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The treatment variable used for analysis must be included. Typically, this would be TRTP, TRTA, TRTxxP, or TRTxxA. See  ADD LINK ADaMIG v1.2 Section 3.2, ADSL Variables, and Section 3.3.2, Record-Level Treatment and Dose Variables for BDS Datasets, for more details on these variables. Additional dosing variables may also be included

Variable Name

Variable Label

Type

Codelista

Controlled Terms

Core

SubClass ADVERSE EVENT Core

CDISC Notes

DOSEON

Treatment Dose at Record Start

Num



Perm

Perm

Dose received at the point in time of the record start date Example derivation:

Obtained from EX.EXDOSE where --STDTC falls between the values of EX.EXSTDTC and EX.EXENDTC

DOSCUMA

Cumulative

Actual Treatment Dose

Num



Perm

Perm

Cumulative actual study drug dosage at the point in time of the record start date

DOSEU

Treatment Dose Units

Char

(UNIT)


Cond

Cond

The units associated with DOSEON and/or DOSCUMA. Conditional on whether DOSEON and/or DOSCUMA are included.

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