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Table 3.3.2.2 Record-Level Dose Variables for BDS Datasets

Metadataspec
keysCore;CDISC Notes

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

DOSEP

Planned Treatment Dose

Num


Perm

DOSEP represents the planned treatment dosage associated with the record.

DOSCUMP

Cumulative Planned Treatment Dose

Num


Perm

Cumulative planned dosage of treatment for the subject at the point in time of the record (e.g., ADT).

DOSEA

Actual Treatment Dose

Num


Perm

DOSEA represents the actual treatment dosage associated with the record.

DOSCUMA

Cumulative Actual Treatment Dose

Num


Perm

Cumulative actual dosage of treatment for the subject at the point in time of the record (e.g., ADT).

DOSEU

Treatment Dose Units

Char


Perm

The units for DOSEP, DOSCUMP, DOSEA, and DOSCUMA. It is permissible to use suffixes such as "P" and "A" if needed, with labels modified accordingly.