The product variable used for analysis must be included. Typically, this would be TRTP, TRTA, TRTxxP, or TRTxxA. See Dose Variables for ADSL Datasets and Record-Level Product and Dose Variables for BDS Datasets, for more details on these variables. Additional dosing variables may also be included
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Variable Name | Variable Label | Type | Codelist | Controlled Terms | Core | SubClass ADVERSE EVENT Core | CDISC Notes |
DOSEON | 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 Product Dose | Num | Perm | Perm | Cumulative actual study drug dosage at the point in time of the record start date | ||
DOSEU | 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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