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).
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/).
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.