CTCAE v4.0: This link takes you to the NCI repository for all CTCAE v4.0 related documents including PDF, Microsoft Excel and OWL formats.
CTCAE v4.0 is applicable to all CTEP protocols approved after 10/1/2009 and those protocols that have formally converted from legacy CTCAE versions. Check the protocol document to determine its assigned version.
This version of CTCAE is MedDRA v12.0 (Medical Dictionary for Regulatory Activities Terminology) compatible at the AE (Adverse Event) term level where each CTCAE term is a MedDRA LLT (Lowest Level Term). CTCAE v4.0 includes 764 AE terms and 26 'Other, specify' options for reporting text terms not listed in CTCAE. 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.
In response to increasing use of lab interfaces for assistance with grading lab values, CTEP has published a new CTEP Guidance: CTCAE v4.0 Grading Scales with Numeric Component. This document is available at the official NCI CTCAE site (http://evs.nci.nih.gov/ftp1/CTCAE/About.html) under Files: Documentation.
CTCAE v3.0 (PDF) (Publish Date August 9, 2006)
CTCAE 3.0 is a legacy CTCAE version and is applicable to a select group of protocols. Check the protocol document to determine its assigned version.
The CTCAE Booklet, published May 22, 2003 does not include all editorial corrections. Therefore, each user must use the Notice of Modifications document to update the Booklets by hand.
A comparison of the versions of the CTEP, NCI CTC and CTCAE.