The NCI Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 is the new standard for oncology clinical trials

Abstract

6098 Background: A need for reproducible, consistent and readily usable adverse event reports led the World Health Organization in 1979 to create a scale for adverse event (AE) description and grading. As the cancer clinical trials endeavor has become more complex, there has been a need for more complex yet easy to use AE criteria. The NCI published its 1st and 2nd versions of the CTC in 1982 and 1998 in response to this need. In 2001 The Cancer Therapy Evaluation Program of the NCI, in response to requersts from investigators, intiatated an effore to update the CTC. Methods: This updated version of naming and grading of adverse events in cancer clinical trials is the result of collaboration among academic, governmental, and pharmaceutical industry clinical investigators. The drafts of the CTCAE v3 were reviewed twice by more than 400 reviewers. Results: The CTCAE v. 3 was launched on the CTEP web site http://ctep.cancer.gov/reporting/ctc.html on June 10, 2003 and is used for all new NCI- sponsored clinical trials as of October 2003. The CTCAE v.3 contains 28 categories and 1056 specific adverse event terms, as compared to 24 and 395 respectively in the CTC v.2. Major changes include the elimination of duration and time- dependent grading of adverse events, integration of acute and late effects into one scoring system, and expansion of criteria relevant to surgical, radiation, and pediatric trials. The creation of supra-ordinate terms allows for greater site and organ specificity, especially in the categories of pain, infection, gastrointestinal and musculoskeletal adverse events. Conclusions: A direct mapping between CTCAE versions 2 and 3 is available to facilitate translation from one system to another . Additionally, both versions of the CTCAE have been mapped to the Medical Dictionary for Regulatory Activities (MedDRA™) for regulatory reporting purposes. It is anticipated that the CTCAE v.3 will replace v. 2 as the world standard for reporting of AEs in cancer clinical trials. The ASCO presentation will focus on changes to the CTCAE, comparisons with the older versions, and implications for AE recording and evaluation. No significant financial relationships to disclose.