Common Terminology Criteria for Adver Events (CTCAE)
Version 4.0
Published: May 28, 2009 (v4.03: June 14, 2010)
U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute
__________
† CTCAE v4.0 incorporates certain elements of the MedDRA terminology. For further details on MedDRA refer to the MedDRA MSSO Web site ( ).
Common Terminology Criteria for Adver Events v4.0 (CTCAE)
Publish Date: May 28, 2009
Quick Reference
The NCI Common Terminology Criteria for Adver Events is a descriptive terminology which can be utilized for Adver Event (AE) reporting. A grading (verity) scale is provided for each AE term. Components and Organization SOC System Organ Class, the highest level of the MedDRA hierarchy, is identified by anatomical or physiological system, etiology, or purpo (e.g., SOC Investigations for laboratory test results). CTCAE terms are grouped by MedDRA Primary SOCs. Within each SOC, AEs are listed and accompanied by descriptions of verity (Grade). CTCAE Terms
An Adver Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or dia temporally associated with the u of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. An AE is a term that is a unique reprentation of a specific event ud for medical documentation and scientific analys. Each CTCAE v4.0 term is a MedDRA LLT (Lowest Level Term).
Definitions
A brief definition is provided to clarify the meaning of each AE term.
Grades Grade refers to the verity of the AE. The CTCAE displays Grades 1 through 5 with unique
clinical descriptions of verity for each AE bad on this general guideline:
Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic obrvations 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; hospitalization or prolongation of hospitalization indicated; disabling; limiting lf care ADL**.
Grade 4 Life-threatening conquences; urgent intervention indicated.
Grade 5
Death related to AE.
A Semi-colon indicates ‘or’ within the description of the grade.
A single dash (-) indicates a grade is not available.
Not all Grades are appropriate for all AEs.
Therefore, some AEs are listed with fewer than
five options for Grade lection. Grade 5 Grade 5 (Death) is not appropriate for some AEs
and therefore is not an option.
Activities of Daily Living (ADL) *Instrumental ADL refer to preparing meals,
shopping for groceries or clothes, using the telephone, managing money, etc. **Self care ADL refer to bathing, dressing and undressing, feeding lf, using the toilet, taking medications, and not bedridden.
CONTENTS
Blood and lymphatic system disorders
Grade
Adver Event12345
Anemia Hemoglobin (Hgb) <LLN - 10.0
g/dL; <LLN - 6.2 mmol/L; <LLN -
100 g/L Hgb <10.0 - 8.0 g/dL; <6.2 - 4.9
mmol/L; <100 - 80g/L
Hgb <8.0 g/dL; <4.9 mmol/L;
<80 g/L; transfusion indicated
Life-threatening conquences;
urgent intervention indicated
Death
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Definition: A disorder characterized by an 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.
Bone marrow hypocellular Mildly hypocellular or <=25%
reduction from normal cellularity
for age Moderately hypocellular or >25 -
<50% reduction from normal
cellularity for age
Severely hypocellular or >50 -
<=75% reduction cellularity from
normal for age
Aplastic persistent for longer
than 2 weeks
Death
Definition: A disorder characterized by the inability of the bone marrow to produce hematopoietic elements.
Disminated intravascular coagulation -Laboratory findings with no
祸从口出bleeding
Laboratory findings and
bleeding
Life-threatening conquences;
urgent intervention indicated
Death
Definition: A disorder characterized by systemic pathological activation of blood clotting mechanisms which results in clot formation throughout the body. There is an increa in the risk of hemorrhage as the body is depleted of platelets and coagulation factors.
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 hour.Life-threatening conquences;
urgent intervention indicated
Death
Definition: A disorder characterized by an ANC <1000/mm3 and a single temperature of >38.3 degre
es C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees F) for more than one hour.
Hemolysis Laboratory evidence of
hemolysis only (e.g., direct
antiglobulin test; DAT; Coombs';
schistocytes; decread
haptoglobin)Evidence of hemolysis and >=2
gm decrea in hemoglobin.
Transfusion or medical
intervention indicated (e.g.,
steroids)
Life-threatening conquences;
urgent intervention indicated
Death
Definition: A disorder characterized by laboratory test results that indicate widespread erythrocyte cell membrane destruction.
Hemolytic uremic syndrome Evidence of RBC destruction
(schistocytosis) without clinical
conquences -Laboratory findings with clinical
conquences (e.g., renal
insufficiency, petechiae)
Life-threatening conquences,
(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 vere thrombocytopenia.
Leukocytosis - ->100,000/mm3Clinical manifestations of
leucostasis; urgent intervention
indicated
Death Definition: A disorder characterized by laboratory test results that indicate an incread number of white blood cells in the blood.
Lymph node pain Mild pain Moderate pain; limiting
instrumental ADL Severe pain; limiting lf care
ADL
- -
Definition: A disorder characterized by a nsation of marked discomfort in a lymph node.
Spleen disorder Incidental findings (e.g., Howell-
Jolly bodies); mild degree of
thrombocytosis and
leukocytosis Prophylactic antibiotics
indicated
-Life-threatening conquences;
urgent intervention indicated
Death
Definition: A disorder of the spleen.阿拉丁和神灯的故事
Thrombotic thrombocytopenic purpura Evidence of RBC destruction
(schistocytosis) without clinical
conquences
-Laboratory findings with clinical
conquences (e.g., renal
insufficiency, petechiae)
Life-threatening conquences,
(e.g., CNS hemorrhage or
thrombosis/embolism or renal
failure)
Death
Definition: A disorder characterized by the prence of microangiopathic hemolytic anemia, thrombocytopenic purpura, fever, renal abnormalities and neurological abnormalities such as izures, hemiplegia, and visual disturbances. It is an acute or subacute condition.
Blood and lymphatic system disorders - Other, specify Asymptomatic or mild
symptoms; clinical or diagnostic
obrvations only; intervention
not indicated
Moderate; minimal, local or
noninvasive intervention
indicated; limiting age-
appropriate instrumental ADL
Severe or medically significant
but not immediately life-
threatening; hospitalization or
prolongation of existing
hospitalization indicated;
disabling; limiting lf care ADL
Life-threatening conquences;
urgent intervention indicated
Death
CTCAE 4.03 - June 14, 2010 : Blood and lymphatic system disorders
Cardiac disorders
Grade
Adver Event12345
Acute coronary syndrome -Symptomatic, progressive
angina; cardiac enzymes
normal; hemodynamically stable Symptomatic, unstable angina
and/or acute myocardial
infarction, cardiac enzymes
abnormal, hemodynamically
stable
Symptomatic, unstable angina
and/or acute myocardial
infarction, cardiac enzymes
abnormal, hemodynamically
unstable
Death
Definition: A disorder characterized by signs and symptoms related to acute ischemia of the myocardium condary to coronary artery dia. The clinical prentation covers a spectrum of heart dias from unstable angina to myocardial infarction.
Aortic valve dia Asymptomatic valvular
thickening with or without mild2018年高考
valvular regurgitation or
stenosis by imaging Asymptomatic; moderate
regurgitation or stenosis by
imaging
南京长江大桥简介Symptomatic; vere
regurgitation or stenosis by
imaging; symptoms controlled
with medical intervention
Life-threatening conquences;
urgent intervention indicated
(e.g., valve replacement,
valvuloplasty)
Death
Definition: A disorder characterized by a defect in aortic valve function or structure.
Asystole Periods of asystole; non-urgent
medical management indicated - -Life-threatening conquences;
urgent intervention indicated
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.
Atrial fibrillation Asymptomatic, intervention not
indicated Non-urgent medical intervention
indicated
Symptomatic and incompletely
controlled medically, or
controlled with device (e.g.,
pacemaker), or ablation
排风扇安装
Life-threatening conquences;
urgent intervention indicated
Death
Definition: A disorder characterized by a dysrhythmia without discernible P waves and an irregular ventricular respon due to multiple reentry circuits. The rhythm disturbance originates above the ventricles.
Atrial flutter Asymptomatic, intervention not
indicated Non-urgent medical intervention
indicated
Symptomatic and incompletely
controlled medically, or
controlled with device (e.g.,
pacemaker), or ablation
Life-threatening conquences;
urgent intervention indicated
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.
Atrioventricular block complete -Non-urgent intervention
indicated Symptomatic and incompletely
controlled medically, or
controlled with device (e.g.,
pacemaker)
Life-threatening conquences;
urgent intervention indicated
Death
Definition: A disorder characterized by a dysrhythmia with complete failure of atrial electrical impul conduction through the AV node to the ventricles.
Atrioventricular block first degree Asymptomatic, intervention not
indicated
Non-urgent intervention
indicated
- - -
Definition: A disorder characterized by a dysrhythmia with a delay in the time required for the conduction of an electrical impul through the atrioventricular (AV) node beyond 0.2 conds; prolongation of the PR interval greater than 200 milliconds.
Cardiac arrest - - -Life-threatening conquences;
urgent intervention indicated
Death Definition: A disorder characterized by cessation of the pumping function of the heart.
Chest pain - cardiac Mild pain Moderate pain; limiting
instrumental ADL Pain at rest; limiting lf care
ADL
- -
Definition: A disorder characterized by substernal discomfort due to insufficient myocardial oxygenation.
Conduction disorder Mild symptoms; intervention not
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indicated Moderate symptoms Severe symptoms; intervention
indicated
Life-threatening conquences;
urgent intervention indicated
Death
Definition: A disorder characterized by pathological irregularities in the cardiac conduction system.
Constrictive pericarditis - -Symptomatic heart failure or
other cardiac symptoms,
responsive to intervention Refractory heart failure or other
poorly controlled cardiac
symptoms
Death
Definition: A disorder characterized by a thickened and fibrotic pericardial sac; the fibrotic changes impede normal myocardial function by restricting myocardial muscle action.
Heart failure Asymptomatic with laboratory
(e.g., BNP [B-Natriuretic
Peptide ]) or cardiac imaging
abnormalities Symptoms with mild to
moderate activity or exertion
Severe with symptoms at rest or
with minimal activity or exertion;
intervention indicated
Life-threatening conquences;
兆欧表的使用方法urgent intervention indicated
(e.g., continuous IV therapy or
mechanical hemodynamic
support)
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.
CTCAE 4.03 - June 14, 2010 : Cardiac disorders
