What is Common Terminology Criteria for Adverse Event (CTCAE)?
CTCAE is a list of adverse event (AE) terms commonly encountered in oncology. Each AE term is defined and accompanied by a grading scale that indicates the severity of the AE. In the new CTCAE v4.0, the AE terms are organized by the System Organ Classes (SOCs) defined by the Medical Dictionary for Regulatory Activities (MedDRA). CTCAE has been developed from the earlier vocabulary known as CTC (Common Toxicity Criteria).
Common Terminology Criteria for Adverse Events(CTCAE) v4.0
May 29, 2009
The National Cancer Institute (NCI) Center for Biomedical Informatics and Information Technology (CBIIT) and the Cancer Therapy Evaluation Program (CTEP) announce the release of the NCI Common Terminology Criteria for Adverse Events (CTCAE v4.0).
This version of CTCAE is harmonized with MedDRA v12.0 (Medical Dictionary for Regulatory Activities Terminology) at the AE (Adverse Event) term level. CTCAE v4.0 includes 790 AE terms, 764 of which are MedDRA LLTs (Lowest Level Terms) and 26 of which are 'Other, specify' options for reporting text terms not listed in MedDRA. Each AE term is associated with a 5-point severity scale.
CTCAE v4.0 information is in the Public Domain and is available now for use by any non-CTEP site. CTEP will notify its own constituents regarding implementation of CTCAE v4.0.
Educational materials and mapping documents to map older versions to the newer version are being rapidly developed and will be available in the near future.
Please visit BiomedGT CTCAE4 Terminology to view the complete terminology.
Please visit this site to download CTCAE 4 in several file formats: CTCAE 4 and Documentation. The pdf and word files also include information about CTCAE4; In addition, a document describing the Governance process for CTCAE4 is available for download.
The most recent files (pdf and owl) are version 4.02 posted in September and October of 2009. Please note that when accessing this link you will see references to version 4.02. The use of this 'version' number refers to revision control of the vocabulary within NCI repositories. The overall content of CTCAE has not changed from the v4.0 release. This link associated with v4.02 contains editorial updates (spacing, etc.) to the original publication of v4.0 on May 29, 2009. The CTCAE v4.0 booklets include the editorial v4.02 updates. CTCAE v4.0 will remain the version referenced in clinical use until significant content is changed (e.g., change of AE term and/or grading scales).
For assistance with CTCAE please send an e-mail to: Help:
For those who would like a hard copy booklet, a limited number of CTCAE v4.0 booklets have been made available and can be ordered at: Booklets.
Discuss CTCAE Terminology
Please go to the Common Terminology Criteria for Adverse Events Discussion page to leave comments regarding the CTCAE Terminology.
Examples of comments may include:
- How you are using this terminology
- Why you decided to use (or not use) this terminology
- Strengths or limitations of the terminology
- Comparisons to other similar terminologies
See frequently asked questions and answers at Common Terminology Criteria for Adverse Events FAQ.