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

• CTCAE v4.0 Conversion Information
• Common Terminology Criteria for Adverse Events (CTCAE) v4.0
• Common Terminology Criteria for Adverse Events (CTCAE) v3.0
• Responsible Adverse Event (AE) Reporting: Finding Appropriate AE Terms
• CTC/CTCAE Mapping Documents
• Retired CTC and CTCAE Versions Archive
• CTC/CTCAE Dictionary and Index
  The CTCAE Dictionary is a web-based application to assist in locating appropriate adverse event terms from CTC v2.0, CTCAE v3.0 and CTCAE v4.0.

CTCAE v4.0 Conversion Information

• CTCAE v3.0 to CTCAE v4.0 Conversion Plan
  The official CTCAE v3.0 to CTCAE v4.0 conversion plan.
• CTCAE v3.0 Detailed Conversion List
  Affected protocols and their conversion requirements/dates as of 6/22/10.
• SOP for Resolving CDUS Merges
  CTEP has developed an SOP for resolving merging issues associated with converting CTC v2.0 or CTCAE v3.0 protocols to CTCAE v4.0.

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.

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.

CTEP Guidance: CTCAE v4.0 Grading Scales with Numeric Component

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.

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.

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.

• 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.

CTC/CTCAE Mapping Documents

A comparison of the versions of the CTEP, NCI CTC and CTCAE.

• CTC v2.0 (MedDRA 10.0) to CTCAE v3.0 (MedDRA 10.0) (Excel) (February 25, 2010)
• CTCAE v3.0 (MedDRA 10.0) to CTCAE v4.0 (MedDRA 12.1) (Excel) (June 14, 2010)
• CTCAE v4.0 (MedDRA 12.1) to CTCAE v3.0 (MedDRA 10.0) (Excel) (December 23, 2009)
• 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 v4.0 and Lay Term Mapping Document (PDF)

Retired CTC and CTCAE Versions Archive

• 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)
• Common Toxicity Criteria (CTC) v2.0
• CTC v2.0 (PDF) (Publish Date April 30,1999)
• Common Toxicity Criteria Manual (PDF) (Updated August 18,1999)
• Common Toxicity Criteria Index Terms (PDF) (Updated July 21, 1999)
• Common Toxicity Criteria (PDF) - Notice of Modifications (Publish Date April 30,1999)
• CTC - Version 2.0 (Microsoft Access 97 Database)