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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

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Variable Name

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Variable Label

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Type

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Codelist

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Controlled Terms

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Core

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SubClass ADVERSE EVENT Core

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CDISC Notes

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DOSEON

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Product Dose at Record Start

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Num

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Perm

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Perm

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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

Include Page
OCCDS Product/Dose Variables
OCCDS Product/Dose Variables

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DOSCUMA

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Cumulative

Actual Product Dose

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Num

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Perm

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Perm

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

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DOSEU

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Product Dose Units

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Char

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(UNIT)

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Cond

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Cond

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Pagenav