CTCAE는 미국 국립암연구소에서 개발하여
항암치료에 사용되는 약물 이상반응들의 표준화된 분류 기준으로 사용되고 있습니다.
Mild (grade 1) 증상이 있지만 심하지 않아 중재가 필요 없음. Moderate (grade2) 경한 증상으로 때때로 중재가 필요함. Severe (grade3) 일상생활 불가능하여 적극적인 중재가 필요함.
Disabling (grade4) 생명을 위협하므로 즉각적인 중재가 필요함.
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
System Organ Class (SOC), 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).
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
* CTCAE v5.0 incorporates certain elements of the MedDRA te
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
Grade 1 Mild; asymptomatic or mild
symptoms; clinical or diagnostic
observations only; intervention
Grade 2 Moderate; minimal, local or
indicated; limiting age-
appropriate instrumental ADL*..
Grade 3 Severe or medically significant but not
hospitalization or prolongation
of hospitalization indicated;
disabling; limiting self care
A Semi-colon indicates ‘or’ within the description
of the grade.
Asingle 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.
ninology. For further details on MedDRA refer to the MedDRA
Grade 5 (Death) is not appropriate for some AEs
and therefore is not an option.
A brief Definition is provided to clarify the
meaning of each AE term. A single dash (-)
indicates a Definition is not available.
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
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.
SO Web site (https://www.meddra.org/).