Common Terminology Criteria for Adverse Events

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Common Terminology Criteria for Adverse Events (CTCAE) is a standard system used to classify and record adverse events caused by drugs and treatments, including abnormal lab findings. Each event gets a severity grade from 1 to 5.

CTCAE started in oncology and is now widely used in clinical trials. The current version is 6.0, the first to come as an Excel spreadsheet and to show changes from version 5.0. A PDF Quick Reference is also available.

Events are described using MedDRA lowest level terms (LLTs). For each term, specific conditions or symptoms are defined for the different grades. The Grade 1–4 guidelines are described in detail, with pediatric applications clarified.

CTCAE was created by the US National Cancer Institute. Its versions have progressed from 2.0 (1999) to 3.0 (2003), 4.0 (2009), and 5.0 (2017).