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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
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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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