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 effect An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. The term complica ...

s of drugs used in

cancer therapy Cancer is a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body. These contrast with benign tumors, which do not spread. Possible signs and symptoms include a lump, abnormal ble ...

. 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 participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...

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 the observed or detectable signs, and experienced symptoms of an illness, injury, or condition. A sign for example may be a higher or lower temperature than normal, raised or lowered blood pressure or an abnormality showin ...

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 eventCommon Terminology Criteria for Adverse Events (CTCAE)Version 5.0 Published: November 27, 2017U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

References

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