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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).
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The ARS Model is designed to support the specification of analyses of data in ADaM datasets, which are expected to be "analysis-ready." In analysis-ready datasets, any complex criteria needed to specify predefined groups within grouping factors will usually have been applied to create specific grouping variables. These grouping variables can usually then be referenced in the specification of simple conditions, so compound expressions should generally not be required for the definition of predefined groups within grouping factors. |
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