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When categories are used for the intended analysis, instead of or in addition to MedDRA or WHO Drug, these generic categorization variables are commonly used:
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Variable Name | Variable Label | Type | Codelist | Controlled Terms | Core | SubClass ADVERSE EVENT Core | CDISC Notes |
--CAT | Category | Char | Perm | Perm | Copied from XX.--CAT This variable label differs depending on the SDTM domain. See SDTM v1.7 Section 2.2, The General Observation Classes, and SDTMIG v3.3 Section 6, Domain Models Based on the General Observation Classes, for details. | ||
--SCAT | Subcategory | Char | Perm | Perm | Copied from XX.--SCAT This variable label differs depending on the SDTM domain. See SDTM v1.7 Section 2.2, The General Observation Classes, and SDTMIG v3.3 Section 6, Domain Models Based on the General Observation Classes, for details. | ||
ACATy | Analysis Category y | Char | Perm | Perm | Category used in analysis. May be derived from --CAT and/or --SCAT. Examples include records of special interest like prohibited medications, concomitant medications taken during an infusion reaction, growth factors, antimicrobial medications, and other such categories not defined elsewhere or present in SDTM domains. |
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