The product variable used for analysis must be included. Typically, this would be TRTP, TRTA, TRTxxP, or TRTxxA. See Section 2.9.5.5, Dose Variables for ADSL Datasets, and Section 2.9.6.2, Record-Level Product and Dose Variables for BDS Datasets, for more details on these variables. Additional dosing variables may also be included

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

DOSEON

Product Dose at Record Start

Num


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 Product Dose

Num


Perm

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

DOSEU

Product Dose Units

Char

(UNIT)

Cond

Conditional on whether DOSEON and/or DOSCUMA are included.

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