analysisSets

This example shows the definition of 3 analysis sets, each of which is represented as an instance of the AnalysisSet class within the analysisSets attribute of the reporting event. The first 2 analysis sets are simple conditions based on a single specified selection value for a population flag variable, and the third is a compound expression that combines the conditions defined for the first 2 analysis sets. The sponsor chose to include a description and label for each of the analysis sets.

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

These analysis sets could be represented in tabular form as shown in the following table where:

• Each represents an instance of either the AnalysisSet class or, for subclauses in a compound expression, the ReferencedAnalysisSet class.
• The values of the id, name, description, and label attributes of the "AnalysisSet_RGXSAF" instance of the analysis set class have been propagated onto all rows representing subclauses defined within the analysis set.
• The logicalOperator attribute from the CompoundSetExpression class, the subClauseId attribute from the ReferencedAnalysisSet class, and all the attributes from the WhereClauseCondition class are represented as separate columns.
• Cells highlighted in yellow contain derived values: the values in the dataset, variable, comparator and value columns have been retrieved from the definitions of the analysis sets using the identifier values specified in the subClauseId attribute.