AnalysisSet

The AnalysisSet class is used in the reporting event's analysisSets attribute to specify the analysis sets, or subject populations, that are defined in the statistical section of the protocol or the SAP, and identify the sets of subjects whose data are to be included in the main analyses. As described in the DataSubset section, the DataSubset class is used to specify any other subsets of subjects or data that are to be included in analyses, but where the subset is not considered to be a defined analysis set. 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.

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 name attribute contains the name of the analysis set (e.g., "Safety Population", "Intent-to-Treat Population").
• The description attribute may be used to record a detailed description of the analysis set.
• The label attribute may be used to record a short description of the analysis set (e.g., "SAF", "ITT").
• 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 subclauses being combined or negated by the specified logical operator. Each subclause is represented as one of the following:
      • A where clause represented as an instance of the WhereClause class, with the subclause expressed using either the condition or compoundExpression attribute.
      • A reference to another defined analysis set represented as an instance of the ReferencedAnalysisSet class, in which the subClauseId attribute contains the identifier value of the referenced analysis set.

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