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At least 1 treatment product variable is required in a BDS dataset. This requirement is satisfied by any of the subject-level treatment product variables (e.g., TRTxxP) or record- level treatment product variables (e.g., TRTP). All treatment 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 treatment product variables are described in ADD LINK Table 3.Section 2.4.
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Variable Name
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Variable Label
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Type
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Codelist/ Controlled Terms
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Core
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CDISC Notes
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TRTP
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Planned Treatment
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Char
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Cond
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TRTP is a record-level identifier that represents the planned treatment attributed to a record for analysis purposes. TRTP indicates how treatment 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 variables in ADSL (e.g., TRTxxP, TRTSEQP, TRxxPGy).
As noted previously, at least one treatment variable is required even in non-randomized trials. This requirement is satisfied by any subject-level or record-level treatment variables (e.g., TRTxxP, TRTP, TRTA). Even if not used for analysis, any ADSL treatment variable may be included in the BDS dataset.
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TRTPN
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Planned Treatment (N)
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Num
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Perm
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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.
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TRTA
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Actual Treatment
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Char
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Cond
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TRTA is a record-level identifier that represents the actual treatment attributed to a record for analysis purposes. TRTA indicates how treatment 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 variables in ADSL (e.g., TRTxxA, TRTSEQA, TRxxAGy).
As noted previously, at least one treatment variable is required. This requirement is satisfied by any subject-level or record-level treatment variables (e.g., TRTxxP, TRTP, TRTA). Even if not used for
analysis, any ADSL treatment variable may be included in the BDS dataset.
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TRTAN
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Actual Treatment (N)
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Num
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Perm
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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.
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TRTPGy
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Planned Pooled Treatment y
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Char
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Perm
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TRTPGy is the planned pooled treatment 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 (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.
9.5.4, Product Variables for ADSL Datasets.
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TRTPGyN
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Planned Pooled Treatment y (N)
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Num
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Perm
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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.
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TRTAGy
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Actual Pooled Treatment y
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Char
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Cond
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TRTAGy is the actual pooled treatment 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.
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TRTAGyN
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Actual Pooled Treatment y (N)
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Num
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Perm
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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 below 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 to—but not instead of, recordof—record-level treatment product variables.
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Variable Name
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Variable Label
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Type
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Codelist/ Controlled Terms
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Core
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CDISC Notes
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DOSEP
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Planned Treatment Dose
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Num
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Perm
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DOSEP represents the planned treatment dosage associated with the record.
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DOSCUMP
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Cumulative Planned Treatment Dose
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Num
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Perm
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Cumulative planned dosage of treatment for the subject at the point in time of the record (e.g., ADT).
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DOSEA
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Actual Treatment Dose
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Num
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Perm
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DOSEA represents the actual treatment dosage associated with the record.
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DOSCUMA
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Cumulative Actual Treatment Dose
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Num
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Perm
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Cumulative actual dosage of treatment for the subject at the point in time of the record (e.g., ADT).
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DOSEU
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Treatment Dose Units
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Char
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Perm
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