Table 3.3.2.2 Record-Level Dose Variables for BDS Datasets
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Variable Name | Variable Label | Type | Codelist/ Controlled Terms | Core | CDISC Notes |
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DOSEP | Planned Treatment Product Dose | Num |
| Perm | DOSEP represents the planned treatment product dosage associated with the record. | DOSCUMP | Cumulative Planned Treatment Product Dose | Num |
| Perm | Cumulative planned dosage of treatment product for the subject at the point in time of the record (e.g., ADT). | DOSEA | Actual Treatment Product Dose | Num |
| Perm | DOSEA represents the actual treatment product dosage associated with the record. | DOSCUMA | Cumulative Actual Treatment Product Dose | Num |
| Perm | Cumulative actual dosage of treatment product for the subject at the point in time of the record (e.g., ADT). | DOSEU | Treatment Product 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. | |