease in density of hair compared to normal for a given individual at a given age and body location.
Navigational Note: -
Body odor
Mild odor; physician intervention not indicated; self care interventionsPronounced odor; psychosocial impact; patient seeks medical intervention - - -
Definition: A disorder characterized by an abnormal body smell resulting from the growth of bacteria on the body.
Navigational Note: -
Dermatitis psoriasiform
Present; topical intervention indicatedoral intervention indicatedIV intervention indicated - -
Definition: A disorder characterized by large, red, rounded plaques covered with thicker scales.
Navigational Note: -
Dermatosis bullous
AsymptomaticPainful blisters; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Blisters covering >50% BSA; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Blisters covering >75% BSA; associated with fluid or electrolyte abnormalities; ICU care or burn unit indicatedDeath
Definition: A disorder characterized by inflammation of the skin characterized by the presence of bullae which are filled with fluid.
Navigational Note: If infectious, consider Infections and infestations: Rash pustular or other site-specific Infections and infestations term.
Dry skin
No associated erythema or pruritusAssociated with erythema or pruritus; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric) - - -
Definition: A disorder characterized by flaky and dull skin; the pores are generally fine, the texture is a papery thin texture.
Navigational Note: -
Eczematous dermatitis
Present; topical intervention indicatedOral intervention indicatedIV intervention indicated - -
Definition: A disorder characterized by dry and itchy patches of skin involving the epidermis and superficial dermis and includes some scaling, crusting, or serous oozing.
Navigational Note: -
Erythema multiforme
Not associated with skin tendernessAssociated with skin tendernessAssociated with oral or genital erosionsAssociated with fluid or electrolyte abnormalities; ICU care or burn unit indicatedDeath
Definition: A disorder characterized by target lesions (a pink-red ring around a pale center).
Navigational Note: -
Erythroderma
 -Erythema covering >90% BSA without associated symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Erythema covering >90% BSA with associated symptoms (e.g., pruritus or tenderness); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Erythema covering >90% BSA with associated fluid or electrolyte abnormalities; ICU care or burn unit indicatedDeath
Definition: A disorder characterized by generalized inflammatory erythema and exfoliation. The inflammatory process involves >90% of the body surface area.
Navigational Note: -
Exfoliative dermatitis
Present; topical intervention indicatedoral intervention indicatedIV intervention indicatedLife-threatening consequencesDeath
Definition: A disorder characterized by diffuse erythema and scaling involving > 90% of the body surface area.
Navigational Note: -
Hair color changes
Present - - - -
Definition: A disorder characterized by change in hair color or loss of normal pigmentation.
Navigational Note: -
Hair texture abnormal
Present - - - -
Definition: A disorder characterized by a change in the way the hair feels.
Navigational Note: -
Hirsutism
In women, increase in length, thickness or density of hair in a male distribution that the patient is able to camouflage by periodic shaving, bleaching, or removal of hairIn women, increase in length, thickness or density of hair in a male distribution that requires daily shaving or consistent destructive means of hair removal to camouflage; associated with psychosocial impact - - -
Definition: A disorder characterized by the presence of excess hair growth in women in anatomic sites where growth is considered to be a secondary male characteristic and under androgen control (beard, moustache, chest, abdomen).
Navigational Note: -
Hyperhidrosis
Limited to one site (palms, soles, or axillae); self care interventionsInvolving >1 site; patient seeks medical intervention; associated with psychosocial impactAssociated with electrolyte/hemodynamic imbalance - -
Definition: A disorder characterized by excessive sweating.
Navigational Note: Synonym: Night sweats, diaphoresis.
Hyperkeratosis
Present -Limiting self-care ADLs or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a thickening of the outer layer of the skin.
Navigational Note: -
Hypertrichosis
Increase in length, thickness or density of hair that the patient is either able to camouflage by periodic shaving or removal of hairs or is not concerned enough about the overgrowth to use any form of hair removalIncrease in length, thickness or density of hair at least on the usual exposed areas of the body [face (not limited to beard/moustache area) plus/minus arms] that requires frequent shaving or use of destructive means of hair removal to camouflage; associated with psychosocial impact - - -
Definition: A disorder characterized by hair density or length beyond the accepted limits of normal in a particular body region, for a particular age or race.
Navigational Note: -
Hypohidrosis
 -Symptomatic; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Increase in body temperature; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by reduced sweating.
Navigational Note: -
Lichenoid dermatitis
Present; topical intervention indicatedoral intervention indicatedIV intervention indicated - -
Definition: A disorder characterized by a symmetric eruption of flat-topped, red or purple papules on the trunk and extremities.
Navigational Note: -
Nail changes
Present - - - -
Definition: A disorder characterized by a change in the nails.
Navigational Note: -
Nail discoloration
Present - - - -
Definition: A disorder characterized by a change in the color of the nail plate.
Navigational Note: -
Nail loss
Asymptomatic separation of the nail bed from the nail plate or nail lossSymptomatic separation of the nail bed from the nail plate or nail loss; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric) - - -
Definition: A disorder characterized by loss of all or a portion of the nail.
Navigational Note: -
Nail ridging
Present - - - -
Definition: A disorder characterized by vertical or horizontal ridges on the nails.
Navigational Note: -
Pain of skin
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the skin.
Navigational Note: Record final diagnosis/cause once determined.
Palmar-plantar erythrodysesthesia syndrome
Minimal skin changes or dermatitis (e.g., erythema, edema, or hyperkeratosis) without painSkin changes (e.g., peeling, blisters, bleeding, fissures, edema, or hyperkeratosis) with pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe skin changes (e.g., peeling, blisters, bleeding, fissures, edema, or hyperkeratosis) with pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by redness, marked discomfort, swelling, and tingling in the palms of the hands or the soles of the feet. Also known as Hand-Foot Syndrome.
Navigational Note: -
Papulovesicular rash
AsymptomaticAssociated with psychosocial impact; mild symptomsCovering >50% BSA; moderate or severe symptomsBlisters covering >75% BSA; life-threatening consequencesDeath
Definition: A disorder characterized by an eruption consisting of papules (a small, raised pimple) and vesicles (a small fluid filled blister).
Navigational Note: -
Photosensitivity
Painless erythemaTender erythemaErythema with blistering; oral corticosteroid therapy indicated; pain control indicated (e.g., narcotics or NSAIDs)Life-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by an increase in sensitivity of the skin to light.
Navigational Note: -
Pruritus
Mild or localized; topical intervention indicatedWidespread and intermittent; skin changes from scratching (e.g., edema, papulation, excoriations, lichenification, oozing/crusts); oral intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Widespread and constant; systemic corticosteroid or immunosuppressive therapy indicated; limiting sleep or self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by an intense itching sensation.
Navigational Note: -
Purpura
Combined area of lesions covering <10% BSACombined area of lesions covering 10 - 30% BSACombined area of lesions covering >30% BSA - -
Definition: A disorder characterized by hemorrhagic areas of the skin and mucous membrane. Newer lesions appear reddish in color. Older lesions are usually a darker purple color and eventually become a brownish-yellow color.
Navigational Note: -
Pustular drug eruption
AsymptomaticAssociated with psychosocial impact; oral antibiotics or steroid indicated; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; IV antibiotic or steroid indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequencesDeath
Definition: A disorder characterized by the development of nonfollicular, sterile pustules on an erythematous base.
Navigational Note: -
Rash maculo-papular
AsymptomaticMild symptomsMacules/papules covering >50% BSA; moderate or severe symptomsLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by the presence of macules (flat) and papules (elevated). Also known as morbilliform rash, it is one of the most common cutaneous adverse events, frequently affecting the upper trunk, spreading centripetally and associated with pruritis.
Navigational Note: Consider Skin and subcutaneous tissue disorders: Pustular drug eruption.
Scalp pain
Mild painModerate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by a sensation of marked discomfort in the skin covering the top and the back of the head.
Navigational Note: Record final diagnosis/cause once determined.
Skin atrophy
Associated with telangiectasias or changes in skin colorAssociated with striae or adnexal structure lossAssociated with ulceration - -
Definition: A disorder characterized by the degeneration and thinning of the epidermis and dermis.
Navigational Note: -
Skin hyperpigmentation
PresentAssociated with psychosocial impact - - -
Definition: A disorder characterized by darkening of the skin due to excessive melanin deposition.
Navigational Note: -
Skin hypopigmentation
PresentAssociated with psychosocial impact - - -
Definition: A disorder characterized by loss of skin pigment (e.g., vitiligo).
Navigational Note: -
Skin induration
Mild induration, able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up)Moderate induration, able to slide skin, unable to pinch skin; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe induration; unable to slide or pinch skin; limiting joint or orifice movement (e.g., mouth, anus); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Generalized; associated with signs or symptoms of impaired breathing or feedingDeath
Definition: A disorder characterized by an area of hardness in the skin.
Navigational Note: -
Skin ulceration
Combined area of ulcers <1 cm; nonblanchable erythema of intact skin with associated warmth or edemaCombined area of ulcers 1 - 2 cm; partial thickness skin loss involving skin or subcutaneous fatCombined area of ulcers >2 cm; full-thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to fasciaAny size ulcer with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin lossDeath
Definition: A disorder characterized by a circumscribed, erosive lesion on the skin.
Navigational Note: -
Stevens-Johnson syndrome
 - -Skin sloughing covering <10% BSASkin sloughing covering >=10% BSA; life-threatening consequencesDeath
Definition: A disorder characterized by less than 10% total body skin area separation of dermis. The syndrome is thought to be a hypersensitivity complex affecting the skin and the mucous membranes.
Navigational Note: -
Subcutaneous emphysema
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicatedSevere or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by air in the subcutaneous tissue.
Navigational Note: -
Telangiectasia
PresentAssociated with psychosocial impact - - -
Definition: A disorder characterized by local dilatation of small vessels resulting in red discoloration of the skin or mucous membranes.
Navigational Note: -
Toxic epidermal necrolysis
 - - -Skin sloughing covering >=30% BSA with associated symptoms (e.g., erythema, purpura, or epidermal detachment); life-threatening consequencesDeath
Definition: A disorder characterized by greater than 30% total body skin area separation of dermis. The syndrome is thought to be a hypersensitivity complex affecting the skin and the mucous membranes.
Navigational Note: -
Urticaria
Topical intervention indicatedOral intervention indicatedIV intervention indicated - -
Definition: A disorder characterized by an itchy skin eruption characterized by wheals with pale interiors and well-defined red margins.
Navigational Note: Consider Immune system disorders: Allergic reaction, Anaphylaxis.
Skin and subcutaneous tissue disorders - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
Navigational Note: -
Social circumstances
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Social circumstances
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Social circumstances - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
Navigational Note: -
Surgical and medical procedures
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Surgical and medical procedures
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Surgical and medical procedures - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
Navigational Note: -
Vascular disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Vascular disorders
CTCAE TermGrade 1Grade 2Grade 3Grade 4Grade 5
Arterial thromboembolism
 - -Urgent intervention indicatedLife-threatening consequences; hemodynamic or neurologic instability; organ damage; loss of extremity(ies)Death
Definition: A disorder characterized by occlusion of an arterial vessel by a blood clot that develops in an artery.
Navigational Note: Consider Nervous system disorders: Stroke, Transient ischemic attacks for CNS-related events or Cardiac disorders: Myocardial infarction.
Capillary leak syndrome
AsymptomaticSymptomatic; medical intervention indicatedSevere symptomsLife-threatening consequencesDeath
Definition: A disorder characterized by leakage of intravascular fluids into the extravascular space. This syndrome is observed in patients who demonstrate a state of generalized leaky capillaries following shock syndromes, low-flow states, ischemia-reperfusion injuries, toxemias, medications, or poisoning. It can lead to generalized edema and multiple organ failure.
Navigational Note: -
Cyanosis
 -Present - - -
Definition: A disorder characterized by a bluish discoloration of the skin and/or mucous membranes.
Navigational Note: -
Flushing
Mild symptoms; clinical or diagnostic observations onlyModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Symptomatic, associated with hypotension and/or tachycardia; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by episodic reddening of the skin, especially face, neck, or chest.
Navigational Note: -
Hematoma
Mild symptoms; intervention not indicatedMinimally invasive evacuation or aspiration indicatedTransfusion; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by a localized collection of blood, usually clotted, in an organ, space, or tissue, due to a break in the wall of a blood vessel.
Navigational Note: Report subdural and epidural hematoma under Nervous system disorders: Intracranial hemorrhage.
Hot flashes
Mild symptoms; intervention not indicatedModerate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by an uncomfortable and temporary sensation of intense body warmth, flushing, sometimes accompanied by sweating upon cooling.
Navigational Note: -
Hypertension
 -Adult: Systolic BP 140 - 159 mmHg or diastolic BP 90 - 99 mmHg; recurrent or persistent; Pediatric and adolescent: Recurrent or persistent (>=24 hrs) BP >ULN; monotherapy indicated; systolic and /or diastolic BP between the 95th percentile and 5 mmHg above the 99th percentile; Adolescent: Systolic between 130 - 139 or diastolic between 80 - 89 even if <95th percentileAdult: Systolic BP 160 - 179 mmHg or diastolic BP 100 - 109 mmHg persisting over 1 hour; SBP >140 and plus either increase in SBP >20 mmHg or increase MAP >15 mmHg from baseline; Pediatric and adolescent: Systolic and/or diastolic >5 mmHg above the 99th percentileAdult and Pediatric: SBP≥180 or DBP ≥110 mmHg persisting over 1 hour; BP associated with acute hypertension mediated organ damage; life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis); urgent intervention indicatedDeath
Definition: A disorder characterized by a pathological increase in blood pressure.
Navigational Note: -
Hypotension
Asymptomatic, intervention not indicatedNon-urgent medical intervention indicatedMedical intervention indicated; hospitalization indicatedLife-threatening consequences and urgent intervention indicatedDeath
Definition: A disorder characterized by a blood pressure that is below the normal expected for an individual in a given environment.
Navigational Note: -
Lymph leakage
 -Symptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicatedLife-threatening consequences; urgent intervention indicatedDeath
Definition: A disorder characterized by the loss of lymph fluid into the surrounding tissue or body cavity.
Navigational Note: -
Lymphedema
Trace thickening or faint discolorationMarked discoloration; leathery skin texture; papillary formation; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric) - -
Definition: A disorder characterized by excessive fluid collection in tissues that causes swelling.
Navigational Note: Record final diagnosis/cause once determined.
Lymphocele
Asymptomatic; clinical or diagnostic observations only; intervention not indicatedSymptomatic; medical intervention indicatedSevere symptoms; invasive intervention indicated - -
Definition: A disorder characterized by a cystic lesion containing lymph.
Navigational Note: -
Peripheral ischemia
 -Brief (<24 hrs) episode of ischemia managed medically and without permanent deficit; claudicationProlonged (>=24 hrs) or recurring symptoms and/or invasive intervention indicated; pain at restLife-threatening consequences; major tissue loss; urgent operative intervention indicatedDeath
Definition: A disorder characterized by impaired circulation to an extremity.
Navigational Note: -
Phlebitis
 -Present - - -
Definition: A disorder characterized by inflammation of the wall of a peripheral vein associated with an intravenous line.
Navigational Note: -
Superficial thrombophlebitis
 -Present - - -
Definition: A disorder characterized by a blood clot and inflammation involving a superficial vein of the extremities.
Navigational Note: -
Superior vena cava syndrome
Asymptomatic; incidental finding of SVC thrombosisSymptomatic; medical intervention indicated (e.g., anticoagulation, radiation or chemotherapy)Severe symptoms; multi-modality intervention indicated (e.g., anticoagulation, chemotherapy, radiation, stenting)Life-threatening consequences; urgent multi-modality intervention indicated (e.g., lysis, thrombectomy, surgery)Death
Definition: A disorder characterized by obstruction of the blood flow in the superior vena cava. Signs and symptoms include swelling and cyanosis of the face, neck, and upper arms, cough, orthopnea and headache.
Navigational Note: -
Vasculitis
Asymptomatic, intervention not indicatedModerate symptoms, medical intervention indicatedSevere symptoms, medical intervention indicated (e.g., steroids)Life-threatening consequences; evidence of peripheral or visceral ischemia; urgent intervention indicatedDeath
Definition: A disorder characterized by inflammation involving the wall of a vessel.
Navigational Note: -
Venous thromboembolism
Medical intervention not indicated (e.g., superficial thrombosis)Medical intervention indicatedUrgent medical intervention indicatedLife-threatening consequences with hemodynamic or neurologic instabilityDeath
Definition: A disorder characterized by occlusion of a vessel by a thrombus that has migrated from a distal site via the blood stream (for example, deep vein thrombosis (DVT), pulmonary embolism (PE), etc.).
Navigational Note: Consider Nervous system disorders: Stroke, Transient ischemic attacks for CNS-related events. Use Vascular disorders: Arterial thromboembolism for arterial thrombi. Use Injury, poisoning and procedural complications: Vascular access complication if related to a catheter.
Vascular disorders - Other, specify
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicatedModerate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)Life-threatening consequences; urgent intervention indicatedDeath
Definition: -
Navigational Note: -
Blood and lymphatic system disorders
Anemia
Grade 1
Hemoglobin (Hgb) <LLN - 10.0 g/dL; <LLN - 6.2 mmol/L; <LLN - 100 g/L
Grade 2
Hgb <10.0 - 8.0 g/dL; <6.2 - 4.9 mmol/L; <100 - 80 g/L
Grade 3
Hgb <8.0 g/dL; <4.9 mmol/L; <80 g/L; transfusion indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a reduction in the amount of hemoglobin in 100 ml of blood. Signs and symptoms of anemia may include pallor of the skin and mucous membranes, shortness of breath, palpitations of the heart, soft systolic murmurs, lethargy, and fatigability.
Navigational Note: -
Aplastic anemia
Grade 1
-
Grade 2
Use of growth factor indicated; transfusion indicated
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by the inability of the bone marrow to make enough new blood cells.
Navigational Note: Do not report individual cell count decreases in addition to this term.
Bone marrow hypocellular
Grade 1
Mildly hypocellular or <=25% reduction from normal cellularity for age
Grade 2
Moderately hypocellular or >25 - <50% reduction from normal cellularity for age
Grade 3
Severely hypocellular or >50 - <=75% reduction cellularity from normal for age
Grade 4
Aplastic persistent for longer than 2 weeks
Grade 5
Death
Definition: A disorder characterized by the inability of the bone marrow to produce hematopoietic elements.
Navigational Note: Consider Blood and lymphatic system disorders: Anemia, Thrombocytopenia, and/or Investigations: Neutrophil count decreased if bone marrow hypocellularity is not seen.
Disseminated intravascular coagulation
Grade 1
-
Grade 2
Laboratory findings with no bleeding
Grade 3
Laboratory findings and bleeding
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by systemic pathological activation of blood clotting mechanisms which results in clot formation throughout the body. There is an increase in the risk of hemorrhage as the body is depleted of platelets and coagulation factors.
Navigational Note: -
Eosinophilia
Grade 1
>ULN and >Baseline
Grade 2
-
Grade 3
Steroids initiated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by laboratory test results that indicate an increased number of eosinophils in the blood.
Navigational Note: -
Febrile neutropenia
Grade 1
-
Grade 2
-
Grade 3
ANC <1000/mm³ with a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees F) for more than one hour
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an ANC <1000/mm³ and a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees F) for more than one hour.
Navigational Note: -
Hemolysis
Grade 1
Laboratory evidence of hemolysis only (e.g., direct antiglobulin test; DAT; Coombs'; schistocytes; decreased haptoglobin)
Grade 2
Evidence of hemolysis and >=2 g decrease in hemoglobin
Grade 3
Transfusion or medical intervention indicated (e.g., steroids)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by laboratory test results that indicate widespread erythrocyte cell membrane destruction.
Navigational Note: -
Hemolytic anemia
Grade 1
<10% drop in Hgb from last assessment; intervention not indicated
Grade 2
<=2 units of PRBCs transfused per day
Grade 3
>2 units of PRBCs per day indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: Anemia resulting from hemolysis.
Navigational Note: -
Hemolytic uremic syndrome
Grade 1
-
Grade 2
-
Grade 3
Laboratory findings with clinical consequences (e.g., renal insufficiency, petechiae)
Grade 4
Life-threatening consequences, (e.g., CNS hemorrhage or thrombosis/embolism or renal failure)
Grade 5
Death
Definition: A disorder characterized by a form of thrombotic microangiopathy with renal failure, hemolytic anemia, and severe thrombocytopenia when the etiology is due to infections with shiga-toxin producing bacteria, such as E coli O157:H7.
Navigational Note: -
Leukocytosis
Grade 1
-
Grade 2
-
Grade 3
>100,000/mm³
Grade 4
Clinical manifestations of leucostasis; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by laboratory test results that indicate an increased number of white blood cells in the blood.
Navigational Note: Do not use for increases due to growth factors, steroids, or leukemias.
Lymph node pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in a lymph node.
Navigational Note: Record final diagnosis/cause once determined.
Lymphopenia
Grade 1
Present
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate a decrease in number of lymphocytes in a blood specimen.
Navigational Note: -
Methemoglobinemia
Grade 1
-
Grade 2
>ULN
Grade 3
Requiring urgent intervention
Grade 4
Life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by laboratory test results that indicate increased methemoglobin in the blood.
Navigational Note: -
Thrombocytopenia
Grade 1
<LLN - 75,000/mm³; <LLN - 75.0 x 10⁹/L
Grade 2
<75,000 - 50,000/mm³; <75.0 - 50.0 x 10⁹/L
Grade 3
<50,000 - 10,000/mm³; <50.0 - 10.0 x 10⁹/L; transfusion indicated
Grade 4
<10,000/mm³; 10.0 x 10⁹/L; life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a decrease in number of platelets in a blood specimen.
Navigational Note: -
Thrombocytosis
Grade 1
Present
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate an increase in number of platelets in a blood specimen.
Navigational Note: -
Thrombotic microangiopathy
Grade 1
-
Grade 2
Outpatient intervention indicated (e.g., modification of immunosuppression)
Grade 3
Transfusion or IV intervention indicated
Grade 4
Life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by a form of thrombotic microangiopathy with laboratory findings that indicate hemolytic anemia, severe thrombocytopenia, and renal insufficiency/failure.
Navigational Note: -
Thrombotic thrombocytopenic purpura
Grade 1
-
Grade 2
-
Grade 3
Laboratory findings with clinical consequences (e.g., renal insufficiency, petechiae)
Grade 4
Life-threatening consequences, (e.g., CNS hemorrhage or thrombosis/embolism or renal failure)
Grade 5
Death
Definition: A disorder characterized by a deficiency of ADAMTS13 and the presence of microangiopathic hemolytic anemia, thrombocytopenic purpura, fever, renal abnormalities and neurological abnormalities such as seizures, hemiplegia, and visual disturbances. It is an acute or subacute condition.
Navigational Note: -
Blood and lymphatic system disorders - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Cardiac disorders
Aortic valve disease
Grade 1
Asymptomatic valvular thickening with or without mild valvular regurgitation or stenosis by imaging
Grade 2
Asymptomatic; moderate regurgitation or stenosis by imaging
Grade 3
Symptomatic; severe regurgitation or stenosis by imaging; symptoms controlled with medical intervention
Grade 4
Life-threatening consequences; urgent intervention indicated (e.g., valve replacement, valvuloplasty)
Grade 5
Death
Definition: A disorder characterized by a defect in aortic valve function or structure.
Navigational Note: -
Asystole
Grade 1
-
Grade 2
-
Grade 3
Intervention indicated; device (e.g., pacemaker)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a dysrhythmia without cardiac electrical activity. Typically, this is accompanied by cessation of the pumping function of the heart.
Navigational Note: -
Atrial fibrillation
Grade 1
Asymptomatic, intervention not indicated
Grade 2
Non-urgent medical intervention indicated; electrical cardioversion
Grade 3
Symptomatic, urgent intervention indicated; device (e.g., pacemaker); ablation; new onset
Grade 4
Life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by a dysrhythmia without discernible P waves and an irregular ventricular response due to multiple reentry circuits. The rhythm disturbance originates above the ventricles.
Navigational Note: -
Atrial flutter
Grade 1
Asymptomatic, intervention not indicated
Grade 2
Non-urgent medical intervention indicated
Grade 3
Symptomatic, urgent intervention indicated; device (e.g., pacemaker); ablation
Grade 4
Life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by a dysrhythmia with organized rhythmic atrial contractions with a rate of 200-300 beats per minute. The rhythm disturbance originates in the atria.
Navigational Note: -
Atrioventricular block complete
Grade 1
-
Grade 2
Non-urgent intervention indicated
Grade 3
Symptomatic and incompletely controlled medically, or controlled with device (e.g., pacemaker); new onset
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a dysrhythmia with complete failure of atrial electrical impulse conduction through the AV node to the ventricles.
Navigational Note: -
Atrioventricular block first degree
Grade 1
Asymptomatic, intervention not indicated
Grade 2
Non-urgent intervention indicated
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a dysrhythmia with a delay in the time required for the conduction of an electrical impulse through the atrioventricular (AV) node beyond 0.2 seconds; prolongation of the PR interval greater than 200 milliseconds.
Navigational Note: -
Cardiac arrest
Grade 1
-
Grade 2
-
Grade 3
-
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by cessation of the pumping function of the heart.
Navigational Note: -
Chest pain - cardiac
Grade 1
Mild pain
Grade 2
Moderate pain; pain on exertion; hemodynamically stable; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Pain at rest; cardiac catheterization; new onset cardiac chest pain; unstable angina; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by substernal discomfort due to insufficient myocardial oxygenation e.g., angina pectoris.
Navigational Note: Consider Cardiac disorders: Myocardial infarction. Record final diagnosis/cause once determined.
Heart failure
Grade 1
Mild symptoms; no initiation or intensification of treatment
Grade 2
Outpatient initiation or intensification of treatment
Grade 3
Hospitalization indicated
Grade 4
Requiring inotropic support, mechanical circulatory support, or consideration of cardiac transplantation
Grade 5
Death
Definition: A disorder characterized by the inability of the heart to pump blood at an adequate volume to meet tissue metabolic requirements, or, the ability to do so only at an elevation in the filling pressure.
Navigational Note: If asymptomatic, consider Cardiac disorders: Left ventricular dysfunction.
Left ventricular dysfunction
Grade 1
Left ventricular ejection fraction (LVEF) ≥50% AND one or more of the following: 1) New relative decline in Global Longitudinal Strain (GLS) >15% from baseline 2) New rise in cardiac biomarkers
Grade 2
LVEF 40 - 49% AND one or more of the following: 1) LVEF reduction by ≥10% 2) New relative decline in GLS >15% from baseline 3) New rise in cardiac biomarkers
Grade 3
New LVEF reduction to <40%
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an ASYMPTOMATIC abnormality of cardiac function.
Navigational Note: If symptomatic, consider Cardiac disorders: Heart failure.
Mitral valve disease
Grade 1
Asymptomatic valvular thickening with or without mild valvular regurgitation or stenosis by imaging
Grade 2
Asymptomatic; moderate regurgitation or stenosis by imaging
Grade 3
Symptomatic; severe regurgitation or stenosis by imaging; symptoms controlled with medical intervention
Grade 4
Life-threatening consequences; urgent intervention indicated (e.g., valve replacement, valvuloplasty)
Grade 5
Death
Definition: A disorder characterized by a defect in mitral valve function or structure.
Navigational Note: -
Mobitz (type) II atrioventricular block
Grade 1
Asymptomatic, intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Symptomatic and incompletely controlled medically, or require a device (e.g., pacemaker)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a dysrhythmia with relatively constant PR interval prior to the block of an atrial impulse. This is the result of intermittent failure of atrial electrical impulse conduction through the atrioventricular (AV) node to the ventricles.
Navigational Note: -
Mobitz type I
Grade 1
Asymptomatic, intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Symptomatic and incompletely controlled medically, or controlled with device (e.g., pacemaker)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a dysrhythmia with a progressively lengthening PR interval prior to the blocking of an atrial impulse. This is the result of intermittent failure of atrial electrical impulse conduction through the atrioventricular (AV) node to the ventricles.
Navigational Note: -
Myocardial infarction
Grade 1
-
Grade 2
Asymptomatic; imaging or ECG features consistent with myocardial infarction which may be of uncertain age
Grade 3
Hemodynamically stable AND detection of a rise and/or fall of Cardiac troponin values with at least 1 value above the 99th percentile URL AND at least 1 of the following: 1) Symptoms of myocardial ischemia; 2) New ischemic ECG changes; 3) Development of pathological Q waves; 4) Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology; 5) Identification of a coronary thrombus by angiography
Grade 4
Life-threatening consequences; hemodynamically UNstable AND detection of a rise and/or fall of Cardiac troponin values with at least 1 value above the 99th percentile URL AND at least 1 of the following: 1) Symptoms of myocardial ischemia; 2) New ischemic ECG changes; 3) Development of pathological Q waves; 4) Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology; 5) Identification of a coronary thrombus by angiography
Grade 5
Death
Definition: A disorder characterized by gross necrosis of the myocardium; this is due to an interruption of blood supply to the area.
Navigational Note: -
Myocarditis
Grade 1
Asymptomatic with Lab or ECG findings only
Grade 2
Symptoms with moderate activity or exertion
Grade 3
Severe with symptoms at rest or with minimal activity or exertion; intervention indicated; new onset of symptoms
Grade 4
Life-threatening consequences; urgent intervention indicated (e.g., continuous IV therapy or mechanical hemodynamic support); hemodynamically unstable requiring non-invasive or invasive ventilation; complete or high grade AV block; significant ventricular arrhythmia
Grade 5
Death
Definition: A disorder characterized by inflammation of the muscle tissue of the heart.
Navigational Note: -
Palpitations
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Intervention indicated
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an unpleasant sensation of irregular and/or forceful beating of the heart.
Navigational Note: Record final diagnosis/cause once determined.
Paroxysmal atrial tachycardia
Grade 1
Asymptomatic, intervention not indicated
Grade 2
Non-urgent medical intervention indicated
Grade 3
Symptomatic, urgent intervention indicated; ablation
Grade 4
Life-threatening consequences; incompletely controlled medically; cardioversion indicated
Grade 5
Death
Definition: A disorder characterized by a dysrhythmia with abrupt onset and sudden termination of atrial contractions with a rate of 150-250 beats per minute. The rhythm disturbance originates in the atria.
Navigational Note: -
Pericardial effusion
Grade 1
-
Grade 2
Asymptomatic effusion size small to moderate
Grade 3
Effusion with physiologic consequences
Grade 4
Life-threatening consequences; hospitalization
Grade 5
Death
Definition: A disorder characterized by fluid collection within the pericardial sac, usually due to inflammation.
Navigational Note: Consider Cardiac disorders: Pericardial tamponade, Pericarditis.
Pericardial tamponade
Grade 1
-
Grade 2
-
Grade 3
-
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an increase in intrapericardial pressure due to the collection of blood or fluid in the pericardium.
Navigational Note: Consider Cardiac disorders: Pericarditis.
Pericarditis
Grade 1
Asymptomatic, ECG or physical findings (e.g., rub) consistent with pericarditis
Grade 2
Symptomatic pericarditis (e.g., chest pain)
Grade 3
Pericarditis with physiologic consequences (e.g., pericardial constriction)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by irritation to the layers of the pericardium (the protective sac around the heart).
Navigational Note: -
Pulmonary valve disease
Grade 1
Asymptomatic valvular thickening with or without mild valvular regurgitation or stenosis by imaging
Grade 2
Asymptomatic; moderate regurgitation or stenosis by imaging
Grade 3
Symptomatic; severe regurgitation or stenosis by imaging; symptoms controlled with medical intervention
Grade 4
Life-threatening consequences; urgent intervention indicated (e.g., valve replacement, valvuloplasty)
Grade 5
Death
Definition: A disorder characterized by a defect in pulmonary valve function or structure.
Navigational Note: -
Sick sinus syndrome
Grade 1
Asymptomatic, intervention not indicated
Grade 2
Symptomatic, intervention not indicated; change in medication initiated
Grade 3
Symptomatic, intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a dysrhythmia with alternating periods of bradycardia and atrial tachycardia accompanied by syncope, fatigue and dizziness.
Navigational Note: -
Sinus bradycardia
Grade 1
Asymptomatic, intervention not indicated
Grade 2
Symptomatic, intervention not indicated; change in medication initiated
Grade 3
Symptomatic, intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a dysrhythmia with a heart rate less than 60 beats per minute that originates in the sinus node.
Navigational Note: -
Sinus tachycardia
Grade 1
Asymptomatic, intervention not indicated
Grade 2
Symptomatic; non-urgent medical intervention indicated
Grade 3
Urgent medical intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a dysrhythmia with a heart rate greater than 100 beats per minute that originates in the sinus node.
Navigational Note: Record final diagnosis/cause once determined.
Supraventricular tachycardia
Grade 1
Asymptomatic, intervention not indicated
Grade 2
Non-urgent medical intervention indicated
Grade 3
Symptomatic, urgent intervention indicated
Grade 4
Life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by a dysrhythmia with a heart rate greater than 100 beats per minute that originates above the ventricles.
Navigational Note: -
Tricuspid valve disease
Grade 1
Asymptomatic valvular thickening with or without mild valvular regurgitation or stenosis
Grade 2
Asymptomatic; moderate regurgitation or stenosis by imaging
Grade 3
Symptomatic; severe regurgitation or stenosis; symptoms controlled with medical intervention
Grade 4
Life-threatening consequences; urgent intervention indicated (e.g., valve replacement, valvuloplasty)
Grade 5
Death
Definition: A disorder characterized by a defect in tricuspid valve function or structure.
Navigational Note: -
Ventricular arrhythmia
Grade 1
Asymptomatic, intervention not indicated
Grade 2
Non-urgent medical intervention indicated
Grade 3
Urgent intervention indicated
Grade 4
Life-threatening consequences; hemodynamic compromise
Grade 5
Death
Definition: A disorder characterized by a dysrhythmia that originates in the ventricles.
Navigational Note: -
Ventricular fibrillation
Grade 1
-
Grade 2
-
Grade 3
-
Grade 4
Life-threatening consequences; hemodynamic compromise
Grade 5
Death
Definition: A disorder characterized by a dysrhythmia without discernible QRS complexes due to rapid repetitive excitation of myocardial fibers without coordinated contraction of the ventricles.
Navigational Note: -
Ventricular tachycardia
Grade 1
-
Grade 2
Non-urgent medical intervention indicated
Grade 3
Symptomatic, urgent intervention indicated
Grade 4
Life-threatening consequences; hemodynamic compromise
Grade 5
Death
Definition: A disorder characterized by a dysrhythmia with a heart rate greater than 100 beats per minute that originates distal to the bundle of His.
Navigational Note: -
Cardiac disorders - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Congenital, familial and genetic disorders
Congenital, familial and genetic disorders - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Ear and labyrinth disorders
Ear pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the ear.
Navigational Note: Record final diagnosis/cause once determined.
External ear pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the external ear region.
Navigational Note: Record final diagnosis/cause once determined.
Hearing impaired
Grade 1
Adult: Subjective change in hearing in the absence of documented hearing loss; threshold shift of 15 - 25 dB averaged at 2 contiguous test frequencies in at least one ear (on a 1, 2, 4, 3, 6, and 8 kHz audiogram); Pediatric (on a 1, 2, 3, 4, 6, and 8 kHz audiogram): Threshold shift >20 dB hearing loss (HL) (i.e., 25 dB HL or greater); sensorineural hearing loss (SNHL) above 4 kHz (i.e., 6 or 8 kHz) in at least one ear
Grade 2
Adult: Hearing loss not requiring hearing aid; intervention not indicated; limiting instrumental ADL; threshold shift of >25 dB averaged at 2 contiguous test frequencies in at least one ear (on a 1, 2, 3, 4, 6, and 8 kHz audiogram); Pediatric (on a 1, 2, 3, 4, 6, and 8 kHz audiogram): Threshold shift >20 dB at 4 kHz in at least one ear; mild/moderate impact on age-appropriate normal daily activity
Grade 3
Adult: Hearing loss requiring hearing aid; intervention indicated; limiting self-care ADL; threshold shift of >25 dB averaged at 3 contiguous test frequencies in at least one ear(on a 1, 2, 3, 4, 6, and 8 kHz audiogram); Pediatric (on a 1, 2, 3, 4, 6, and 8 kHz audiogram): Hearing loss sufficient to indicate therapeutic intervention, including hearing aids; threshold shift >20 dB at 2 to <4 kHz in at least one ear; severe impact on age-appropriate normal daily activity
Grade 4
Adult: Nonservicable hearing; decrease in hearing to profound bilateral loss (absolute threshold >80 dB HL at 2 kHz and above); Pediatric: Audiologic indication for cochlear implant; >40 dB HL (i.e., 45 dB HL or more); SNHL at 2 kHz and above
Grade 5
-
Definition: A disorder characterized by partial or complete loss of the ability to detect or understand sounds resulting from damage to ear structures.
Navigational Note: -
Middle ear inflammation
Grade 1
Serous otitis
Grade 2
Serous otitis, medical intervention indicated
Grade 3
Mastoiditis; necrosis of canal soft tissue or bone
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by inflammation (physiologic response to irritation), swelling and redness to the middle ear.
Navigational Note: -
Tinnitus
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by noise in the ears, such as ringing, buzzing, roaring or clicking.
Navigational Note: -
Vertigo
Grade 1
Mild symptoms
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation as if the external world were revolving around the patient (objective vertigo) or as if he himself were revolving in space (subjective vertigo).
Navigational Note: -
Vestibular disorder
Grade 1
-
Grade 2
Symptomatic; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by dizziness, imbalance, nausea, and vision problems.
Navigational Note: -
Ear and labyrinth disorders - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Endocrine disorders
Adrenal insufficiency
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
Severe symptoms; hospitalization indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by the adrenal cortex not producing enough of the hormone cortisol and in some cases, the hormone aldosterone. It may be due to a disorder of the adrenal cortex as in Addison's disease or primary adrenal insufficiency.
Navigational Note: -
Cushingoid
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
Severe symptoms, medical intervention or hospitalization indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by signs and symptoms that resemble Cushing's disease or syndrome: buffalo hump obesity, striations, adiposity, hypertension, diabetes, and osteoporosis, usually due to exogenous corticosteroids.
Navigational Note: -
Delayed puberty
Grade 1
-
Grade 2
No breast development by age 13 yrs for females; testes volume of <3 cc or no Tanner Stage 2 development by age 14.5 yrs for males
Grade 3
No breast development by age 14 yrs for females; no increase in testes volume or no Tanner Stage 2 by age 16 yrs for males; hormone replacement indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by unusually late sexual maturity.
Navigational Note: -
Hyperparathyroidism
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an increase in production of parathyroid hormone by the parathyroid glands. This results in hypercalcemia (abnormally high levels of calcium in the blood).
Navigational Note: -
Hyperthyroidism
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; thyroid suppression therapy indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by excessive levels of thyroid hormone in the body. Common causes include an overactive thyroid gland or thyroid hormone overdose.
Navigational Note: -
Hypogonadism
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a decrease in production of sex hormones from the gonads.
Navigational Note: -
Hypoparathyroidism
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
Severe symptoms; medical intervention or hospitalization indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a decrease in production of parathyroid hormone by the parathyroid glands.
Navigational Note: -
Hypophysitis
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by inflammation and cellular infiltration of the pituitary gland.
Navigational Note: -
Hypopituitarism
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a decrease in production of hormones from the pituitary gland.
Navigational Note: Consider Endocrine disorders: Hypophysitis.
Hypothyroidism
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; thyroid replacement initiated; increase in current thyroid replacement therapy; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a decrease in production of thyroid hormone by the thyroid gland.
Navigational Note: Consider Endocrine disorders: Hypophysitis.
Precocious puberty
Grade 1
Physical signs of puberty with no biochemical markers for females <8 years and males <9 years
Grade 2
Physical signs and biochemical markers of puberty for females <8 years and males <9 years
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by unusually early development of secondary sexual features; the onset of sexual maturation begins usually before age 8 for girls and before age 9 for boys.
Navigational Note: -
Testosterone deficiency
Grade 1
Asymptomatic; mild symptoms with no intervention indicated
Grade 2
Replacement therapy initiated
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by low testosterone.
Navigational Note: -
Thyroiditis
Grade 1
Asymptomatic
Grade 2
Medical intervention indicated
Grade 3
Hospitalization indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by inflammation or destruction of the thyroid gland.
Navigational Note: -
Virilization
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by inappropriate masculinization occurring in a female or prepubertal male.
Navigational Note: -
Endocrine disorders - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Eye disorders
Blurred vision
Grade 1
Intervention not indicated
Grade 2
Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Best corrected visual acuity of 20/200 or worse in the affected eye
Grade 5
-
Definition: A disorder characterized by visual perception of unclear or fuzzy images.
Navigational Note: Consider: Eye disorders: Uveitis.
Cataract
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline); glare symptoms affecting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Best corrected visual acuity of 20/200 or worse in the affected eye
Grade 5
-
Definition: A disorder characterized by partial or complete opacity of the crystalline lens of one or both eyes. This results in a decrease in visual acuity and eventual blindness if untreated.
Navigational Note: -
Corneal ulcer
Grade 1
-
Grade 2
-
Grade 3
Corneal ulcer without perforation in the affected eye
Grade 4
Perforation in the affected eye
Grade 5
-
Definition: A disorder characterized by an area of epithelial tissue loss on the surface of the cornea. It is associated with inflammatory cells in the cornea and anterior chamber.
Navigational Note: -
Decreased night vision
Grade 1
Symptomatic but not limiting ADL
Grade 2
Moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Best corrected visual acuity of 20/200 or worse in the affected eye
Grade 5
-
Definition: A disorder characterized by an inability to see clearly in dim light.
Navigational Note: -
Dry eye
Grade 1
Clinical or diagnostic observations only; symptoms relieved by lubricants
Grade 2
Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)
Grade 3
Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by dryness of the cornea and conjunctiva.
Navigational Note: If corneal ulcer is present, grade under Eye disorders: Corneal ulcer. If related to syndromes not present in CTCAE (ex. Sjogren's syndrome, etc.), report as Other, specify in the most representative SOC.
Extraocular muscle paresis
Grade 1
Asymptomatic; clinical or diagnostic observations only
Grade 2
Unilateral paresis without double vision
Grade 3
Bilateral paresis or unilateral paresis causing double vision in peripheral gaze, but not in central gaze
Grade 4
Bilateral paresis requiring head turning to see beyond central 60 degrees or double vision in central gaze
Grade 5
-
Definition: A disorder characterized by incomplete paralysis of an extraocular muscle.
Navigational Note: -
Eye pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the eye.
Navigational Note: Record final diagnosis/cause once determined.
Eyelid function disorder
Grade 1
Clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; nonoperative intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Operative intervention indicated requiring hospitalization; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by impaired eyelid function.
Navigational Note: -
Flashing lights
Grade 1
Symptomatic
Grade 2
Limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sudden or brief burst of light.
Navigational Note: Consider Eye disorders: Retinal tear, Retinal detachment.
Floaters
Grade 1
Symptomatic
Grade 2
Limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an individual seeing spots before their eyes. The spots are shadows of opaque cell fragments in the vitreous humor or lens.
Navigational Note: Consider Eye disorders: Retinal tear, Retinal detachment.
Glaucoma
Grade 1
Less than 8 mmHg of elevated intraocular pressure (EIOP); no visual field deficit
Grade 2
Topical medication indicated
Grade 3
EIOP causing visual field deficits
Grade 4
Visual field deficit within the central 10 degrees of the visual field in the affected eye
Grade 5
-
Definition: A disorder characterized by an increase in pressure in the eyeball due to obstruction of the aqueous humor outflow.
Navigational Note: -
Keratitis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)
Grade 3
Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); corneal ulcer; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Perforation; best corrected visual acuity of 20/200 or worse in the affected eye
Grade 5
-
Definition: A disorder characterized by inflammation to the cornea of the eye.
Navigational Note: Consider Eye disorders: Corneal ulcer.
Optic nerve disorder
Grade 1
Asymptomatic; clinical or diagnostic observations only
Grade 2
Moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)
Grade 3
Marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200)
Grade 4
Best corrected visual acuity of 20/200 or worse in the affected eye
Grade 5
-
Definition: A disorder characterized by involvement of the optic nerve (second cranial nerve).
Navigational Note: -
Papilledema
Grade 1
Asymptomatic; no visual field deficit
Grade 2
Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)
Grade 3
Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200)
Grade 4
Best corrected visual acuity of 20/200 or worse in the affected eye
Grade 5
-
Definition: A disorder characterized by swelling around the optic disc.
Navigational Note: Record final diagnosis/cause once determined.
Periorbital edema
Grade 1
Soft or non-pitting
Grade 2
Indurated or pitting edema; topical intervention indicated
Grade 3
Edema associated with visual disturbance; increased intraocular pressure, glaucoma or retinal hemorrhage; diuretics indicated; operative intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by swelling due to an excessive accumulation of fluid around the orbits of the face.
Navigational Note: Record final diagnosis/cause once determined.
Photophobia
Grade 1
Symptomatic
Grade 2
Limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by fear and avoidance of light.
Navigational Note: -
Retinal detachment
Grade 1
-
Grade 2
-
Grade 3
Macular sparing rhegmatogenous detachment
Grade 4
Macula-off rhegmatogenous retinal detachment
Grade 5
-
Definition: A disorder characterized by the separation of the inner retina layers from the underlying pigment epithelium.
Navigational Note: -
Retinal tear
Grade 1
No retinal detachment and treatment not indicated
Grade 2
No retinal detachment and treatment indicated
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a small laceration of the retina. Symptoms include flashes and floaters.
Navigational Note: If retinal detachment is present, grade under Eye disorders: Retinal detachment.
Retinal vascular disorder
Grade 1
-
Grade 2
Retinal vascular disorder without neovascularization
Grade 3
Retinal vascular disorder with neovascularization
Grade 4
-
Grade 5
-
Definition: A disorder characterized by pathological retinal blood vessels that adversely affects vision.
Navigational Note: If vitreous hemorrhage is present, report under Eye disorders: Vitreous hemorrhage.
Retinopathy
Grade 1
Asymptomatic; clinical or diagnostic observations only
Grade 2
Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Best corrected visual acuity of 20/200 or worse in the affected eye
Grade 5
-
Definition: A disorder involving the retina.
Navigational Note: If vitreous hemorrhage is present, report under Eye disorders: Vitreous hemorrhage.
Scleral disorder
Grade 1
No change in vision from baseline
Grade 2
Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Best corrected visual acuity of 20/200 or worse in the affected eye
Grade 5
-
Definition: A disorder characterized by involvement of the sclera of the eye.
Navigational Note: -
Uveitis
Grade 1
Anterior uveitis with trace cells
Grade 2
Anterior uveitis with 1+ or 2+ cells
Grade 3
Anterior uveitis with 3+ or greater cells; intermediate posterior or pan-uveitis
Grade 4
Best corrected visual acuity of 20/200 or worse in the affected eye
Grade 5
-
Definition: A disorder characterized by inflammation to the uvea of the eye.
Navigational Note: -
Vision decreased
Grade 1
-
Grade 2
Moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)
Grade 3
Marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200)
Grade 4
Best corrected visual acuity of 20/200 or worse in the affected eye
Grade 5
-
Definition: A disorder characterized by a decrease in visual acuity.
Navigational Note: If etiology is known, use a more specific CTCAE term. Consider: Eye disorders: Uveitis
Vitreous hemorrhage
Grade 1
Intervention not indicated
Grade 2
Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); vitrectomy indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Best corrected visual acuity of 20/200 or worse in the affected eye
Grade 5
-
Definition: A disorder characterized by bleeding into the vitreous humor.
Navigational Note: -
Watering eyes
Grade 1
Intervention not indicated
Grade 2
Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)
Grade 3
Marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200)
Grade 4
Best corrected visual acuity of 20/200 or worse in the affected eye
Grade 5
-
Definition: A disorder characterized by excessive tearing in the eyes; it can be caused by overproduction of tears or impaired drainage of the tear duct.
Navigational Note: -
Eye disorders - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; no change in vision
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately sight-threatening; decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Sight-threatening consequences; urgent intervention indicated; best corrected visual acuity of 20/200 or worse in the affected eye
Grade 5
-
Definition: -
Navigational Note: -
Gastrointestinal disorders
Abdominal distension
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe discomfort; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by swelling of the abdomen.
Navigational Note: -
Abdominal pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the abdominal region.
Navigational Note: Record final diagnosis/cause once determined.
Anal fissure
Grade 1
Asymptomatic
Grade 2
Symptomatic
Grade 3
Invasive intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a tear in the lining of the anus.
Navigational Note: -
Anal fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the opening in the anal canal to the perianal skin.
Navigational Note: -
Anal mucositis
Grade 1
Asymptomatic or mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by ulceration or inflammation of the mucous membrane of the anus.
Navigational Note: Report Grade 4 and 5 as Gastrointestinal disorders: Anal ulcer.
Anal necrosis
Grade 1
-
Grade 2
-
Grade 3
TPN or hospitalization indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a necrotic process occurring in the anal region.
Navigational Note: -
Anal pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the anal region.
Navigational Note: Record final diagnosis/cause once determined.
Anal stenosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function
Grade 3
Symptomatic and severely altered GI function; non-emergent operative intervention indicated; TPN or hospitalization indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a narrowing of the lumen of the anal canal.
Navigational Note: -
Anal ulcer
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function
Grade 3
Severely altered GI function; TPN indicated; elective invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the anal canal.
Navigational Note: -
Ascites
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; medical intervention or paracentesis indicated
Grade 3
Severe symptoms; catheter placement indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by accumulation of serous or hemorrhagic fluid in the peritoneal cavity.
Navigational Note: Record final diagnosis/cause once determined.
Belching
Grade 1
Increase from baseline
Grade 2
Intervention initiated (including over the counter medications)
Grade 3
-
Grade 4
-
Grade 5
-
Definition: To expel gas noisily from the mouth.
Navigational Note: Synonym: Burping
Bloating
Grade 1
No change in bowel function or oral intake
Grade 2
Symptomatic, decreased oral intake; change in bowel function
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by subject-reported feeling of uncomfortable fullness of the abdomen.
Navigational Note: -
Cecal hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the cecum.
Navigational Note: -
Cheilitis
Grade 1
Clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by inflammation of the lip.
Navigational Note: -
Chylous ascites
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated (e.g., fat-restricted diet); paracentesis or tube drainage indicated
Grade 3
Severe symptoms; elective operative intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by accumulation of milky fluid in the peritoneal cavity.
Navigational Note: -
Colitis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Abdominal pain; mucus or blood in stool
Grade 3
Severe abdominal pain; peritoneal signs
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by inflammation of the colon.
Navigational Note: -
Colonic fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the large intestine and another organ or anatomic site.
Navigational Note: -
Colonic obstruction
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function
Grade 3
Hospitalization indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by blockage of the normal flow of the intestinal contents in the colon.
Navigational Note: -
Colonic perforation
Grade 1
-
Grade 2
Invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a rupture in the colonic wall.
Navigational Note: Consider Gastrointestinal disorders: Colitis.
Colonic stenosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function
Grade 3
Severely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a narrowing of the lumen of the colon.
Navigational Note: -
Colonic ulcer
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function
Grade 3
Severely altered GI function; TPN indicated; elective invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the colon.
Navigational Note: -
Constipation
Grade 1
Occasional or intermittent symptoms; occasional use of stool softeners, laxatives, dietary modification, or enema
Grade 2
Persistent symptoms with regular use of laxatives or enemas; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Obstipation with manual evacuation indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by irregular and infrequent or difficult evacuation of the bowels.
Navigational Note: -
Dental caries
Grade 1
One or more dental caries, not involving the root
Grade 2
Dental caries involving the root
Grade 3
Dental caries resulting in pulpitis or periapical abscess or resulting in tooth loss
Grade 4
-
Grade 5
-
Definition: A disorder characterized by the decay of a tooth, in which it becomes softened, discolored and/or porous.
Navigational Note: -
Diarrhea
Grade 1
Change in consistency or frequency
Grade 2
Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric); change in consistency or frequency AND limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Increase of >=7 stools per day over baseline; hospitalization indicated; severe increase in ostomy output compared to baseline; requires IV intervention; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an increase in frequency and/or loose or watery bowel movements.
Navigational Note: Consider Gastrointestinal disorders: Colitis, Enterocolitis.
Dry mouth
Grade 1
Symptomatic (e.g., dry or thick saliva) without significant dietary alteration; unstimulated saliva flow >0.2 ml/min
Grade 2
Moderate symptoms; oral intake alterations (e.g., copious water, other lubricants, diet limited to purees and/or soft, moist foods); unstimulated saliva 0.1 to 0.2 ml/min
Grade 3
Inability to adequately aliment orally; tube feeding or TPN indicated; unstimulated saliva <0.1 ml/min
Grade 4
-
Grade 5
-
Definition: A disorder characterized by reduced salivary flow in the oral cavity.
Navigational Note: If related to syndromes not present in CTCAE (ex. Sjogren's syndrome, etc.), report as Other, specify in the most representative SOC.
Duodenal fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the duodenum and another organ or anatomic site.
Navigational Note: -
Duodenal hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the duodenum.
Navigational Note: Consider Gastrointestinal disorders: Enterocolitis.
Duodenal obstruction
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function
Grade 3
Hospitalization indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by blockage of the normal flow of stomach contents through the duodenum.
Navigational Note: -
Duodenal perforation
Grade 1
-
Grade 2
Invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a rupture in the duodenal wall.
Navigational Note: Consider Gastrointestinal disorders: Enterocolitis.
Duodenal stenosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function
Grade 3
Severely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a narrowing of the lumen of the duodenum.
Navigational Note: -
Duodenal ulcer
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severely altered GI function; TPN indicated; elective invasive intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the duodenal wall.
Navigational Note: -
Dyspepsia
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
Severe symptoms; operative intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an uncomfortable, often painful feeling in the stomach, resulting from impaired digestion. Symptoms include burning stomach, bloating, heartburn, nausea and vomiting.
Navigational Note: Consider Gastrointestinal disorders: Gastritis, Gastroparesis.
Dysphagia
Grade 1
Symptomatic, able to eat regular diet
Grade 2
Symptomatic and altered eating/swallowing
Grade 3
Severely altered eating/swallowing; tube feeding, TPN, or hospitalization indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by difficulty in swallowing.
Navigational Note: -
Enterocolitis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Abdominal pain; mucus or blood in stool
Grade 3
Severe or persistent abdominal pain; fever; ileus; peritoneal signs
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by inflammation of the small and large intestines.
Navigational Note: If reporting a known abnormality of the colon, use Gastrointestinal disorders: Colitis. If reporting a documented infection, use Infections and infestations: Enterocolitis infectious.
Enterovesical fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the urinary bladder and the intestine.
Navigational Note: -
Esophageal fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the esophagus and another organ or anatomic site.
Navigational Note: -
Esophageal hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the esophagus.
Navigational Note: -
Esophageal necrosis
Grade 1
-
Grade 2
-
Grade 3
Inability to aliment adequately by GI tract; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a necrotic process occurring in the esophageal wall.
Navigational Note: -
Esophageal obstruction
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Hospitalization indicated; invasive intervention indicated; limiting self care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by blockage of the normal flow of the contents in the esophagus.
Navigational Note: -
Esophageal pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the esophageal region.
Navigational Note: Record final diagnosis/cause once determined.
Esophageal perforation
Grade 1
-
Grade 2
Invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a rupture in the wall of the esophagus.
Navigational Note: -
Esophageal stenosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function
Grade 3
Severely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a narrowing of the lumen of the esophagus.
Navigational Note: -
Esophageal ulcer
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severely altered GI function; TPN indicated; elective invasive intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the esophageal wall.
Navigational Note: -
Esophageal varices hemorrhage
Grade 1
-
Grade 2
Self-limited; intervention not indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from esophageal varices.
Navigational Note: -
Esophagitis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered eating/swallowing; oral supplements indicated
Grade 3
Severely altered eating/swallowing; tube feeding, TPN, or hospitalization indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by inflammation of the esophageal wall.
Navigational Note: -
Fecal incontinence
Grade 1
Occasional use of pads required
Grade 2
Daily use of pads required
Grade 3
Severe symptoms; elective operative intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by inability to control the escape of stool from the rectum.
Navigational Note: -
Flatulence
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate; persistent; psychosocial sequelae
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a discharge of excessive gas from the lower GI tract.
Navigational Note: -
Gastric fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the stomach and another organ or anatomic site.
Navigational Note: -
Gastric hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the gastric wall.
Navigational Note: -
Gastric necrosis
Grade 1
-
Grade 2
-
Grade 3
Inability to aliment adequately by GI tract; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a necrotic process occurring in the gastric wall.
Navigational Note: -
Gastric perforation
Grade 1
-
Grade 2
Invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a rupture in the stomach wall.
Navigational Note: -
Gastric stenosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function
Grade 3
Severely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a narrowing of the lumen of the stomach.
Navigational Note: -
Gastric ulcer
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severely altered GI function; TPN indicated; elective invasive intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the stomach.
Navigational Note: -
Gastritis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function; medical intervention indicated
Grade 3
Severely altered eating or gastric function; TPN or hospitalization indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by inflammation of the stomach.
Navigational Note: -
Gastroesophageal reflux disease
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
Severe symptoms; operative intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by reflux of the gastric and/or duodenal contents into the distal esophagus. It is chronic in nature and usually caused by incompetence of the lower esophageal sphincter, and may result in injury to the esophageal mucosal. Symptoms include heartburn and acid indigestion.
Navigational Note: -
Gastrointestinal fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between any part of the gastrointestinal system and another organ or anatomic site.
Navigational Note: -
Gastrointestinal pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the gastrointestinal region.
Navigational Note: Consider Gastrointestinal disorders: Colitis, Enterocolitis. Record final diagnosis/cause once determined.
Gastroparesis
Grade 1
Mild nausea, early satiety and bloating, able to maintain caloric intake on regular diet
Grade 2
Moderate symptoms; able to maintain nutrition with dietary and lifestyle modifications; may need pharmacologic intervention
Grade 3
Weight loss >=20% from baseline; tube feeding or TPN indicated; elective operative intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
-
Definition: A disorder characterized by an incomplete paralysis of the muscles of the stomach wall resulting in delayed emptying of the gastric contents into the small intestine.
Navigational Note: -
Gingival pain
Grade 1
Mild pain
Grade 2
Moderate pain interfering with oral intake
Grade 3
Severe pain; inability to aliment orally
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the gingival region.
Navigational Note: Record final diagnosis/cause once determined.
Hematemesis
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by the vomiting of blood.
Navigational Note: Record final diagnosis/cause once determined.
Hematochezia
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by the passage of fresh blood per anus, usually in or with stools.
Navigational Note: Consider Gastrointestinal disorders: Colitis, Enterocolitis, Proctitis; Record final diagnosis/cause once determined.
Hemorrhoidal hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the hemorrhoids.
Navigational Note: -
Hemorrhoids
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; banding or medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by the presence of dilated veins in the rectum and surrounding area.
Navigational Note: -
Ileal fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the ileum and another organ or anatomic site.
Navigational Note: -
Ileal hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the ileal wall.
Navigational Note: Consider Gastrointestinal disorders: Enterocolitis.
Ileal obstruction
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function; naso-gastric tube indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Hospitalization indicated; invasive intervention indicated; long intestinal tube indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by blockage of the normal flow of the intestinal contents in the ileum.
Navigational Note: -
Ileal perforation
Grade 1
-
Grade 2
Invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a rupture in the ileal wall.
Navigational Note: Consider Gastrointestinal disorders: Enterocolitis.
Ileal stenosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function
Grade 3
Severely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a narrowing of the lumen of the ileum.
Navigational Note: -
Ileal ulcer
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function
Grade 3
Severely altered GI function; TPN indicated; elective invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the ileum.
Navigational Note: -
Ileus
Grade 1
Asymptomatic and radiologic observations only
Grade 2
Symptomatic; altered GI function; bowel rest indicated
Grade 3
Severely altered GI function; TPN indicated; tube placement indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by failure of the ileum to transport intestinal contents.
Navigational Note: -
Intra-abdominal hemorrhage
Grade 1
-
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding in the abdominal cavity.
Navigational Note: -
Jejunal fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the jejunum and another organ or anatomic site.
Navigational Note: -
Jejunal hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the jejunal wall.
Navigational Note: Consider Gastrointestinal disorders: Enterocolitis.
Jejunal obstruction
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Hospitalization indicated; invasive intervention indicated; limiting self care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by blockage of the normal flow of the intestinal contents in the jejunum.
Navigational Note: -
Jejunal perforation
Grade 1
-
Grade 2
Invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a rupture in the jejunal wall.
Navigational Note: Consider Gastrointestinal disorders: Enterocolitis.
Jejunal stenosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function
Grade 3
Severely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a narrowing of the lumen of the jejunum.
Navigational Note: -
Jejunal ulcer
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function
Grade 3
Severely altered GI function; TPN indicated; elective invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the jejunum.
Navigational Note: -
Lip pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort of the lip.
Navigational Note: Record final diagnosis/cause once determined.
Malabsorption
Grade 1
-
Grade 2
Altered diet; oral intervention indicated
Grade 3
Inability to aliment adequately; TPN indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by inadequate absorption of nutrients in the small intestine. Symptoms include abdominal marked discomfort, bloating and diarrhea.
Navigational Note: -
Melena
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by black, tarry stools.
Navigational Note: Record final diagnosis/cause once determined.
Mucositis oral
Grade 1
Asymptomatic or mild symptoms; intervention not indicated
Grade 2
Moderate pain or ulcer that does not interfere with oral intake; modified diet indicated
Grade 3
Severe pain; interfering with oral intake
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by ulceration or inflammation of the oral mucosal.
Navigational Note: -
Nausea
Grade 1
Loss of appetite without alteration in eating habits
Grade 2
Oral intake decreased without significant weight loss, dehydration or malnutrition; IV intervention indicated
Grade 3
Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a queasy sensation and/or the urge to vomit.
Navigational Note: Consider Gastrointestinal disorders: Enterocolitis, Gastritis and/or Endocrine disorders: Adrenal insufficiency, Hypophysitis.
Obstruction gastric
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Hospitalization indicated; invasive intervention indicated; limiting self care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by blockage of the normal flow of the contents in the stomach.
Navigational Note: -
Oral cavity fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the oral cavity and another organ or anatomic site.
Navigational Note: -
Oral dysesthesia
Grade 1
Mild discomfort; not interfering with oral intake
Grade 2
Moderate pain; interfering with oral intake
Grade 3
Disabling pain; tube feeding or TPN indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a burning or tingling sensation on the lips, tongue or entire mouth.
Navigational Note: -
Oral hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the mouth.
Navigational Note: -
Oral pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the mouth, tongue or lips.
Navigational Note: Record final diagnosis/cause once determined.
Pancreatic duct stenosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function
Grade 3
Severely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a narrowing of the lumen of the pancreatic duct.
Navigational Note: -
Pancreatic fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the pancreas and another organ or anatomic site.
Navigational Note: -
Pancreatic hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the pancreas.
Navigational Note: -
Pancreatic insufficiency
Grade 1
Asymptomatic and pancreatic enzymes <LLN
Grade 2
Increase in stool frequency, bulk, or odor; steatorrhea
Grade 3
Sequelae of absorption deficiency
Grade 4
-
Grade 5
-
Definition: A disorder characterized by impaired exocrine pancreatic function usually associated with decreased pancreatic exocrine enzymes production.
Navigational Note: -
Pancreatic necrosis
Grade 1
-
Grade 2
-
Grade 3
Tube feeding or TPN indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a necrotic process occurring in the pancreas.
Navigational Note: -
Pancreatitis
Grade 1
-
Grade 2
Radiologic findings only
Grade 3
Severe pain; vomiting; medical intervention indicated (e.g., analgesia, nutritional support)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by inflammation of the pancreas with no documented pancreas infection.
Navigational Note: -
Periodontal disease
Grade 1
Gingival recession or gingivitis; limited bleeding on probing; mild local bone loss
Grade 2
Moderate gingival recession or gingivitis; multiple sites of bleeding on probing; moderate bone loss
Grade 3
Spontaneous bleeding; severe bone loss with or without tooth loss; osteonecrosis of maxilla or mandible
Grade 4
-
Grade 5
-
Definition: A disorder in the gingival tissue around the teeth.
Navigational Note: -
Peritoneal necrosis
Grade 1
-
Grade 2
-
Grade 3
Tube feeding or TPN indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a necrotic process occurring in the peritoneum.
Navigational Note: -
Proctitis
Grade 1
Rectal discomfort, intervention not indicated
Grade 2
Symptomatic (e.g., rectal discomfort, passing blood or mucus); fecal urgency or stool incontinence; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by inflammation of the rectum.
Navigational Note: Consider Gastrointestinal disorders: Fecal incontinence.
Rectal fissure
Grade 1
Asymptomatic
Grade 2
Symptomatic
Grade 3
Invasive intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a tear in the lining of the rectum.
Navigational Note: -
Rectal fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the rectum and another organ or anatomic site.
Navigational Note: -
Rectal mucositis
Grade 1
Asymptomatic or mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by ulceration or inflammation of the mucous membrane of the rectum.
Navigational Note: -
Rectal necrosis
Grade 1
-
Grade 2
-
Grade 3
Tube feeding or TPN indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a necrotic process occurring in the rectal wall.
Navigational Note: -
Rectal obstruction
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Hospitalization indicated; invasive intervention indicated; limiting self care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by blockage of the normal flow of the intestinal contents in the rectum.
Navigational Note: -
Rectal pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the rectal region.
Navigational Note: Record final diagnosis/cause once determined.
Rectal perforation
Grade 1
-
Grade 2
Invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a rupture in the rectal wall.
Navigational Note: -
Rectal stenosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function
Grade 3
Severely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a narrowing of the lumen of the rectum.
Navigational Note: -
Rectal ulcer
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function (e.g., altered dietary habits, vomiting, diarrhea)
Grade 3
Severely altered GI function; TPN indicated; elective invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the rectum.
Navigational Note: -
Retroperitoneal hemorrhage
Grade 1
-
Grade 2
Self-limited; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the retroperitoneal area.
Navigational Note: -
Salivary duct inflammation
Grade 1
Slightly thickened saliva; slightly altered taste (e.g., metallic)
Grade 2
Thick, ropy, sticky saliva; markedly altered taste; alteration in diet indicated; secretion-induced symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Acute salivary gland necrosis; severe secretion-induced symptoms (e.g., thick saliva/oral secretions or gagging); tube feeding or TPN indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by inflammation of the salivary duct.
Navigational Note: -
Salivary gland fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between a salivary gland and another organ or anatomic site.
Navigational Note: -
Small intestinal mucositis
Grade 1
Asymptomatic or mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; interfering with oral intake; tube feeding, TPN or hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by ulceration or inflammation of the mucous membrane of the small intestine.
Navigational Note: -
Small intestinal obstruction
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Hospitalization indicated; invasive intervention indicated; limiting self care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by blockage of the normal flow of the intestinal contents of the small intestine.
Navigational Note: -
Small intestinal perforation
Grade 1
-
Grade 2
Invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a rupture in the small intestine wall.
Navigational Note: Consider Gastrointestinal disorders: Enterocolitis.
Small intestinal stenosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function
Grade 3
Symptomatic and severely altered GI function; tube feeding, TPN or hospitalization indicated; non-emergent operative intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a narrowing of the lumen of the small intestine.
Navigational Note: -
Small intestine ulcer
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severely altered GI function; TPN indicated; elective invasive intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the small intestine.
Navigational Note: -
Stomach pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the stomach.
Navigational Note: Record final diagnosis/cause once determined.
Tooth development disorder
Grade 1
Asymptomatic; hypoplasia of tooth or enamel
Grade 2
Impairment correctable with oral surgery
Grade 3
Maldevelopment with impairment not surgically correctable; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a pathological process of the teeth occurring during tooth development.
Navigational Note: -
Tooth discoloration
Grade 1
Surface stains
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a change in tooth hue or tint.
Navigational Note: -
Toothache
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the tooth.
Navigational Note: -
Typhlitis
Grade 1
-
Grade 2
-
Grade 3
Symptomatic (e.g., abdominal pain, fever, change in bowel habits with ileus); peritoneal signs
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by necrotizing enterocolitis in neutropenic patients. Also referred to as neutropenic enterocolitis, ileocecal syndrome, or cecitis.
Navigational Note: Includes Clostridioides difficile (c. diff, c. difficile). Also report Investigations: Neutrophil count decreased; Also consider Infections and infestations: Cecal infection.
Upper gastrointestinal hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the upper gastrointestinal tract (oral cavity, pharynx, esophagus, and stomach).
Navigational Note: -
Visceral arterial ischemia
Grade 1
-
Grade 2
Brief (<24 hrs) episode of ischemia managed medically and without permanent deficit
Grade 3
Prolonged (>=24 hrs) or recurring symptoms and/or invasive intervention indicated
Grade 4
Life-threatening consequences; evidence of end organ damage; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a decrease in blood supply due to narrowing or blockage of a visceral (mesenteric) artery.
Navigational Note: -
Vomiting
Grade 1
Intervention not indicated
Grade 2
Initiation of outpatient IV hydration; medical intervention indicated
Grade 3
Initiation of tube feeding, or TPN; hospitalization indicated
Grade 4
Life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth.
Navigational Note: Consider Gastrointestinal disorders: Enterocolitis, Gastritis and/or Endocrine disorders: Adrenal insufficiency, Hypophysitis.
Gastrointestinal disorders - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
General disorders and administration site conditions
Chills
Grade 1
Mild sensation of cold; shivering; chattering of teeth
Grade 2
Moderate tremor of the entire body; narcotics indicated
Grade 3
Severe or prolonged, not responsive to narcotics
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of cold that often marks a physiologic response to sweating after a fever.
Navigational Note: Consider Injury, poisoning and procedural complications: Infusion related reaction.
Death neonatal
Grade 1
-
Grade 2
-
Grade 3
-
Grade 4
Neonatal loss of life
Grade 5
-
Definition: Newborn death occurring during the first 28 days after birth.
Navigational Note: -
Death NOS
Grade 1
-
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
Death
Definition: Death that cannot be attributed to a CTCAE term associated with Grade 5.
Navigational Note: If death is due to an AE (ex., Cardiac disorders: Cardiac arrest), report as a Grade 5 event under that AE.
Disease progression
Grade 1
-
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
Death
Definition: Death due to disease progression that cannot be attributed to a CTCAE term associated with Grade 5.
Navigational Note: If death is due to an AE (ex., Cardiac disorders: Cardiac arrest), report as a Grade 5 event under that AE.
Edema face
Grade 1
Localized edema
Grade 2
Moderate localized edema; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe swelling; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by swelling due to excessive fluid accumulation in facial area tissues.
Navigational Note: Record final diagnosis/cause once determined.
Facial pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the face.
Navigational Note: Record final diagnosis/cause once determined.
Fatigue
Grade 1
Fatigue relieved by rest
Grade 2
Fatigue not relieved by rest; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Fatigue not relieved by rest, limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities.
Navigational Note: Record final diagnosis/cause once determined.
Fever
Grade 1
38.0 - 39.0 degrees C (100.4 - 102.2 degrees F)
Grade 2
>39.0 - 40.0 degrees C (102.3 - 104.0 degrees F)
Grade 3
>40.0 degrees C (>104.0 degrees F) for <=24 hrs
Grade 4
>40.0 degrees C (>104.0 degrees F) for >24 hrs
Grade 5
Death
Definition: A disorder characterized by elevation of the body's temperature above the upper limit of normal.
Navigational Note: Consider Injury, poisoning and procedural complications: Infusion related reaction.
Flu like symptoms
Grade 1
Mild flu-like symptoms present
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a group of symptoms similar to those observed in patients with the flu. It includes fever, chills, body aches, malaise, loss of appetite and dry cough.
Navigational Note: Synonym: Flu, Influenza; Consider Injury, poisoning and procedural complications: Infusion related reaction.
Gait disturbance
Grade 1
Mild change in gait (e.g., wide-based, limping or hobbling)
Grade 2
Moderate change in gait (e.g., wide-based, limping or hobbling); assistive device indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by walking difficulties.
Navigational Note: -
Generalized edema
Grade 1
Noted on exam; 1+ pitting edema
Grade 2
Oral therapy initiated; interfering with instrumental ADLs or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Interferes with self-care ADL or severe impact on age-appropriate normal daily activity (pediatric); intravenous IV therapy indicated; skin breakdown
Grade 4
Life-threatening consequences
Grade 5
-
Definition: A disorder characterized by fluid accumulation in the tissues of the body including the skin.
Navigational Note: Record final diagnosis/cause once determined.
Hypothermia
Grade 1
-
Grade 2
35 - >32 degrees C; 95 - >89.6 degrees F
Grade 3
32 - >28 degrees C; 89.6 - >82.4 degrees F
Grade 4
<=28 degrees C; 82.4 degrees F; life-threatening consequences (e.g., coma, hypotension, pulmonary edema, acidemia, ventricular fibrillation)
Grade 5
Death
Definition: A disorder characterized by an abnormally low body temperature. Treatment is required when the body temperature is 35C (95F) or below.
Navigational Note: -
Infusion site extravasation
Grade 1
Painless edema
Grade 2
Erythema with associated symptoms (e.g., edema, pain, induration, phlebitis)
Grade 3
Ulceration or necrosis; severe tissue damage; operative intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by leakage of the infusion into the surrounding tissue. Signs and symptoms may include induration, erythema, swelling, burning sensation and marked discomfort at the infusion site.
Navigational Note: -
Injection site reaction
Grade 1
Tenderness with or without associated symptoms (e.g., warmth, erythema, itching)
Grade 2
Pain; lipodystrophy; edema; phlebitis
Grade 3
Ulceration or necrosis; severe tissue damage; operative intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an intense adverse reaction (usually immunologic) developing at the site of an injection.
Navigational Note: -
Localized edema
Grade 1
Localized to dependent areas, no disability or functional impairment
Grade 2
Moderate localized edema and intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe localized edema and intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by swelling due to excessive fluid accumulation at a specific anatomic site.
Navigational Note: Prior to using this term consider specific edema areas and/or causes: Cardiac disorders: Heart failure; General disorders and administration site conditions: Edema face, Peripheral edema; Nervous system disorders: Edema cerebral; Respiratory, thoracic and mediastinal disorders: Laryngeal edema, Pulmonary edema; Eye disorders: Periorbital edema; Vascular disorders: Lymphedema. Record final diagnosis/cause once determined.
Malaise
Grade 1
Uneasiness or lack of well being
Grade 2
Uneasiness or lack of well being limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Uneasiness or lack of well being limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a feeling of general discomfort or uneasiness, an out-of-sorts feeling.
Navigational Note: -
Multi-organ failure
Grade 1
-
Grade 2
-
Grade 3
Shock with azotemia and acid-base disturbances; significant coagulation abnormalities
Grade 4
Life-threatening consequences (e.g., vasopressor dependent and oliguric or anuric or ischemic colitis or lactic acidosis)
Grade 5
Death
Definition: A disorder characterized by progressive deterioration of the lungs, liver, kidney and clotting mechanisms.
Navigational Note: -
Non-cardiac chest pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the chest unrelated to a heart disorder.
Navigational Note: Record final diagnosis/cause once determined.
Pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by the sensation of marked discomfort, distress or agony.
Navigational Note: Prior to using this term consider using a specific body part pain term found throughout the CTCAE (over 40 different pain terms). Record final diagnosis/cause once determined.
Peripheral edema
Grade 1
Swelling or obscuration of anatomic architecture on close inspection
Grade 2
Readily apparent obscuration of anatomic architecture; obliteration of skin folds; readily apparent deviation from normal anatomic contour; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Gross deviation from normal anatomic contour; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by swelling due to excessive fluid accumulation in the body periphery.
Navigational Note: Consider Cardiac disorders: Heart failure; Record final diagnosis/cause once determined.
Pneumatosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
Severe symptoms; operative intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of gas in the bowel wall.
Navigational Note: -
Sudden death NOS
Grade 1
-
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
Death
Definition: An unexpected death that cannot be attributed to a CTCAE term associated with Grade 5.
Navigational Note: If death is due to an AE (ex., Cardiac disorders: Cardiac arrest), report as a Grade 5 event under that AE.
Vaccination site lymphadenopathy
Grade 1
Local lymph node enlargement
Grade 2
Localized ulceration; generalized lymph node enlargement
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by lymph node enlargement after vaccination.
Navigational Note: -
General disorders and administration site conditions - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Hepatobiliary disorders
Bile duct stenosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function; IV fluids indicated <24 hrs
Grade 3
Severely altered GI function; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a narrowing of the lumen of the bile duct.
Navigational Note: -
Biliary fistula
Grade 1
-
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the bile ducts and another organ or anatomic site.
Navigational Note: -
Biliary obstruction
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function; IV fluids indicated <24 hrs
Grade 3
Symptomatic and severely altered GI function; hospitalization indicated; non-emergent operative intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by blockage of the normal flow of the normal flow of bile.
Navigational Note: -
Budd-Chiari syndrome
Grade 1
-
Grade 2
Medical management indicated
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; asterixis; mild encephalopathy
Grade 4
Life-threatening consequences; moderate to severe encephalopathy; coma
Grade 5
Death
Definition: A disorder characterized by occlusion of the hepatic veins and typically presents with abdominal pain, ascites and hepatomegaly.
Navigational Note: -
Cholecystitis
Grade 1
-
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by inflammation involving the gallbladder. It may be associated with the presence of gallstones.
Navigational Note: -
Gallbladder fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the gallbladder and another organ or anatomic site.
Navigational Note: -
Gallbladder necrosis
Grade 1
-
Grade 2
-
Grade 3
-
Grade 4
Life-threatening consequences; urgent invasive intervention indicated
Grade 5
Death
Definition: A disorder characterized by a necrotic process occurring in the gallbladder.
Navigational Note: -
Gallbladder obstruction
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; altered GI function; IV fluids indicated <24 hrs
Grade 3
Symptomatic and severely altered GI function; hospitalization indicated; non-emergent operative intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by blockage of the normal flow of the contents of the gallbladder.
Navigational Note: -
Gallbladder pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the gallbladder region.
Navigational Note: Record final diagnosis/cause once determined.
Gallbladder perforation
Grade 1
-
Grade 2
-
Grade 3
-
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a rupture in the gallbladder wall.
Navigational Note: -
Hepatic failure
Grade 1
-
Grade 2
-
Grade 3
Asterixis; mild encephalopathy; drug-induced liver injury (DILI); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; moderate to severe encephalopathy; coma
Grade 5
Death
Definition: A disorder characterized by the inability of the liver to metabolize chemicals in the body. Laboratory test results reveal abnormal plasma levels of ammonia, bilirubin, lactic dehydrogenase, alkaline phosphatase, aminotransferase, and/or prolongation of prothrombin time (INR.) Drug-induced liver injury (DILI) as defined by Hy's Law.
Navigational Note: -
Hepatic hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the liver.
Navigational Note: -
Hepatic necrosis
Grade 1
-
Grade 2
-
Grade 3
-
Grade 4
Life-threatening consequences; urgent invasive intervention indicated
Grade 5
Death
Definition: A disorder characterized by a necrotic process occurring in the hepatic parenchyma.
Navigational Note: -
Hepatic pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the liver region.
Navigational Note: Record final diagnosis/cause once determined.
Hepatitis
Grade 1
-
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
Symptomatic liver dysfunction; compensated cirrhosis; hospitalization or prolongation of existing hospitalization indicated
Grade 4
Life-threatening consequences; severe decompensated liver function (e.g., coagulopathy, encephalopathy, coma)
Grade 5
Death
Definition: A disorder characterized by inflammation of the liver.
Navigational Note: Consider Infections and infestations: Hepatitis viral, Hepatobiliary disorders: Hepatic failure. Report Autoimmune hepatitis under Hepatobiliary disorders: Other, specify.
Perforation bile duct
Grade 1
-
Grade 2
-
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a rupture in the wall of the extrahepatic or intrahepatic bile duct.
Navigational Note: -
Portal hypertension
Grade 1
-
Grade 2
Decreased portal vein flow
Grade 3
Reversal/retrograde portal vein flow; associated with varices and/or ascites
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an increase in blood pressure in the portal venous system.
Navigational Note: -
Portal vein thrombosis
Grade 1
-
Grade 2
Intervention not indicated
Grade 3
Medical intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by the formation of a thrombus (blood clot) in the portal vein.
Navigational Note: -
Sinusoidal obstruction syndrome
Grade 1
-
Grade 2
Blood bilirubin 2 - 5 mg/dL; minor interventions required (i.e., blood product, diuretic, oxygen)
Grade 3
Blood bilirubin >5 mg/dL; coagulation modifier indicated (e.g., defibrotide); reversal of flow on ultrasound
Grade 4
Life-threatening consequences (e.g., ventilatory support, dialysis, plasmapheresis, peritoneal drainage)
Grade 5
Death
Definition: A disorder characterized by severe hepatic injury as a result of the blood vessels of the liver becoming inflamed and/or blocked.
Navigational Note: -
Hepatobiliary disorders - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Immune system disorders
Allergic reaction
Grade 1
Systemic intervention not indicated
Grade 2
Oral intervention indicated
Grade 3
Bronchospasm; hospitalization indicated for clinical sequelae; IV intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an adverse general response from exposure to an allergen.
Navigational Note: If related to infusion, consider Injury, poisoning and procedural complications: Infusion related reaction. If related to immunization, consider Injury, poisoning and procedural complications: Systemic post-immunization reaction. Do not report both.
Anaphylaxis
Grade 1
-
Grade 2
-
Grade 3
Symptomatic bronchospasm, with or without urticaria; parenteral intervention indicated; allergy-related edema/angioedema; hypotension
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an acute inflammatory reaction resulting from the release of histamine and histamine-like substances from mast cells, causing a hypersensitivity immune response. Clinically, it presents with breathing difficulty, dizziness, hypotension, cyanosis and loss of consciousness and may lead to death.
Navigational Note: If related to infusion, consider Injury, poisoning and procedural complications: Infusion related reaction. Do not report both.
Autoimmune disorder
Grade 1
Asymptomatic; serologic or other evidence of autoimmune reaction, with normal organ function; intervention not indicated
Grade 2
Evidence of autoimmune reaction involving a non-essential organ or function (e.g., hypothyroidism)
Grade 3
Autoimmune reactions involving major organ (e.g., colitis, anemia, myocarditis, kidney)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by loss of function or tissue destruction of an organ or multiple organs, arising from humoral or cellular immune responses of the individual to his own tissue constituents.
Navigational Note: Prior to using this term consider specific autoimmune AEs.
Cytokine release syndrome
Grade 1
Fever with or without constitutional symptoms
Grade 2
Hypotension responding to fluids; hypoxia requiring low-flow nasal cannula or blow-by
Grade 3
Hypotension managed with one pressor; hypoxia requiring high-flow nasal cannula, facemask, nonrebreather mask, or Venturi mask
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by fever, tachypnea, headache, tachycardia, hypotension, rash, and/or hypoxia caused by the release of cytokines.
Navigational Note: Consider reporting other organ dysfunctions including neurological toxicities such as: Psychiatric disorders: Confusion, Hallucinations; Nervous system disorders: Dysphasia, Headache, Seizure, Tremor.
Graft versus host disease
Grade 1
-
Grade 2
Oral intervention indicated
Grade 3
IV intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by donor cells attacking the recipient's organs.
Navigational Note: -
Secondary hemophagocytic lymphohistiocytosis
Grade 1
Asymptomatic or mild symptoms; requiring clinical and/or diagnostic evaluation; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated (e.g., immunosuppressive agents)
Grade 3
Severe or medically significant but not immediately life threatening; hospitalization or prolongation of existing hospitalization indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by the development of a pathological and biochemical hyperinflammatory syndrome characterized by fever, cytopenias, hyperferritinemia, coagulopathy, hypofibrinogenemia and/or transaminitis and is attributable to therapy.
Navigational Note: -
Serum sickness
Grade 1
Clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate arthralgia; fever, rash, urticaria, antihistamines indicated
Grade 3
Severe arthralgia or arthritis; extensive rash; steroids or IV fluids indicated
Grade 4
Life-threatening consequences; pressor or ventilatory support indicated
Grade 5
Death
Definition: A disorder characterized by a delayed-type hypersensitivity reaction to foreign proteins derived from an animal serum. It occurs approximately six to twenty-one days following the administration of the foreign antigen. Symptoms include fever, arthralgias, myalgias, skin eruptions, lymphadenopathy, chest marked discomfort and dyspnea.
Navigational Note: -
Immune system disorders - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: Use for diagnoses not present in CTCAE (ex. Sjogren's syndrome, etc.).
Infections and infestations
Abdominal infection
Grade 1
-
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the abdominal cavity.
Navigational Note: -
Anorectal infection
Grade 1
Localized, local intervention indicated
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the anal area and the rectum.
Navigational Note: -
Appendicitis
Grade 1
-
Grade 2
-
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by acute inflammation to the vermiform appendix caused by a pathogenic agent.
Navigational Note: -
Appendicitis perforated
Grade 1
-
Grade 2
-
Grade 3
Medical intervention indicated; operative intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by acute inflammation to the vermiform appendix caused by a pathogenic agent with gangrenous changes resulting in the rupture of the appendiceal wall. The appendiceal wall rupture causes the release of inflammatory and bacterial contents from the appendiceal lumen into the abdominal cavity.
Navigational Note: -
Arteritis infective
Grade 1
-
Grade 2
-
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving an artery.
Navigational Note: -
Aseptic meningitis
Grade 1
-
Grade 2
-
Grade 3
Steroid therapy indicated; severe changes in mental status; self-limited seizure activity; neurologic abnormalities
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an inflammatory process of the meninges of the brain and/or spinal cord.
Navigational Note: Consider Infections and infestations: Meningitis.
Bacteremia
Grade 1
-
Grade 2
Blood culture positive with no signs or symptoms
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by the presence of bacteria in the blood stream.
Navigational Note: Grade 2 with hospitalization is acceptable; Consider Infections and infestations: Sepsis (Grades 3, 4 & 5).
Biliary tract infection
Grade 1
-
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the biliary tract.
Navigational Note: -
Bladder infection
Grade 1
-
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the bladder.
Navigational Note: -
Bone infection
Grade 1
-
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the bones.
Navigational Note: -
Breast infection
Grade 1
-
Grade 2
Local infection with moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; severe infection; axillary adenitis
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the breast.
Navigational Note: -
Bronchial infection
Grade 1
-
Grade 2
Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the bronchi.
Navigational Note: -
Candidiasis
Grade 1
Asymptomatic; local symptom management indicated
Grade 2
Oral intervention indicated (e.g., antifungal)
Grade 3
IV antifungal intervention indicated
Grade 4
Life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by a fungal infection caused by candida.
Navigational Note: If recovered in bloodstream report as Infections and infestations: Fungemia.
Catheter related infection
Grade 1
-
Grade 2
Localized; local intervention indicated; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process that involves a catheter or port.
Navigational Note: If related to a device other than a catheter or port, use Infections and infestations: Device related infection.
Cecal infection
Grade 1
-
Grade 2
Localized; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the cecum.
Navigational Note: -
Cervicitis infection
Grade 1
-
Grade 2
Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the uterine cervix.
Navigational Note: -
Conjunctivitis
Grade 1
Asymptomatic or mild symptoms; intervention not indicated
Grade 2
Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)
Grade 3
Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Best corrected visual acuity of 20/200 or worse in the affected eye
Grade 5
-
Definition: A disorder characterized by inflammation, swelling and redness to the conjunctiva of the eye.
Navigational Note: Consider Infections and infestations: Conjunctivitis infective if caused by infection.
Conjunctivitis infective
Grade 1
-
Grade 2
Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
-
Definition: A disorder characterized by an infectious process involving the conjunctiva. Clinical manifestations include pink or red color in the eyes.
Navigational Note: -
Corneal infection
Grade 1
-
Grade 2
Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the cornea.
Navigational Note: -
Cranial nerve infection
Grade 1
-
Grade 2
-
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving a cranial nerve.
Navigational Note: -
Cytomegalovirus infection reactivation
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; IV intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated; blindness
Grade 5
Death
Definition: A disorder characterized by the reactivation of cytomegalovirus (CMV).
Navigational Note: Synonym: CMV
Device related infection
Grade 1
-
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the use of a medical device.
Navigational Note: If related to a catheter or port, use Infections and infestations: Catheter related infection.
Duodenal infection
Grade 1
-
Grade 2
Moderate symptoms; medical intervention indicated (e.g., oral antibiotics)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the duodenum.
Navigational Note: -
Encephalitis
Grade 1
-
Grade 2
-
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; steroid therapy indicated; severe changes in mental status; self-limited seizure activity; neurologic abnormalities
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious or inflammatory process involving the brain tissue.
Navigational Note: -
Encephalomyelitis
Grade 1
-
Grade 2
-
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; steroid therapy indicated; severe changes in mental status; self-limited seizure activity; neurologic abnormalities
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious or inflammatory process involving the brain and spinal cord tissues.
Navigational Note: -
Endocarditis infective
Grade 1
-
Grade 2
-
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the endocardial layer of the heart.
Navigational Note: -
Endophthalmitis
Grade 1
-
Grade 2
Local intervention indicated
Grade 3
Systemic intervention; hospitalization indicated
Grade 4
Best corrected visual acuity of 20/200 or worse in the affected eye
Grade 5
-
Definition: A disorder characterized by an infectious process involving the internal structures of the eye.
Navigational Note: -
Enterocolitis infectious
Grade 1
-
Grade 2
Passage of >3 unformed stools per 24 hrs or duration of illness >48 hrs; moderate abdominal pain; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated; profuse watery diarrhea with signs of hypovolemia; bloody diarrhea; fever; severe abdominal pain; hospitalization indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the small and/or large intestines.
Navigational Note: Includes Clostridioides difficile (c. diff, c. difficile). Consider Gastrointestinal disorders: Typhlitis, Infections and infestations: Cecal infection.
Epstein-Barr virus infection reactivation
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; IV intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by the reactivation of Epstein-Barr virus (EBV).
Navigational Note: Synonym: EBV
Esophageal infection
Grade 1
-
Grade 2
Local intervention indicated (e.g., oral antibiotic, antifungal, antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the esophagus.
Navigational Note: -
Eye infection
Grade 1
-
Grade 2
Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated; enucleation
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the eye.
Navigational Note: -
Folliculitis
Grade 1
No intervention indicated
Grade 2
Topical intervention initiated
Grade 3
Systemic intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by inflammation or infection of the hair follicles.
Navigational Note: -
Fungemia
Grade 1
-
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by the presence of fungus in the blood stream.
Navigational Note: -
Gallbladder infection
Grade 1
-
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the gallbladder.
Navigational Note: -
Gum infection
Grade 1
Local therapy indicated (swish and swallow)
Grade 2
Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the gums.
Navigational Note: -
Hepatic infection
Grade 1
-
Grade 2
Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the liver.
Navigational Note: -
Hepatitis B reactivation
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; IV intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated; severe decompensated liver function (e.g., coagulopathy, encephalopathy, coma)
Grade 5
Death
Definition: A disorder characterized by the reactivation of hepatitis B virus.
Navigational Note: -
Hepatitis viral
Grade 1
Asymptomatic, intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
Symptomatic liver dysfunction; fibrosis by biopsy; compensated cirrhosis; hospitalization or prolongation of existing hospitalization indicated
Grade 4
Life-threatening consequences; severe decompensated liver function (e.g., coagulopathy, encephalopathy, coma)
Grade 5
Death
Definition: A disorder characterized by a viral pathologic process involving the liver parenchyma.
Navigational Note: -
Herpes simplex reactivation
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; IV intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by the reactivation of Herpes simplex virus.
Navigational Note: -
Infective myositis
Grade 1
-
Grade 2
Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the skeletal muscles.
Navigational Note: -
Joint infection
Grade 1
-
Grade 2
Localized; local intervention indicated; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral); needle aspiration indicated (single or multiple)
Grade 3
Arthroscopic intervention indicated (e.g., drainage) or arthrotomy (e.g., open surgical drainage)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving a joint.
Navigational Note: -
Kidney infection
Grade 1
-
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the kidney.
Navigational Note: -
Laryngitis
Grade 1
-
Grade 2
Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an inflammatory process involving the larynx.
Navigational Note: For symptoms and no intervention, consider Respiratory, thoracic and mediastinal disorders: Hoarseness, Sore throat.
Lip infection
Grade 1
Localized, local intervention indicated
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an infectious process involving the lips.
Navigational Note: -
Lymph gland infection
Grade 1
-
Grade 2
Localized; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the lymph nodes.
Navigational Note: -
Mediastinal infection
Grade 1
-
Grade 2
-
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the mediastinum.
Navigational Note: -
Meningitis
Grade 1
-
Grade 2
-
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; steroid therapy indicated; severe changes in mental status; self-limited seizure activity; neurologic abnormalities
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious or inflammatory process of the meninges of the brain and/or spinal cord.
Navigational Note: Consider Infections and infestations: Aseptic meningitis.
Meningoencephalitis
Grade 1
-
Grade 2
-
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; steroid therapy indicated; severe changes in mental status; self-limited seizure activity; neurologic abnormalities
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious or inflammatory process involving the meninges and the brain tissue.
Navigational Note: -
Mucosal infection
Grade 1
Localized, local intervention indicated
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving a mucosal surface.
Navigational Note: -
Myelitis
Grade 1
Asymptomatic; mild signs (e.g., Babinski's reflex or Lhermitte's sign)
Grade 2
Moderate weakness or sensory loss; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe weakness or sensory loss; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by inflammation involving the spinal cord. Symptoms include weakness, paresthesia, sensory loss, marked discomfort and incontinence.
Navigational Note: -
Nail infection
Grade 1
Localized, local intervention indicated
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an infectious process involving the nail.
Navigational Note: -
Otitis externa
Grade 1
Localized, local intervention indicated
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the outer ear and ear canal. Contributory factors include excessive water exposure (swimmer's ear infection) and cuts in the ear canal. Symptoms include fullness, itching, swelling and marked discomfort in the ear and ear drainage.
Navigational Note: Changes associated with radiation to external ear (pinnae) are graded under Injury, poisoning and procedural complications: Dermatitis radiation.
Otitis media
Grade 1
-
Grade 2
Localized; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the middle ear.
Navigational Note: -
Ovarian infection
Grade 1
-
Grade 2
Localized; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the ovary.
Navigational Note: -
Pancreas infection
Grade 1
-
Grade 2
-
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the pancreas.
Navigational Note: -
Paronychia
Grade 1
Nail fold edema or erythema; disruption of the cuticle
Grade 2
Local intervention indicated; oral intervention indicated (e.g., antibiotic, antifungal, antiviral); nail fold edema or erythema with pain; associated with discharge or nail plate separation; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Operative intervention indicated; IV antibiotics indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an infectious process involving the soft tissues around the nail.
Navigational Note: -
Pelvic infection
Grade 1
-
Grade 2
Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the pelvic cavity.
Navigational Note: -
Penile infection
Grade 1
Localized, local intervention indicated
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the penis.
Navigational Note: -
Periorbital infection
Grade 1
-
Grade 2
Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process near or around the orbit of the eye.
Navigational Note: -
Peripheral nerve infection
Grade 1
-
Grade 2
Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the peripheral nerves.
Navigational Note: -
Peritoneal infection
Grade 1
-
Grade 2
-
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the peritoneum.
Navigational Note: -
Pharyngitis
Grade 1
-
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by inflammation of the throat.
Navigational Note: For Grade 1 Consider Respiratory, thoracic and mediastinal disorders: Sore throat.
Phlebitis infective
Grade 1
Localized, local intervention indicated
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the vein. Clinical manifestations include erythema, marked discomfort, swelling, and induration along the course of the infected vein.
Navigational Note: -
Pleural infection
Grade 1
-
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the pleura.
Navigational Note: -
Pneumonia
Grade 1
-
Grade 2
Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the lungs, including pneumonia.
Navigational Note: Replaces Lung infection as this term is more commonly used. If due to aspiration, consider reporting Respiratory, thoracic and mediastinal disorders: Aspiration
Prostate infection
Grade 1
-
Grade 2
Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the prostate gland.
Navigational Note: -
Rash pustular
Grade 1
-
Grade 2
Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a circumscribed and elevated skin lesion filled with pus.
Navigational Note: Consider Skin and subcutaneous tissue disorders: Pustular drug eruption.
Rhinitis infective
Grade 1
-
Grade 2
Localized; local intervention indicated
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an infectious process involving the nasal mucosal.
Navigational Note: -
Salivary gland infection
Grade 1
-
Grade 2
Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the salivary gland.
Navigational Note: -
Scrotal infection
Grade 1
Localized, local intervention indicated
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the scrotum.
Navigational Note: -
Sepsis
Grade 1
-
Grade 2
-
Grade 3
IV intervention indicated
Grade 4
Life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by the presence of pathogenic microorganisms in the blood stream that cause varying degrees of organ dysfunction due to a dysregulated host response to infection.
Navigational Note: Consider Infections and infestations: Bacteremia (Grade 2).
Shingles
Grade 1
Localized, local intervention indicated
Grade 2
Local infection with moderate symptoms; oral intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; IV intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by the reactivation of herpes zoster virus.
Navigational Note: Synonym: Herpes zoster
Sinusitis
Grade 1
-
Grade 2
Localized; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the mucous membranes of the paranasal sinuses.
Navigational Note: -
Skin infection
Grade 1
Localized, local intervention indicated
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the skin such as cellulitis.
Navigational Note: -
Small intestine infection
Grade 1
-
Grade 2
Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the small intestine.
Navigational Note: -
Soft tissue infection
Grade 1
-
Grade 2
Localized; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving soft tissues.
Navigational Note: -
Splenic infection
Grade 1
-
Grade 2
-
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the spleen.
Navigational Note: -
Stoma site infection
Grade 1
Localized, local intervention indicated
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving a stoma (surgically created opening on the surface of the body).
Navigational Note: -
Tooth infection
Grade 1
-
Grade 2
Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving a tooth.
Navigational Note: Record final diagnosis/cause once determined.
Tracheitis
Grade 1
-
Grade 2
Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the trachea.
Navigational Note: -
Upper respiratory infection
Grade 1
-
Grade 2
Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the upper respiratory tract (nose, paranasal sinuses, pharynx, larynx, or trachea).
Navigational Note: -
Urethral infection
Grade 1
-
Grade 2
Localized; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the urethra.
Navigational Note: -
Urinary tract infection
Grade 1
-
Grade 2
Localized; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the urinary tract, most commonly the bladder and the urethra.
Navigational Note: -
Uterine infection
Grade 1
-
Grade 2
Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the endometrium. It may extend to the myometrium and parametrial tissues.
Navigational Note: -
Vaginal infection
Grade 1
Localized, local intervention indicated
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the vagina.
Navigational Note: -
Viremia
Grade 1
-
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by the presence of a virus in the blood stream.
Navigational Note: -
Vulval infection
Grade 1
Localized, local intervention indicated
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the vulva.
Navigational Note: -
Wound infection
Grade 1
Localized, local intervention indicated
Grade 2
Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
Grade 3
IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an infectious process involving the wound.
Navigational Note: -
Infections and infestations - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Injury, poisoning and procedural complications
Anesthetic complication
Grade 1
-
Grade 2
Any anesthesia effects requiring medical intervention for reversal of symptomatic effects and requiring unplanned hospitalization of <24 hours.
Grade 3
Any anesthesia effects requiring medical intervention for reversal of symptomatic effects and requiring unplanned hospitalization of >=24 hours.
Grade 4
Anesthesia effects with life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by reactions related to the administration of local or moderate sedation given for a procedure.
Navigational Note: -
Aortic injury
Grade 1
-
Grade 2
Operative intervention not indicated
Grade 3
Severe symptoms; repair or revision indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; evidence of end organ damage; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of damage to the aorta.
Navigational Note: -
Arterial injury
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; repair or revision not indicated
Grade 3
Severe symptoms; repair or revision indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; evidence of end organ damage; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of damage to an artery.
Navigational Note: -
Biliary anastomotic leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage of bile due to breakdown of a biliary anastomosis (surgical connection of two separate anatomic structures).
Navigational Note: -
Bladder anastomotic leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage of urine due to breakdown of a bladder anastomosis (surgical connection of two separate anatomic structures).
Navigational Note: -
Bruising
Grade 1
Localized or in a dependent area
Grade 2
Generalized
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A finding of injury of the soft tissues or bone characterized by leakage of blood into surrounding tissues.
Navigational Note: -
Burn
Grade 1
Minimal symptoms; intervention not indicated
Grade 2
Medical intervention; minimal debridement indicated
Grade 3
Moderate to major debridement or reconstruction indicated
Grade 4
Life-threatening consequences
Grade 5
Death
Definition: A finding of impaired integrity to the anatomic site of an adverse thermal reaction. Burns can be caused by exposure to chemicals, direct heat, electricity, flames and radiation. The extent of damage depends on the length and intensity of exposure and time until provision of treatment.
Navigational Note: -
Dermatitis radiation
Grade 1
Faint erythema or dry desquamation
Grade 2
Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema
Grade 3
Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion
Grade 4
Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated
Grade 5
Death
Definition: A finding of cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of ionizing radiation.
Navigational Note: Synonym: Radiation induced skin toxicities (CTCAE v3.0 )
Esophageal anastomotic leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage due to breakdown of an esophageal anastomosis (surgical connection of two separate anatomic structures).
Navigational Note: -
Fall
Grade 1
Minor with no resultant injuries; intervention not indicated
Grade 2
Symptomatic; noninvasive intervention indicated
Grade 3
Hospitalization indicated; invasive intervention indicated
Grade 4
-
Grade 5
-
Definition: A finding of sudden movement downward, usually resulting in injury.
Navigational Note: -
Fallopian tube anastomotic leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage due to breakdown of a fallopian tube anastomosis (surgical connection of two separate anatomic structures).
Navigational Note: -
Fallopian tube perforation
Grade 1
-
Grade 2
Invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated (e.g., organ resection)
Grade 5
Death
Definition: A disorder characterized by a rupture of the fallopian tube wall.
Navigational Note: -
Fracture
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic but non-displaced; immobilization indicated
Grade 3
Severe symptoms; displaced or open wound with bone exposure; operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A state in which the continuity of the bone is broken.
Navigational Note: -
Gastric anastomotic leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage due to breakdown of a gastric anastomosis (surgical connection of two separate anatomic structures).
Navigational Note: -
Gastrointestinal anastomotic leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage due to breakdown of a gastrointestinal anastomosis (surgical connection of two separate anatomic structures).
Navigational Note: -
Gastrointestinal stoma necrosis
Grade 1
-
Grade 2
Superficial necrosis; intervention not indicated
Grade 3
Severe symptoms; hospitalization indicated; elective operative intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a necrotic process occurring in the gastrointestinal tract stoma.
Navigational Note: -
Infusion related reaction
Grade 1
Mild transient reaction; infusion interruption not indicated; intervention not indicated
Grade 2
Therapy or infusion interruption indicated but responds promptly to symptomatic treatment (e.g., antihistamines, NSAIDS, narcotics, IV fluids); prophylactic medications indicated for <=24 hrs
Grade 3
Prolonged (e.g., not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by adverse reaction to the infusion of pharmacological or biological substances.
Navigational Note: If the reaction is an allergic reaction related to an agent, consider reporting as Immune system disorders: Allergic reaction. Do not report both.
Injury to carotid artery
Grade 1
-
Grade 2
Repair or revision not indicated
Grade 3
Severe symptoms (e.g., transient cerebral ischemia); repair or revision indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to the carotid artery.
Navigational Note: -
Injury to inferior vena cava
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; repair or revision not indicated
Grade 3
Severe symptoms; repair or revision indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to the inferior vena cava.
Navigational Note: -
Injury to jugular vein
Grade 1
-
Grade 2
Repair or revision not indicated
Grade 3
Symptomatic; repair or revision indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to the jugular vein.
Navigational Note: -
Injury to superior vena cava
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; repair or revision not indicated
Grade 3
Severe symptoms; repair or revision indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to the superior vena cava.
Navigational Note: -
Intestinal stoma leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage of contents from an intestinal stoma (surgically created opening on the surface of the body).
Navigational Note: -
Intestinal stoma obstruction
Grade 1
-
Grade 2
Self-limited; intervention not indicated
Grade 3
Severe symptoms; IV fluids, tube feeding, or TPN indicated >=24 hrs; elective operative intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by blockage of the normal flow of the contents of the intestinal stoma.
Navigational Note: -
Intestinal stoma site bleeding
Grade 1
Minimal bleeding identified on clinical exam; intervention not indicated
Grade 2
Moderate bleeding; medical intervention indicated
Grade 3
Invasive intervention indicated; hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the intestinal stoma.
Navigational Note: -
Intraoperative arterial injury
Grade 1
Primary repair of injured organ/structure indicated
Grade 2
Partial resection of injured organ/structure indicated
Grade 3
Complete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to an artery during a surgical procedure.
Navigational Note: -
Intraoperative breast injury
Grade 1
Primary repair of injured organ/structure indicated
Grade 2
Partial resection of injured organ/structure indicated
Grade 3
Complete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to the breast parenchyma during a surgical procedure.
Navigational Note: -
Intraoperative cardiac injury
Grade 1
-
Grade 2
-
Grade 3
Primary repair of injured organ/structure indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to the heart during a surgical procedure.
Navigational Note: -
Intraoperative ear injury
Grade 1
Primary repair of injured organ/structure indicated
Grade 2
Partial resection of injured organ/structure indicated
Grade 3
Complete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL (e.g., impaired hearing; impaired balance) or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to the ear during a surgical procedure.
Navigational Note: -
Intraoperative endocrine injury
Grade 1
Primary repair of injured organ/structure indicated
Grade 2
Partial resection of injured organ/structure indicated
Grade 3
Complete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to the endocrine gland during a surgical procedure.
Navigational Note: -
Intraoperative gastrointestinal injury
Grade 1
Primary repair of injured organ/structure indicated
Grade 2
Partial resection of injured organ/structure indicated
Grade 3
Complete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to the gastrointestinal system during a surgical procedure.
Navigational Note: -
Intraoperative head and neck injury
Grade 1
Primary repair of injured organ/structure indicated
Grade 2
Partial resection of injured organ/structure indicated
Grade 3
Complete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to the head and neck during a surgical procedure.
Navigational Note: -
Intraoperative hemorrhage
Grade 1
-
Grade 2
-
Grade 3
Postoperative invasive intervention indicated; hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of uncontrolled bleeding during a surgical procedure.
Navigational Note: -
Intraoperative hepatobiliary injury
Grade 1
Primary repair of injured organ/structure indicated
Grade 2
Partial resection of injured organ/structure indicated
Grade 3
Complete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to the hepatic parenchyma and/or biliary tract during a surgical procedure.
Navigational Note: -
Intraoperative musculoskeletal injury
Grade 1
Primary repair of injured organ/structure indicated
Grade 2
Partial resection of injured organ/structure indicated
Grade 3
Complete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to the musculoskeletal system during a surgical procedure.
Navigational Note: -
Intraoperative neurological injury
Grade 1
Primary repair of injured organ/structure indicated
Grade 2
Partial resection of injured organ/structure indicated
Grade 3
Complete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to the nervous system during a surgical procedure.
Navigational Note: -
Intraoperative ocular injury
Grade 1
Primary repair of injured organ/structure indicated
Grade 2
Partial resection of injured organ/structure indicated
Grade 3
Complete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to the eye during a surgical procedure.
Navigational Note: -
Intraoperative renal injury
Grade 1
Primary repair of injured organ/structure indicated
Grade 2
Partial resection of injured organ/structure indicated
Grade 3
Complete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to the kidney during a surgical procedure.
Navigational Note: -
Intraoperative reproductive tract injury
Grade 1
Primary repair of injured organ/structure indicated
Grade 2
Partial resection of injured organ/structure indicated
Grade 3
Complete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to the reproductive organs during a surgical procedure.
Navigational Note: -
Intraoperative respiratory injury
Grade 1
Primary repair of injured organ/structure indicated
Grade 2
Partial resection of injured organ/structure indicated
Grade 3
Complete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to the respiratory system during a surgical procedure.
Navigational Note: -
Intraoperative splenic injury
Grade 1
-
Grade 2
Primary repair of injured organ/structure indicated
Grade 3
Resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to the spleen during a surgical procedure.
Navigational Note: -
Intraoperative urinary injury
Grade 1
Primary repair of injured organ/structure indicated
Grade 2
Partial resection of injured organ/structure indicated
Grade 3
Complete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to the urinary system during a surgical procedure.
Navigational Note: -
Intraoperative venous injury
Grade 1
Primary repair of injured organ/structure indicated
Grade 2
Partial resection of injured organ/structure indicated
Grade 3
Complete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to a vein during a surgical procedure.
Navigational Note: -
Kidney anastomotic leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage of urine due to breakdown of a kidney anastomosis (surgical connection of two separate anatomic structures).
Navigational Note: -
Large intestinal anastomotic leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage due to breakdown of an anastomosis (surgical connection of two separate anatomic structures) in the large intestine.
Navigational Note: -
Nerve injury
Grade 1
-
Grade 2
Limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Invasive intervention indicated; hospitalization; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to a nerve.
Navigational Note: -
Pancreatic anastomotic leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage due to breakdown of a pancreatic anastomosis (surgical connection of two separate anatomic structures).
Navigational Note: -
Pharyngeal anastomotic leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage due to breakdown of a pharyngeal anastomosis (surgical connection of two separate anatomic structures).
Navigational Note: -
Post biopsy bleeding
Grade 1
-
Grade 2
Requiring additional observation
Grade 3
Transfusion indicated; invasive intervention indicated; hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding as a result of a biopsy procedure.
Navigational Note: -
Postoperative hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate bleeding requiring transfusion <2 units (10 cc/kg for pediatrics) of pRBCs
Grade 3
Transfusion indicated of >=2 units (10 cc/kg for pediatrics) pRBCs; invasive intervention indicated; hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding occurring after a surgical procedure.
Navigational Note: Consider Injury, poisoning and procedural complications: Post biopsy bleeding.
Postoperative thoracic procedure complication
Grade 1
-
Grade 2
Extubated within 24 - 72 hrs postoperatively
Grade 3
Extubated >72 hrs postoperatively, but before tracheostomy indicated
Grade 4
Life-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)
Grade 5
Death
Definition: A finding of a previously undocumented problem that occurs after a thoracic procedure.
Navigational Note: -
Prolapse of intestinal stoma
Grade 1
Asymptomatic; reducible
Grade 2
Recurrent after manual reduction; local irritation or stool leakage; difficulty to fit appliance; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; elective operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of protrusion of the intestinal stoma (surgically created opening on the surface of the body) above the abdominal surface.
Navigational Note: -
Prolapse of urostomy
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Local care or maintenance; minor revision indicated
Grade 3
Dysfunctional stoma; elective operative intervention or major stomal revision indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of displacement of the urostomy.
Navigational Note: -
Radiation recall reaction (dermatologic)
Grade 1
Faint erythema or dry desquamation
Grade 2
Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema
Grade 3
Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion
Grade 4
Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated
Grade 5
Death
Definition: A finding of acute skin inflammatory reaction caused by drugs, especially chemotherapeutic agents, for weeks or months following radiotherapy. The inflammatory reaction is confined to the previously irradiated skin and the symptoms disappear after the removal of the pharmaceutical agent.
Navigational Note: -
Rectal anastomotic leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage due to breakdown of a rectal anastomosis (surgical connection of two separate anatomic structures).
Navigational Note: -
Seroma
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; simple aspiration indicated
Grade 3
Symptomatic, elective invasive intervention indicated
Grade 4
-
Grade 5
-
Definition: A finding of tumor-like collection of serum in the tissues.
Navigational Note: -
Small intestinal anastomotic leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage due to breakdown of an anastomosis (surgical connection of two separate anatomic structures) in the small bowel.
Navigational Note: -
Spermatic cord anastomotic leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage due to breakdown of a spermatic cord anastomosis (surgical connection of two separate anatomic structures).
Navigational Note: -
Stenosis of gastrointestinal stoma
Grade 1
-
Grade 2
Symptomatic; IV fluids indicated <24 hrs; manual dilation at bedside
Grade 3
Severely altered GI function; tube feeding, TPN or hospitalization indicated; elective operative intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of narrowing of the gastrointestinal stoma (surgically created opening on the surface of the body).
Navigational Note: -
Stomal ulcer
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; elective operative intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a circumscribed, erosive lesion on the jejunal mucosal surface close to the anastomosis site following a gastroenterostomy procedure.
Navigational Note: -
Systemic post-immunization reaction
Grade 1
Mild pain; erythema 2.5 - 5 cm; induration/swelling 2.5 - 5 cm; does not interfere with activity
Grade 2
Moderate pain; erythema >5 - 10 cm; Induration/swelling >5 - 10 cm; lipodystrophy; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; erythema >10 cm; Induration/swelling >10 cm; necrosis; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
-
Definition: A disorder characterized by a systemic manifestation that occurs after the injection of a substance with antigenic properties, administered to activate the immune system.
Navigational Note: -
Tissue injury
Grade 1
-
Grade 2
Limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Invasive intervention indicated; hospitalization; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A finding of damage to an organ or tissue as a result of a procedure.
Navigational Note: -
Tracheal hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the trachea.
Navigational Note: -
Tracheal obstruction
Grade 1
Partial asymptomatic obstruction on examination (e.g., visual, radiologic or endoscopic)
Grade 2
Symptomatic (e.g., noisy airway breathing), no respiratory distress; medical intervention indicated (e.g., steroids); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Stridor or respiratory distress; invasive intervention indicated (e.g., stent, laser); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)
Grade 5
Death
Definition: A disorder characterized by blockage of the lumen of the trachea.
Navigational Note: -
Tracheostomy site bleeding
Grade 1
Minimal bleeding identified on clinical exam; intervention not indicated
Grade 2
Moderate bleeding; medical intervention indicated
Grade 3
Invasive intervention indicated; hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the tracheostomy site.
Navigational Note: -
Ureteric anastomotic leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage due to breakdown of a ureteral anastomosis (surgical connection of two separate anatomic structures).
Navigational Note: -
Urethral anastomotic leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage due to breakdown of a urethral anastomosis (surgical connection of two separate anatomic structures).
Navigational Note: -
Urostomy leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage of contents from a urostomy.
Navigational Note: -
Urostomy obstruction
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; dilation or endoscopic repair or stent placement indicated
Grade 3
Altered organ function (e.g., sepsis or hydronephrosis, or renal dysfunction); elective operative intervention indicated
Grade 4
Life-threatening consequences; organ failure; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by blockage of the urostomy.
Navigational Note: -
Urostomy site bleeding
Grade 1
Minimal bleeding identified on clinical exam; intervention not indicated
Grade 2
Moderate bleeding; medical intervention indicated
Grade 3
Invasive intervention indicated; hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the urostomy site.
Navigational Note: -
Urostomy stenosis
Grade 1
-
Grade 2
Symptomatic but no hydronephrosis, sepsis, or renal dysfunction; dilation or endoscopic repair or stent placement indicated
Grade 3
Symptomatic (e.g., hydronephrosis, or renal dysfunction); elective operative intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of narrowing of the opening of a urostomy.
Navigational Note: -
Uterine anastomotic leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage due to breakdown of a uterine anastomosis (surgical connection of two separate anatomic structures).
Navigational Note: -
Uterine perforation
Grade 1
-
Grade 2
Invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a rupture in the uterine wall.
Navigational Note: -
Vaginal anastomotic leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage due to breakdown of a vaginal anastomosis (surgical connection of two separate anatomic structures).
Navigational Note: -
Vas deferens anastomotic leak
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of leakage due to breakdown of a vas deferens anastomosis (surgical connection of two separate anatomic structures).
Navigational Note: -
Vascular access complication
Grade 1
TPA administration into line with no intent for systemic therapy indicated
Grade 2
Device dislodgement, blockage, leak, or malposition; device replacement indicated
Grade 3
Pulmonary embolism, deep vein or cardiac thrombosis; intervention indicated
Grade 4
Life-threatening consequences with hemodynamic or neurologic instability
Grade 5
Death
Definition: A finding of a previously undocumented problem related to the vascular access site.
Navigational Note: -
Venous injury
Grade 1
Asymptomatic diagnostic finding; intervention not indicated
Grade 2
Symptomatic (e.g., claudication); repair or revision not indicated
Grade 3
Severe symptoms; repair or revision indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; evidence of end organ damage; urgent operative intervention indicated
Grade 5
Death
Definition: A finding of damage to a vein.
Navigational Note: -
Wound complication
Grade 1
Observation only; topical intervention indicated
Grade 2
Bedside local care indicated
Grade 3
Operative intervention indicated
Grade 4
Life-threatening consequences
Grade 5
Death
Definition: A finding of development of a new problem at the site of an existing wound.
Navigational Note: Prior to using this term consider Injury, poisoning and procedural complications: Wound dehiscence or Infections and infestations: Wound infection.
Wound dehiscence
Grade 1
Incisional separation, intervention not indicated
Grade 2
Incisional separation, local care (e.g., suturing) or medical intervention indicated (e.g., analgesic)
Grade 3
Fascial disruption or dehiscence without evisceration; revision by operative intervention indicated
Grade 4
Life-threatening consequences; symptomatic hernia with evidence of strangulation; fascial disruption with evisceration; major reconstruction flap, grafting, resection, or amputation indicated
Grade 5
Death
Definition: A finding of separation of the approximated margins of a surgical wound.
Navigational Note: Consider Infections and infestations: Wound infection.
Injury, poisoning and procedural complications - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Investigations
Activated partial thromboplastin time prolonged
Grade 1
>ULN - 1.5 x ULN
Grade 2
>1.5 - 2.5 x ULN
Grade 3
>2.5 x ULN; bleeding
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results in which the partial thromboplastin time is found to be greater than the control value. As a possible indicator of coagulopathy, a prolonged partial thromboplastin time (PTT) may occur in a variety of diseases and disorders, both primary and related to treatment.
Navigational Note: -
Alanine aminotransferase increased
Grade 1
>ULN - 3.0 x ULN if baseline was normal or less than normal; 1.0 - 1.5 x baseline if baseline was >ULN
Grade 2
>3.0 - 5.0 x ULN if baseline was normal or less than normal; >1.5 - 2.0 x baseline if baseline was >ULN
Grade 3
>5.0 - 20.0 x ULN if baseline was normal or less than normal; >2.0 - 4.0 x baseline if baseline was >ULN up to 5 x ULN
Grade 4
>20.0 x ULN if baseline was normal or less than normal; >4.0 x baseline if baseline was >ULN
Grade 5
-
Definition: A finding based on laboratory test results that indicate an increase in the level of alanine aminotransferase (ALT or SGPT) in the blood specimen.
Navigational Note: Consider Hepatobiliary disorders: Hepatic failure. Report Autoimmune hepatitis under Hepatobiliary disorders: Other, specify.
Alkaline phosphatase increased
Grade 1
>Baseline and ULN
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate an increase in the level of alkaline phosphatase (ALP) in a blood specimen.
Navigational Note: -
Aspartate aminotransferase increased
Grade 1
>ULN - 3.0 x ULN if baseline was normal or less than normal; 1.0 - 1.5 x baseline if baseline was >ULN
Grade 2
>3.0 - 5.0 x ULN if baseline was normal or less than normal; >1.5 - 2.0 x baseline if baseline was >ULN
Grade 3
>5.0 - 20.0 x ULN if baseline was normal or less than normal; >2.0 - 4.0 x baseline if baseline was >ULN up to 5 x ULN
Grade 4
>20.0 x ULN if baseline was normal or less than normal; >4.0 x baseline if baseline was >ULN
Grade 5
-
Definition: A finding based on laboratory test results that indicate an increase in the level of aspartate aminotransferase (AST or SGOT) in a blood specimen.
Navigational Note: Consider Hepatobiliary disorders: Hepatic failure. Report Autoimmune hepatitis under Hepatobiliary disorders: Other, specify.
Blood antidiuretic hormone abnormal
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Hospitalization indicated
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate abnormal levels of antidiuretic hormone (ADH) in the blood specimen.
Navigational Note: -
Blood bicarbonate decreased
Grade 1
<LLN and no intervention initiated
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate a decrease in levels of bicarbonate in a venous blood specimen.
Navigational Note: Consider Metabolism and nutrition disorders: Acidosis, Alkalosis.
Blood bilirubin increased
Grade 1
>ULN - 1.5 x ULN if baseline was normal or less than normal; 1.0 - 1.5 x baseline if baseline was >ULN
Grade 2
>1.5 - 3.0 x ULN if baseline was normal or less than normal; >1.5 - 2.5 x baseline if baseline was >ULN
Grade 3
>3.0 - 10.0 x ULN if baseline was normal or less than normal; >2.5 - 10.0 x baseline if baseline was >ULN
Grade 4
>10.0 x ULN if baseline was normal or less than normal; >10.0 x baseline if baseline was >ULN
Grade 5
-
Definition: A finding based on laboratory test results that indicate an abnormally high level of total bilirubin in the blood. Excess bilirubin is associated with jaundice.
Navigational Note: Consider Hepatobiliary disorders: Hepatic failure. Report Autoimmune hepatitis under Hepatobiliary disorders: Other, specify.
Blood corticotrophin decreased
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Hospitalization indicated
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate a decrease in the expected levels of corticotrophin (ACTH) in a blood specimen.
Navigational Note: -
Blood gonadotrophin abnormal
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate abnormal levels of gonadotrophin hormone in a blood specimen.
Navigational Note: -
Blood lactate dehydrogenase increased
Grade 1
>ULN
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate increased levels of lactate dehydrogenase (LDH) in the blood specimen.
Navigational Note: -
Blood prolactin abnormal
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate abnormal levels of prolactin hormone in a blood specimen.
Navigational Note: -
Carbon monoxide diffusing capacity decreased
Grade 1
3 - 5 units below LLN if no baseline available; for follow-up, a decrease of 3 - 5 units (ml/min/mmHg) below the baseline value; asymptomatic and intervention not indicated
Grade 2
6 - 8 units below LLN if no baseline available; for follow-up, an asymptomatic decrease of >5 - 8 units (ml/min/mmHg) below the baseline value; symptomatic and intervention not indicated
Grade 3
Asymptomatic decrease of >8 units drop; >5 units drop along with the presence of pulmonary symptoms (e.g., >Grade 2 hypoxia or >Grade 2 dyspnea); intervention indicated
Grade 4
-
Grade 5
-
Definition: A finding based on lung function test results that indicate a decrease in the lung capacity to absorb carbon monoxide (DLCO or TLCO).
Navigational Note: Consider Respiratory, thoracic and mediastinal disorders: Dyspnea, Respiratory failure.
CD4 lymphocytes decreased
Grade 1
<LLN - 500/mm³; <LLN - 0.5 x 10⁹/L
Grade 2
<500 - 200/mm³; <0.5 - 0.2 x 10⁹/L
Grade 3
<200 - 50/mm³; <0.2 - 0.05 x 10⁹/L
Grade 4
<50/mm³; <0.05 x 10⁹/L
Grade 5
-
Definition: A finding based on laboratory test results that indicate a decrease in levels of CD4 lymphocytes in a blood specimen.
Navigational Note: -
Cholesterol high
Grade 1
>ULN - 300 mg/dL; >ULN - 7.75 mmol/L
Grade 2
>300 - 400 mg/dL; >7.75 - 10.34 mmol/L
Grade 3
>400 - 500 mg/dL; >10.34 - 12.92 mmol/L
Grade 4
>500 mg/dL; >12.92 mmol/L
Grade 5
-
Definition: A finding based on laboratory test results that indicate higher than normal levels of cholesterol in a blood specimen.
Navigational Note: -
Creatinine clearance decreased
Grade 1
-
Grade 2
26 - 49 ml/min
Grade 3
10 - 25 ml/min
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate a decrease in creatinine clearance (CrCl) in a 24-hour urine collection.
Navigational Note: Report Grade 4 and 5 as Renal and urinary disorders: Acute kidney injury or Chronic kidney disease.
Creatinine increased
Grade 1
>ULN - 1.5 x ULN
Grade 2
>1.5 - 3.0 x if baseline is below LLN; >1.5 - 3.0 x ULN
Grade 3
>3.0 x if baseline is below LLN; >3.0 - 6.0 x ULN
Grade 4
>6.0 x ULN
Grade 5
-
Definition: A finding based on laboratory test results that indicate increased levels of creatinine in a biological specimen.
Navigational Note: Consider Renal and urinary disorders: Acute kidney injury, Glomerulonephritis, Tubulointerstitial nephritis.
Electrocardiogram QT corrected interval prolonged
Grade 1
Average QTc 450 - 480 ms
Grade 2
Average QTc 481 - 500 ms
Grade 3
Average QTc >500 ms; >60 ms change from baseline
Grade 4
Life-threatening consequences; Torsade de pointes; polymorphic ventricular tachycardia
Grade 5
-
Definition: A finding of a cardiac dysrhythmia characterized by an abnormally long corrected QT interval.
Navigational Note: Consider Cardiac disorders: Ventricular arrhythmia, Ventricular fibrillation, Ventricular tachycardia.
Fibrinogen decreased
Grade 1
<1.0 - 0.75 x LLN; if abnormal, <25% decrease from baseline
Grade 2
<0.75 - 0.5 x LLN; if abnormal, 25 - <50% decrease from baseline
Grade 3
<0.5 - 0.25 x LLN; if abnormal, 50 - <75% decrease from baseline
Grade 4
<0.25 x LLN; if abnormal, 75% decrease from baseline; absolute value <50 mg/dL
Grade 5
-
Definition: A finding based on laboratory test results that indicate an decrease in levels of fibrinogen in a blood specimen.
Navigational Note: -
Forced expiratory volume decreased
Grade 1
FEV1% (percentages of observed FEV1 and FVC related to their respective predicted values) 99 - 70% predicted; Global Lung Function Initiative (GLI) Z-score -1.65 to -2.5
Grade 2
FEV1% 60 - 69%; GLI Z-score <-2.5 to -4
Grade 3
FEV1% 50 - 59%; GLI Z-score <-4
Grade 4
-
Grade 5
-
Definition: A finding based on test results that indicate a relative decrease in the fraction of the forced vital capacity that is exhaled in a specific number of seconds.
Navigational Note: Consider Respiratory, thoracic and mediastinal disorders: Dyspnea, Respiratory failure.
GGT increased
Grade 1
>ULN - 2.5 x ULN if baseline was normal or less than normal; 1.0 - 1.5 x baseline if baseline was >ULN
Grade 2
>2.5 - 5.0 x ULN if baseline was normal or less than normal; >1.5 - 3.0 x baseline if baseline was >ULN
Grade 3
>5.0 - 20.0 x ULN if baseline was normal or less than normal; >3.0 - 10.0 x baseline if baseline was >ULN
Grade 4
>20.0 x ULN if baseline was normal or less than normal; >10.0 x baseline if baseline was >ULN
Grade 5
-
Definition: A finding based on laboratory test results that indicate higher than normal levels of the enzyme gamma-glutamyltransferase in the blood specimen. GGT (gamma-glutamyltransferase ) catalyzes the transfer of a gamma glutamyl group from a gamma glutamyl peptide to another peptide, amino acids or water.
Navigational Note: -
Growth hormone abnormal
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate abnormal levels of growth hormone (GH) in a biological specimen.
Navigational Note: -
Haptoglobin decreased
Grade 1
<LLN
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate an decrease in levels of haptoglobin (HP) in a blood specimen.
Navigational Note: -
HDL decreased
Grade 1
<LLN
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate a decrease in HDL in a blood specimen.
Navigational Note: -
Hemoglobin increased
Grade 1
Increase in >0 - 2 g/dL above ULN
Grade 2
Increase in >2 - 4 g/dL above ULN
Grade 3
Increase in >4 g/dL above ULN
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate increased levels of hemoglobin (Hgb) above normal.
Navigational Note: -
INR increased
Grade 1
>1.2 - 1.5; >1 - 1.5 x baseline if on anticoagulation; monitoring only indicated
Grade 2
>1.5 - 2.5; >1.5 - 2.5 x baseline if on anticoagulation; dose adjustment indicated
Grade 3
>2.5; >2.5 x baseline if on anticoagulation; bleeding
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate an increase in the ratio of the patient's prothrombin time (PT) to a control sample in the blood.
Navigational Note: -
LDL increased
Grade 1
>ULN
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate an increase in LDL in a blood specimen.
Navigational Note: -
Lipase increased
Grade 1
>ULN - 1.5 x ULN
Grade 2
>1.5 - 3.0 x ULN; >3.0 - 5.0 x ULN and asymptomatic
Grade 3
>3.0 - 5.0 x ULN with signs or symptoms; >5.0 x ULN and asymptomatic
Grade 4
>5.0 x ULN and with signs or symptoms
Grade 5
-
Definition: A finding based on laboratory test results that indicate an increase in the level of lipase in a biological specimen.
Navigational Note: Consider Gastrointestinal disorders: Pancreatitis.
Lymphocyte count increased
Grade 1
-
Grade 2
>4000/mm³ - 20,000/mm³
Grade 3
>20,000/mm³
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate an abnormal increase in the number of lymphocytes in the blood, effusions or bone marrow.
Navigational Note: -
Neutrophil count decreased
Grade 1
<1500 - 1000/mm³; <1.5 - 1.0 x 10⁹/L
Grade 2
<1000 - 500/mm³; <1.0 - 0.5 x 10⁹/L
Grade 3
<500 - 100/mm³; <0.5 - 0.1 x 10⁹/L
Grade 4
<100/mm³; <0.1 x 10⁹/L
Grade 5
-
Definition: A finding based on laboratory test results that indicate a decrease in number of neutrophils (ANC) in a blood specimen.
Navigational Note: -
Neutrophil count increased
Grade 1
Present
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate an increase in number of neutrophils (ANC) in a blood specimen.
Navigational Note: -
Serum amylase increased
Grade 1
>ULN - 1.5 x ULN
Grade 2
>1.5 - 2.0 x ULN; >2.0 - 5.0 x ULN and asymptomatic or with mild signs or symptoms
Grade 3
>2.0 - 5.0 x ULN with moderate or severe signs or symptoms; >5.0 x ULN and asymptomatic
Grade 4
>5.0 x ULN and with signs or symptoms
Grade 5
-
Definition: A finding based on laboratory test results that indicate an increase in the levels of amylase in a serum specimen.
Navigational Note: Consider Gastrointestinal disorders: Pancreatitis.
Thyroid stimulating hormone increased
Grade 1
TSH increased and no intervention indicated
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an increase in thyroid stimulating hormone (TSH).
Navigational Note: If intervention initiated or symptomatic, report as Endocrine disorders: Hypothyroidism.
Urinary protein increased
Grade 1
Adult: 1+ proteinuria; urinary protein ≥ULN - <1.0 g/24 hrs; P/C <1; Pediatric: 1 + proteinuria
Grade 2
Adult: 2+ and 3+ proteinuria; urinary protein 1.0 - <3.5 g/24 hrs; P/C 1 - 3.5; Pediatric: Urine P/C (Protein/Creatinine) ratio 0.5 - 1.9; 2 - 3+ proteinuria
Grade 3
Adult: Urinary protein >=3.5 g/24 hrs; 4+ proteinuria; P/C >3.5; Pediatric: Urine P/C (Protein/Creatinine) ratio >1.9, 4+ proteinuria
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate the presence of excessive protein in the urine. It is predominantly albumin, but also globulin.
Navigational Note: 24-hour urine collection takes precedence over dipstick.
Urine output decreased
Grade 1
-
Grade 2
-
Grade 3
Adult: Oliguria (<80 ml in 8 hr); Infants: <1 ml/kg/hour; Children: <0.5 ml/kg/hour
Grade 4
Adult: Anuria (<240 ml in 24 hr); Pediatric: No urine output over 12 hours
Grade 5
-
Definition: A finding based on test results that indicate urine production is less relative to previous output.
Navigational Note: -
Vital capacity abnormal
Grade 1
90 - 75% of predicted value
Grade 2
<75 - 50% of predicted value; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
<50% of predicted value; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A finding based on pulmonary function test results that indicate an abnormal vital capacity (VC) (amount of exhaled after a maximum inhalation) when compared to the predicted value.
Navigational Note: Consider Investigations: Forced expiratory volume decreased; Respiratory, thoracic and mediastinal disorders: Dyspnea, Respiratory failure.
Vitamin D decreased
Grade 1
Vitamin D decreased <LLN
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A finding based on laboratory test results that indicate a low concentration of Vitamin D in the blood.
Navigational Note: -
Weight gain
Grade 1
5 - <10% from baseline
Grade 2
10 - <20% from baseline
Grade 3
>=20% from baseline
Grade 4
-
Grade 5
-
Definition: A finding characterized by an unexpected or abnormal increase in overall body weight; for pediatrics, percentages represent the absolute increase above that expected from the baseline growth curve (not change in growth percentiles).
Navigational Note: -
Weight loss
Grade 1
5 - <10% from baseline; intervention not indicated
Grade 2
10 - <20% from baseline; nutritional support indicated
Grade 3
>=20% from baseline; tube feeding or TPN indicated
Grade 4
-
Grade 5
-
Definition: A finding characterized by a decrease in overall body weight; for pediatrics, less than the baseline growth curve.
Navigational Note: -
White blood cell decreased
Grade 1
<LLN - 3000/mm³; <LLN - 3.0 x 10⁹/L
Grade 2
<3000 - 2000/mm³; <3.0 - 2.0 x 10⁹/L
Grade 3
<2000 - 1000/mm³; <2.0 - 1.0 x 10⁹/L
Grade 4
<1000/mm³; <1.0 x 10⁹/L
Grade 5
-
Definition: A finding based on laboratory test results that indicate an decrease in number of white blood cells (WBC) in a blood specimen.
Navigational Note: -
Investigations - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Metabolism and nutrition disorders
Acidosis
Grade 1
pH <normal, but >=7.3
Grade 2
-
Grade 3
pH <7.3
Grade 4
Life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by abnormally high acidity (high hydrogen-ion concentration) of the blood and other body tissues.
Navigational Note: -
Alcohol intolerance
Grade 1
-
Grade 2
Present
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an increase in sensitivity to the adverse effects of alcohol, which can include nasal congestion, skin flushes, heart dysrhythmias, nausea, vomiting, indigestion and headaches.
Navigational Note: -
Alkalosis
Grade 1
pH >normal, but <=7.5
Grade 2
-
Grade 3
pH >7.5
Grade 4
Life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by abnormally high alkalinity (low hydrogen-ion concentration) of the blood and other body tissues.
Navigational Note: -
Anorexia
Grade 1
Loss of appetite without alteration in eating habits
Grade 2
Oral intake altered without significant weight loss or malnutrition; oral nutritional supplements indicated
Grade 3
Associated with significant weight loss or malnutrition (e.g., inadequate oral caloric and/or fluid intake); tube feeding or TPN indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a loss of appetite.
Navigational Note: -
Dehydration
Grade 1
Increased oral fluids indicated; dry mucous membranes; diminished skin turgor
Grade 2
IV fluids indicated
Grade 3
Hospitalization indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by excessive loss of water from the body. It is usually caused by severe diarrhea, vomiting or diaphoresis.
Navigational Note: -
Diabetes mellitus
Grade 1
Abnormal glucose above baseline; diet changes only; no change in baseline diabetic management
Grade 2
Oral antiglycemic agent initiated; insulin sliding scale initiated
Grade 3
Insulin therapy initiated or increased; hospitalization indicated
Grade 4
Life-threatening consequences; urgent intervention indicated; diabetic ketoacidosis
Grade 5
Death
Definition: A disorder characterized by increased Hgb A1C that may result in organ damage.
Navigational Note: Consider Metabolism and nutrition disorders: Hyperglycemia.
Failure to thrive
Grade 1
-
Grade 2
Limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A condition characterized by global decline with weight loss, decreased appetite, poor intake, and/or inactivity.
Navigational Note: -
Hypercalcemia
Grade 1
Corrected serum calcium of >ULN - 11.5 mg/dL; >ULN - 2.9 mmol/L; Ionized calcium >ULN - 1.5 mmol/L
Grade 2
Corrected serum calcium of >11.5 - 12.5 mg/dL; >2.9 - 3.1 mmol/L; Ionized calcium >1.5 - 1.6 mmol/L; symptomatic
Grade 3
Corrected serum calcium of >12.5 - 13.5 mg/dL; >3.1 - 3.4 mmol/L; Ionized calcium >1.6 - 1.8 mmol/L; hospitalization indicated
Grade 4
Corrected serum calcium of >13.5 mg/dL; >3.4 mmol/L; Ionized calcium >1.8 mmol/L; life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of calcium (corrected for albumin) in blood.
Navigational Note: -
Hyperglycemia
Grade 1
Fasting glucose value >ULN - 160 mg/dL; Fasting glucose value >ULN - 8.9 mmol/L
Grade 2
Fasting glucose value >160 - 250 mg/dL; Fasting glucose value >8.9 - 13.9 mmol/L
Grade 3
>250 - 500 mg/dL; >13.9 - 27.8 mmol/L; hospitalization indicated
Grade 4
>500 mg/dL; >27.8 mmol/L; life-threatening consequences
Grade 5
-
Definition: A condition characterized by laboratory test results that indicate a confirmed, short lasting and unexpected elevation in the concentration of blood sugar (glycemia).
Navigational Note: Consider Metabolism and nutrition disorders: Diabetes mellitus.
Hyperkalemia
Grade 1
>ULN - 5.5 mmol/L
Grade 2
>5.5 - 6.0 mmol/L; intervention initiated
Grade 3
>6.0 - 7.0 mmol/L; hospitalization indicated
Grade 4
>7.0 mmol/L; life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of potassium in the blood; associated with kidney failure or sometimes with the use of diuretic drugs.
Navigational Note: -
Hyperlipidemia
Grade 1
Requiring diet changes
Grade 2
Requiring pharmaceutical intervention
Grade 3
Hospitalization
Grade 4
Life-threatening consequences
Grade 5
-
Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of lipids in blood.
Navigational Note: Consider Gastrointestinal disorders: Pancreatitis.
Hypermagnesemia
Grade 1
>ULN - 3.0 mg/dL; >ULN - 1.23 mmol/L
Grade 2
-
Grade 3
>3.0 - 8.0 mg/dL; >1.23 - 3.30 mmol/L
Grade 4
>8.0 mg/dL; >3.30 mmol/L; life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of magnesium in the blood.
Navigational Note: -
Hypernatremia
Grade 1
>ULN - 150 mmol/L
Grade 2
>150 - 155 mmol/L; intervention initiated
Grade 3
>155 - 160 mmol/L; hospitalization indicated
Grade 4
>160 mmol/L; life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of sodium in the blood.
Navigational Note: -
Hyperphosphatemia
Grade 1
Laboratory finding only and intervention not indicated
Grade 2
Noninvasive intervention indicated
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated
Grade 4
Life-threatening consequences; urgent intervention indicated (e.g., dialysis)
Grade 5
Death
Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of phosphate in a blood.
Navigational Note: -
Hypertriglyceridemia
Grade 1
150 mg/dL - 300 mg/dL; 1.71 mmol/L - 3.42 mmol/L
Grade 2
>300 mg/dL - 500 mg/dL; >3.42 mmol/L - 5.7 mmol/L
Grade 3
>500 mg/dL - 1000 mg/dL; >5.7 mmol/L - 11.4 mmol/L
Grade 4
>1000 mg/dL; >11.4 mmol/L; life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of triglyceride concentration in the blood.
Navigational Note: -
Hyperuricemia
Grade 1
>ULN without physiologic consequences
Grade 2
-
Grade 3
>ULN with physiologic consequences
Grade 4
Life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of uric acid.
Navigational Note: -
Hypoalbuminemia
Grade 1
<LLN - 3 g/dL; <LLN - 30 g/L
Grade 2
<3 - 2 g/dL; <30 - 20 g/L
Grade 3
<2 g/dL; <20 g/L
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by laboratory test results that indicate a low concentration of albumin in the blood.
Navigational Note: -
Hypocalcemia
Grade 1
Corrected serum calcium of <LLN - 8.0 mg/dL; <LLN - 2.0 mmol/L; Ionized calcium <LLN - 1.0 mmol/L
Grade 2
Corrected serum calcium of <8.0 - 7.0 mg/dL; <2.0 - 1.75 mmol/L; Ionized calcium <1.0 - 0.9 mmol/L; symptomatic
Grade 3
Corrected serum calcium of <7.0 - 6.0 mg/dL; <1.75 - 1.5 mmol/L; Ionized calcium <0.9 - 0.8 mmol/L; hospitalization indicated
Grade 4
Corrected serum calcium of <6.0 mg/dL; <1.5 mmol/L; Ionized calcium <0.8 mmol/L; life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by laboratory test results that indicate a low concentration of calcium (corrected for albumin) in the blood.
Navigational Note: -
Hypoglycemia
Grade 1
<LLN - 55 mg/dL; <LLN - 3.0 mmol/L
Grade 2
<55 - 40 mg/dL; <3.0 - 2.2 mmol/L
Grade 3
<40 - 30 mg/dL; <2.2 - 1.7 mmol/L
Grade 4
<30 mg/dL; <1.7 mmol/L; life-threatening consequences; seizures
Grade 5
Death
Definition: A condition characterized by laboratory test results that indicate a low concentration of glucose in the blood.
Navigational Note: -
Hypokalemia
Grade 1
<LLN - 3.0 mmol/L
Grade 2
Symptomatic with <LLN - 3.0 mmol/L; intervention indicated
Grade 3
<3.0 - 2.5 mmol/L; hospitalization indicated
Grade 4
<2.5 mmol/L; life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by laboratory test results that indicate a low concentration of potassium in the blood.
Navigational Note: -
Hypomagnesemia
Grade 1
<LLN - 1.2 mg/dL; <LLN - 0.5 mmol/L
Grade 2
<1.2 - 0.9 mg/dL; <0.5 - 0.4 mmol/L
Grade 3
<0.9 - 0.7 mg/dL; <0.4 - 0.3 mmol/L
Grade 4
<0.7 mg/dL; <0.3 mmol/L; life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by laboratory test results that indicate a low concentration of magnesium in the blood.
Navigational Note: -
Hyponatremia
Grade 1
<LLN - 130 mmol/L
Grade 2
125 - <130 mmol/L and asymptomatic
Grade 3
125 - <130 mmol/L symptomatic; 120 - <125 mmol/L regardless of symptoms
Grade 4
<120 mmol/L; life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by laboratory test results that indicate a low concentration of sodium in the blood.
Navigational Note: -
Hypophosphatemia
Grade 1
Laboratory finding only and intervention not indicated
Grade 2
Oral replacement therapy indicated
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated
Grade 4
Life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by laboratory test results that indicate a low concentration of phosphates in the blood.
Navigational Note: -
Iron overload
Grade 1
-
Grade 2
Moderate symptoms; intervention not indicated
Grade 3
Severe symptoms; intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by accumulation of iron in the tissues.
Navigational Note: -
Tumor lysis syndrome
Grade 1
Laboratory tumor lysis syndrome (LTLS) AND creatinine >ULN - 1.5 × ULN
Grade 2
LTLS AND creatinine >1.5 – 3.0 × ULN; cardiac arrhythmia managed medically; one brief generalized seizure; seizure(s) well controlled by anticonvulsants; infrequent focal motor seizures not limiting age-appropriate instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
LTLS AND creatinine >3.0 – 6.0 × ULN; cardiac arrhythmia controlled with device (e.g. defibrillator); seizure in which consciousness is altered; poorly controlled seizure disorder; breakthrough generalized seizures despite medical intervention
Grade 4
LTLS AND creatinine >6.0 x ULN; life-threatening cardiac arrhythmia or seizure
Grade 5
Death
Definition: A disorder characterized by metabolic abnormalities that result from a spontaneous or therapy-related cytolysis of tumor cells. Clinical tumor lysis syndrome (CTLS) requires one or more clinical manifestations along with criteria for laboratory tumor lysis syndrome (LTLS). LTLS is defined by two or more of the following laboratory abnormalities within 3 days before or 7 days after the initiation of chemotherapy: Uric acid ≥ 476 mcmol/L or 25% increase from baseline, Potassium ≥ 6.0 mmol/L or 25% increase from baseline, Phosphorous ≥ 2.1 mmol/L (children), ≥1.45 mmol/L (adults) or 25% increase from baseline, Calcium ≤ 1.75 mmol/L or 25% decrease from baseline.
Navigational Note: -
Metabolism and nutrition disorders - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Musculoskeletal and connective tissue disorders
Abdominal soft tissue necrosis
Grade 1
-
Grade 2
Local wound care; medical intervention indicated (e.g., dressings or topical medications)
Grade 3
Operative debridement or other invasive intervention indicated (e.g., tissue reconstruction, flap, or grafting)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the abdominal wall.
Navigational Note: -
Arthralgia
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in a joint.
Navigational Note: Report Inflammatory arthritis as Musculoskeletal and connective tissue disorder - Other, specify (Inflammatory arthritis).
Arthritis
Grade 1
Mild pain with inflammation, erythema, or joint swelling
Grade 2
Moderate pain associated with signs of inflammation, erythema, or joint swelling; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain associated with signs of inflammation, erythema, or joint swelling; irreversible joint damage; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by inflammation involving a joint.
Navigational Note: Report Inflammatory arthritis as Musculoskeletal and connective tissue disorder - Other, specify (Inflammatory arthritis).
Back pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the back region.
Navigational Note: Consider Injury, poisoning and procedural complications: Infusion related reaction; Record final diagnosis/cause once determined.
Bone pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the bones.
Navigational Note: Record final diagnosis/cause once determined.
Buttock pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the buttocks.
Navigational Note: Record final diagnosis/cause once determined.
Chest wall necrosis
Grade 1
-
Grade 2
Local wound care; medical intervention indicated (e.g., dressings or topical medications)
Grade 3
Operative debridement or other invasive intervention indicated (e.g., tissue reconstruction, flap, or grafting)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the chest wall including breast.
Navigational Note: -
Chest wall pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the chest wall.
Navigational Note: Report Inflammatory costochondritis as Musculoskeletal and connective tissue disorder - Other, specify (Inflammatory costochondritis). Record final diagnosis/cause once determined.
Exostosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; elective operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by non-neoplastic overgrowth of bone.
Navigational Note: -
Fibrosis deep connective tissue
Grade 1
Mild induration, able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up)
Grade 2
Moderate induration, able to slide skin, unable to pinch skin; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe induration; unable to slide or pinch skin; limiting joint or orifice movement (e.g., mouth, anus); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Generalized; associated with signs or symptoms of impaired breathing or feeding
Grade 5
Death
Definition: A disorder characterized by fibrotic degeneration of the deep connective tissues.
Navigational Note: -
Flank pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort on the lateral side of the body in the region below the ribs and above the hip.
Navigational Note: Record final diagnosis/cause once determined.
Generalized muscle weakness
Grade 1
Symptomatic; perceived by patient but not evident on physical exam
Grade 2
Symptomatic; evident on physical exam; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a reduction in the strength of muscles in multiple anatomic sites.
Navigational Note: Record final diagnosis/cause once determined.
Growth accelerated
Grade 1
-
Grade 2
>=+2 SD (standard deviation) above mid parental height or target height
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by greater growth than expected for age.
Navigational Note: -
Growth suppression
Grade 1
Reduction in growth velocity by 10 - 29% ideally measured over the period of a year
Grade 2
Reduction in growth velocity by 30 - 49% ideally measured over the period of a year or 0 - 49% reduction in growth from the baseline growth curve
Grade 3
Reduction in growth velocity of >=50% ideally measured over the period of a year
Grade 4
-
Grade 5
-
Definition: A disorder characterized by stature that is smaller than normal as expected for age.
Navigational Note: -
Head soft tissue necrosis
Grade 1
-
Grade 2
Local wound care; medical intervention indicated (e.g., dressings or topical medications)
Grade 3
Operative debridement or other invasive intervention indicated (e.g., tissue reconstruction, flap, or grafting)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the head.
Navigational Note: Consider Respiratory, thoracic and mediastinal disorders: Sinus disorder, Grade 4.
Joint effusion
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; invasive intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by excessive fluid in a joint, usually as a result of joint inflammation.
Navigational Note: -
Joint range of motion decreased
Grade 1
<=25% loss of ROM (range of motion); decreased ROM limiting athletic activity
Grade 2
>25 - 50% decrease in ROM; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
>50% decrease in ROM; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a decrease in joint flexibility of any joint.
Navigational Note: Report Inflammatory arthritis as Musculoskeletal and connective tissue disorder - Other, specify (Inflammatory arthritis).
Joint range of motion decreased cervical spine
Grade 1
Mild restriction of rotation or flexion between 60 - 70 degrees
Grade 2
Rotation <60 degrees to right or left; <60 degrees of flexion
Grade 3
Ankylosed/fused over multiple segments with no C-spine rotation
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a decrease in flexibility of a cervical spine joint.
Navigational Note: Report Inflammatory arthritis as Musculoskeletal and connective tissue disorder - Other, specify (Inflammatory arthritis).
Joint range of motion decreased lumbar spine
Grade 1
Stiffness; difficulty bending to the floor to pick up a very light object but able to do athletic activity
Grade 2
Pain with range of motion (ROM) in lumbar spine; requires a reaching aid to pick up a very light object from the floor
Grade 3
<50% lumbar spine flexion; associated with symptoms of ankylosis or fused over multiple segments with no L-spine flexion (e.g., unable to reach to floor to pick up a very light object)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a decrease in flexibility of a lumbar spine joint.
Navigational Note: Report Inflammatory arthritis as Musculoskeletal and connective tissue disorder - Other, specify (Inflammatory arthritis).
Kyphosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate accentuation; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe accentuation; operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an abnormal increase in the curvature of the thoracic portion of the spine.
Navigational Note: -
Lordosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate accentuation; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe accentuation; operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an abnormal increase in the curvature of the lumbar portion of the spine.
Navigational Note: -
Muscle cramp
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by marked cramping sensation originating from a muscle or group of muscles.
Navigational Note: Synonym: Muscle spasm
Muscle weakness lower limb
Grade 1
Symptomatic; perceived by patient but not evident on physical exam
Grade 2
Symptomatic; evident on physical exam; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a reduction in the strength of the lower limb muscles.
Navigational Note: Consider Musculoskeletal and connective tissue disorders: Myositis; Immune system disorders: Immune system disorders - Other, specify; Injury, poisoning and procedural complications: Fall.
Muscle weakness trunk
Grade 1
Symptomatic; perceived by patient but not evident on physical exam
Grade 2
Symptomatic; evident on physical exam; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a reduction in the strength of the trunk muscles.
Navigational Note: Consider Musculoskeletal and connective tissue disorders: Myositis; Immune system disorders: Immune system disorders - Other, specify; Injury, poisoning and procedural complications: Fall.
Muscle weakness upper limb
Grade 1
Symptomatic; perceived by patient but not evident on physical exam
Grade 2
Symptomatic; evident on physical exam; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a reduction in the strength of the upper limb muscles.
Navigational Note: Consider Musculoskeletal and connective tissue disorders: Myositis; Immune system disorders: Immune system disorders - Other, specify; Injury, poisoning and procedural complications: Fall.
Musculoskeletal deformity
Grade 1
Cosmetically and functionally insignificant hypoplasia
Grade 2
Deformity, hypoplasia, or asymmetry able to be remediated by prosthesis (e.g., shoe insert) or covered by clothing
Grade 3
Significant deformity, hypoplasia, or asymmetry, unable to be remediated by prosthesis or covered by clothing; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an abnormality of the musculoskeletal system.
Navigational Note: -
Myalgia
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by marked discomfort sensation originating from a muscle or group of muscles.
Navigational Note: Record final diagnosis/cause once determined.
Myositis
Grade 1
Mild pain
Grade 2
Moderate pain associated with weakness; pain limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Pain associated with severe weakness; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
-
Definition: A disorder characterized by inflammation involving the skeletal muscles.
Navigational Note: Record final diagnosis/cause once determined.
Neck pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the neck area.
Navigational Note: Record final diagnosis/cause once determined.
Neck soft tissue necrosis
Grade 1
-
Grade 2
Local wound care; medical intervention indicated (e.g., dressings or topical medications)
Grade 3
Operative debridement or other invasive intervention indicated (e.g., tissue reconstruction, flap, or grafting)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the neck.
Navigational Note: -
Osteonecrosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated (e.g., analgesics or bisphosphonates); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; elective operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by necrotic changes in the bone tissue due to interruption of blood supply. Most often affecting the epiphysis of the long bones, the necrotic changes result in the collapse and the destruction of the bone structure.
Navigational Note: -
Osteonecrosis of jaw
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated (e.g., topical agents); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; elective operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a necrotic process occurring in the bone of the mandible.
Navigational Note: -
Osteoporosis
Grade 1
Adult: Radiologic evidence of osteoporosis or Bone Mineral Density (BMD) t-score -1 to -2.5 (osteopenia); Pediatric: BMD z score of <=-2.0 and no history of significant fractures
Grade 2
Adult: BMD t-score <-2.5; loss of height <2 cm; therapy to improve BMD indicated; limiting instrumental ADL; Pediatric: BMD z-score <=-2.0 and significant fracture history (defined as a long bone fracture of the lower extremity, vertebral compression, 2 or more long bone fractures of the upper extremities); mild/moderate impact on age-appropriate normal daily activity
Grade 3
Adult: Loss of height >=2 cm; hospitalization indicated; limiting self-care ADL; Pediatric: Severe impact on age-appropriate normal daily activity
Grade 4
-
Grade 5
-
Definition: A disorder characterized by reduced bone mass, with a decrease in cortical thickness and in the number and size of the trabeculae of cancellous bone (but normal chemical composition), resulting in increased fracture incidence.
Navigational Note: -
Pain in extremity
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the upper or lower extremities.
Navigational Note: Record final diagnosis/cause once determined.
Pelvic soft tissue necrosis
Grade 1
-
Grade 2
Local wound care; medical intervention indicated (e.g., dressings or topical medications)
Grade 3
Operative debridement or other invasive intervention indicated (e.g., tissue reconstruction, flap, or grafting)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the pelvis.
Navigational Note: -
Rhabdomyolysis
Grade 1
Asymptomatic, intervention not indicated; laboratory findings only
Grade 2
Non-urgent intervention indicated
Grade 3
Symptomatic, urgent intervention indicated
Grade 4
Life-threatening consequences; dialysis
Grade 5
Death
Definition: A disorder characterized by the breakdown of muscle tissue resulting in the release of muscle fiber contents into the bloodstream.
Navigational Note: Record final diagnosis/cause once determined.
Rotator cuff injury
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental AD or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an injury of the rotator cuff.
Navigational Note: -
Scoliosis
Grade 1
<20 degrees; clinically undetectable
Grade 2
>20 - 45 degrees; visible by forward flexion; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
>45 degrees; scapular prominence in forward flexion; operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a lateral curvature of the spine.
Navigational Note: -
Soft tissue necrosis lower limb
Grade 1
-
Grade 2
Local wound care; medical intervention indicated (e.g., dressings or topical medications)
Grade 3
Operative debridement or other invasive intervention indicated (e.g., tissue reconstruction, flap, or grafting)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the lower extremity.
Navigational Note: -
Soft tissue necrosis upper limb
Grade 1
-
Grade 2
Local wound care; medical intervention indicated (e.g., dressings or topical medications)
Grade 3
Operative debridement or other invasive intervention indicated (e.g., tissue reconstruction, flap, or grafting)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the upper extremity.
Navigational Note: -
Superficial soft tissue fibrosis
Grade 1
Mild induration, able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up)
Grade 2
Moderate induration, able to slide skin, unable to pinch skin; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe induration; unable to slide or pinch skin; limiting joint or orifice movement (e.g., mouth, anus); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Generalized; associated with signs or symptoms of impaired breathing or feeding
Grade 5
Death
Definition: A disorder characterized by fibrotic degeneration of the superficial soft tissues.
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Trismus
Grade 1
Decreased ROM (range of motion) without impaired eating
Grade 2
Decreased ROM requiring small bites, soft foods or purees
Grade 3
Decreased ROM with inability to adequately aliment or hydrate orally
Grade 4
-
Grade 5
-
Definition: A disorder characterized by lack of ability to open the mouth fully due to a decrease in the range of motion of the muscles of mastication.
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Unequal limb length
Grade 1
Mild length discrepancy <2 cm
Grade 2
Moderate length discrepancy 2 - 5 cm; shoe lift indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe length discrepancy >5 cm; operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a discrepancy between the lengths of the lower or upper extremities.
Navigational Note: -
Musculoskeletal and connective tissue disorder - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Differentiation syndrome
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local, or noninvasive intervention indicated; limiting age appropriate instrumental ADL
Grade 3
Severe or medically significant but not immediately life-threatening; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A potentially fatal complication of treatment in certain molecular subgroups of leukemia characterized by fever, rash, dyspnea and/or hypoxia, pulmonary infiltrates, peripheral edema with rapid weight gain, pleuropericardial effusion, acute renal failure, disseminated intravascular coagulation (DIC), bone pain and/or hypotension.
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Keratoacanthoma
Grade 1
-
Grade 2
Present
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a cutaneous tumor that most commonly presents a dome-shaped nodule with a central keratin-filled crater.
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Leukemia secondary to oncology chemotherapy
Grade 1
-
Grade 2
-
Grade 3
-
Grade 4
Present
Grade 5
Death
Definition: A disorder characterized by leukemia arising as a result of the mutagenic effect of chemotherapy agents.
Navigational Note: -
Myelodysplastic syndrome
Grade 1
-
Grade 2
-
Grade 3
-
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by insufficiently healthy hematapoietic cell production by the bone marrow.
Navigational Note: -
Retinoic acid syndrome
Grade 1
Fluid retention; <3 kg of weight gain; intervention with fluid restriction and/or diuretics indicated
Grade 2
Moderate signs or symptoms; steroids indicated
Grade 3
Severe symptoms; hospitalization indicated
Grade 4
Life-threatening consequences; ventilatory support indicated
Grade 5
Death
Definition: A disorder characterized by weight gain, dyspnea, pleural and pericardial effusions, leukocytosis and/or renal failure originally described in patients treated with all-trans retinoic acid.
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Skin papilloma
Grade 1
Asymptomatic; intervention not indicated
Grade 2
Intervention initiated
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by the presence of one or more warts.
Navigational Note: -
Treatment related secondary malignancy
Grade 1
-
Grade 2
-
Grade 3
Non life-threatening secondary malignancy
Grade 4
Acute life-threatening secondary malignancy; blast crisis in leukemia
Grade 5
Death
Definition: A disorder characterized by development of a malignancy most probably as a result of treatment for a previously existing malignancy.
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Tumor hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding in a tumor.
Navigational Note: -
Tumor pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort from a neoplasm that may be pressing on a nerve, blocking blood vessels, inflamed or fractured from metastasis.
Navigational Note: Record final diagnosis/cause once determined.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Nervous system disorders
Abducens nerve disorder
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by dysfunction of the abducens nerve (sixth cranial nerve).
Navigational Note: Consider Nervous system disorders: Peripheral motor neuropathy, Peripheral sensory neuropathy.
Accessory nerve disorder
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by dysfunction of the accessory nerve (eleventh cranial nerve).
Navigational Note: Consider Nervous system disorders: Peripheral motor neuropathy, Peripheral sensory neuropathy.
Acoustic nerve disorder NOS
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by dysfunction of the acoustic nerve (eighth cranial nerve).
Navigational Note: Consider Nervous system disorders: Peripheral motor neuropathy, Peripheral sensory neuropathy.
Akathisia
Grade 1
Mild restlessness or increased motor activity
Grade 2
Moderate restlessness or increased motor activity; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe restlessness or increased motor activity; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an uncomfortable feeling of inner restlessness and inability to stay still; this is a side effect of some psychotropic drugs.
Navigational Note: -
Amnesia
Grade 1
Mild; transient memory loss
Grade 2
Moderate; short term memory loss; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe; long term memory loss; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by systematic and extensive loss of memory.
Navigational Note: -
Anosmia
Grade 1
Present
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a change in the sense of smell.
Navigational Note: Consider Nervous system disorders: Olfactory nerve disorder.
Arachnoiditis
Grade 1
Mild symptoms
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by inflammation of the arachnoid membrane and adjacent subarachnoid space.
Navigational Note: -
Ataxia
Grade 1
Mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; mechanical assistance indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by lack of coordination of muscle movements resulting in the impairment or inability to perform voluntary activities.
Navigational Note: Record final diagnosis/cause once determined.
Autonomic neuropathy
Grade 1
Mild symptoms
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by damage to nerves that control your internal organs.
Navigational Note: -
Brachial plexopathy
Grade 1
Mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by regional paresthesia of the brachial plexus, marked discomfort and muscle weakness, and limited movement in the arm or hand.
Navigational Note: -
Brain fog
Grade 1
Present
Grade 2
Limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by thinking and memory problems that a patient with cancer may have during or after cancer treatment.
Navigational Note: -
Central nervous system necrosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; corticosteroids indicated
Grade 3
Severe symptoms; medical intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a necrotic process occurring in the brain and/or spinal cord.
Navigational Note: -
Cerebral venous sinus thrombosis
Grade 1
-
Grade 2
Intervention not indicated
Grade 3
Medical intervention indicated (e.g., anticoagulants)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a thrombus (blood clot) in the brain’s venous sinuses leading to swelling and bleeding.
Navigational Note: -
Cerebrospinal fluid leakage
Grade 1
Post-craniotomy: asymptomatic; post-lumbar puncture: transient headache; postural care indicated
Grade 2
Post-craniotomy: moderate symptoms; medical intervention indicated; post-lumbar puncture: persistent moderate symptoms; blood patch indicated
Grade 3
Severe symptoms; medical intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by loss of cerebrospinal fluid into the surrounding tissues.
Navigational Note: -
Cognitive disturbance
Grade 1
Mild cognitive disability; not interfering with work/school/life performance; specialized educational services/devices not indicated
Grade 2
Moderate cognitive disability; interfering with work/school/life performance but capable of independent living; specialized resources on part time basis indicated
Grade 3
Severe cognitive disability; significant impairment of work/school/life performance
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a conspicuous change in cognitive function.
Navigational Note: Record final diagnosis/cause once determined.
Concentration impairment
Grade 1
Mild inattention or decreased level of concentration
Grade 2
Moderate impairment in attention or decreased level of concentration; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe impairment in attention or decreased level of concentration; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a deterioration in the ability to concentrate.
Navigational Note: -
Depressed level of consciousness
Grade 1
Decreased level of alertness
Grade 2
Sedation; slow response to stimuli; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Difficult to arouse
Grade 4
Life-threatening consequences; coma; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a decrease in ability to perceive and respond.
Navigational Note: Record final diagnosis/cause once determined.
Dizziness
Grade 1
Mild unsteadiness or sensation of movement
Grade 2
Moderate unsteadiness or sensation of movement; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe unsteadiness or sensation of movement; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a disturbing sensation of lightheadedness, unsteadiness, giddiness, spinning or rocking.
Navigational Note: Record final diagnosis/cause once determined.
Dysarthria
Grade 1
Mild slurred speech
Grade 2
Moderate impairment of articulation or slurred speech
Grade 3
Severe impairment of articulation or slurred speech
Grade 4
-
Grade 5
-
Definition: A disorder characterized by slow and slurred speech resulting from an inability to coordinate the muscles used in speech.
Navigational Note: Record final diagnosis/cause once determined.
Dysesthesia
Grade 1
Mild sensory alteration
Grade 2
Moderate sensory alteration; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe sensory alteration; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by distortion of sensory perception, resulting in an abnormal and unpleasant sensation.
Navigational Note: Record final diagnosis/cause once determined.
Dysgeusia
Grade 1
Altered taste but no change in diet
Grade 2
Altered taste with change in diet (e.g., oral supplements); noxious or unpleasant taste; loss of taste
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by abnormal sensual experience with the taste of foodstuffs; it can be related to a decrease in the sense of smell.
Navigational Note: -
Dysphasia
Grade 1
Awareness of receptive or expressive characteristics; not impairing ability to communicate
Grade 2
Moderate receptive or expressive characteristics; impairing ability to communicate spontaneously
Grade 3
Severe receptive or expressive characteristics; impairing ability to read, write or communicate intelligibly
Grade 4
Total loss of the ability to read, write, or communicate intelligibly
Grade 5
-
Definition: A disorder characterized by impairment of verbal communication skills, often resulting from brain damage.
Navigational Note: Record final diagnosis/cause once determined.
Edema cerebral
Grade 1
Radiographic finding only and no medical management initiated
Grade 2
-
Grade 3
New onset; worsening from baseline; initiation of steroid therapy
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by swelling due to an excessive accumulation of fluid in the brain.
Navigational Note: Record final diagnosis/cause once determined.
Encephalopathy
Grade 1
Mild symptoms
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a pathologic process involving the brain.
Navigational Note: -
Extrapyramidal disorder
Grade 1
Mild involuntary movements
Grade 2
Moderate involuntary movements; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe involuntary movements or torticollis; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by abnormal, repetitive, involuntary muscle movements, frenzied speech and extreme restlessness.
Navigational Note: -
Facial muscle weakness
Grade 1
Mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a reduction in the strength of the facial muscles.
Navigational Note: Record final diagnosis/cause once determined.
Facial nerve disorder
Grade 1
Mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by dysfunction of the facial nerve (seventh cranial nerve).
Navigational Note: -
Glossopharyngeal nerve disorder
Grade 1
Mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by dysfunction of the glossopharyngeal nerve (ninth cranial nerve).
Navigational Note: -
Guillain-Barre syndrome
Grade 1
Mild symptoms
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated; intubation
Grade 5
Death
Definition: A disorder characterized by the body's immune system attacking the peripheral nervous system causing ascending paralysis.
Navigational Note: -
Headache
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in various parts of the head, not confined to the area of distribution of any nerve.
Navigational Note: -
Hemiparesis
Grade 1
Symptomatic; perceived by patient but not evident on physical exam
Grade 2
Symptomatic; evident on physical exam; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a reduction in the strength of the muscles on one side of the body.
Navigational Note: -
Hydrocephalus
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; intervention not indicated
Grade 3
Severe symptoms or neurological deficit; intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal increase of cerebrospinal fluid in the ventricles of the brain.
Navigational Note: -
Hypersomnia
Grade 1
Mild increased need for sleep
Grade 2
Moderate increased need for sleep
Grade 3
Severe increased need for sleep
Grade 4
-
Grade 5
-
Definition: A disorder characterized by excessive sleepiness during the daytime.
Navigational Note: -
Hypoglossal nerve disorder
Grade 1
Mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by dysfunction of the hypoglossal nerve (twelfth cranial nerve).
Navigational Note: -
Immune effector cell-associated neurotoxicity syndrome
Grade 1
Mild symptoms; Immune Effector Cell-Associated Encephalopathy (ICE) score 7 - 9; Cornell Assessment of Pediatric Delirium (CAPD) score 1 - 8 AND awakens spontaneously
Grade 2
Moderate symptoms; ICE score 3 - 6; CAPD score 1 - 8 AND awakens to voice; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; ICE score 0 - 2; CAPD score >=9 AND awakens only to tactile stimulus; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a pathologic process involving the central nervous system following any immune therapy that results in the activation or engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms or signs can be progressive and may include aphasia, altered level of consciousness, impairment of cognitive skills, motor weakness, seizures, and cerebral edema.
Navigational Note: -
Intracranial hemorrhage
Grade 1
Mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Ventriculostomy, ICP monitoring, intraventricular thrombolysis, or invasive intervention indicated; hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from within the cranium.
Navigational Note: -
Lethargy
Grade 1
Mild symptoms; reduced alertness and awareness
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a decrease in consciousness characterized by mental and physical inertness.
Navigational Note: Record final diagnosis/cause once determined.
Leukoencephalopathy
Grade 1
Asymptomatic; small focal T2/FLAIR hyperintensities; involving periventricular white matter or <1/3 of susceptible areas of cerebrum +/- mild increase in subarachnoid space (SAS) and/or mild ventriculomegaly
Grade 2
Moderate symptoms; focal T2/FLAIR hyperintensities, involving periventricular white matter extending into centrum semiovale or involving 1/3 to 2/3 of susceptible areas of cerebrum +/- moderate increase in SAS and/or moderate ventriculomegaly
Grade 3
Severe symptoms; extensive T2/FLAIR hyperintensities, involving periventricular white matter involving 2/3 or more of susceptible areas of cerebrum +/- moderate to severe increase in SAS and/or moderate to severe ventriculomegaly
Grade 4
Life-threatening consequences; extensive T2/FLAIR hyperintensities, involving periventricular white matter involving most of susceptible areas of cerebrum +/- moderate to severe increase in SAS and/or moderate to severe ventriculomegaly
Grade 5
Death
Definition: A disorder characterized by diffuse reactive astrocytosis with multiple areas of necrotic foci without inflammation.
Navigational Note: -
Memory impairment
Grade 1
Mild memory impairment
Grade 2
Moderate memory impairment; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe memory impairment; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a deterioration in memory function.
Navigational Note: -
Meningismus
Grade 1
Mild symptoms
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by neck stiffness, headache, and photophobia resulting from irritation of the cerebral meninges.
Navigational Note: -
Movements involuntary
Grade 1
Mild symptoms
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by uncontrolled and purposeless movements.
Navigational Note: -
Myasthenia gravis
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by weakness and rapid fatigue of any of the skeletal muscles.
Navigational Note: -
Neuralgia
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by intense painful sensation along a nerve or group of nerves.
Navigational Note: -
Nystagmus
Grade 1
-
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by involuntary movements of the eyeballs.
Navigational Note: -
Oculomotor nerve disorder
Grade 1
Mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by dysfunction of the oculomotor nerve (third cranial nerve).
Navigational Note: -
Olfactory nerve disorder
Grade 1
-
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by dysfunction of the olfactory nerve (first cranial nerve).
Navigational Note: -
Optic neuritis
Grade 1
Asymptomatic or mild symptoms; only enhancement on MRI scan with no change in vision
Grade 2
Treatment indicated; best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline in the affected eye; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately sight-threatening; decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200) in the affected eye; oral steroids indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Sight-threatening consequences; urgent intervention indicated; best corrected visual acuity of 20/200 or worse in the affected eye: significant visual field loss; marked optic disc edema or enhancement on MRI scan; intravenous steroids indicated; blindness
Grade 5
-
Definition: A disorder characterized by inflammation and demyelination of the optic nerve that causes acute, usually monocular, visual loss.
Navigational Note: -
Paresthesia
Grade 1
Mild symptoms
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by functional disturbances of sensory neurons resulting in abnormal cutaneous sensations of tingling, numbness, pressure, cold, and/or warmth.
Navigational Note: Consider Nervous system disorders: Peripheral motor neuropathy, Peripheral sensory neuropathy.
Peripheral motor neuropathy
Grade 1
Mild symptoms; clinical or diagnostic observations only
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by damage or dysfunction of the peripheral motor nerves.
Navigational Note: Consider Nervous system disorders: Peripheral sensory neuropathy.
Peripheral sensory neuropathy
Grade 1
Mild symptoms
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
-
Definition: A disorder characterized by damage or dysfunction of the peripheral sensory nerves.
Navigational Note: -
Phantom pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort related to a limb or an organ that is removed from or is not physically part of the body.
Navigational Note: Record final diagnosis/cause once determined.
Presyncope
Grade 1
-
Grade 2
Present (e.g., near fainting)
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an episode of lightheadedness and dizziness which may precede an episode of syncope.
Navigational Note: Record final diagnosis/cause once determined.
Pyramidal tract syndrome
Grade 1
Mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by dysfunction of the corticospinal (pyramidal) tracts of the spinal cord. Symptoms include an increase in the muscle tone in the lower extremities, hyperreflexia, positive Babinski and a decrease in fine motor coordination.
Navigational Note: -
Radiculitis
Grade 1
Mild symptoms
Grade 2
Moderate symptoms; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by inflammation involving a nerve root. Patients experience marked discomfort radiating along a nerve path because of spinal pressure on the connecting nerve root.
Navigational Note: -
Recurrent laryngeal nerve palsy
Grade 1
Mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms
Grade 3
Severe symptoms; medical intervention indicated (e.g., thyroplasty, vocal cord injection)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by paralysis of the recurrent laryngeal nerve.
Navigational Note: -
Reversible posterior leukoencephalopathy syndrome
Grade 1
-
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; hospitalization; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by headaches, mental status changes, visual disturbances, and/or seizures associated with imaging findings of posterior leukoencephalopathy. It has been observed in association with hypertensive encephalopathy, eclampsia, and immunosuppressive and cytotoxic drug treatment. It is an acute or subacute reversible condition. Also known as posterior reversible encephalopathy syndrome (PRES).
Navigational Note: -
Seizure
Grade 1
Brief partial/focal seizure and no loss of consciousness
Grade 2
Brief generalized seizure; seizure(s) well controlled by anticonvulsants; infrequent partial/focal motor seizures
Grade 3
New onset seizures (partial/focal or generalized); multiple seizures despite medical intervention
Grade 4
Life-threatening consequences; prolonged repetitive generalized seizures
Grade 5
Death
Definition: A disorder characterized by a sudden, involuntary skeletal muscular contractions of cerebral or brain stem origin.
Navigational Note: -
Somnolence
Grade 1
Mild but more than usual drowsiness or sleepiness
Grade 2
Moderate sedation; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Obtundation or stupor
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by characterized by excessive sleepiness and drowsiness.
Navigational Note: -
Spasticity
Grade 1
Mild or slight increase in muscle tone
Grade 2
Moderate increase in muscle tone and increase in resistance through range of motion
Grade 3
Severe increase in muscle tone and increase in resistance through range of motion
Grade 4
Life-threatening consequences; unable to move active or passive range of motion
Grade 5
Death
Definition: A disorder characterized by increased involuntary muscle tone that affects the regions interfering with voluntary movement. It results in gait, movement, and speech disturbances.
Navigational Note: -
Spinal cord compression
Grade 1
Radiologic findings only
Grade 2
Mild or moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by pressure on the spinal cord.
Navigational Note: -
Stroke
Grade 1
Incidental radiographic findings only
Grade 2
Mild to moderate neurologic deficit; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe neurologic deficit; hospitalization; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an interruption of blood supply to parts of the brain resulting in neurological damage.
Navigational Note: -
Syncope
Grade 1
-
Grade 2
-
Grade 3
Fainting; orthostatic collapse
Grade 4
-
Grade 5
-
Definition: A disorder characterized by spontaneous loss of consciousness caused by insufficient blood supply to the brain.
Navigational Note: Record final diagnosis/cause once determined.
Tendon reflex decreased
Grade 1
Ankle reflex reduced
Grade 2
Ankle reflex absent; other reflexes reduced
Grade 3
Absence of all reflexes
Grade 4
-
Grade 5
-
Definition: A disorder characterized by less than normal deep tendon reflexes.
Navigational Note: Consider Nervous system disorders: Peripheral motor neuropathy, Peripheral sensory neuropathy.
Transient ischemic attacks
Grade 1
Mild neurologic deficit with or without imaging confirmation
Grade 2
Moderate neurologic deficit with or without imaging confirmation
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a brief attack (less than 24 hours) of cerebral dysfunction of vascular origin, with no persistent neurological deficit.
Navigational Note: If >24 hours, Consider Nervous system disorders: Stroke.
Tremor
Grade 1
Mild symptoms
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by the uncontrolled shaking movement of the whole body or individual parts.
Navigational Note: -
Trigeminal nerve disorder
Grade 1
Mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by dysfunction of the trigeminal nerve (fifth cranial nerve).
Navigational Note: -
Trochlear nerve disorder
Grade 1
Mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by dysfunction of the trochlear nerve (fourth cranial nerve).
Navigational Note: -
Tumor inflammation-associated neurotoxicity
Grade 1
Headaches associated with fevers; mild worsening of existing neurological clinical signs and symptoms from baseline, resulting in minor functional deficits for which only observation or symptomatic management is needed
Grade 2
Moderate changes in the neurological exam from baseline that substantially affect function
Grade 3
Severe neurological clinical signs and symptoms that may affect critical cardiorespiratory functions; clinical signs and symptoms of increased intracranial pressure (>20 mmHg) that are responsive to intervention
Grade 4
Life-threatening, clinically significant elevated ICP (>20 mmHg) refractory to CSF drainage with no improvement in clinical symptoms in response to CSF drainage, possibly warranting urgent escalation of neurosurgical intervention; clinical signs and symptoms of impending/early herniation; severe medullary dysfunction requiring endotracheal intubation for airway protection and/or mechanical ventilation
Grade 5
Death
Definition: A disorder characterized by localized neurotoxicity related to cellular therapies or other immunotherapies for CNS tumors (TIAN).
Navigational Note: -
Vagus nerve disorder
Grade 1
Mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by dysfunction of the vagus nerve (tenth cranial nerve).
Navigational Note: Record final diagnosis/cause once determined.
Vasovagal reaction
Grade 1
-
Grade 2
No management indicated
Grade 3
Requires active management
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a sudden drop of the blood pressure, bradycardia, and peripheral vasodilation that may lead to loss of consciousness. It results from an increase in the stimulation of the vagus nerve.
Navigational Note: -
Nervous system disorders - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Pregnancy, puerperium and perinatal conditions
Fetal growth retardation
Grade 1
-
Grade 2
5 - <10% percentile of weight for gestational age
Grade 3
1 - <5% percentile of weight for gestational age
Grade 4
<1% percentile of weight for gestational age
Grade 5
-
Definition: A disorder characterized by inhibition of fetal growth resulting in the inability of the fetus to achieve its potential weight.
Navigational Note: -
Pregnancy loss
Grade 1
-
Grade 2
-
Grade 3
-
Grade 4
Fetal loss at any gestational age
Grade 5
-
Definition: Death in utero.
Navigational Note: -
Premature delivery
Grade 1
Delivery of a liveborn infant at >34 to 37 weeks gestation
Grade 2
Delivery of a liveborn infant at >28 to 34 weeks gestation
Grade 3
Delivery of a liveborn infant at 24 to 28 weeks gestation
Grade 4
Delivery of a liveborn infant at 24 weeks of gestation or less
Grade 5
-
Definition: A disorder characterized by delivery of a viable infant before the normal end of gestation. Typically, viability is achievable between the twentieth and thirty-seventh week of gestation.
Navigational Note: -
Pregnancy, puerperium and perinatal conditions - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Psychiatric disorders
Agitation
Grade 1
Mild mood alteration
Grade 2
Moderate mood alteration
Grade 3
Severe agitation; hospitalization not indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
-
Definition: A disorder characterized by a state of restlessness associated with unpleasant feelings of irritability and tension.
Navigational Note: -
Anorgasmia
Grade 1
Inability to achieve orgasm not adversely affecting relationship
Grade 2
Inability to achieve orgasm adversely affecting relationship
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an inability to achieve orgasm.
Navigational Note: -
Anxiety
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
-
Definition: A disorder characterized by apprehension of danger and dread accompanied by restlessness, tension, tachycardia, and dyspnea unattached to a clearly identifiable stimulus.
Navigational Note: -
Confusion
Grade 1
Mild disorientation
Grade 2
Moderate disorientation; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe disorientation; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
-
Definition: A disorder characterized by a lack of clear and orderly thought and behavior.
Navigational Note: -
Delayed orgasm
Grade 1
Delay in achieving orgasm not adversely affecting relationship
Grade 2
Delay in achieving orgasm adversely affecting relationship
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by sexual dysfunction characterized by a delay in climax.
Navigational Note: -
Delirium
Grade 1
Mild acute confusional state
Grade 2
Moderate and acute confusional state; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe and acute confusional state; hospitalization indicated; urgent intervention indicated; new onset; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences, threats of harm to self or others; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by the acute and sudden development of confusion, illusions, movement changes, inattentiveness, agitation, and hallucinations. Usually, it is a reversible condition.
Navigational Note: -
Delusions
Grade 1
-
Grade 2
Moderate delusional symptoms
Grade 3
Severe delusional symptoms; outpatient management; new onset
Grade 4
Life-threatening consequences, threats of harm to self or others; hospitalization indicated
Grade 5
Death
Definition: A disorder characterized by false personal beliefs held contrary to reality, despite contradictory evidence and common sense.
Navigational Note: -
Depression
Grade 1
Mild depressive symptoms
Grade 2
Moderate depressive symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe depressive symptoms; hospitalization not indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences, threats of harm to self or others; hospitalization indicated
Grade 5
Death
Definition: A disorder characterized by melancholic feelings of grief or unhappiness.
Navigational Note: -
Euphoria
Grade 1
Mild mood elevation
Grade 2
Moderate mood elevation
Grade 3
Severe mood elevation (e.g., hypomania)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an exaggerated feeling of well-being which is disproportionate to events and stimuli.
Navigational Note: -
Hallucinations
Grade 1
Mild hallucinations (e.g., perceptual distortions)
Grade 2
Moderate hallucinations
Grade 3
Severe hallucinations; hospitalization not indicated
Grade 4
Life-threatening consequences, threats of harm to self or others; hospitalization indicated
Grade 5
Death
Definition: A disorder characterized by a false sensory perception in the absence of an external stimulus.
Navigational Note: -
Insomnia
Grade 1
Mild difficulty falling asleep, staying asleep or waking up early
Grade 2
Moderate difficulty falling asleep, staying asleep or waking up early
Grade 3
Severe difficulty in falling asleep, staying asleep or waking up early
Grade 4
-
Grade 5
-
Definition: A disorder characterized by difficulty in falling asleep and/or remaining asleep.
Navigational Note: -
Irritability
Grade 1
Mild; easily consolable
Grade 2
Moderate; increased attention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe abnormal or excessive response; inconsolable; medical or psychiatric intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an abnormal responsiveness to stimuli or physiological arousal; may be in response to pain, fright, a drug, an emotional situation or a medical condition.
Navigational Note: -
Libido decreased
Grade 1
Decrease in sexual interest not adversely affecting relationship
Grade 2
Decrease in sexual interest adversely affecting relationship
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a decrease in sexual desire.
Navigational Note: -
Libido increased
Grade 1
Present
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an increase in sexual desire.
Navigational Note: -
Mania
Grade 1
Mild manic symptoms (e.g., elevated mood, rapid thoughts, rapid speech, decreased need for sleep)
Grade 2
Moderate manic symptoms (e.g., relationship and work difficulties; poor hygiene)
Grade 3
Severe manic symptoms (e.g., hypomania; major sexual or financial indiscretions); hospitalization not indicated; new onset
Grade 4
Life-threatening consequences, threats of harm to self or others; hospitalization indicated
Grade 5
Death
Definition: A disorder characterized by excitement of psychotic proportions manifested by mental and physical hyperactivity, disorganization of behavior and elevation of mood.
Navigational Note: -
Personality change
Grade 1
Mild personality change
Grade 2
Moderate personality change
Grade 3
Severe personality change; hospitalization not indicated
Grade 4
Life-threatening consequences, threats of harm to self or others; hospitalization indicated
Grade 5
-
Definition: A disorder characterized by a conspicuous change in a person's behavior and thinking.
Navigational Note: -
Psychosis
Grade 1
Mild psychotic symptoms
Grade 2
Moderate psychotic symptoms (e.g., disorganized speech; impaired reality testing)
Grade 3
Severe psychotic symptoms (e.g., paranoid, extreme disorganization); hospitalization not indicated; new onset
Grade 4
Life-threatening consequences, threats of harm to self or others; hospitalization indicated
Grade 5
Death
Definition: A disorder characterized by personality change, impaired functioning, and loss of touch with reality. It may be a manifestation of schizophrenia, bipolar disorder or brain tumor.
Navigational Note: -
Restlessness
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an inability to rest, relax or be still.
Navigational Note: -
Suicidal ideation
Grade 1
Increased thoughts of death but no wish to kill oneself
Grade 2
Suicidal ideation with no specific plan or intent
Grade 3
Specific plan to commit suicide without serious intent to die which may not require hospitalization
Grade 4
Specific plan to commit suicide with serious intent to die which requires hospitalization
Grade 5
-
Definition: A disorder characterized by thoughts of taking one's own life.
Navigational Note: -
Suicide attempt
Grade 1
-
Grade 2
-
Grade 3
Suicide attempt or gesture without intent to die
Grade 4
Suicide attempt with intent to die which requires hospitalization
Grade 5
Death
Definition: A disorder characterized by self-inflicted harm in an attempt to end one's own life.
Navigational Note: -
Psychiatric disorders - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; hospitalization or urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Renal and urinary disorders
Acute kidney injury
Grade 1
-
Grade 2
-
Grade 3
Hospitalization indicated
Grade 4
Life-threatening consequences; dialysis indicated
Grade 5
Death
Definition: A disorder characterized by the acute loss of renal function (within 2 weeks).
Navigational Note: Consider Investigations: Creatinine increased; Renal and urinary disorders: Tubulointerstitial nephritis.
Bladder perforation
Grade 1
-
Grade 2
Invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; organ failure; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a rupture in the bladder wall.
Navigational Note: -
Bladder spasm
Grade 1
Intervention not indicated
Grade 2
Antispasmodics indicated
Grade 3
Hospitalization indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sudden and involuntary contraction of the bladder wall.
Navigational Note: -
Chronic kidney disease
Grade 1
eGFR (estimated Glomerular Filtration Rate) or CrCl (creatinine clearance) <LLN - 60 ml/min/1.73 m2 or proteinuria 2+ present; urine protein/creatinine >0.5
Grade 2
eGFR or CrCl <60 - 30 ml/min/1.73 m2
Grade 3
eGFR or CrCl <30 - 15 ml/min/1.73 m2
Grade 4
eGFR or CrCl <15 ml/min/1.73 m2; dialysis or renal transplant indicated
Grade 5
Death
Definition: A disorder characterized by loss of kidney function greater than three months duration.
Navigational Note: -
Cystitis noninfective
Grade 1
Microscopic hematuria; minimal increase in frequency, urgency, dysuria, or nocturia; new onset of incontinence
Grade 2
Moderate hematuria; moderate increase in frequency, urgency, dysuria, nocturia or incontinence; urinary catheter placement or bladder irrigation indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Gross hematuria; transfusion, IV medications, or hospitalization indicated; elective invasive intervention indicated
Grade 4
Life-threatening consequences; urgent invasive intervention indicated
Grade 5
Death
Definition: A disorder characterized by inflammation of the bladder which is not caused by an infection of the urinary tract.
Navigational Note: -
Dysuria
Grade 1
Present
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by painful urination.
Navigational Note: If associated with an infection, report the infection. For grades higher than Grade 1, consider Renal and urinary disorders: Bladder spasm, Cystitis noninfective; Infections and infestations: Urinary tract infection.
Glomerulonephritis
Grade 1
Asymptomatic; laboratory findings only
Grade 2
Declining glomerular filtration rate (GFR); edema; hypertension; oral management indicated
Grade 3
IV therapy indicated; immunosuppressant indicated; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated; renal replacement therapy
Grade 5
Death
Definition: A disorder characterized by inflammation of the glomerulus, usually based on renal biopsy.
Navigational Note: -
Glucosuria
Grade 1
Present
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by laboratory test results that indicate glucose in the urine.
Navigational Note: -
Hematuria
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; urinary catheter or bladder irrigation indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Gross hematuria; transfusion, IV medications, or hospitalization indicated; elective invasive intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent invasive intervention indicated
Grade 5
Death
Definition: A disorder characterized by laboratory test results that indicate blood in the urine.
Navigational Note: -
Hemoglobinuria
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by laboratory test results that indicate the presence of free hemoglobin in the urine.
Navigational Note: Report underlying AE if > Grade 1.
Nephrotic syndrome
Grade 1
-
Grade 2
-
Grade 3
IV therapy indicated; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated; renal replacement therapy; anasarca
Grade 5
Death
Definition: A disorder characterized by symptoms that include severe edema, proteinuria, and hypoalbuminemia; it is indicative of renal dysfunction.
Navigational Note: -
Nocturia
Grade 1
Present
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by the need to get up at night on a regular basis to urinate.
Navigational Note: -
Renal calculi
Grade 1
Asymptomatic or mild symptoms; occasional use of nonprescription analgesics indicated
Grade 2
Symptomatic; oral antiemetics indicated; around the clock nonprescription analgesics or any oral narcotic analgesics indicated
Grade 3
Hospitalization indicated; IV intervention (e.g., analgesics, antiemetics); elective invasive intervention indicated
Grade 4
Life-threatening consequences; urgent invasive intervention indicated
Grade 5
Death
Definition: A disorder characterized by the formation of crystals/kidney stones in the pelvis of the kidney.
Navigational Note: -
Renal colic
Grade 1
Mild pain not interfering with activity; nonprescription medication indicated
Grade 2
Moderate pain; prescription medication indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by paroxysmal and severe flank marked discomfort radiating to the inguinal area. Often, the cause is the passage of crystals/kidney stones.
Navigational Note: -
Renal hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Analgesics and hematocrit monitoring indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the kidney.
Navigational Note: -
Tubulointerstitial nephritis
Grade 1
Laboratory findings without increase in creatinine
Grade 2
Increase in creatinine; oral management indicated with steroid
Grade 3
IV therapy indicated; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by inflammation of the renal tubule and surrounding tissues.
Navigational Note: -
Urinary fistula
Grade 1
-
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent invasive intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between any part of the urinary system and another organ or anatomic site.
Navigational Note: -
Urinary frequency
Grade 1
Present
Grade 2
Medical management indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by urination at short intervals.
Navigational Note: -
Urinary incontinence
Grade 1
Occasional (e.g., with coughing, sneezing, etc.), pads not indicated
Grade 2
Spontaneous; pads indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Intervention indicated (e.g., clamp, collagen injections); operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by inability to control the flow of urine from the bladder.
Navigational Note: -
Urinary retention
Grade 1
Urinary, suprapubic or intermittent catheter placement not indicated; able to void with some residual
Grade 2
Placement of urinary, suprapubic or intermittent catheter placement indicated; medication indicated
Grade 3
Elective invasive intervention indicated; substantial loss of affected kidney function or mass
Grade 4
Life-threatening consequences; organ failure; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by accumulation of urine within the bladder because of the inability to urinate.
Navigational Note: -
Urinary tract obstruction
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic but no hydronephrosis, sepsis, or renal dysfunction; urethral dilation, urinary or suprapubic catheter indicated
Grade 3
Altered organ function (e.g., hydronephrosis or renal dysfunction); invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by blockage of the normal flow of contents of the urinary tract.
Navigational Note: -
Urinary tract pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the urinary tract.
Navigational Note: Record final diagnosis/cause once determined.
Urinary urgency
Grade 1
Present
Grade 2
Medical management indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sudden compelling urge to urinate.
Navigational Note: -
Urine discoloration
Grade 1
Present
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a change in the color of the urine.
Navigational Note: -
Renal and urinary disorders - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Reproductive system and breast disorders
Amenorrhea
Grade 1
-
Grade 2
Present
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by the abnormal absence of menses for at least three consecutive menstrual cycles.
Navigational Note: -
Azoospermia
Grade 1
-
Grade 2
Absence of sperm in ejaculate
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by laboratory test results that indicate complete absence of spermatozoa in the semen.
Navigational Note: -
Breast pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the breast region.
Navigational Note: Record final diagnosis/cause once determined.
Dysmenorrhea
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by abnormally painful abdominal cramps during menses.
Navigational Note: -
Dyspareunia
Grade 1
Mild discomfort or pain associated with vaginal penetration; discomfort relieved with use of vaginal lubricants or estrogen
Grade 2
Moderate discomfort or pain associated with vaginal penetration; discomfort or pain partially relieved with use of vaginal lubricants or estrogen
Grade 3
Severe discomfort or pain associated with vaginal penetration; discomfort or pain unrelieved by vaginal lubricants or estrogen
Grade 4
-
Grade 5
-
Definition: A disorder characterized by painful or difficult coitus.
Navigational Note: -
Ejaculation disorder
Grade 1
Diminished ejaculation
Grade 2
Anejaculation or retrograde ejaculation
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by problems related to ejaculation. This category includes premature, delayed, retrograde and painful ejaculation.
Navigational Note: -
Erectile dysfunction
Grade 1
Decrease in erectile function (frequency or rigidity of erections) but intervention not indicated (e.g., medication or use of mechanical device, penile pump)
Grade 2
Decrease in erectile function (frequency/rigidity of erections), erectile intervention indicated, (e.g., medication or mechanical devices such as penile pump)
Grade 3
Decrease in erectile function (frequency/rigidity of erections) but erectile intervention not helpful (e.g., medication or mechanical devices such as penile pump); placement of a permanent penile prosthesis indicated (not previously present)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by the persistent or recurrent inability to achieve or to maintain an erection during sexual activity.
Navigational Note: -
Fallopian tube obstruction
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; elective intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by blockage of the normal flow of the contents in the fallopian tube.
Navigational Note: -
Feminization acquired
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by the development of secondary female sex characteristics in males due to extrinsic factors.
Navigational Note: -
Gynecomastia
Grade 1
Asymptomatic
Grade 2
Symptomatic (e.g., pain or psychosocial impact)
Grade 3
Severe symptoms; elective operative intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by excessive development of the breasts in males.
Navigational Note: -
Hematosalpinx
Grade 1
Minimal bleeding identified on imaging study or laparoscopy; intervention not indicated
Grade 2
Moderate bleeding; medical intervention indicated
Grade 3
Invasive intervention indicated; hospitalization
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by the presence of blood in a fallopian tube.
Navigational Note: -
Irregular menstruation
Grade 1
Intermittent/irregular menses for <=3 consecutive menstrual cycles
Grade 2
Intermittent/irregular menses for >3 consecutive menstrual cycles
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a change in cycle or duration of menses from baseline.
Navigational Note: Consider Reproductive system and breast disorders: Amenorrhea.
Lactation disorder
Grade 1
Mild changes in lactation, not significantly affecting production or expression of breast milk
Grade 2
Changes in lactation, significantly affecting breast production or expression of breast milk
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by disturbances of milk secretion. It is not necessarily related to pregnancy that is observed in females and can be observed in males.
Navigational Note: -
Menorrhagia
Grade 1
Mild; iron supplements indicated
Grade 2
Moderate symptoms; medical intervention indicated (e.g., hormones)
Grade 3
Hospitalization; operative intervention indicated (e.g., hysterectomy)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by abnormally heavy vaginal bleeding during menses.
Navigational Note: -
Nipple deformity
Grade 1
Asymptomatic; asymmetry with slight retraction and/or thickening of the nipple areolar complex
Grade 2
Symptomatic; asymmetry of nipple areolar complex with moderate retraction and/or thickening of the nipple areolar complex
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an abnormality of the nipple.
Navigational Note: -
Oligospermia
Grade 1
Sperm concentration >0 to <15 million/ml
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a decrease in the number of spermatozoa in the semen.
Navigational Note: -
Ovarian function insufficiency
Grade 1
Intermittent/irregular menses for 3 consecutive months with basal FSH levels >25 IU/L but less than postmenopausal range
Grade 2
Amenorrhea for 3 consecutive months with basal FSH levels >40 IU/L or in the postmenopausal range
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by the development of oligomenorrhea or amenorrhea for at least 3 consecutive months and serum follicle-stimulating hormone (FSH) levels in the menopausal range before age 40. Symptoms of estrogen deficiency may include hot flashes, night sweats, mood swings, and vaginal dryness. Laboratory findings include elevated serum FSH. Other supportive laboratory findings include decreased serum estradiol and anti-Mullerian hormone (AMH) levels.
Navigational Note: -
Ovarian hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the ovary.
Navigational Note: -
Ovarian rupture
Grade 1
Asymptomatic clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic and intervention not indicated
Grade 3
Transfusion; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by tearing or disruption of the ovarian tissue.
Navigational Note: -
Ovulation pain
Grade 1
-
Grade 2
Present
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in one side of the abdomen between menstrual cycles, around the time of the discharge of the ovum from the ovarian follicle.
Navigational Note: Record final diagnosis/cause once determined.
Pelvic floor muscle weakness
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic, not interfering with bladder, bowel, or vaginal function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a reduction in the strength of the muscles of the pelvic floor.
Navigational Note: -
Pelvic pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the pelvis.
Navigational Note: Record final diagnosis/cause once determined.
Penile pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the penis.
Navigational Note: Record final diagnosis/cause once determined.
Perineal pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the area between the genital organs and the anus.
Navigational Note: Record final diagnosis/cause once determined.
Prostatic hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the prostate gland.
Navigational Note: -
Prostatic obstruction
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; elective intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by compression of the urethra secondary to enlargement of the prostate gland. This results in voiding difficulties (straining to void, slow urine stream, and incomplete emptying of the bladder).
Navigational Note: -
Prostatic pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the prostate gland.
Navigational Note: Record final diagnosis/cause once determined.
Scrotal pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the scrotal area.
Navigational Note: Record final diagnosis/cause once determined.
Spermatic cord hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the spermatic cord.
Navigational Note: -
Spermatic cord obstruction
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; elective intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by blockage of the normal flow of the contents of the spermatic cord.
Navigational Note: -
Testicular disorder
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic but not interfering with sexual function; intervention not indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; interfering with sexual function; intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
-
Definition: A disorder characterized by abnormal function or appearance of the testis.
Navigational Note: Consider other AE terms in the Renal and urinary disorders SOC or Reproductive system and breast disorders SOC.
Testicular hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the testis.
Navigational Note: -
Testicular pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the testis.
Navigational Note: Record final diagnosis/cause once determined.
Uterine fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the uterus and another organ or anatomic site.
Navigational Note: -
Uterine hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the uterus.
Navigational Note: -
Uterine obstruction
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; elective intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by blockage of the uterine outlet.
Navigational Note: -
Uterine pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the uterus.
Navigational Note: Record final diagnosis/cause once determined.
Vaginal discharge
Grade 1
Mild vaginal discharge (greater than baseline for patient)
Grade 2
Moderate to heavy vaginal discharge; use of perineal pad or tampon indicated
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by vaginal secretions. Mucus produced by the cervical glands is discharged from the vagina naturally, especially during the childbearing years.
Navigational Note: -
Vaginal dryness
Grade 1
Mild vaginal dryness not interfering with sexual function
Grade 2
Moderate vaginal dryness interfering with sexual function or causing frequent discomfort
Grade 3
Severe vaginal dryness resulting in dyspareunia or severe discomfort
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an uncomfortable feeling of itching and burning in the vagina.
Navigational Note: -
Vaginal fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the vagina and another organ or anatomic site.
Navigational Note: -
Vaginal hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the vagina.
Navigational Note: -
Vaginal inflammation
Grade 1
Mild discomfort or pain, edema, or redness
Grade 2
Moderate discomfort or pain, edema, or redness; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe discomfort or pain, edema, or redness; small areas of mucosal ulceration; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; widespread areas of mucosal ulceration; urgent intervention indicated
Grade 5
-
Definition: A disorder characterized by inflammation involving the vagina. Symptoms may include redness, edema, marked discomfort and an increase in vaginal discharge.
Navigational Note: -
Vaginal obstruction
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; elective intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by blockage of vaginal canal.
Navigational Note: -
Vaginal pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the vagina.
Navigational Note: Record final diagnosis/cause once determined.
Vaginal perforation
Grade 1
-
Grade 2
Invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a rupture in the vaginal wall.
Navigational Note: -
Vaginal stricture
Grade 1
Asymptomatic; mild vaginal shortening or narrowing
Grade 2
Vaginal narrowing and/or shortening not interfering with physical examination
Grade 3
Vaginal narrowing and/or shortening interfering with the use of tampons, sexual activity or physical examination
Grade 4
-
Grade 5
Death
Definition: A disorder characterized by a narrowing of the vaginal canal.
Navigational Note: -
Reproductive system and breast disorders - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
Grade 1
-
Grade 2
-
Grade 3
Present with radiologic findings; intubation not indicated
Grade 4
Life-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by progressive and life-threatening pulmonary distress in the absence of an underlying pulmonary condition, usually following major trauma or surgery.
Navigational Note: Consider Respiratory, thoracic and mediastinal disorders: Pneumonitis.
Allergic rhinitis
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an inflammation of the nasal mucous membranes caused by an IgE-mediated response to external allergens. The inflammation may also involve the mucous membranes of the sinuses, eyes, middle ear, and pharynx. Symptoms include sneezing, nasal congestion, rhinorrhea and itching.
Navigational Note: -
Aphonia
Grade 1
-
Grade 2
-
Grade 3
Voicelessness; unable to speak
Grade 4
-
Grade 5
-
Definition: A disorder characterized by the inability to speak. It may result from injuries to the vocal cords or may be functional (psychogenic).
Navigational Note: -
Apnea
Grade 1
-
Grade 2
-
Grade 3
Present; medical intervention indicated
Grade 4
Life-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by cessation of breathing.
Navigational Note: -
Aspiration
Grade 1
Clinical or diagnostic observations only; intervention not indicated
Grade 2
Altered eating habits; coughing or choking episodes after eating or swallowing; medical intervention indicated (e.g., suction or oxygen)
Grade 3
Dyspnea and pneumonia symptoms (e.g., aspiration pneumonia); hospitalization indicated; unable to aliment orally
Grade 4
Life-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by inhalation of solids or liquids into the lungs.
Navigational Note: -
Atelectasis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic (e.g., dyspnea, cough); medical intervention indicated (e.g., chest physiotherapy, suctioning); bronchoscopic suctioning
Grade 3
Supplemental oxygen indicated; hospitalization or elective operative intervention indicated (e.g., stent, laser)
Grade 4
Life-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by the collapse of part or the entire lung.
Navigational Note: -
Bronchial fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the bronchus and another organ or anatomic site.
Navigational Note: -
Bronchial obstruction
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic (e.g., mild wheezing); endoscopic evaluation indicated; radiographic evidence of atelectasis/lobar collapse; medical management indicated (e.g., steroids, bronchodilators)
Grade 3
Shortness of breath with stridor; endoscopic intervention indicated (e.g., laser, stent placement)
Grade 4
Life-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by blockage of a bronchus passage, most often by bronchial secretions and exudates.
Navigational Note: -
Bronchial stricture
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic (e.g., rhonchi or wheezing) but without respiratory distress; medical intervention indicated (e.g., steroids, bronchodilators)
Grade 3
Shortness of breath with stridor; endoscopic intervention indicated (e.g., laser, stent placement)
Grade 4
Life-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a narrowing of the bronchial tube.
Navigational Note: -
Bronchopleural fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Hospitalization; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between a bronchus and the pleural cavity.
Navigational Note: -
Bronchopulmonary hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; invasive intervention not indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; intubation or urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the bronchial wall and/or lung parenchyma.
Navigational Note: -
Bronchospasm
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Supplemental oxygen indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a sudden contraction of the smooth muscles of the bronchial wall or narrowing of the airway. May be manifested as wheezing.
Navigational Note: -
Chylothorax
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated (e.g., fat-restricted diet); thoracentesis or tube drainage indicated
Grade 3
Severe symptoms; elective operative intervention indicated
Grade 4
Life-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by milky pleural effusion (abnormal collection of fluid) resulting from accumulation of lymph fluid in the pleural cavity.
Navigational Note: -
Cough
Grade 1
Mild symptoms; nonprescription intervention indicated
Grade 2
Moderate symptoms, medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by sudden, often repetitive, spasmodic contraction of the thoracic cavity, resulting in violent release of air from the lungs and usually accompanied by a distinctive sound.
Navigational Note: Record final diagnosis/cause once determined.
Dyspnea
Grade 1
Shortness of breath with moderate exertion
Grade 2
Shortness of breath with minimal exertion; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Shortness of breath at rest; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an uncomfortable sensation of difficulty breathing.
Navigational Note: Consider Cardiac disorders: Heart failure; Record final diagnosis/cause once determined.
Epistaxis
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated (e.g., nasal packing, cauterization; topical vasoconstrictors)
Grade 3
Transfusion; invasive intervention indicated (e.g., hemostasis of bleeding site)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the nose.
Navigational Note: -
Hiccups
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; interfering with sleep; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by repeated gulp sounds that result from an involuntary opening and closing of the glottis. This is attributed to a spasm of the diaphragm.
Navigational Note: -
Hoarseness
Grade 1
Mild or intermittent voice change; fully understandable; self-resolves
Grade 2
Moderate or persistent voice changes; may require occasional repetition but understandable on telephone; medical evaluation indicated
Grade 3
Severe voice changes including predominantly whispered speech
Grade 4
-
Grade 5
-
Definition: A disorder characterized by harsh and raspy voice arising from or spreading to the larynx.
Navigational Note: -
Hypoxia
Grade 1
Asymptomatic decrease in oxygen saturation <LLN
Grade 2
Decreased oxygen saturation with exercise (e.g., pulse oximeter <88%); intermittent supplemental oxygen
Grade 3
Decreased oxygen saturation at rest (e.g., pulse oximeter <88% or PaO2 <=55 mmHg); continuous supplemental oxygen
Grade 4
Life-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)
Grade 5
Death
Definition: A disorder characterized by a decrease in the level of oxygen in the body.
Navigational Note: Consider Respiratory, thoracic and mediastinal disorders: Dyspnea, Pneumonitis; Record final diagnosis/cause once determined.
Laryngeal edema
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated (e.g., dexamethasone, epinephrine, antihistamines)
Grade 3
Stridor; respiratory distress; hospitalization indicated
Grade 4
Life-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)
Grade 5
Death
Definition: A disorder characterized by swelling due to an excessive accumulation of fluid in the larynx.
Navigational Note: Record final diagnosis/cause once determined.
Laryngeal fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the larynx and another organ or anatomic site.
Navigational Note: -
Laryngeal hemorrhage
Grade 1
Mild cough or trace hemoptysis; laryngoscopic findings
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated (e.g., tracheotomy or intubation)
Grade 5
Death
Definition: A disorder characterized by bleeding from the larynx.
Navigational Note: -
Laryngeal inflammation
Grade 1
Mild sore throat; raspy voice
Grade 2
Moderate sore throat; analgesics indicated
Grade 3
Severe throat pain; endoscopic intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an inflammation involving the larynx.
Navigational Note: -
Laryngeal mucositis
Grade 1
Endoscopic findings only; mild discomfort with normal intake
Grade 2
Moderate pain, analgesics indicated; altered oral intake; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; severely altered eating/swallowing; medical intervention indicated
Grade 4
Life-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)
Grade 5
Death
Definition: A disorder characterized by ulceration or inflammation involving the mucous membrane of the larynx.
Navigational Note: -
Laryngeal obstruction
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic (e.g., noisy airway breathing), no respiratory distress; medical intervention indicated (e.g., steroids); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Stridor; endoscopic intervention indicated (e.g., stent, laser); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by blockage of the laryngeal airway.
Navigational Note: -
Laryngeal stenosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic (e.g., noisy airway breathing), no respiratory distress; medical intervention indicated (e.g., steroids); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Stridor; endoscopic intervention indicated (e.g., stent, laser); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a narrowing of the laryngeal airway.
Navigational Note: -
Laryngopharyngeal dysesthesia
Grade 1
Mild symptoms; no anxiety; intervention not indicated
Grade 2
Moderate symptoms; mild anxiety, but no dyspnea; short duration of observation and/or anxiolytic indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; dyspnea and swallowing difficulty; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by an uncomfortable persistent sensation in the area of the laryngopharynx.
Navigational Note: -
Laryngospasm
Grade 1
-
Grade 2
Transient episode; intervention not indicated
Grade 3
Recurrent episodes; noninvasive intervention indicated (e.g., breathing technique, pressure point massage)
Grade 4
Persistent or severe episodes associated with syncope; urgent intervention indicated (e.g., fiberoptic laryngoscopy, intubation, botox injection)
Grade 5
Death
Definition: A disorder characterized by paroxysmal spasmodic muscular contraction of the vocal cords.
Navigational Note: -
Mediastinal hemorrhage
Grade 1
Mild symptoms; intervention not indicated; radiologic evidence only
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the mediastinum.
Navigational Note: -
Nasal congestion
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
Associated with bloody nasal discharge or epistaxis
Grade 4
-
Grade 5
-
Definition: A disorder characterized by obstruction of the nasal passage due to mucosal edema.
Navigational Note: -
Oropharyngeal pain
Grade 1
Mild pain
Grade 2
Moderate pain; altered oral intake; non-narcotics initiated; topical analgesics initiated
Grade 3
Severe pain; severely altered eating/swallowing; narcotics initiated; requires parenteral nutrition
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the oropharynx or pain on swallowing.
Navigational Note: Record final diagnosis/cause once determined.
Pharyngeal fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the pharynx and another organ or anatomic site.
Navigational Note: -
Pharyngeal hemorrhage
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; intervention indicated
Grade 3
Hospitalization
Grade 4
Life-threatening consequences; intubation or urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the pharynx.
Navigational Note: -
Pharyngeal mucositis
Grade 1
Endoscopic findings only; minimal symptoms with normal oral intake; mild pain but analgesics not indicated
Grade 2
Moderate pain, analgesics indicated; altered oral intake; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; unable to adequately aliment or hydrate orally; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by ulceration or inflammation involving the mucous membrane of the pharynx.
Navigational Note: -
Pharyngeal necrosis
Grade 1
-
Grade 2
-
Grade 3
Inability to aliment adequately by GI tract; invasive intervention indicated; tube feeding or TPN indicated
Grade 4
Life-threatening consequences; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by a necrotic process occurring in the pharynx.
Navigational Note: -
Pharyngeal stenosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic (e.g., noisy airway breathing), no respiratory distress; medical intervention indicated (e.g., steroids); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Stridor; endoscopic intervention indicated (e.g., stent, laser); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)
Grade 5
Death
Definition: A disorder characterized by a narrowing of the pharyngeal airway.
Navigational Note: -
Pharyngolaryngeal pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the pharyngolaryngeal region.
Navigational Note: Record final diagnosis/cause once determined.
Pleural effusion
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; intervention indicated (e.g., diuretics or therapeutic thoracentesis)
Grade 3
Symptomatic with respiratory distress and hypoxia; operative intervention including chest tube or pleurodesis indicated
Grade 4
Life-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an increase in amounts of fluid within the pleural cavity. Symptoms include shortness of breath, cough and marked chest discomfort.
Navigational Note: Record final diagnosis/cause once determined.
Pleural hemorrhage
Grade 1
Asymptomatic; mild hemorrhage confirmed by thoracentesis
Grade 2
Symptomatic or associated with pneumothorax; chest tube drainage indicated
Grade 3
>1000 ml of blood evacuated; persistent bleeding (150-200 ml/hr for 2 - 4 hr); persistent transfusion indicated; elective operative intervention indicated; hospitalization
Grade 4
Life-threatening consequences; intubation or urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by bleeding from the pleural cavity.
Navigational Note: -
Pleuritic pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the pleura.
Navigational Note: Record final diagnosis/cause once determined.
Pneumonitis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; oxygen indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening respiratory compromise; urgent intervention indicated (e.g., tracheotomy or intubation)
Grade 5
Death
Definition: A disorder characterized by inflammation focally or diffusely affecting the lung parenchyma.
Navigational Note: -
Pneumothorax
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; intervention indicated
Grade 3
Sclerosis and/or operative intervention indicated; hospitalization indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by abnormal presence of air in the pleural cavity resulting in the collapse of the lung.
Navigational Note: -
Postnasal drip
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by excessive mucous secretion in the back of the nasal cavity or throat, causing sore throat and/or coughing.
Navigational Note: -
Productive cough
Grade 1
Occasional/minimal production of sputum with cough
Grade 2
Moderate sputum production; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Persistent or copious production of sputum; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by expectorated secretions upon coughing.
Navigational Note: Record final diagnosis/cause once determined.
Pulmonary edema
Grade 1
Radiologic findings only; minimal dyspnea on exertion
Grade 2
Moderate dyspnea on exertion; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe dyspnea or dyspnea at rest; oxygen indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening respiratory compromise; urgent intervention or intubation with ventilatory support indicated
Grade 5
Death
Definition: A disorder characterized by accumulation of fluid in the lung tissues that causes a disturbance of the gas exchange that may lead to respiratory failure.
Navigational Note: Unless there is a clear non-cardiac cause, please record this event as Cardiac disorders: Heart failure. Record final diagnosis/cause once determined.
Pulmonary fibrosis
Grade 1
Radiologic pulmonary fibrosis <25% of lung volume associated with hypoxia
Grade 2
Evidence of pulmonary hypertension; radiographic pulmonary fibrosis 25 - 50% associated with hypoxia
Grade 3
Severe hypoxia; evidence of right-sided heart failure; radiographic pulmonary fibrosis >50 - 75%
Grade 4
Life-threatening consequences (e.g., hemodynamic/pulmonary complications); intubation with ventilatory support indicated; radiographic pulmonary fibrosis >75% with severe honeycombing
Grade 5
Death
Definition: A disorder characterized by the replacement of the lung tissue by connective tissue, leading to progressive dyspnea, respiratory failure or right heart failure.
Navigational Note: -
Pulmonary fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the lung and another organ or anatomic site.
Navigational Note: -
Pulmonary hypertension
Grade 1
Asymptomatic; radiographic, physical, or diagnostic findings
Grade 2
Symptomatic; requiring medical intervention
Grade 3
Severe symptoms, associated with hypoxia, right heart failure; oxygen indicated
Grade 4
Life-threatening airway consequences; urgent intervention indicated (e.g., tracheotomy or intubation)
Grade 5
Death
Definition: A disorder characterized by an increase in pressure within the pulmonary circulation due to lung or heart disorder.
Navigational Note: -
Respiratory failure
Grade 1
-
Grade 2
-
Grade 3
-
Grade 4
Life-threatening consequences; urgent intervention, intubation, or ventilatory support indicated
Grade 5
Death
Definition: A disorder characterized by impaired gas exchange by the respiratory system resulting in hypoxia and a decrease in oxygenation of the tissues that may be associated with an increase in arterial levels of carbon dioxide.
Navigational Note: Consider Respiratory, thoracic and mediastinal disorders: Pneumonitis.
Rhinorrhea
Grade 1
Present
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by excessive mucous secretions draining from the nose.
Navigational Note: -
Sinus disorder
Grade 1
Asymptomatic mucosal crusting; blood-tinged secretions
Grade 2
Symptomatic stenosis or edema/narrowing interfering with airflow; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Stenosis with significant nasal obstruction; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Necrosis of soft tissue or bone; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by involvement of the paranasal sinuses.
Navigational Note: -
Sinus pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the face, between the eyes, or upper teeth originating from the sinuses.
Navigational Note: Record final diagnosis/cause once determined.
Sleep apnea
Grade 1
Snoring and nocturnal sleep arousal without apneic periods
Grade 2
Moderate apnea and oxygen desaturation; excessive daytime sleepiness; medical evaluation indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Oxygen desaturation; associated with pulmonary hypertension; medical intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Cardiovascular or neuropsychiatric symptoms; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by cessation of breathing for short periods during sleep.
Navigational Note: -
Sneezing
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; medical intervention indicated
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by the involuntary expulsion of air from the nose.
Navigational Note: -
Sore throat
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting ability to swallow; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by marked discomfort in the throat.
Navigational Note: -
Stridor
Grade 1
-
Grade 2
-
Grade 3
Respiratory distress; medical intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)
Grade 5
Death
Definition: A disorder characterized by a high pitched breathing sound due to laryngeal or upper airway obstruction.
Navigational Note: -
Tracheal fistula
Grade 1
Asymptomatic
Grade 2
Symptomatic, invasive intervention not indicated
Grade 3
Invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an abnormal communication between the trachea and another organ or anatomic site.
Navigational Note: -
Tracheal mucositis
Grade 1
Endoscopic findings only; minimal hemoptysis, pain, or respiratory symptoms
Grade 2
Moderate symptoms; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; hemorrhage or respiratory symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an inflammation or ulceration involving the mucous membrane of the trachea.
Navigational Note: -
Tracheal stenosis
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic (e.g., noisy airway breathing), no respiratory distress; medical intervention indicated (e.g., steroids); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Stridor or respiratory distress; invasive intervention indicated (e.g., stent, laser); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)
Grade 5
Death
Definition: A disorder characterized by a narrowing of the trachea.
Navigational Note: -
Voice alteration
Grade 1
Mild or intermittent change from normal voice
Grade 2
Moderate or persistent change from normal voice; still understandable
Grade 3
Severe voice changes including predominantly whispered speech; may require frequent repetition or face-to-face contact for understandability; may require assistive technology
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a change in the sound and/or speed of the voice.
Navigational Note: -
Respiratory, thoracic and mediastinal disorders - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Skin and subcutaneous tissue disorders
Alopecia
Grade 1
Hair loss of <50% of normal for that individual that is not obvious from a distance but only on close inspection; a different hair style may be required to cover the hair loss but it does not require a wig or hair piece to camouflage
Grade 2
Hair loss of >=50% normal for that individual that is readily apparent to others; a wig or hair piece is necessary if the patient desires to completely camouflage the hair loss; associated with psychosocial impact
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a decrease in density of hair compared to normal for a given individual at a given age and body location.
Navigational Note: -
Body odor
Grade 1
Mild odor; physician intervention not indicated; self care interventions
Grade 2
Pronounced odor; psychosocial impact; patient seeks medical intervention
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an abnormal body smell resulting from the growth of bacteria on the body.
Navigational Note: -
Dermatitis psoriasiform
Grade 1
Present; topical intervention indicated
Grade 2
oral intervention indicated
Grade 3
IV intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by large, red, rounded plaques covered with thicker scales.
Navigational Note: -
Dermatosis bullous
Grade 1
Asymptomatic
Grade 2
Painful blisters; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Blisters covering >50% BSA; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Blisters covering >75% BSA; associated with fluid or electrolyte abnormalities; ICU care or burn unit indicated
Grade 5
Death
Definition: A disorder characterized by inflammation of the skin characterized by the presence of bullae which are filled with fluid.
Navigational Note: If infectious, consider Infections and infestations: Rash pustular or other site-specific Infections and infestations term.
Dry skin
Grade 1
No associated erythema or pruritus
Grade 2
Associated with erythema or pruritus; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by flaky and dull skin; the pores are generally fine, the texture is a papery thin texture.
Navigational Note: -
Eczematous dermatitis
Grade 1
Present; topical intervention indicated
Grade 2
Oral intervention indicated
Grade 3
IV intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by dry and itchy patches of skin involving the epidermis and superficial dermis and includes some scaling, crusting, or serous oozing.
Navigational Note: -
Erythema multiforme
Grade 1
Not associated with skin tenderness
Grade 2
Associated with skin tenderness
Grade 3
Associated with oral or genital erosions
Grade 4
Associated with fluid or electrolyte abnormalities; ICU care or burn unit indicated
Grade 5
Death
Definition: A disorder characterized by target lesions (a pink-red ring around a pale center).
Navigational Note: -
Erythroderma
Grade 1
-
Grade 2
Erythema covering >90% BSA without associated symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Erythema covering >90% BSA with associated symptoms (e.g., pruritus or tenderness); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Erythema covering >90% BSA with associated fluid or electrolyte abnormalities; ICU care or burn unit indicated
Grade 5
Death
Definition: A disorder characterized by generalized inflammatory erythema and exfoliation. The inflammatory process involves >90% of the body surface area.
Navigational Note: -
Exfoliative dermatitis
Grade 1
Present; topical intervention indicated
Grade 2
oral intervention indicated
Grade 3
IV intervention indicated
Grade 4
Life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by diffuse erythema and scaling involving > 90% of the body surface area.
Navigational Note: -
Hair color changes
Grade 1
Present
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by change in hair color or loss of normal pigmentation.
Navigational Note: -
Hair texture abnormal
Grade 1
Present
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a change in the way the hair feels.
Navigational Note: -
Hirsutism
Grade 1
In women, increase in length, thickness or density of hair in a male distribution that the patient is able to camouflage by periodic shaving, bleaching, or removal of hair
Grade 2
In women, increase in length, thickness or density of hair in a male distribution that requires daily shaving or consistent destructive means of hair removal to camouflage; associated with psychosocial impact
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by the presence of excess hair growth in women in anatomic sites where growth is considered to be a secondary male characteristic and under androgen control (beard, moustache, chest, abdomen).
Navigational Note: -
Hyperhidrosis
Grade 1
Limited to one site (palms, soles, or axillae); self care interventions
Grade 2
Involving >1 site; patient seeks medical intervention; associated with psychosocial impact
Grade 3
Associated with electrolyte/hemodynamic imbalance
Grade 4
-
Grade 5
-
Definition: A disorder characterized by excessive sweating.
Navigational Note: Synonym: Night sweats, diaphoresis.
Hyperkeratosis
Grade 1
Present
Grade 2
-
Grade 3
Limiting self-care ADLs or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a thickening of the outer layer of the skin.
Navigational Note: -
Hypertrichosis
Grade 1
Increase in length, thickness or density of hair that the patient is either able to camouflage by periodic shaving or removal of hairs or is not concerned enough about the overgrowth to use any form of hair removal
Grade 2
Increase in length, thickness or density of hair at least on the usual exposed areas of the body [face (not limited to beard/moustache area) plus/minus arms] that requires frequent shaving or use of destructive means of hair removal to camouflage; associated with psychosocial impact
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by hair density or length beyond the accepted limits of normal in a particular body region, for a particular age or race.
Navigational Note: -
Hypohidrosis
Grade 1
-
Grade 2
Symptomatic; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Increase in body temperature; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by reduced sweating.
Navigational Note: -
Lichenoid dermatitis
Grade 1
Present; topical intervention indicated
Grade 2
oral intervention indicated
Grade 3
IV intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a symmetric eruption of flat-topped, red or purple papules on the trunk and extremities.
Navigational Note: -
Nail changes
Grade 1
Present
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a change in the nails.
Navigational Note: -
Nail discoloration
Grade 1
Present
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a change in the color of the nail plate.
Navigational Note: -
Nail loss
Grade 1
Asymptomatic separation of the nail bed from the nail plate or nail loss
Grade 2
Symptomatic separation of the nail bed from the nail plate or nail loss; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by loss of all or a portion of the nail.
Navigational Note: -
Nail ridging
Grade 1
Present
Grade 2
-
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by vertical or horizontal ridges on the nails.
Navigational Note: -
Pain of skin
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the skin.
Navigational Note: Record final diagnosis/cause once determined.
Palmar-plantar erythrodysesthesia syndrome
Grade 1
Minimal skin changes or dermatitis (e.g., erythema, edema, or hyperkeratosis) without pain
Grade 2
Skin changes (e.g., peeling, blisters, bleeding, fissures, edema, or hyperkeratosis) with pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe skin changes (e.g., peeling, blisters, bleeding, fissures, edema, or hyperkeratosis) with pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by redness, marked discomfort, swelling, and tingling in the palms of the hands or the soles of the feet. Also known as Hand-Foot Syndrome.
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Papulovesicular rash
Grade 1
Asymptomatic
Grade 2
Associated with psychosocial impact; mild symptoms
Grade 3
Covering >50% BSA; moderate or severe symptoms
Grade 4
Blisters covering >75% BSA; life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by an eruption consisting of papules (a small, raised pimple) and vesicles (a small fluid filled blister).
Navigational Note: -
Photosensitivity
Grade 1
Painless erythema
Grade 2
Tender erythema
Grade 3
Erythema with blistering; oral corticosteroid therapy indicated; pain control indicated (e.g., narcotics or NSAIDs)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by an increase in sensitivity of the skin to light.
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Pruritus
Grade 1
Mild or localized; topical intervention indicated
Grade 2
Widespread and intermittent; skin changes from scratching (e.g., edema, papulation, excoriations, lichenification, oozing/crusts); oral intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Widespread and constant; systemic corticosteroid or immunosuppressive therapy indicated; limiting sleep or self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an intense itching sensation.
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Purpura
Grade 1
Combined area of lesions covering <10% BSA
Grade 2
Combined area of lesions covering 10 - 30% BSA
Grade 3
Combined area of lesions covering >30% BSA
Grade 4
-
Grade 5
-
Definition: A disorder characterized by hemorrhagic areas of the skin and mucous membrane. Newer lesions appear reddish in color. Older lesions are usually a darker purple color and eventually become a brownish-yellow color.
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Pustular drug eruption
Grade 1
Asymptomatic
Grade 2
Associated with psychosocial impact; oral antibiotics or steroid indicated; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; IV antibiotic or steroid indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by the development of nonfollicular, sterile pustules on an erythematous base.
Navigational Note: -
Rash maculo-papular
Grade 1
Asymptomatic
Grade 2
Mild symptoms
Grade 3
Macules/papules covering >50% BSA; moderate or severe symptoms
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by the presence of macules (flat) and papules (elevated). Also known as morbilliform rash, it is one of the most common cutaneous adverse events, frequently affecting the upper trunk, spreading centripetally and associated with pruritis.
Navigational Note: Consider Skin and subcutaneous tissue disorders: Pustular drug eruption.
Scalp pain
Grade 1
Mild pain
Grade 2
Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a sensation of marked discomfort in the skin covering the top and the back of the head.
Navigational Note: Record final diagnosis/cause once determined.
Skin atrophy
Grade 1
Associated with telangiectasias or changes in skin color
Grade 2
Associated with striae or adnexal structure loss
Grade 3
Associated with ulceration
Grade 4
-
Grade 5
-
Definition: A disorder characterized by the degeneration and thinning of the epidermis and dermis.
Navigational Note: -
Skin hyperpigmentation
Grade 1
Present
Grade 2
Associated with psychosocial impact
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by darkening of the skin due to excessive melanin deposition.
Navigational Note: -
Skin hypopigmentation
Grade 1
Present
Grade 2
Associated with psychosocial impact
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by loss of skin pigment (e.g., vitiligo).
Navigational Note: -
Skin induration
Grade 1
Mild induration, able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up)
Grade 2
Moderate induration, able to slide skin, unable to pinch skin; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe induration; unable to slide or pinch skin; limiting joint or orifice movement (e.g., mouth, anus); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Generalized; associated with signs or symptoms of impaired breathing or feeding
Grade 5
Death
Definition: A disorder characterized by an area of hardness in the skin.
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Skin ulceration
Grade 1
Combined area of ulcers <1 cm; nonblanchable erythema of intact skin with associated warmth or edema
Grade 2
Combined area of ulcers 1 - 2 cm; partial thickness skin loss involving skin or subcutaneous fat
Grade 3
Combined area of ulcers >2 cm; full-thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to fascia
Grade 4
Any size ulcer with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss
Grade 5
Death
Definition: A disorder characterized by a circumscribed, erosive lesion on the skin.
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Stevens-Johnson syndrome
Grade 1
-
Grade 2
-
Grade 3
Skin sloughing covering <10% BSA
Grade 4
Skin sloughing covering >=10% BSA; life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by less than 10% total body skin area separation of dermis. The syndrome is thought to be a hypersensitivity complex affecting the skin and the mucous membranes.
Navigational Note: -
Subcutaneous emphysema
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by air in the subcutaneous tissue.
Navigational Note: -
Telangiectasia
Grade 1
Present
Grade 2
Associated with psychosocial impact
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by local dilatation of small vessels resulting in red discoloration of the skin or mucous membranes.
Navigational Note: -
Toxic epidermal necrolysis
Grade 1
-
Grade 2
-
Grade 3
-
Grade 4
Skin sloughing covering >=30% BSA with associated symptoms (e.g., erythema, purpura, or epidermal detachment); life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by greater than 30% total body skin area separation of dermis. The syndrome is thought to be a hypersensitivity complex affecting the skin and the mucous membranes.
Navigational Note: -
Urticaria
Grade 1
Topical intervention indicated
Grade 2
Oral intervention indicated
Grade 3
IV intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an itchy skin eruption characterized by wheals with pale interiors and well-defined red margins.
Navigational Note: Consider Immune system disorders: Allergic reaction, Anaphylaxis.
Skin and subcutaneous tissue disorders - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Social circumstances
Social circumstances - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Surgical and medical procedures
Surgical and medical procedures - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -
Vascular disorders
Arterial thromboembolism
Grade 1
-
Grade 2
-
Grade 3
Urgent intervention indicated
Grade 4
Life-threatening consequences; hemodynamic or neurologic instability; organ damage; loss of extremity(ies)
Grade 5
Death
Definition: A disorder characterized by occlusion of an arterial vessel by a blood clot that develops in an artery.
Navigational Note: Consider Nervous system disorders: Stroke, Transient ischemic attacks for CNS-related events or Cardiac disorders: Myocardial infarction.
Capillary leak syndrome
Grade 1
Asymptomatic
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms
Grade 4
Life-threatening consequences
Grade 5
Death
Definition: A disorder characterized by leakage of intravascular fluids into the extravascular space. This syndrome is observed in patients who demonstrate a state of generalized leaky capillaries following shock syndromes, low-flow states, ischemia-reperfusion injuries, toxemias, medications, or poisoning. It can lead to generalized edema and multiple organ failure.
Navigational Note: -
Cyanosis
Grade 1
-
Grade 2
Present
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a bluish discoloration of the skin and/or mucous membranes.
Navigational Note: -
Flushing
Grade 1
Mild symptoms; clinical or diagnostic observations only
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Symptomatic, associated with hypotension and/or tachycardia; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by episodic reddening of the skin, especially face, neck, or chest.
Navigational Note: -
Hematoma
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Minimally invasive evacuation or aspiration indicated
Grade 3
Transfusion; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a localized collection of blood, usually clotted, in an organ, space, or tissue, due to a break in the wall of a blood vessel.
Navigational Note: Report subdural and epidural hematoma under Nervous system disorders: Intracranial hemorrhage.
Hot flashes
Grade 1
Mild symptoms; intervention not indicated
Grade 2
Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by an uncomfortable and temporary sensation of intense body warmth, flushing, sometimes accompanied by sweating upon cooling.
Navigational Note: -
Hypertension
Grade 1
-
Grade 2
Adult: Systolic BP 140 - 159 mmHg or diastolic BP 90 - 99 mmHg; recurrent or persistent; Pediatric and adolescent: Recurrent or persistent (>=24 hrs) BP >ULN; monotherapy indicated; systolic and /or diastolic BP between the 95th percentile and 5 mmHg above the 99th percentile; Adolescent: Systolic between 130 - 139 or diastolic between 80 - 89 even if <95th percentile
Grade 3
Adult: Systolic BP 160 - 179 mmHg or diastolic BP 100 - 109 mmHg persisting over 1 hour; SBP >140 and plus either increase in SBP >20 mmHg or increase MAP >15 mmHg from baseline; Pediatric and adolescent: Systolic and/or diastolic >5 mmHg above the 99th percentile
Grade 4
Adult and Pediatric: SBP≥180 or DBP ≥110 mmHg persisting over 1 hour; BP associated with acute hypertension mediated organ damage; life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis); urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a pathological increase in blood pressure.
Navigational Note: -
Hypotension
Grade 1
Asymptomatic, intervention not indicated
Grade 2
Non-urgent medical intervention indicated
Grade 3
Medical intervention indicated; hospitalization indicated
Grade 4
Life-threatening consequences and urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by a blood pressure that is below the normal expected for an individual in a given environment.
Navigational Note: -
Lymph leakage
Grade 1
-
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by the loss of lymph fluid into the surrounding tissue or body cavity.
Navigational Note: -
Lymphedema
Grade 1
Trace thickening or faint discoloration
Grade 2
Marked discoloration; leathery skin texture; papillary formation; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
-
Grade 5
-
Definition: A disorder characterized by excessive fluid collection in tissues that causes swelling.
Navigational Note: Record final diagnosis/cause once determined.
Lymphocele
Grade 1
Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2
Symptomatic; medical intervention indicated
Grade 3
Severe symptoms; invasive intervention indicated
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a cystic lesion containing lymph.
Navigational Note: -
Peripheral ischemia
Grade 1
-
Grade 2
Brief (<24 hrs) episode of ischemia managed medically and without permanent deficit; claudication
Grade 3
Prolonged (>=24 hrs) or recurring symptoms and/or invasive intervention indicated; pain at rest
Grade 4
Life-threatening consequences; major tissue loss; urgent operative intervention indicated
Grade 5
Death
Definition: A disorder characterized by impaired circulation to an extremity.
Navigational Note: -
Phlebitis
Grade 1
-
Grade 2
Present
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by inflammation of the wall of a peripheral vein associated with an intravenous line.
Navigational Note: -
Superficial thrombophlebitis
Grade 1
-
Grade 2
Present
Grade 3
-
Grade 4
-
Grade 5
-
Definition: A disorder characterized by a blood clot and inflammation involving a superficial vein of the extremities.
Navigational Note: -
Superior vena cava syndrome
Grade 1
Asymptomatic; incidental finding of SVC thrombosis
Grade 2
Symptomatic; medical intervention indicated (e.g., anticoagulation, radiation or chemotherapy)
Grade 3
Severe symptoms; multi-modality intervention indicated (e.g., anticoagulation, chemotherapy, radiation, stenting)
Grade 4
Life-threatening consequences; urgent multi-modality intervention indicated (e.g., lysis, thrombectomy, surgery)
Grade 5
Death
Definition: A disorder characterized by obstruction of the blood flow in the superior vena cava. Signs and symptoms include swelling and cyanosis of the face, neck, and upper arms, cough, orthopnea and headache.
Navigational Note: -
Vasculitis
Grade 1
Asymptomatic, intervention not indicated
Grade 2
Moderate symptoms, medical intervention indicated
Grade 3
Severe symptoms, medical intervention indicated (e.g., steroids)
Grade 4
Life-threatening consequences; evidence of peripheral or visceral ischemia; urgent intervention indicated
Grade 5
Death
Definition: A disorder characterized by inflammation involving the wall of a vessel.
Navigational Note: -
Venous thromboembolism
Grade 1
Medical intervention not indicated (e.g., superficial thrombosis)
Grade 2
Medical intervention indicated
Grade 3
Urgent medical intervention indicated
Grade 4
Life-threatening consequences with hemodynamic or neurologic instability
Grade 5
Death
Definition: A disorder characterized by occlusion of a vessel by a thrombus that has migrated from a distal site via the blood stream (for example, deep vein thrombosis (DVT), pulmonary embolism (PE), etc.).
Navigational Note: Consider Nervous system disorders: Stroke, Transient ischemic attacks for CNS-related events. Use Vascular disorders: Arterial thromboembolism for arterial thrombi. Use Injury, poisoning and procedural complications: Vascular access complication if related to a catheter.
Vascular disorders - Other, specify
Grade 1
Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
Grade 4
Life-threatening consequences; urgent intervention indicated
Grade 5
Death
Definition: -
Navigational Note: -