The National Cancer Institute issued the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 on November 27, 2017.
So what is CTCAE and what is it used for?
The terminology NCI CTCAE is a descriptive terminology that can be used for the declaration of adverse events (AEs). A grade scale (or severity) is provided for each term.
The oncology community has a standard classification and severity grading scale for adverse events in cancer therapy clinical trials and this is what it is described in the CTCAE reference.
The SOC (System Organ Class or Organ Class) is the highest level of the hierarchy of the MedDRA dictionary. It is identified by a physiological or anatomical classification, etiological or a result (ex: SOC investigations for laboratory results). The terms of the CTCAE are grouped together according to the MedDRA primary SOCs. Within each SOC, the terms are listed and accompanied a description of the severity (grade).
An adverse event is an unexpected sign, symptom or disease, unexpected (this includes biological results), associated chronologically with the use of a treatment, a procedure, to be connected to this treatment or procedure. An IE is a unique term representing an event specifically used for the medical report and the scientific analyzes. Each term of the CTCAE is a MedDRA LLT level term (Low Level Term, lowest level of the hierarchy).
Grades refer to the severity of AEs. The CTCAE is divided into 5 grades, each with unique medical description for each term, based on the following main lines: Grade 1: Light; asymptomatic or mild symptoms; diagnosis on clinical examination only; born not requiring treatment Grade 2: Moderate; requiring minimal, local or non-invasive treatment; interfering with activities instrumentalities of everyday life Grade 3: Severe or medically significant but without immediate life-threatening; indication of hospitalization or prolongation of hospitalization; invalidating; interfering with activities elementary of everyday life Grade 4: Life-threatening; requiring emergency care Grade 5: Death related to AE and it is not appropriate for some AEs and therefore is not an option.
|MedDRA code||CTCAE v5.0 Term||Grade 1||Grade 2||Grade 3||Grade 4||Grade 5||Definition|
|Death||A disorder characterized by cessation of the pumping function of the heart.|
CTCAE is still the formal reporting for AEs and grading dependent upon clinician judgement of medical significance.
A copy is located here: CTCAE version 5.0.
Feature image: CTCAE-4 by Stefano Peruzzi (apple app)
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