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The abstract GroupingFactor class provides a template for the structure of its 2 specializations:

• The SubjectGroupingFactor class, which is used in the reporting event's analysisGroupings attribute to define subject grouping factors, which are characteristics used to subdivide the subject population into groups for analysis (e.g., treatment, sex, age group). Refer to the SubjectGroupingFactor section for more information about subject grouping factors.
• The DataGroupingFactor class, which is used in the reporting event's dataGroupings attribute to define data grouping factors, which are characteristics used to subdivide analysis dataset records into groups for analysis (e.g., "system organ class" or "preferred term" in an adverse events analysis dataset, "parameter" or "visit" in a vital signs analysis dataset). Refer to the DataGroupingFactor section for more information about data grouping factors.

Each grouping factor is represented as an instance of 1 of the specializations of the GroupingFactor class and, in each instance:

• The id attribute contains the assigned identifier value for the grouping factor.
• The label attribute contains a short description of the grouping factor (e.g., "Treatment" or "Sex" for a subject grouping factor, "System Organ Class" or "Vital Signs Parameter" for a data grouping factor).
• The groupingVariable may contain the name of the variable whose values are used to subdivide subjects or data records. This attribute:
  • 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, each represented as an instance of the specialization of the Group class that corresponds with the specialization of the GroupingFactor class:
  • The AnalysisGroup class is used to specify predefined groups in the SubjectGroupingFactor class.
  • The DataGroup class is used to specify predefined groups in the DataGroupingFactor class.

When predefined groups are specified, each predefined group is defined as an instance of the appropriate specialization of the Group class (which is itself a specialization of the WhereClause class). In each instance,:

• The id attribute contains the assigned identifier value for the predefined group.
• The label attribute contains a short description for the predefined group, for example:

• 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, etc.). 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 references to other instances of the specialization of the Group class that is the same as the one in which the compound expression is being defined. Each reference is represented as an identifier value.

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

Example definitions of subject grouping factors can be found in the SubjectGroupingFactor section and examples of data grouping factors can be found in the DataGroupingFactor section.

Once a grouping factor has been defined in the analysisGroupings or dataGroupings attribute of the reporting event, it can be included in the specification of any analysis by recording its identifier value in the groupingId attribute of 1 of the instances of the OrderedGroupingFactor class in the orderedGroupings attribute of the analysis.