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The Common Terminology Criteria for Adverse Events , formerly called the Common Toxicity Criteria , are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. The CTCAE system is a product of the US National Cancer Institute.
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 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:
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 ADLGrade 4: is Life threatening consequences; urgent or emergent intervention neededGrade 5: Death related to or due to adverse event