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:
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:
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: 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.
Row | id | name | label | level | order | dataset | variable | comparator | value |
---|---|---|---|---|---|---|---|---|---|
1 | Dss01_TEAE | Treatment-Emergent Adverse Events | TEAE | 1 | 1 | ADAE | TRTEMFL | EQ | Y |
2 | Dss09_VS_AnRec | Vital Signs Analysis Records | 1 | 1 | ADVS | ANL01FL | EQ | Y |