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:
|
| 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:
|
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 |