Record-Level Product and Dose Variables for BDS Datasets

At least 1 product variable is required in a BDS dataset. This requirement is satisfied by any of the subject-level product variables (e.g., TRTxxP) or record- level product variables (e.g., TRTP). All product variables defined in ADaMIG Table 3.3.2.1 are record level, meaning that the values contained in the variable may vary by record within a subject. Subject-level product variables are described in Section 2.9.5.4, Product Variables for ADSL Datasets.

Variable Name	Variable Label	Type	Core	CDISC Notes
TRTP	Planned Product	Char	Cond	TRTP is a record-level identifier that represents the planned product attributed to a record for analysis purposes. TRTP indicates how 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 product variables in ADSL (e.g., TRTxxP, TRTSEQP, TRxxPGy). As noted previously, at least one product variable is required even in non-randomized trials. This requirement is satisfied by any subject-level or record-level product variables (e.g., TRTxxP, TRTP, TRTA). Even if not used for analysis, any ADSL product variable may be included in the BDS dataset.
TRTPN	Planned 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 Product	Char	Cond	TRTA is a record-level identifier that represents the actual product attributed to a record for analysis purposes. TRTA indicates how 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 product variables in ADSL (e.g., TRTxxA, TRTSEQA, TRxxAGy). As noted previously, at least one product variable is required. This requirement is satisfied by any subject-level or record-level product variables (e.g., TRTxxP, TRTP, TRTA). Even if not used for analysis, any ADSL product variable may be included in the BDS dataset.
TRTAN	Actual 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 Product y	Char	Perm	TRTPGy is the planned pooled 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 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 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 Product y	Char	Cond	TRTAGy is the actual pooled 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 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.

All dose variables defined in the following table are record level. This means that the values contained in the variable may vary by record within a subject. These record-level dose variables, plus ADSL subject-level dose variables, can be used in addition to—but not instead of—record-level product variables.

Variable Name	Variable Label	Type	Core	CDISC Notes
DOSEP	Planned Product Dose	Num	Perm	DOSEP represents the planned product dosage associated with the record.
DOSCUMP	Cumulative Planned Product Dose	Num	Perm	Cumulative planned dosage of product for the subject at the point in time of the record (e.g., ADT).
DOSEA	Actual Product Dose	Num	Perm	DOSEA represents the actual product dosage associated with the record.
DOSCUMA	Cumulative Actual Product Dose	Num	Perm	Cumulative actual dosage of product for the subject at the point in time of the record (e.g., ADT).
DOSEU	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.

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Record-Level Product and Dose Variables for BDS Datasets