Table 3.3.2.1 Record-Level Treatment Variables for BDS Datasets
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Variable Name | Variable Label | Type | Codelist/ Controlled Terms | Core | CDISC Notes |
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TRTP | Planned TreatmentProduct | Char |
| Cond | TRTP is a record-level identifier that represents the planned treatment product attributed to a record for analysis purposes. TRTP indicates how treatment product varies by record within a subject and enables analysis of crossover and other designs. Though there is no requirement that TRTP will correspond to the TRTxxP as defined by the record's value of APERIOD, if populated, TRTP must match at least one value of the character planned treatment product variables in ADSL (e.g., TRTxxP, TRTSEQP, TRxxPGy). As noted previously, at least one treatment product variable is required even in non-randomized trials. This requirement is satisfied by any subject-level or record-level treatment product variables (e.g., TRTxxP, TRTP, TRTA). Even if not used for analysis, any ADSL treatment product variable may be included in the BDS dataset. | TRTPN | Planned Treatment Product (N) | Num |
| Perm | Numeric representation of TRTP. There must be a one-to-one relationship between TRTPN and TRTP within a study. TRTPN cannot be present unless TRTP is also present. When TRTP and TRTPN are present, then on a given record, either both must be populated or both must be null. | TRTA | Actual TreatmentProduct | Char |
| Cond | TRTA is a record-level identifier that represents the actual treatment product attributed to a record for analysis purposes. TRTA indicates how treatment product varies by record within a subject and enables analysis of crossover and other multi-period designs. Though there is no requirement that TRTA will correspond to the TRTxxA as defined by the record's value of APERIOD, TRTA must match at least one value of the character actual treatment product variables in ADSL (e.g., TRTxxA, TRTSEQA, TRxxAGy). As noted previously, at least one treatment product variable is required. This requirement is satisfied by any subject-level or record-level treatment product variables (e.g., TRTxxP, TRTP, TRTA). Even if not used for analysis, any ADSL treatment product variable may be included in the BDS dataset. | TRTAN | Actual Treatment Product (N) | Num |
| Perm | Numeric representation of TRTA. There must be a one-to-one relationship between TRTAN and TRTA within a study. TRTAN cannot be present unless TRTA is also present. When TRTA and TRTAN are present, then on a given record, either both must be populated or both must be null. | TRTPGy | Planned Pooled Treatment Product y | Char |
| Perm | TRTPGy is the planned pooled treatment product y attributed to a record for analysis purposes. "y" represents an integer [1-99, not zero-padded] corresponding to a particular pooling scheme. Useful when planned treatments products (TRTP) are pooled together for analysis, for example when all doses of Drug A (TRTPG1=All doses of Drug A) are compared to all doses of Drug B (TRTPG1=All doses of Drug B). Each value of TRTP is pooled within at most one value of TRTPGy. | TRTPGyN | Planned Pooled Treatment Product y (N) | Num |
| Perm | Numeric representation of TRTPGy. There must be a one-to-one relationship between TRTPGyN and TRTPGy within a study. TRTPGyN cannot be present unless TRTPGy is also present. When TRTPGy and TRTPGyN are present, then on a given record, either both must be populated or both must be null. | TRTAGy | Actual Pooled Treatment Product y | Char |
| Cond | TRTAGy is the actual pooled treatment product y attributed to a record for analysis purposes. "y" represents an integer [1-99, not zero-padded] corresponding to a particular pooling scheme. Required when TRTPGy is present and TRTA is present. | TRTAGyN | Actual Pooled Treatment Product y (N) | Num |
| Perm | Numeric representation of TRTAGy. There must be a one-to-one relationship between TRTAGyN and TRTAGy within a study. TRTAGyN cannot be present unless TRTAGy is also present. When TRTAGy and TRTAGyN are present, then on a given record, either both must be populated or both must be null. | |