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Model Documentation

Class: 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:

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.

Example

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.

Lines 2-13:

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 14-25:

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 26-40:

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'

YAML Example
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 datasetvariable, comparator and value columns have been retrieved from the definitions of the analysis sets using the identifier values specified in the subClauseId attribute.

$titleHtml
idnamedescriptionlabellevelorderlogicalOperatorsubClauseIddatasetvariablecomparatorvalue
AnalysisSet_SAFSafety PopulationAll subjects randomized and known to have taken at least one dose of randomized drugSAF11

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

ADSLRGXFLEQY
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




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 drugRGXSAF21
AnalysisSet_RGXADSLRGXFLEQY
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
$warningHtml

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.

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