Common terminology criteria for adverse events
- Diane MF Savarese, MD
Diane MF Savarese, MD
- Senior Deputy Editor — UpToDate
- Deputy Editor — Oncology and Palliative Care
- Clinical Instructor of Medicine
- Harvard Medical School
The National Cancer Institute (NCI) of the National Institutes of Health (NIH) has published standardized definitions for adverse events (AEs), known as the Common Terminology Criteria for Adverse Events (CTCAE, also called "common toxicity criteria"), to describe the severity of organ toxicity for patients receiving cancer therapy. This topic presents selected tables describing some of the AEs graded in the most recent CTCAE (version 4.0), and provides references for other adverse events reporting systems.
Additional information about specific chemotherapy- and radiation therapy-associated toxicity is presented in separate topic reviews, which are mentioned under the disease-specific headings included herein.
General effects of radiation therapy and molecularly-targeted agents (eg, vascular endothelial growth factor inhibitors, tyrosine kinase inhibitors) are also discussed in separate reviews. (See "Toxicity of molecularly targeted antiangiogenic agents: Non-cardiovascular effects" and "Clinical manifestations, prevention, and treatment of radiation-induced fibrosis".)
CTCAE stands for Common Terminology Criteria for Adverse Events; these criteria are also called "common toxicity criteria." In CTCAE, an adverse event (AE) is defined as any abnormal clinical finding temporally associated with the use of a therapy; causality is not required. These criteria are used for the management of chemotherapy administration and dosing, and in clinical trials to provide standardization and consistency in the definition of treatment-related toxicity. A comprehensive listing is available from the NCI at NCI CTCAE.
Toxicity is graded as mild (Grade 1), moderate (Grade 2), severe (Grade 3), or life-threatening (Grade 4), with specific parameters according to the organ system involved. Death (Grade 5) is used for some of the criteria to denote a fatality. Approximately 10 percent of the items in the NCI CTCAE represent symptoms and these are currently reported by clinicians rather than patients. Versions of the CTCAE that rely on patient-reported outcomes are discussed below. (See 'Other adverse event reporting systems' below.)
- Launay-Vacher V. Cancer and the kidney: individualizing dosage according to renal function. Ann Oncol 2013; 24:2713.
- Basch E, Reeve BB, Mitchell SA, et al. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst 2014; 106.
- Dueck AC, Mendoza TR, Mitchell SA, et al. Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncol 2015; 1:1051.
- Kluetz PG, Chingos DT, Basch EM, Mitchell SA. Patient-Reported Outcomes in Cancer Clinical Trials: Measuring Symptomatic Adverse Events With the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Am Soc Clin Oncol Educ Book 2016; 35:67.
- Atkinson TM, Ryan SJ, Bennett AV, et al. The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review. Support Care Cancer 2016; 24:3669.
- http://www.umc-products.com/DynPage.aspx?id=73589&mn1=1107&mn2=1664 (Accessed on November 12, 2013).