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

Page

3

6

15

16

19

22

28

55

61

65

68

87

107

114

119

128

129

141

142

147

153

164

179

188

189

190

2. Blood and lymphatic system disorders

Blood and lymphatic system disorders

Grade

Adverse Event

Anemia

1

2

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

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download