Other Categorization Variables

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:

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

--CAT

Category

Char

Perm

Copied from XX.--CAT

This variable label differs depending on the SDTM domain.

--SCAT

Subcategory

Char

Perm

Copied from XX.--SCAT

This variable label differs depending on the SDTM domain.

ACATy

Analysis Category y

Char

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.

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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Other Categorization Variables