CTCAE is a list of adverse event (AE) terms commonly encountered in oncology. Each AE term is defined and accompanied by a grading scale that indicates the severity of the AE.

Published on November 27, 2017 CTCAE v5.0 AE terms are organized by the System Organ Classes (SOCs) defined by the Medical Dictionary for Regulatory Activities (MedDRA). 

CTCAE v6.0 was published on July 22, 2025.  Please see the Contents Tab for FAQs on versions 6.0 and 5.0. 

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Common Terminology Criteria for
Adverse Events (CTCAE)
Version 5.0
Published: November 27, 2017
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute

CTCAE v6.0 Implementation FAQs
September 9, 2025

❖ General Questions:
When can CTCAE v6.0 be used?

• CTCAE v6.0 is ready for immediate use for any study except NCI CTEP or DCP NCORP studies.

o If you have questions about whether you may or may not use CTCAE v6.0, please contact your study sponsor.

Are further changes anticipated to CTCAE v6.0?

• No further changes are planned. The release version is the final version of CTCAE v6.0.
• If you have comments regarding CTCAE v6.0, please send them to NCI CTEP CTCAE Comments at: ncictcaehelp@mail.nih.gov. Comments will be discussed during the CTCAE v7.0 update.
• CTCAE v7.0 is expected to be developed and released between 2027 and 2030.

How should multiple CTCAE versions be managed if data needs to be consolidated into a single version (e.g., for regulatory reporting or aggregate analysis)?

• The NCI has developed a comprehensive mapping resource that aligns all term and grade combinations from CTCAE v5.0 to their corresponding terms and grades in CTCAE v6.0.

❖ Specific Information for NCI CTEP/DCP-supported Studies:
Will NCI CTEP/DCP studies using CTCAE v5.0 be required to convert existing data to
v6.0?

• No. Data conversion will not be required by NCI CTEP/DCP.

o All NCI CTEP/DCP studies currently reporting in CTCAE v5.0 will continue to report in CTCAE v5.0 throughout the life of the study.
o All NCI CTEP/DCP data reporting (CDUS, DMU, CTEP-AERS) will remain in CTCAE v5.0.

Which NCI CTEP/DCP studies will be required to use CTCAE v6.0?

• CTCAE v6.0 will be required for ALL NEW NCI CTEP/DCP studies whose Rave study build begins after the CTCAE v6.0 Rave ALS (ALS 7.2) is released.

o This applies to all NCI CTEP and DCP studies regardless of IND status and includes nonIND and IND-Exempt studies.

When will Rave ALS 7.2 be released?

• The release of Rave ALS 7.2 is tentatively scheduled for July 2026.
• The timeline may be further pushed back based on resource needs in support of other Medidata-related priorities.

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