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

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class

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is

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 used in the reporting event'

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s analysisGroupings attribute to define

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grouping factors, which are characteristics used to subdivide the subject population or analysis dataset records into groups for analysis

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. 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)

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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).

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 The name attribute contains a short description the name 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 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. This attributeThese 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, 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

When predefined groups are specified in the

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When predefined groups are specifiedgroups attribute, 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 ,of the Group class:

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

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• • 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 valuesubclauses 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.

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Once a grouping factor has been defined in the analysisGroupings or dataGroupings attribute of the reporting event, it can be used in the specification of any analysis by including its identifier value in the groupingId attribute of 1 of the instances of the OrderedGroupingFactor class in the orderedGroupings attribute of the analysis. In general, grouping factors are defined with reference to a single grouping variable. However, multiple separate grouping factors may be referenced in the specification of an analysis, so it is possible to define analyses of subjects and data records that are grouped by multiple factors.

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