Health / Medical Topics

    CDISC SDTM Common Terminology Criteria for Adverse Event Grade Terminology Version 4.0

    Definition 1

    Terminology codelist used with the version 4.0 Common Terminology Criteria for Adverse Event Grade within the Clinical Data Interchange Standards Consortium Study Data Tabulation Model. (NCI Thesaurus)

    Definition 2

    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 Thesaurus/CDISC)




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