dataGroupings

This example shows the definition of 2 data grouping factors, each of which is represented as an instance of the DataGroupingFactor class within the dataGroupings attribute of the reporting event.

Lines 2-6:

Show the attributes of the instance of the DataGroupingFactor class for the first subject grouping factor, "Vital Signs Parameter" (line 3), which is defined as being based on the PARAMCD grouping variable (line 4). The grouping factor is not data-driven (line 5), so the groups attribute is included (line 6) and contains 2 predefined groups, each specified as a simple condition represented as an instance of the DataGroup class:

Lines 7-16: Show the first predefined group (order = 1), which is identified as "DataGrouping_01_Param_1", labeled as "Systolic Blood Pressure (mmHg)", and contains a simple condition specifying that the value of the PARAMCD variable in the ADVS dataset is equal to "SYSBP", which could be expressed as:
- ADVS.PARAMCD EQ 'SYSBP'
Lines 17-26: Show the second predefined group (order = 2), which is identified as "DataGrouping_01_Param_2", labeled as "Diastolic Blood Pressure (mmHg)", and contains a simple condition specifying that that the value of the TRT01A variable in the ADSL dataset is equal to "Xanomeline Low Dose", which could be expressed as:
- ADVS.PARAMCD EQ 'DIABP'

Lines 27-30:

Show the attributes of the instance of the DataGroupingFactor class for the second subject grouping factor, "System Organ Class" (line 28), which is defined as being based on the AESOC grouping variable (line 29). The grouping factor is data-driven (line 30), so the groups attribute is not included; the groups within this data grouping factor are derived from the distinct values in the AESOC variable.

YAML Example

dataGroupings:
- id: DataGrouping_01_Param
  dataDriven: false
  label: Vital Signs Parameter
  groupingVariable: PARAMCD
  groups:
  - id: DataGrouping_01_Param_1
    label: Systolic Blood Pressure (mmHg)
    level: 1
    order: 1
    condition:
      dataset: ADVS
      variable: PARAMCD
      comparator: EQ
      value:
      - SYSBP
  - id: DataGrouping_01_Param_2
    label: Diastolic Blood Pressure (mmHg)
    level: 1
    order: 2
    condition:
      dataset: ADVS
      variable: PARAMCD
      comparator: EQ
      value:
      - DIABP
- id: DataGrouping_02_Soc
  label: System Organ Class
  groupingVariable: AESOC
  dataDriven: true

These data grouping factors and their predefined groups could be represented in tabular form as shown in the following table where each instance of the DataGroup class is represented on a separate line, with attribute values for the related instance of the DataGroupingFactor 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 shown with values only shown for the DataGroupingFactor attributes.

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id	label	groupingVariable	dataDriven	group_id	group_label	level	order	dataset	variable	comparator	value
DataGrouping_01_Param	Vital Signs Parameter	PARAMCD	FALSE	DataGrouping_01_Param_1	Systolic Blood Pressure (mmHg)	1	1	ADVS	PARAMCD	EQ	SYSBP
DataGrouping_01_Param	Vital Signs Parameter	PARAMCD	FALSE	DataGrouping_01_Param_2	Diastolic Blood Pressure (mmHg)	1	2	ADVS	PARAMCD	EQ	DIABP
DataGrouping_02_Soc	System Organ Class	AESOC	TRUE

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