Common Terminology Criteria for Adverse Events (CTCAE) and Common Toxicity Criteria (CTC)

• CTEP Active CTCAE Version (Active as of 10/1/2009)
  The CTEP Active CTCAE Version 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.
• Common Terminology Criteria for Adverse Events (CTCAE) v3.0
  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.
• Common Toxicity Criteria (CTC) v2.0
  CTC 2.0 is a legacy CTC version and is applicable to a very small group of protocols. Check the protocol document to determine its assigned version.
• CTC/CTCAE Dictionary and Index
  The CTCAE Dictionary is a web-based application to assist in locating appropriate adverse event terms from both CTC v2.0 and CTCAE v3.0. Expansion to CTCAE 4.0 to occur in 2010.
• Responsible Adverse Event (AE) Reporting: Finding Appropriate AE Terms
  The Responsible Adverse Event (AE) Reporting: Finding Appropriate AE Terms is a Power Point slide presentation to provide an overview of AE related information and illustrates the search capabilities of the tools available from the CTCAE v3.0 and CTC v2.0 websites.
• CTC/CTCAE Mapping Documents
  Mapping documents between the various versions of CTC and CTCAE.
• Retired CTC and CTCAE Versions Archive

CTEP Active CTCAE Version (Active as of 10/1/2009)

Common Terminology Criteria for Adverse Events (CTCAE) v4.0

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.

The CTEP Active CTCAE Version 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. CTEP will notify our constituents regarding CTEP implementation of CTCAE v4.0.

CTEP Legacy CTC and CTCAE Versions

Common Terminology Criteria for Adverse Events (CTCAE) v3.0

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.

IMPORTANT: CTCAE v3.0, originally published March 31, 2003 is updated with minor editorial changes described in CTCAE v3.0 Notice of Modifications (PDF) (Publish Date August 9, 2006). 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. Since the number of corrections was small, the Booklets have not been reprinted.

Note: Information provided in the CTCAE v3.0 Index (PDF) and CTCAE v3.0 Glossary (PDF) can be found within the CTCAE v3.0 Online Instructions and Guidelines.

• CTCAE v3.0 Online Instructions and Guidelines (Updated August 9, 2006)
  An instructional tool providing detailed guidelines regarding the use of the CTCAE and the changes made from CTC v2.0.
• CTCAE v3.0 Frequently Asked Questions (Updated June 30, 2006)
  Answers to commonly asked questions regarding the CTCAE v3.0, MedDRA, changes from CTC v2.0, and others.
• CTCAE v3.0 Notice of Modifications (PDF) (Publish Date August 9, 2006)
  The Notice of Modifications details the revisions made to the CTCAE v3.0 since its initial publication on March 31, 2003.
• CTCAE v3.0 Implementation (PDF) (Updated June 30, 2006)
  A guideline for CTCAE v3.0 accommodation in databases.
• CTCAE v3.0 and Lay Term Mapping Document - Cover Memo (MS Word)
  Memo discussing the document mapping CTCAE v3.0 adverse event terms to lay terms for use in informed consent form text.
• CTCAE v3.0 and Lay Term Mapping Document (MS Excel)
  A document mapping CTCAE v3.0 adverse event terms to lay terms for use in informed consent form text.
• CTCAE v3.0 Index (PDF) (October 22, 2003)
  An alphabetical listing of signs, symptoms, Adverse Events, and synonyms associated with one AE in one or more CATEGORIES and their respective location (page number) within the CTCAE v3.0 document.
• CTCAE v3.0 Glossary (PDF) (October 22, 2003)
  An alphabetical listing of Adverse Events and other related terminology definitions used within the CTCAE v3.0.

Common Toxicity Criteria (CTC) v2.0

CTC v2.0 (PDF) (Publish Date April 30,1999)
CTC v2.0 is a legacy CTCAE version and is applicable to a select group of protocols. Check the protocol document to determine its assigned version.

• Common Toxicity Criteria Manual (PDF) (Updated August 18,1999)
  Reference document based on the CTC v2.0.
• Common Toxicity Criteria Index Terms (PDF) (Updated July 21, 1999)
  Synonyms and concepts associated with CTC v2.0 terms.
• Common Toxicity Criteria (PDF) - Notice of Modifications (Publish Date April 30,1999)
  Detailed listing of modifications to CTC v2.0.
• CTC - Version 2.0 (Microsoft Access 97 Database)
  Access file to provide a spreadsheet format for integrating the CTC v2.0 into user applications.

CTC/CTCAE Mapping Documents

A comparison of the two legacy versions of the CTEP, NCI CTCAE. CTCAE 4.0 mapping is anticipated by 10/1/2009.

• CTCAE v3.0 to CTC v2.0 (PDF) (July 16, 2003)
• CTC v2.0 to CTCAE v3.0 (PDF) (July 16, 2003)
• CTC v2.0 (MedDRA 5.0) to CTCAE v3.0 (MedDRA 6.0) (Excel) (September 8, 2003)
• CTC v2.0 to CTCAE v3.0 Grade Mapping (Excel) (October 7, 2003)
• CTC v2.0 to CTCAE v3.0 with Short Names (Excel) (October 7, 2003)
• CTCAE v3.0 to CTCAE v4.0 (Excel) (November 5, 2009)

Retired CTC and CTCAE Versions Archive

N/A at present