Model Documentation
Class: DataSubset
The DataSubset class, which is a specialization of the WhereClause class, is used in the reporting event's dataSubsets attribute to specify any defined data subsets that are used to restrict the records that are included in any given analysis (e.g., inclusion of only treatment-emergent adverse events in an AE summary analysis). Once a data subset has been defined in the reporting event's dataSubsets attribute, it can be used for any analysis by specifying its identifier value in the dataSubsetId attribute of the instance of the Analysis class that represents the analysis, as described in the Analysis section.
Each data subset is defined as an instance of the DataSubset class, in which:
- The id attribute contains the assigned identifier value for the data subset.
- The label attribute contains a short description for the data subset (e.g., "Treatment-Emergent Adverse Events").
- The level and order attributes are both assigned a value of "1".
- Either:
- The condition attribute contains the definition of a simple data selection criterion represented as an instance of the WhereClauseCondition class, as described in the WhereClauseCondition section.
Or:
- The compoundExpression attribute contains the definition of a compound expression represented as an instance of the CompoundSubsetExpression class, in which:
- The logicalOperator attribute contains a value from the ExpressionLogicalOperatorEnum enumeration.
- The whereClauses attribute contains 1 or more other sub-clauses, each represented as an instance of the WhereClause class.
- The compoundExpression attribute contains the definition of a compound expression represented as an instance of the CompoundSubsetExpression class, in which:
Refer to the WhereClauseCompoundExpression section for more information about compound expressions, including examples of data subsets defined as a compound expressions.
Example
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:
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:
|
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. |
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 data subset and subclause is represented on a separate row, and multiple condition values are represented as a pipe (|)-delimited list.
id | name | label | level | order | logicalOperator | subClauseId | dataset | variable | comparator | value |
---|---|---|---|---|---|---|---|---|---|---|
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 |