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- 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.
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For example, to define an analysis of the occurrence of adverse events by treatment, system organ class and preferred term, 3 separate grouping factors would be defined (1 for treatment, 1 for system organ class, and 1 for preferred term). All 3 grouping factors would then be used in the definition of the analysis by including each of their identifier values in the groupingId attribute of 1 of 3 instances of the OrderedGroupingFactor class in the orderedGroupings attribute of the analysis definition. |
Refer to the Analysis section for more information about the specification of analyses.
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