GroupingFactor

The GroupingFactor class is used in the reporting event's analysisGroupings attribute to define grouping factors, which are characteristics used to subdivide the subject population or analysis dataset records into groups for analysis. Examples of grouping factors include subject characteristics (such as sex or age group), planned or actual treatment, "system organ class" or "preferred term" in an adverse events analysis dataset, and "parameter" or "visit" in a vital signs analysis dataset. Each grouping factor may either contain a set of specified groups (e.g., “Male” and “Female” for a sex grouping) or be defined as "data-driven", where the group values are obtained from the data (e.g., "system organ class" or "preferred term" for adverse events).

ER Diagram: GroupingFactor

Each grouping factor is represented as an instance of the GroupingFactor class and, in each instance:

• The id attribute contains the assigned identifier value for the grouping factor.
• The name attribute contains the name of the grouping factor (e.g., "Treatment", "Sex", "System Organ Class" or "Vital Signs Parameter").
• The description attribute may be used to record a detailed description of the grouping factor.
• The label attribute may be used to record a short description of the grouping factor.
• The groupingDataset and groupingVariable attributes may contain, respectively, the dataset name and variable name of the variable whose values are used to subdivide subjects or data records. These attributes:
  
  • May be blank for groupings that include predefined groups that are specified using compound expressions that reference more than one variable.
  • Must be populated for data-driven groupings.
• The dataDriven attribute contains either "true" or "false" to indicate whether the grouping factor is data-driven. The groups within a data-driven grouping factor (where dataDriven = true) are not predefined; they are determined from the distinct values contained within the specified groupingVariable.
• For grouping factors that are not data-driven (dataDriven = false), the groups attribute contains the specifications of 2 or more predefined groups.

When predefined groups are specified in the groups attribute, each predefined group is defined as an instance of the Group class. In each instance of the Group class:

• The id attribute contains the assigned identifier value for the predefined group.
• The name attribute contains the assigned name for the predefined group, for example:

• The description attribute may be used to record a detailed description of the predefined group.
• The label attribute may be used to record a short description of the predefined group, such as might be used in a display with limited space.
• The level attribute is assigned a value of "1".
• The order attribute contains an integer used to order the predefined group with respect to the other predefined groups in the grouping factor (i.e., "1" for the first predefined group, "2" for the second, and so on). The value of this attribute is assigned according to the order in which the predefined groups should be displayed in outputs.
• Either:
  • The condition attribute contains the definition of a simple data selection criterion represented as an instance of the WhereClauseCondition class, as described in the WhereClauseCondition section.

Or:

• • The compoundExpression attribute contains the definition of a compound expression represented as an instance of the CompoundGroupExpression class, in which:
    • The logicalOperator attribute contains a value from the ExpressionLogicalOperatorEnum enumeration.
    • The whereClauses attribute contains 1 or more subclauses being combined or negated by the specified logical operator. Each subclause is represented as one of the following:
      • A where clause represented as an instance of the WhereClause class, with the subclause expressed using either the condition or compoundExpression attribute.
      • A reference to another predefined group represented as an instance of the ReferencedGroup class, in which the subClauseId attribute contains the identifier value of the referenced group.

Refer to the WhereClauseCompoundExpression section for more information about compound expressions.

analysisGroupings:
- id: AnlsGrouping_01_Sex
  name: Sex
  groupingDataset: ADSL
  groupingVariable: SEX
  dataDriven: false
  groups:
  - id: AnlsGrouping_01_Sex_1
    name: Female
    label: F
    level: 1
    order: 1
    condition:
      dataset: ADSL
      variable: SEX
      comparator: EQ
      value:
      - F
  - id: AnlsGrouping_01_Sex_2
    name: Male
    label: M
    level: 1
    order: 2
    condition:
      dataset: ADSL
      variable: SEX
      comparator: EQ
      value:
      - M
- id: AnlsGrouping_02_Cntry
  name: Country
  GroupingDataset: ADSL
  groupingVariable: COUNTRY
  dataDriven: true
- id: AnlsGrouping_03_Param
  name: Vital Signs Parameter
  groupingDataset: ADVS
  groupingVariable: PARAMCD
  dataDriven: false
  groups:
  - id: AnlsGrouping_03_Param_1
    name: Systolic Blood Pressure (mmHg)
    level: 1
    order: 1
    condition:
      dataset: ADVS
      variable: PARAMCD
      comparator: EQ
      value:
      - SYSBP
  - id: AnlsGrouping_03_Param_2
    name: Diastolic Blood Pressure (mmHg)
    level: 1
    order: 2
    condition:
      dataset: ADVS
      variable: PARAMCD
      comparator: EQ
      value:
      - DIABP
- id: AnlsGrouping_04_Soc
  name: System Organ Class
  groupingDataset: ADAE
  groupingVariable: AESOC
  dataDriven: true