U.S. National Institutes of Health
Last Updated: 05/29/08

CTC v2.0 and Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

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

Common Terminology Criteria for Adverse Events v3.0 (CTCAE) (PDF) (Publish Date August 9, 2006)
CTCAE v3.0 includes Adverse Events applicable to all oncology clinical trials regardless of chronicity or modality.

CTC v2.0 is active for a few legacy protocols only. Supporting documents are archived on the web. CTEP data systems accommodate AE reporting for both CTC v2.0 and CTCAE v3.0.

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.

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.

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.

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 Implementation (PDF) (Updated June 30, 2006)
A guideline for CTCAE v3.0 accommodation in databases.

Information provided in the CTCAE v3.0 Index and CTCAE v3.0 Glossary PDF files can be found within the CTCAE v3.0 Online Instructions and Guidelines (see link above).

CTCAE/CTC Archive

CTCAE v3.0

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.

CTCAE Mapping Documents
A comparison of the two active versions of the CTEP, NCI CTCAE.

CTC v2.0 is active for a few legacy protocols only. CTEP data systems accommodate AE reporting for both CTC v2.0 and CTCAE v3.0.

AdEERS Templates were designed to use CTC v2.0. The Templates, Template List of Values, and Template Instructions were retired in 2003 and do not reflect current AdEERS data requirements.

  • Single Agent Template (Updated 2/12/2002)
    When the AdEERS web application is unavailable, this paper form is to be used to submit reports for protocols using a single agent.
  • Multiple Agents Template (Updated 2/12/2002)
    When the AdEERS web application is unavailable, this paper form is to be used to submit reports for protocols using a single agent.
  • AdEERS Template Instructions (Updated 2/12/2002)
    Comprehensive guide for the completion and submission of the AdEERS Templates
  • AdEERS Template List of Values (Updated 2/12/2002)
    Lists of standard values that must be used to complete the Templates. When received at NCI, data submitted on Templates will be entered into the AdEERS database. Therefore, reports with free-text data entry are not acceptable and will be returned to the submitter for resubmission with the standard values.

Common Toxicity Criteria v2.0 Tutorial

The CTC v2.0 Tutorial is designed to support health care professionals in the integration of CTC v2.0 into practice. The tutorial provides guidance in the organization of the CTC, defines adverse event grading, assignment of attribution, explains grading related toxicities, and outlines grading adverse events in special populations.

Background:

The National Cancer Institute's (NCI) Cancer Therapy Evaluation Program (CTEP) developed the original Common Toxicity Criteria in 1982 in an effort to provide standard language for reporting adverse events occurring in cancer clinical trials sponsored by the NCI. The CTC were widely adopted internationally and as new agents were introduced and new adverse events identified, many groups added supplemental criteria. This independent revision of the CTC resulted in nonstandard adverse event nomenclature and inconsistent definitions for severity. In keeping with international harmonization efforts, a CTC Review Committee with representation from the pharmaceutical industry, the Food and Drug Administration (FDA), the Committee for Proprietary Medicinal Products (CPMP), and major clinical trials groups in the US, Canada, Europe, and Japan was convened. The objective of the committee was to improve accuracy, precision and completeness of the CTC and to standardize reporting. As part of its commitment to the International Conference on Harmonization (ICH), the US FDA agreed to adopt an internationally agreed upon International Medical Terminology (IMT) based on the Medicines Control Agency's Medical Dictionary for Drug Regulatory Reporting (MedDRA) for use in reporting medical information from clinical trials. To facilitate data transfer, NCI has mapped adverse event names from the CTC version 2.0 to preferred terms in the IMT.

Your computer must meet the following requirements:

(To print these requirements and instructions , click your browsers print button or select file; Print from the menu bar.)

Item Requirement
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Screen resolution* Set to 1024 X 768 pixels
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Color Palette* Set to High Color (16 bit)
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OR

Netscape® Communicator version 4.0 or later
Processor Pentium
Monitor VGA display

* From the Control Panel, choose Display. Go to the Settings tab to change these settings.

To activate the new settings, restart the PC.

Before you begin:

1. Download a free copy of Neuron. Download Neuron by clicking Here

  • Choose to save the file to your desktop.
  • Then double-click the new file to execute the installation program.

This file will take approximately 30-50 minutes to download depending on the speed of your modem.

2. Start the CTC tutorial. Click to start tutorial

Notes:

  • A basic understanding of a Windows environment is required.
  • The navigational buttons on your browser will not allow you to navigate within the tutorial.You must use the navigational buttons provided within the tutorial.
  • To exit the tutorial, use the Exit  button provided within the CBT.Not exiting properly will cause errors.
  • To return to this page once you have exited the tutorial, use your browser's back button.

Inquiries specifically regarding theCommon Toxicity Criteria (CTC) or this tutorial should be addressed to: ncictephelp@ctep.nci.nih.gov

General Information: info@ctep.nci.nih.gov
Webmaster: webmaster@ctep.nci.nih.gov