...
Xfancy |
---|
|
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: 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: The sponsor chose not to assign a label for this data subset. |
|
Code Block |
---|
title | YAML Example |
---|
linenumbers | true |
---|
|
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 instance of the DataSubset class data subset and subclause is represented on a separate row, and multiple condition values are represented as a pipe (|)-delimited list.
Dataset2 |
---|
Row | id | name | label | level | order | logicalOperator | subClauseId | dataset | variable | comparator | value | 1 |
---|
Dss01_TEAE | Treatment-Emergent Adverse Events | TEAE | 1 | 1 |
|
| ADAE | TRTEMFL | EQ | Y | Dss02_RelTEAE | Related Treatment-Emergent Adverse Events | Related TEAE | 1 | 1 | AND |
|
|
|
|
| Dss02_RelTEAE | Related Treatment-Emergent Adverse Events | Related TEAE | 2 | 1 |
| Dss01_TEAE |
|
|
|
| Dss02_RelTEAE | Related Treatment-Emergent Adverse Events | Related TEAE | 2 | 2 |
|
| ADAE | AEREL | IN | POSSIBLE|PROBABLE | Dss09_VS_AnRec | Vital Signs Analysis Records |
| 1 | 1 |
|
| ADVS | ANL01FL | EQ | Y |
|