CTCAE4
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CTCAE 4.0 Released
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.
CTEP implementation
See the CTEP website [1] for information regarding CTEP implementation of CTCAE v4.0.
Download the terminology and documentation
See the ftp site [2] to download CTCAE 4.0 as the OWL data file, a pdf file, or Excel spreadsheet. NOTE: The most recent files are version 4.03 posted June 14, 2010. Version 4.03 contains several small revisions that are listed in the file revisions.txt. This wiki does not contain these changes.
The Governance document is also available from the FTP site.
Educational materials and mapping documents to map older versions to the newer version are being developed and will be available in the near future.
Pending OID for CTCAE is OID== 2.16.840.1.113883.3.26.1.6.
