Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Publish Date: November 27, 2017
Introduction
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.
SOC
System Organ Class (SOC), the highest level of the
MedDRA
1
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
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 representation of a
specific event used for medical documentation and
scientific analyses. Each CTCAE v4.0 term is a
MedDRA LLT (Lowest Level Term).
Grades
Grade refers to the severity of the AE. The CTCAE
displays Grades 1 through 5 with unique clinical
descriptions of severity for each AE based on this
general guideline:
Grade 1 Mild; 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;
hospitalization or prolongation of
hospitalization indicated; disabling;
limiting self care ADL**.
Grade 4 Life-threatening consequences; 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 selection.
Grade 5
Grade 5 (Death) is not appropriate for some AEs
and therefore is not an option.
Definitions
A brief Definition is provided to clarify the meaning
of each AE term. A single dash (-) indicates a
Definition is not available.
Navigational Notes
A Navigational Note is used to assist the reporter in
choosing a correct AE. It may list other AEs that
should be considered in addition to or in place of
the AE in question. A single dash (-) indicates a
Navigational Note has not been defined for the AE
term.
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 self, using the toilet, taking
medications, and not bedridden.
1
CTCAE v5.0 incorporates certain elements of the MedDRA terminology. For further details on MedDRA refer to the MedDRA MSSO Web site (https://www.meddra.org/).