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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.

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Lines 2-1113:

Show the "Safety Population" analysis set defined as a simple condition that specifies that the value of the SAFFL variable in the ADSL dataset is equal to "Y". This condition could be expressed as:

  • ADSL.SAFFL EQ 'Y'
Lines 1214-2125:

Show the "Region X Population" analysis set defined as a simple condition that specifies that the value of the RGXFL variable in the ADSL dataset is equal to "Y". This condition could be expressed as:

  • ADSL.RGXFL EQ 'Y'
Lines 2226-3040:

Show the "Region X Safety Population" analysis set defined as a compound expression that uses the "AND" logical operator to combine the conditions specified for the "Region X Population" and "Safety Population" analysis sets (meaning that only subjects meeting both conditions are included in the analysis set ). When the references to the other analysis sets are resolved, this expression could be expressed as:

  • ADSL.RGXFL EQ 'Y' AND ADSL.SAFFL EQ 'Y'
Code Block
titleYAML Example
linenumberstrue
analysisSets:
- id: AnalysisSet_SAF
  labelname: 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
  labelname: 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
  labelname: 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 is represented on a separate rowor, 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 be been propagated onto all rows representing subclauses defined within the analysis set.
  • The identifier values of the analysis sets referenced in the whereClauses attribute of the compound expression are shown in a column called "subclause_id" 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 level values are calculated as being 1 greater than that of the instance of the analysis set containing the compound expression.The order values are assigned according to the order of the analysis set references within the whereClauses attribute.The values in the datasetvariable, comparator and value columns have been retrieved from the definitions of the analysis sets using the identifier value values specified in the whereClauses subClauseId attribute.
Dataset2
hi1style#fffae5
hi14,5,level,order,dataset,variable,comparator,value
tableidanalysisSets
1
idRownameiddescriptionlabellevelorderlogicalOperatorsubclause_idsubClauseIddatasetvariablecomparatorvalue
AnalysisSet_SAFSafety PopulationAll subjects randomized and known to have taken at least one dose of randomized drugSAF11

ADSLSAFFLEQY2
AnalysisSet_RGXRegion X PopulationAll subjects enrolled at sites in country A, B, or CRGX11

ADSLRGXFLEQY3
AnalysisSet_RGXSAFRegion X Safety PopulationAll subjects enrolled at sites in country A, B, or C, randomized, and known to have taken at least one dose of randomized drugRGXSAF11AND




4AnalysisSet_RGXSAFRegion X Safety PopulationAll subjects enrolled at sites in country A, B, or C, randomized, and known to have taken at least one dose of randomized drugRGXSAF21
AnalysisSet_RGXADSLRGXFLEQY5
AnalysisSet_RGXSAFRegion X Safety PopulationAll subjects enrolled at sites in country A, B, or C, randomized, and known to have taken at least one dose of randomized drugRGXSAF22
AnalysisSet_SAFADSLSAFFLEQY