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This example shows the definition of 3 subject grouping factors, each of which is represented as an instance of the SubjectGroupingFactor class within the analysisGroupings attribute of the reporting event.

Lines 2-6:

Show the attributes of the instance of the SubjectGroupingFactor class for the first subject grouping factor, "Treatment" (line 3), which is defined as being based on the TRT01A grouping variable (line 4). The grouping factor is not data-driven (line 5), so the groups attribute is included (line 6) and contains 3 predefined groups, each specified as a simple condition represented as an instance of the AnalysisGroup class:

  • Lines 7-16: Show the first predefined group (order = 1), which is identified as "AnlsGrouping_01_Trt_1" and contains a simple condition specifying that the value of the TRT01A variable in the ADSL dataset is equal to "Placebo", which could be expressed as:
    • ADSL.TRT01A EQ 'Placebo'
  • Lines 17-26: Show the second predefined group (order = 2), which is identified as "AnlsGrouping_01_Trt_2" and contains a simple condition specifying that the value of the TRT01A variable in the ADSL dataset is equal to "Xanomeline Low Dose", which could be expressed as:
    • ADSL.TRT01A EQ 'Xanomeline Low Dose'
  • Lines 27-36: Show the third predefined group (order = 3), which is identified as "AnlsGrouping_01_Trt_3" and contains a simple condition specifying that the value of the TRT01A variable in the ADSL dataset is equal to "Xanomeline High Dose", which could be expressed as:
    • ADSL.TRT01A EQ 'Xanomeline High Dose'
Lines 37-40:

Show the attributes of the instance of the SubjectGroupingFactor class for the second subject grouping factor, "Country" (line 38), which is defined as being based on the COUNTRY grouping variable (line 39). The grouping factor is data-driven (line 40), so the groups attribute is not included; the groups within this subject grouping factor are derived from the distinct values in the COUNTRY variable.

Lines 41-45:

Show the attributes of the instance of the SubjectGroupingFactor class for the third subject grouping factor, "On Active Treatment" (line 42). Although the groups within this grouping factor are defined as compound expressions (lines 50 and 59), the grouping variable is specified as TRT01A (line 43) because all the sub-clauses of the compound expression are identified as groups that are simple conditions based on the TRT01A variable. The grouping factor is not data-driven (line 44), so the groups attribute is included (line 45) and contains 2 predefined groups, each specified as a compound expression represented as an instance of the AnalysisGroup class:

  • Lines 46-54: Show the first predefined group (order = 1) in which the compound expression uses the "OR" logical operator (line 51) to combines the conditions specified in the instances of the AnalysisGroup class identified as "AnlsGrouping_01_Trt_2" (line 53) and "AnlsGrouping_01_Trt_2" (line 54). When these identifier values are used to retrieve the definitions of the groups, this compound expression could be expressed as:
    • ADSL.TRT01A EQ 'Xanomeline Low Dose' OR ADSL.TRT01A EQ 'Xanomeline High Dose'
  • Lines 55-62: Show the second predefined group (order = 2) in which the compound expression uses the "NOT" logical operator (line 60) to negate the condition(s) specified in the instance of the AnalysisGroup class identified as "AnlsGrouping_03_ActTrt_1" (line 62). When the identifier values for this referenced group ("AnlsGrouping_03_ActTrt_1") and groups it references ("AnlsGrouping_01_Trt_2" and "AnlsGrouping_01_Trt_2") are used to retrieve the original group definitions, this compound expression could be expressed as:
    • NOT (ADSL.TRT01A EQ 'Xanomeline Low Dose' OR ADSL.TRT01A EQ 'Xanomeline High Dose')

YAML Example
analysisGroupings:
- id: AnlsGrouping_01_Trt
  label: Treatment
  groupingVariable: TRT01A
  dataDriven: false
  groups:
  - id: AnlsGrouping_01_Trt_1
    label: Placebo
    level: 1
    order: 1
    condition:
      dataset: ADSL
      variable: TRT01A
      comparator: EQ
      value:
      - Placebo
  - id: AnlsGrouping_01_Trt_2
    label: Xanomeline Low Dose
    level: 1
    order: 2
    condition:
      dataset: ADSL
      variable: TRT01A
      comparator: EQ
      value:
      - Xanomeline Low Dose
  - id: AnlsGrouping_01_Trt_3
    label: Xanomeline High Dose
    level: 1
    order: 3
    condition:
      dataset: ADSL
      variable: TRT01A
      comparator: EQ
      value:
      - Xanomeline High Dose
- id: AnlsGrouping_02_Cntry
  label: Country
  groupingVariable: COUNTRY
  dataDriven: true
- id: AnlsGrouping_03_ActTrt
  label: On Active Treatment
  groupingVariable: TRT01A
  dataDriven: false
  groups:
  - id: AnlsGrouping_03_ActTrt_1
    label: Y
    level: 1
    order: 1
    compoundExpression:
      logicalOperator: OR
      whereClauses:
      - AnlsGrouping_01_Trt_2
      - AnlsGrouping_01_Trt_3
  - id: AnlsGrouping_03_ActTrt_2
    label: N
    level: 1
    order: 2
    compoundExpression:
      logicalOperator: NOT
      whereClauses:
      - AnlsGrouping_03_ActTrt_1

These subject grouping factors and their predefined groups could be represented in tabular form as shown in the following table where:

  • Each instance of the AnalysisGroup class is represented on a separate line, with attribute values for the related instance of the SubjectGroupingFactor class represented on every row. If there are no predefined groups in the grouping factor (i.e., it is data-driven), a single row is included with values only shown for the SubjectGroupingFactor attributes.
  • The identifier values of any predefined groups referenced in the whereClauses attribute of compound expressions are shown in a column called "subclause_id".
  • Although it would be possible, in this representation, the referenced identifier values have not been used to retrieve the details of the simple conditions from the original group definitions.

$titleHtml
idlabelgroupingVariabledataDrivengroup_idgroup_labellevelorderlogicalOperatorsubclause_iddatasetvariablecomparatorvalue
AnlsGrouping_01_TrtTreatmentTRT01AFALSEAnlsGrouping_01_Trt_1Placebo11

ADSLTRT01AEQPlacebo
AnlsGrouping_01_TrtTreatmentTRT01AFALSEAnlsGrouping_01_Trt_2Xanomeline Low Dose12

ADSLTRT01AEQXanomeline Low Dose
AnlsGrouping_01_TrtTreatmentTRT01AFALSEAnlsGrouping_01_Trt_3Xanomeline High Dose13

ADSLTRT01AEQXanomeline High Dose
AnlsGrouping_02_CntryCountryCOUNTRYTRUE









AnlsGrouping_03_ActTrtAge GroupTRT01AFALSEAnlsGrouping_03_ActTrt_1Y11OR




AnlsGrouping_03_ActTrtAge GroupTRT01AFALSEAnlsGrouping_03_ActTrt_1Y21
AnlsGrouping_01_Trt_1



AnlsGrouping_03_ActTrtAge GroupTRT01AFALSEAnlsGrouping_03_ActTrt_1Y22
AnlsGrouping_01_Trt_2



AnlsGrouping_03_ActTrtAge GroupTRT01AFALSEAnlsGrouping_03_ActTrt_2N12NOT




AnlsGrouping_03_ActTrtAge GroupTRT01AFALSEAnlsGrouping_03_ActTrt_2N12
AnlsGrouping_03_ActTrt_1



$warningHtml

  • No labels