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The treatment product 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, See Dose Variables for ADSL Datasets and Record-Level Treatment 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 | Codelista | Controlled Terms | Core | SubClass ADVERSE EVENT Core | CDISC Notes |
DOSEON | Treatment Product 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 Product Dose | Num | Perm | Perm | Cumulative actual study drug dosage at the point in time of the record start date | ||
DOSEU | Treatment Product 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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