AnalysisSet

The AnalysisSet class, which is a specialization of the WhereClause class, is used in the reporting event's analysisSets attribute to specify 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. Once an analysis set has been defined in the reporting event's analysisSets attribute, it can be used for any analysis by specifying its identifier value in the analysisSetId attribute of the instance of the Analysis class that represents the analysis, as described in the Analysis section.

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.

analysisSets:
- id: AnalysisSet_SAF
  name: Safety Population
  description: All subjects randomized and known to have taken at least one dose of randomized drug
  label: SAF
  level: 1
  order: 1
  condition:
    dataset: ADSL
    variable: SAFFL
    comparator: EQ
    value:
    - Y
- id: AnalysisSet_RGX
  name: Region X Population
  description: All subjects enrolled at sites in country A, B, or C
  label: RGX
  level: 1
  order: 1
  condition:
    dataset: ADSL
    variable: RGXFL
    comparator: EQ
    value:
    - Y
- id: AnalysisSet_RGXSAF
  name: Region X Safety Population
  description: All subjects enrolled at sites in country A, B, or C, randomized, and known to have taken at least one dose of randomized drug
  label: RGXSAF
  level: 1
  order: 1
  compoundExpression:
    logicalOperator: AND
    whereClauses:
    - level: 2
      order: 1
      subClauseId: AnalysisSet_RGX
    - level: 2
      order: 2
      subClauseId: AnalysisSet_SAF