This example shows the definition of 2 grouping factors based, each represented as an instance of the GroupingFactor class within the analysisGroupings attribute of the reporting event.

Lines 2-37:

Show the attributes of the instance of the GroupingFactor class for the first grouping factor, "Treatment" (line 3), which is defined as being based on the ADSL TRT01A grouping variable (lines 4 and 5). The grouping factor is not data-driven (line 6), so the groups attribute is included (line 7) and contains 3 predefined groups, each specified as a simple condition represented as an instance of the Group class:

  • Lines 8-17: Show the first predefined group (order = 1), which is identified as "AnlsGrouping_05_Trt_1", named as "Placebo" (line 9), 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 18-27: Show the second predefined group (order = 2), which is identified as "AnlsGrouping_05_Trt_2", named as "Xanomeline Low Dose" (line 19), 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 28-37: Show the third predefined group (order = 3), which is identified as "AnlsGrouping_05_Trt_3", named as "Xanomeline High Dose" (line 29), 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 38-68:

Show the attributes of the instance of the GroupingFactor class for the third grouping factor, "On Active Treatment" (line 39). Although the groups within this grouping factor are defined as compound expressions (lines 49 and 63), the grouping variable is specified as ADSL TRT01A (lines 40 and 41) because all the subclauses of the compound expressions are identified as groups that are simple conditions based on the TRT01A variable. The grouping factor is not data-driven (line 42), so the groups attribute is included (line 43) and contains 2 predefined groups, each specified as a compound expression represented as an instance of the Group class:

  • Lines 44-57: Show the first predefined group (order = 1), which is identified as "AnlsGrouping_06_ActTrt_1", named as "Yes", and labeled as "Y". The compound expression defined for this group uses the "OR" logical operator (line 50) to combine 2 subclauses, each of which is represented as an instance of the ReferencedGroup class.
    • Lines 52-54: Show the first subclause (level = 2, order = 1), which is a reference to the instance of the Group class identified as "AnlsGrouping_05_Trt_2" (line 54).
    • Lines 55-57: Show the second subclause (level = 2, order = 2), which is a reference to the instance of the Group class identified as "AnlsGrouping_05_Trt_2" (line 57).

      When the identifier values specified the 2 subclauses are used to retrieve the definitions of the identified groups, this compound expression could be expressed as:

    • ADSL.TRT01A EQ 'Xanomeline Low Dose' OR ADSL.TRT01A EQ 'Xanomeline High Dose'
  • Lines 58-68: Show the second predefined group (order = 2), which is identified as "AnlsGrouping_06_ActTrt_2", named as "No", and labeled as "N". The compound expression defined for this group uses the "NOT" logical operator (line 64) to negate the condition(s) specified by the subclause. The subclause is specified as an instance of the ReferencedGroup class, in which the subClauseId attribute references the instance of the Group class identified as "AnlsGrouping_06_ActTrt_1" (line 68). When the identifier values for this referenced group ("AnlsGrouping_06_ActTrt_1") and groups it references ("AnlsGrouping_05_Trt_2" and "AnlsGrouping_05_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_05_Trt
  name: Treatment
  groupingDataset: ADSL
  groupingVariable: TRT01A
  dataDriven: false
  groups:
  - id: AnlsGrouping_05_Trt_1
    name: Placebo
    level: 1
    order: 1
    condition:
      dataset: ADSL
      variable: TRT01A
      comparator: EQ
      value:
      - Placebo
  - id: AnlsGrouping_05_Trt_2
    name: Xanomeline Low Dose
    level: 1
    order: 2
    condition:
      dataset: ADSL
      variable: TRT01A
      comparator: EQ
      value:
      - Xanomeline Low Dose
  - id: AnlsGrouping_05_Trt_3
    name: Xanomeline High Dose
    level: 1
    order: 3
    condition:
      dataset: ADSL
      variable: TRT01A
      comparator: EQ
      value:
      - Xanomeline High Dose
- id: AnlsGrouping_06_ActTrt
  name: On Active Treatment
  groupingDataset: ADSL
  groupingVariable: TRT01A
  dataDriven: false
  groups:
  - id: AnlsGrouping_06_ActTrt_1
    name: Yes
    label: Y
    level: 1
    order: 1
    compoundExpression:
      logicalOperator: OR
      whereClauses:
      - level: 2
        order: 1
        subClauseId: AnlsGrouping_05_Trt_2
      - level: 2
        order: 2
        subClauseId: AnlsGrouping_05_Trt_3
  - id: AnlsGrouping_06_ActTrt_2
    name: No
    label: N
    level: 1
    order: 2
    compoundExpression:
      logicalOperator: NOT
      whereClauses:
      - level: 2
        order: 1
        subClauseId: AnlsGrouping_06_ActTrt_1

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

  • Each row represents an instance of one of the following classes, with attribute values for the related instance of the GroupingFactor class represented on every row:
    • Group: each predefined group is represented on a separate line (rows where level = 1).
    • ReferencedGroup: for each predefined group that includes a compound expression, any subclause that references another predefined predefined group by identifier is represented on a separate row (rows where level = 2), where the identifier value of the referenced predefined group shown in the "subClauseId" column and the attribute values of the related instance of the Group class are also shown.
  • 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
idnamegroupingDatasetgroupingVariabledataDrivengroup_idgroup_namegroup_labellevelorderlogicalOperatorsubClauseIddatasetvariablecomparatorvalue
AnlsGrouping_05_TrtTreatmentADSLTRT01AFALSEAnlsGrouping_05_Trt_1Placebo
11

ADSLTRT01AEQPlacebo
AnlsGrouping_05_TrtTreatmentADSLTRT01AFALSEAnlsGrouping_05_Trt_2Xanomeline Low Dose
12

ADSLTRT01AEQXanomeline Low Dose
AnlsGrouping_05_TrtTreatmentADSLTRT01AFALSEAnlsGrouping_05_Trt_3Xanomeline High Dose
13

ADSLTRT01AEQXanomeline High Dose
AnlsGrouping_06_ActTrt

On Active Treatment

ADSLTRT01AFALSEAnlsGrouping_06_ActTrt_1YesY11OR




AnlsGrouping_06_ActTrtOn Active TreatmentADSLTRT01AFALSEAnlsGrouping_06_ActTrt_1YesY21
AnlsGrouping_05_Trt_2



AnlsGrouping_06_ActTrtOn Active TreatmentADSLTRT01AFALSEAnlsGrouping_06_ActTrt_1YesY22
AnlsGrouping_05_Trt_3



AnlsGrouping_06_ActTrtOn Active TreatmentADSLTRT01AFALSEAnlsGrouping_06_ActTrt_2NoN12NOT




AnlsGrouping_06_ActTrtOn Active TreatmentADSLTRT01AFALSEAnlsGrouping_06_ActTrt_2NoN21
AnlsGrouping_06_ActTrt_1



$warningHtml

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