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Model Documentation

Class: AnalysisSet

The AnalysisSet class, which is a specialization of the WhereClause class, is used in the analysisSets attribute of the ReportingEvent class to define the analysis sets, or subject populations, that define the sets of subjects whose data are to be included in the main analyses, as defined in the statistical section of the protocol.

ER Diagram: AnalysisSet

Each analysis set is defined as an instance of the AnalysisSet class, in which:

  • The id attribute contains the assigned identifier value for the analysis set.
  • The label attribute contains a short description for the analysis set (e.g., "Safety Population").
  • The level and order attributes are both assigned a value of "1".
  • 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.

Or:

    • The compoundExpression attribute contains the definition of a compound expression represented as an instance of the CompoundSetExpression 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 AnalysisSet class represented as identifier values.

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

Note that 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 define analysis sets will usually have been applied to create population flag variables. These population flag variables can usually then be referenced in the specification of simple conditions, so compound expressions should generally not be required for the definition of analysis sets.

Example

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