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• The SubjectGroupingFactor class, which is used in the reporting event's 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 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 See the DataGroupingFactor section for more information about data grouping factors.

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

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