Common Terminology Criteria for Adverse Events
The Common Terminology Criteria for Adverse Events are a set of criteria for standardized classification when recording adverse events of drugs and treatments, each with an associated severity scale in the range 15. The system originated in oncology but is now also often used in clinical trials. The version 6.0 is the first in spreadsheet form, and the first to track changes from the previous version 5.0. It also continues to be available as a PDF document.
The classification of events uses the MedDRA at its granular level. For each term, specific conditions, findings and/or symptoms are stated for the different severity grades, which are organized as follows:
The guidelines used for grades 14 are stated in some detail, with their application to paediatric cases now clarified:
This system of criteria and severity grading originated in application to cancer therapy, as a product of the US National Cancer Institute. The first iteration was prior to 1998, with subsequent versions 2.0 released in 1999, 3.0 in 2003, 4.0 in 2009 and 5.0 in 2017.