Common Terminology Criteria for Adverse Events (CTCAE)

[Pages:195]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

Definitions

Not all Grades are appropriate for all AEs.

The NCI Common Terminology Criteria for A brief definition is provided to clarify the Therefore, some AEs are listed with fewer than

Adverse Events is a descriptive terminology which meaning of each AE term.

five options for Grade selection.

can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE Grades

Grade 5

term.

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.

Components and Organization

descriptions of severity for each AE based on this Activities of Daily Living (ADL)

SOC

general guideline:

*Instrumental ADL refer to preparing meals,

System Organ Class, the highest level of the Grade 1 Mild; asymptomatic or mild shopping for groceries or clothes, using the

MedDRA hierarchy, is identified by anatomical or

symptoms; clinical or diagnostic telephone, managing money, etc.

physiological system, etiology, or purpose (e.g.,

observations only; intervention not

SOC Investigations for laboratory test results).

indicated.

**Self care ADL refer to bathing, dressing and

CTCAE terms are grouped by MedDRA Primary SOCs. Within each SOC, AEs are listed and accompanied by descriptions of severity (Grade).

Grade 2

Moderate; minimal, local or undressing, feeding self, using the toilet, taking noninvasive intervention indicated; medications, and not bedridden.

limiting

age-appropriate

CTCAE Terms

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 considered related to the medical treatment or procedure. An AE is a term that is a unique

Grade 3 Grade 4

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.

representation of a specific event used for Grade 5 Death related to AE.

medical documentation and scientific analyses.

Each CTCAE v4.0 term is a MedDRA LLT (Lowest A Semi-colon indicates `or' within the description

Level Term).

of the grade.

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

1

2

3

4

5

Anemia

Hemoglobin (Hgb) ................
................

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