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Table 3.3.2.2 Record-Level Dose Variables for BDS Datasets
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
Cumulative planned dosage of treatment for the subject at the point in time of the record (e.g., ADT).
DOSEA
Actual Treatment Dose
DOSEA represents the actual treatment dosage associated with the record.
DOSCUMA
Cumulative Actual Treatment Dose
Cumulative actual dosage of treatment for the subject at the point in time of the record (e.g., ADT).
DOSEU
Treatment Dose Units
Char
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.