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• Attributes for components used to itemize and organize the contents of the reporting event, or which may be used in the specification of either analyses or outputs:
  • listOfPlannedAnalyses: A structured list of the analyses defined for the reporting event. The list is defined using the NestedList class, which allows referenced analyses (and outputs) to be organized into sections and sub-sections.
    
  • listOfPlannedOutputs: An optional separate structured list of the outputs defined for the reporting event. The list is defined using the NestedList class, which allows referenced outputs (and analyses) to be organized into sections and sub-sections.
    
  • referenceDocuments: The documents referenced within the reporting event, either for documentation or for programming code. Each reference document is defined using the ReferenceDocument class.
    
  • terminologyExtensions: Any sponsor-defined extensions to extensible ARS terminology. One or more additional, sponsor-defined terms may be added to each extensible enumeration using the TerminologyExtension class.
    
  • analysisOutputCategorizations: Any categorizations used to tag analyses or outputs.  For example, a “Type of analysis” categorization could be created to tag defined analyses or outputs as “Subject Population”, “Safety” or “Efficacy”, and/or an “Estimand Analysis Type” categorization could be created to tag analyses as “Primary Estimator”, “Sensitivity Analysis”, “Supplementary Analysis”.  Each categorization is defined using the AnalysisOutputCategorization class. 
    
• Attributes for components used to define and describe analyses:
  • analysisSets: The analysis sets defined for the reporting event. Each analysis set, or subject population, is defined using the AnalysisSet class as a set of subjects whose data are to be included in the main analyses. This is as defined in the statistical section of the protocol.
    
  • analysisGroupings: Characteristics used to subdivide the subject population (e.g., treatment, sex, age group). Each analysis grouping is defined using the SubjectGroupingFactor class and 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., country of origin in a large multinational study).
  • dataSubsets: Any defined data subsets that are used to restrict the records that are included in any given analysis (e.g., inclusion of only treatment-emergent adverse events in an AE summary analysis). Each data subset is defined using the DataSubset class.
    
  • dataGroupings: Characteristics used to subdivide the records in an analysis dataset (e.g., "system organ class" or "preferred term" in an adverse events analysis dataset, "parameter" or "visit" in a vital signs analysis dataset). Each data grouping is defined using the DataGroupingFactor class and may either contain a set of specified groups (e.g., “Systolic Blood Pressure” and “Temperature” for a vital signs parameter 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).
    
  • methods: Defined methods used to analyze any analysis variable. Each method, which is defined using the AnalysisMethod class, may contain multiple individual operations. For example, a “summary "summary of categorical variable” variable" method might include separate operations for “count "count of subject by group” group" and “percent "percent of subjects by group”group".
    
  • analyses: The analyses defined for the reporting event. Each analysis is described, using the Analysis class, as a set of operations (i.e., a referenced AnalysisMethod) performed on a specified analysis variable for any specified subset of data records (i.e., any referenced DataSubset) for a given subject population (i.e., a referenced AnalysisSet) which may be subdivided by one or more factors (i.e., any referenced SubjectGroupingFactor or DataGroupingFactor). The results of each analysis are contained within the Analysis class as a property of the analysis and each result is associated with references to all analysis components needed to give the result context (i.e., the operation used to calculate the result and a specific value for each grouping factors used for the analysis such as treatment, sex, age group, etc.).
    
• Attributes for components used to define and describe outputs:
  • globalDisplaySections: Text values that may be used in a specific display section (title, footnote, etc.) of any display. Each global display section is defined using the GlobalDisplaySection class.
    
  • outputs: The outputs defined for the reporting event. Each output is defined using the Output class and may contain one or more defined displays.

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