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 2-11: | 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:
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Lines 12-21: | 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:
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dataSubsets: - id: Dss01_TEAE label: Treatment-Emergent Adverse Events level: 1 order: 1 condition: dataset: ADAE variable: TRTEMFL comparator: EQ value: - Y - id: Dss09_VS_AnRec label: 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.
Row | id | label | level | order | dataset | variable | comparator | value |
---|---|---|---|---|---|---|---|---|
1 | Dss01_TEAE | Treatment-Emergent Adverse Events | 1 | 1 | ADAE | TRTEMFL | EQ | Y |
2 | Dss09_VS_AnRec | Vital Signs Analysis Records | 1 | 1 | ADVS | ANL01FL | EQ | Y |