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.

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