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Common Terminology Criteria for Adverse Events
From Wikipedia, the free encyclopedia
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The Common Terminology Criteria for Adverse Events (CTCAE),[1] formerly called the Common Toxicity Criteria (CTC or NCI-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).
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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]
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See also
- Adverse event – Any event, symptom, or disease occurring during a medical treatment
- Cancer research – Research into causes and treatment of cancer
- EudraVigilance – Processing Network
- Good clinical practice – International quality standard for drug testing and production
- National Cancer Institute – American governmental health agency
- Pharmacovigilance – Drug safety; subdiscipline of pharmacy relating to prevention of adverse effects of drugs
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References
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