CTCAE

The first version dates back to before 1998. In 1999, the FDA published version 2.0. This was followed in 2009 by CTCAE version 4.0 with an update to version 4.03 in 2010.[2] The current version 5.0 was published on November 27, 2017. Many clinical trials that now extend beyond oncology code their observations based on the CTCAE system.

CTCAE is the acronym for Common Terminology Criteria for Adverse Events. The Common Terminology Criteria for Adverse Events, formerly known as the Common Toxicity Criteria (CTC or NCI-CTC), are a set of criteria for the standardized classification of adverse events for drugs and treatments used in cancer therapy. The CTCAE system is a product of the US National Cancer Institute (NCI). The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology that can be used for reporting adverse events (AEs). A rating scale (severity) is provided for each AE term.

An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease that is temporally associated with the use of a medical treatment or procedure and may or may not be considered related to the medical treatment or procedure. An AE is a term that uniquely represents a specific event and is used for medical documentation and scientific analysis.

Adverse events are graded. The grade refers to the severity of the AE. The CTCAE shows a grading from 1 to 5 with clear clinical descriptions of severity for each AE based on this general guideline:

• Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
• Grade 2 Moderate; minimal, local or non-invasive intervention indicated; age-appropriate instrumental ADL* limited.
• Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; self-care ADLs** limited.
• Grade 4: Life-threatening consequences; urgent intervention indicated.
• Grade 5: Death related to AE.

Note: A semicolon indicates "or" within the grade description. A single hyphen (-) means that no grade is available. Not all grades are appropriate for all AEs. Therefore, some AEs are listed with fewer than five options for severity grade selection. Severity 5 Severity 5 (death) is not appropriate for some AEs and is therefore not an option.

1. US Department of Health and Human Services (2017) . Common terminology criteria for adverse events (CTCAE) version 5.0. National Institutes of Health, National Cancer Institute