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The Common Toxicity Criteria is a standard language for reporting adverse events occurring in cancer clinical trials. The National Cancer Institute's (NCI) Cancer Therapy Evaluation Program (CTEP) developed the original CTC in 1982. The CTC was revised in 1998 in order to promote accuracy and precision of reporting, and to avoid development of non-standard adverse event nomenclature or inconsistent definitions for severity.
The NCI terms are a set of medical terms very useful for the classification of adverse events related to cytotoxic drugs. These terms are not international codes for reporting adverse events to the Health Authorities. They are very frequently used in handling adverse events from oncology trials. The coding should not be performed with the NCI terms but they could be employed in establishing a relationship between these terms and the corresponding MedDRA terms since the MedDRA dictionary is the internationally agreed terminology for coding of adverse drug reactions or adverse events following the use of new agents. Some mapping documents may be accessed, and downloaded through the CTEP Web site.
The CTCAE Mapping documents provide additional information to support the implementation of CTCAE version 3.0 and the transition from CTC version 2.0 (MedDRA version 5.0) to CTCAE version 3.0 (MedDRA v6.0).
Common Toxicity Criteria Document for Adverse Events (CTCAE) v4.0
Issues associated with converting CTC v2.0 or CTCAE v3.0 protocols to CTCAE v4.0.
CTEP Guidance: CTCAE v4.0 Grading Scales with Numeric Component
Responsible Adverse Event (AE) Reporting: Finding Appropriate AE Terms
Common Toxicity Criteria Document for Adverse Events v2.0 (CTCAE) (PDF)
Common Terminology Criteria for Adverse Events v3.0 (CTCAE) (PDF)
CTCAE Mapping Documents:
- 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)
- CTCAE v3.0 and Lay Term Mapping Document (MS Excel)
- CTCAE v4.0 and Lay Term Mapping Document (PDF)
- CTC version 2.0 to CTCAE version 3.0 document
- CTCAE version 3.0 to CTC version 2.0 document
- CTC version 2.0 (MedRA 5.0) to CTCAE version 3.0 (MedRA 6.0)
- CTC version 2.0 to CTCAE version 3.0 Grade Mapping (Excel)
- CTC version 2.0 to CTCAE version 3.0 Mapping with Short Name
Below is an example of NCI-MedDRA mapping version performed by Pharmadhoc. If you need to link this version to a specific coding tool or to set up a complete relationship between NCI terms (CTC version 2.0 or 3.0) and the corresponding MedDRA terms latest versions, please contact M. Azzouzi at:
Tel: +33 (0)8 71 76 88 17
Tel: +33 (0)6 73 51 37 96
or send an email to Pharmadhoc
NCI CTC terms and MedDRA corresponding codes
CTC and CTCAE Versions Archive
• 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 v2.0 to CTCAE v3.0 with Short Names (Excel) (October 7, 2003)
• Common Terminology Criteria for Adverse Events (CTCAE) v3.0
- CTCAE v3.0 (PDF) (Publish Date August 9, 2006)
- CTCAE v3.0 Notice of Modifications (PDF) (Publish Date August 9, 2006)
The NCI terms are a set of medical terms very useful for the classification of adverse events related to cytotoxic drugs. These terms are not international codes for reporting adverse events to the Health Authorities. They are very frequently used in handling adverse events from oncology trials. The coding should not be performed with the NCI terms but they could be employed in establishing a relationship between these terms and the corresponding MedDRA terms since the MedDRA dictionary is the internationally agreed terminology for coding of adverse drug reactions or adverse events following the use of new agents. Some mapping documents may be accessed, and downloaded through the CTEP Web site.
The CTCAE Mapping documents provide additional information to support the implementation of CTCAE version 3.0 and the transition from CTC version 2.0 (MedDRA version 5.0) to CTCAE version 3.0 (MedDRA v6.0).
Common Toxicity Criteria Document for Adverse Events (CTCAE) v4.0
Issues associated with converting CTC v2.0 or CTCAE v3.0 protocols to CTCAE v4.0.
CTEP Guidance: CTCAE v4.0 Grading Scales with Numeric Component
Responsible Adverse Event (AE) Reporting: Finding Appropriate AE Terms
Common Toxicity Criteria Document for Adverse Events v2.0 (CTCAE) (PDF)
Common Terminology Criteria for Adverse Events v3.0 (CTCAE) (PDF)
CTCAE Mapping Documents:
- 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)
- CTCAE v3.0 and Lay Term Mapping Document (MS Excel)
- CTCAE v4.0 and Lay Term Mapping Document (PDF)
- CTC version 2.0 to CTCAE version 3.0 document
- CTCAE version 3.0 to CTC version 2.0 document
- CTC version 2.0 (MedRA 5.0) to CTCAE version 3.0 (MedRA 6.0)
- CTC version 2.0 to CTCAE version 3.0 Grade Mapping (Excel)
- CTC version 2.0 to CTCAE version 3.0 Mapping with Short Name
Below is an example of NCI-MedDRA mapping version performed by Pharmadhoc. If you need to link this version to a specific coding tool or to set up a complete relationship between NCI terms (CTC version 2.0 or 3.0) and the corresponding MedDRA terms latest versions, please contact M. Azzouzi at:
Tel: +33 (0)8 71 76 88 17
Tel: +33 (0)6 73 51 37 96
or send an email to Pharmadhoc
NCI CTC terms and MedDRA corresponding codes
CTC and CTCAE Versions Archive
• 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 v2.0 to CTCAE v3.0 with Short Names (Excel) (October 7, 2003)
• Common Terminology Criteria for Adverse Events (CTCAE) v3.0
- CTCAE v3.0 (PDF) (Publish Date August 9, 2006)
- CTCAE v3.0 Notice of Modifications (PDF) (Publish Date August 9, 2006)