Common Terminology Criteria for Adverse Events (CTCAE)
1. CTCAE 4.03
Common Terminology Criteria
for Adverse 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
Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
Publish Date: May 28, 2009
Quick Reference
The NCI Common Terminology Criteria for
Adverse Events is a descriptive terminology which
can be utilized for Adverse Event (AE) reporting.
A grading (severity) 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 purpose (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 severity (Grade).
CTCAE Terms
Not all Grades are appropriate for all AEs.
A brief definition is provided to clarify the Therefore, some AEs are listed with fewer than
five options for Grade selection.
meaning of each AE term.
Definitions
Grade 5
Grades
Grade refers to the severity of the AE. The CTCAE Grade 5 (Death) is not appropriate for some AEs
displays Grades 1 through 5 with unique clinical and therefore is not an option.
descriptions of severity for each AE based on this Activities of Daily Living (ADL)
general guideline:
*Instrumental ADL refer to preparing meals,
Grade 1 Mild; asymptomatic or mild shopping for groceries or clothes, using the
symptoms; clinical or diagnostic telephone, managing money, etc.
observations only; intervention not
indicated.
**Self care ADL refer to bathing, dressing and
Grade 2 Moderate; minimal, local or undressing, feeding self, using the toilet, taking
noninvasive intervention indicated; medications, and not bedridden.
Grade 3
An Adverse Event (AE) is any unfavorable and
unintended sign (including an abnormal
laboratory finding), symptom, or disease
temporally associated with the use of a medical
treatment or procedure that may or may not be
Grade 4
considered related to the medical treatment or
procedure. An AE is a term that is a unique
representation of a specific event used for
Grade 5
medical documentation and scientific analyses.
Each CTCAE v4.0 term is a MedDRA LLT (Lowest A Semi-colon
of the grade.
Level Term).
limiting
age-appropriate
instrumental ADL*.
Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
hospitalization indicated; disabling;
limiting self care ADL**.
Life-threatening
consequences;
urgent intervention indicated.
Death related to AE.
indicates ¡®or¡¯ within the description
A single dash (-) indicates a grade is not available.
__________
? CTCAE v4.0 incorporates certain elements of the MedDRA terminology. For further details on MedDRA refer to the MedDRA MSSO Web site ().
SOC
Blood and lymphatic system disorders
Cardiac disorders
Congenital, familial and genetic disorders
Ear and labyrinth disorders
Endocrine disorders
Eye disorders
Gastrointestinal disorders
General disorders and administration site conditions
Hepatobiliary disorders
Immune system disorders
Infections and infestations
Injury, poisoning and procedural complications
Investigations
Metabolism and nutrition disorders
Musculoskeletal and connective tissue disorders
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nervous system disorders
Pregnancy, puerperium and perinatal conditions
Psychiatric disorders
Renal and urinary disorders
Reproductive system and breast disorders
Respiratory, thoracic and mediastinal disorders
Skin and subcutaneous tissue disorders
Social circumstances
Surgical and medical procedures
Vascular disorders
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2. Blood and lymphatic system disorders
Blood and lymphatic system disorders
Grade
Adverse Event
Anemia
1
2
Hemoglobin (Hgb) ................
................
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