analysisGroupings: Subject Characteristics

This example shows the definition of 3 grouping factors based on subject characteristics recorded in the ADSL dataset. Each grouping factor is 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_01_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_01_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_01_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 38-42:	Show the attributes of the instance of the GroupingFactor class for the second grouping factor, "Country" (line 39), which is defined as being based on the ADSL COUNTRY grouping variable (lines 40 and 41). The grouping factor is data-driven (line 42), so the groups attribute is not included; the groups within this subject grouping factor are derived from the distinct values in the ADSL COUNTRY variable.
Lines 43-73:	Show the attributes of the instance of the GroupingFactor class for the third grouping factor, "On Active Treatment" (line 44). Although the groups within this grouping factor are defined as compound expressions (lines 54 and 68), the grouping variable is specified as ADSL TRT01A (lines 45 and 46) 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 47), so the groups attribute is included (line 48) and contains 2 predefined groups, each specified as a compound expression represented as an instance of the Group class: Lines 49-62: Show the first predefined group (order = 1), which is identified as "AnlsGrouping_03_ActTrt_1", named as "Yes", and labeled as "Y". The compound expression defined for this group uses the "OR" logical operator (line 55) to combine 2 subclauses, each of which is represented as an instance of the ReferencedGroup class. Lines 57-59: Show the first subclause (level = 2, order = 1), which is a reference to the instance of the Group class identified as "AnlsGrouping_01_Trt_2" (line 58). Lines 60-62: Show the second subclause (level = 2, order = 2), which is a reference to the instance of the Group class identified as "AnlsGrouping_01_Trt_2" (line 61). 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 63-73: Show the second predefined group (order = 2), which is identified as "AnlsGrouping_03_ActTrt_2", named as "No", and labeled as "N". The compound expression defined for this group uses the "NOT" logical operator (line 69) 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_03_ActTrt_1" (line 73). 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
  name: Treatment
  groupingDataset: ADSL
  groupingVariable: TRT01A
  dataDriven: false
  groups:
  - id: AnlsGrouping_01_Trt_1
    name: Placebo
    level: 1
    order: 1
    condition:
      dataset: ADSL
      variable: TRT01A
      comparator: EQ
      value:
      - Placebo
  - id: AnlsGrouping_01_Trt_2
    name: Xanomeline Low Dose
    level: 1
    order: 2
    condition:
      dataset: ADSL
      variable: TRT01A
      comparator: EQ
      value:
      - Xanomeline Low Dose
  - id: AnlsGrouping_01_Trt_3
    name: Xanomeline High Dose
    level: 1
    order: 3
    condition:
      dataset: ADSL
      variable: TRT01A
      comparator: EQ
      value:
      - Xanomeline High Dose
- id: AnlsGrouping_02_Cntry
  name: Country
  GroupingDataset: ADSL
  groupingVariable: COUNTRY
  dataDriven: true
- id: AnlsGrouping_03_ActTrt
  name: On Active Treatment
  groupingDataset: ADSL
  groupingVariable: TRT01A
  dataDriven: false
  groups:
  - id: AnlsGrouping_03_ActTrt_1
    name: Yes
    label: Y
    level: 1
    order: 1
    compoundExpression:
      logicalOperator: OR
      whereClauses:
      - level: 2
        order: 1
        subClauseId: AnlsGrouping_01_Trt_2
      - level: 2
        order: 2
        subClauseId: AnlsGrouping_01_Trt_3
  - id: AnlsGrouping_03_ActTrt_2
    name: No
    label: N
    level: 1
    order: 2
    compoundExpression:
      logicalOperator: NOT
      whereClauses:
      - level: 2
        order: 1
        subClauseId: AnlsGrouping_03_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:
- GroupingFactor: 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 GroupingFactor attributes.
- Group: each predefined group is represented on a separate line, with attribute values for the related instance of the GroupingFactor class represented on every row.
- 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, with the identifier value of the referenced predefined group shown in the "subClauseId" column. The attribute values of the related instance of the Group class (and those of its related instance of the GroupingFactor class) are represented on every row.
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. ARSP-34 - Getting issue details... STATUS

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id	name	groupingDataset	groupingVariable	dataDriven	group_id	group_name	group_label	level	order	logicalOperator	subClauseId	dataset	variable	comparator	value
AnlsGrouping_01_Trt	Treatment	ADSL	TRT01A	FALSE	AnlsGrouping_01_Trt_1	Placebo		1	1			ADSL	TRT01A	EQ	Placebo
AnlsGrouping_01_Trt	Treatment	ADSL	TRT01A	FALSE	AnlsGrouping_01_Trt_2	Xanomeline Low Dose		1	2			ADSL	TRT01A	EQ	Xanomeline Low Dose
AnlsGrouping_01_Trt	Treatment	ADSL	TRT01A	FALSE	AnlsGrouping_01_Trt_3	Xanomeline High Dose		1	3			ADSL	TRT01A	EQ	Xanomeline High Dose
AnlsGrouping_02_Cntry	Country	ADSL	COUNTRY	TRUE
AnlsGrouping_03_ActTrt	On Active Treatment	ADSL	TRT01A	FALSE	AnlsGrouping_03_ActTrt_1	Yes	Y	1	1	OR
AnlsGrouping_03_ActTrt	On Active Treatment	ADSL	TRT01A	FALSE	AnlsGrouping_03_ActTrt_1	Yes	Y	2	1		AnlsGrouping_01_Trt_2
AnlsGrouping_03_ActTrt	On Active Treatment	ADSL	TRT01A	FALSE	AnlsGrouping_03_ActTrt_1	Yes	Y	2	2		AnlsGrouping_01_Trt_3
AnlsGrouping_03_ActTrt	On Active Treatment	ADSL	TRT01A	FALSE	AnlsGrouping_03_ActTrt_2	No	N	1	2	NOT
AnlsGrouping_03_ActTrt	On Active Treatment	ADSL	TRT01A	FALSE	AnlsGrouping_03_ActTrt_2	No	N	2	1		AnlsGrouping_03_ActTrt_1

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analysisGroupings: Subject Characteristics