Meaning of CDISC SDTM Common Terminology Criteria for Adverse Event Grade Terminology Version 4.0
The version 4.0 standard terminology developed to report adverse events occurring in cancer clinical trials. Common terminology criteria for adverse events (CTCAE) are used to study adverse event summaries and Investigational New Drug reports to the Food and Drug Administration. The CTCAE contain a grading scale for each adverse event term representing the severity of the event. (NCI)
Source: http://evs.nci.nih.gov/ftp1/CDISC/SDTM/SDTM%20Terminology.xls
Web site to visit: http://evs.nci.nih.gov
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