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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 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 13-22:

Show the "Vital Signs Analysis Records" data subset defined as a simple condition 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.

YAML Example
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: 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 instance of the DataSubset class is represented on a separate row.

$titleHtml
Rowidnamelabellevelorderdatasetvariablecomparatorvalue
1Dss01_TEAETreatment-Emergent Adverse EventsTEAE11ADAETRTEMFLEQY
2Dss09_VS_AnRecVital Signs Analysis Records
11ADVSANL01FLEQY
$warningHtml

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