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Metadataspec

Variable Name

Variable Label

Type

Codelist

a

/ Controlled Terms

Core

SubClass ADVERSE EVENT Core

CDISC Notes

DOSEON

Treatment

Product Dose

at Record

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

Actual 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

CondThe units associated with DOSEON and/or DOSCUMA. Conditional

Conditional on whether DOSEON and/or DOSCUMA are included

.
aCodelists in parenthesis are the names of CDISC Controlled Terminology

.