The Common Terminology Criteria for Adverse Events (CTCAE), formerly called the Common Toxicity Criteria (CTC or NCI-CTC), are a set of criteria for the standardized classification of
adverse events
In pharmaceuticals, an adverse event (AE) is any unexpected or harmful medical occurrence that happens to a patient during medical treatment or a clinical trial. Unlike direct side effects, an adverse event does not necessarily mean the medicatio ...
of drugs and treatment used in
cancer therapy
Cancer treatments are a wide range of treatments available for the many different types of cancer, with each cancer type needing its own specific treatment. Treatments can include surgery, chemotherapy, radiation therapy, hormonal therapy, targe ...
.
The CTCAE system is a product of the US
National Cancer Institute
The National Cancer Institute (NCI) coordinates the United States National Cancer Program and is part of the National Institutes of Health (NIH), which is one of eleven agencies that are part of the U.S. Department of Health and Human Services. ...
(NCI).
The first Iteration was prior to 1998. In 1999, the FDA released version 2.0. CTCAE version 4.0 in 2009 with an update to y version 4.03 in 2010. The current version 5.0 was released on November 27, 2017. Many
clinical trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...
s, now extending beyond oncology, encode their observations based on the CTCAE system.
It uses a range of grades from 1 to 5. Specific conditions and
symptom
Signs and symptoms are diagnostic indications of an illness, injury, or condition.
Signs are objective and externally observable; symptoms are a person's reported subjective experiences.
A sign for example may be a higher or lower temperature ...
s may have values or descriptive comment for each level, but the general guideline is:
:1 - Mild
:2 - Moderate
:3 - Severe
:4 - Life-threatening
:5 - Death
Grade 1: is defined as mild, asymptomatic symptoms. Clinical or diagnostic observations only; Intervention not indicated.
Grade 2: is moderate; minimal, local or noninvasive intervention was needed.
Grade 3: Severe symptoms or medically significant but not life-threatening but may be disabling or limit self care in ADL
Grade 4: is Life threatening consequences; urgent or emergent intervention needed
Grade 5: Death related to or due to adverse event
[Common Terminology Criteria for Adverse Events (CTCAE)Version 5.0
Published: November 27, 2017U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES]
See also
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References
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Cancer research
Clinical research
Clinical trials
Good clinical practice
Good practice
Human subject research
National Institutes of Health
Oncology