The Common Terminology Criteria for Adverse Events (CTCAE),[1] formerly called the Common Toxicity Criteria (CTCorNCI-CTC), are a set of criteria for the standardized classification of adverse events of drugs and treatment used in cancer therapy.
The CTCAE system is a product of the US National Cancer Institute (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.[2] The current version 5.0 was released on November 27, 2017. Many clinical trials, 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 symptoms 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[3]
Cancer research – Scientific inquiry into the causes and treatment of abnormal cell growth diseases
EudraVigilance – Processing NetworkPages displaying wikidata descriptions as a fallback
Good clinical practice – international quality standard for conducting clinical trials involving human subjectsPages displaying wikidata descriptions as a fallback
^PharmaSUG 2019 - Paper BP-128
Implementing Laboratory Toxicity Grading for CTCAE Version 5
Keith Shusterman, Reata Pharmaceutics, Inc.;
Mario Widel, Independent Contractor
^Common Terminology Criteria for Adverse Events (CTCAE)Version 5.0
Published: November 27, 2017U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
