This example shows the definition of 2 data subsets, each of which is a based on a simple condition represented as an instance of the DataSubset class within the dataSubets attribute of the reporting event.

Lines 2-12:

Show the "Treatment-Emergent Adverse Events" data subset defined as a simple condition (line 7) that specifies that the value of the TRTEMFL variable in the ADAE dataset is equal to "Y". This condition could be expressed as:

  • ADAE.TRTEMFL EQ 'Y'

The sponsor chose to assign a label of "TEAE" for this data subset (line 4).

Lines 13-32:

Show the "Related Treatment-Emergent Adverse Events" data subset, which the sponsor chose to label as "Related TEAE" (line 15). This data subset is defined as a compound expression (line 18) that combines 2 subclauses using the "AND" logical operator (line 19).

Lines 21-23: Show the first subclause defined as an instance of the ReferencedDataSubset class that references the instance of the DataSubset class identified as "Dss01_TEAE" (line 22).

Lines 24-32: Show the second subclause defined as a simple condition that specifies that the value of the AEREL variable in the ADAE dataset is either "POSSIBLE" or "PROBABLE". This subclause condition could be expressed as:

    • ADAE.AEREL IN ('POSSIBLE', 'PROBABLE')

When the condition for the data subset referenced by the first subclause is retrieved and combined with the condition for the second subclause using the specified logical operator, this compound expression could be expressed as:

  • ADAE.TRTEMFL EQ 'Y' AND ADAE.AEREL IN ('POSSIBLE', 'PROBABLE')
Lines 33-42:

Show the "Vital Signs Analysis Records" data subset defined as a simple condition (line 37) that specifies that the value of the ANL01FL variable in the ADVS dataset is equal to "Y". This condition could be expressed as:

  • ADVS.ANL01FL EQ 'Y'

The sponsor chose not to assign a label for this data subset.

dataSubsets:
- id: Dss01_TEAE
  name: Treatment-Emergent Adverse Events
  label: TEAE
  level: 1
  order: 1
  condition:
    dataset: ADAE
    variable: TRTEMFL
    comparator: EQ
    value:
    - Y
- id: Dss02_RelTEAE
  name: Related Treatment-Emergent Adverse Events
  label: Related TEAE
  level: 1
  order: 1
  compoundExpression:
    logicalOperator: AND
    whereClauses:
    - level: 2
      order: 1
      subClauseId: Dss01_TEAE
    - level: 2
      order: 2
      condition:
        dataset: ADAE
        variable: AEREL
        comparator: IN
        value:
        - POSSIBLE
        - PROBABLE
- id: Dss09_VS_AnRec
  name: Vital Signs Analysis Records
  level: 1
  order: 1
  condition:
    dataset: ADVS
    variable: ANL01FL
    comparator: EQ
    value:
    - Y

These data subsets could be represented in tabular form as shown in the following table where each data subset and subclause is represented on a separate row, and multiple condition values are represented as a pipe (|)-delimited list.

idnamelabellevelorderlogicalOperatorsubClauseIddatasetvariablecomparatorvalue
Dss01_TEAETreatment-Emergent Adverse EventsTEAE11

ADAETRTEMFLEQY
Dss02_RelTEAERelated Treatment-Emergent Adverse EventsRelated TEAE11AND




Dss02_RelTEAERelated Treatment-Emergent Adverse EventsRelated TEAE21
Dss01_TEAE



Dss02_RelTEAERelated Treatment-Emergent Adverse EventsRelated TEAE22

ADAEAERELINPOSSIBLE|PROBABLE
Dss09_VS_AnRecVital Signs Analysis Records
11

ADVSANL01FLEQY