This example shows the definition of 3 subject grouping factors, each of which is represented as an instance of the SubjectGroupingFactor class within the analysisGroupings attribute of the reporting event.
Lines 2-6: | Show the attributes of the instance of the SubjectGroupingFactor class for the first subject grouping factor, "Treatment" (line 3), which is defined as being based on the TRT01A grouping variable (line 4). The grouping factor is not data-driven (line 5), so the groups attribute is included (line 6) and contains 3 predefined groups, each specified as a simple condition represented as an instance of the AnalysisGroup class:
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Lines 37-40: | Show the attributes of the instance of the SubjectGroupingFactor class for the second subject grouping factor, "Country" (line 38), which is defined as being based on the COUNTRY grouping variable (line 39). The grouping factor is data-driven (line 40), so the groups attribute is not included; the groups within this subject grouping factor are derived from the distinct values in the COUNTRY variable. |
Lines 41-45: | Show the attributes of the instance of the SubjectGroupingFactor class for the third subject grouping factor, "On Active Treatment" (line 42). Although the groups within this grouping factor are defined as compound expressions (lines 50 and 59), the grouping variable is specified as TRT01A (line 43) because all the sub-clauses of the compound expression are identified as groups that are simple conditions based on the TRT01A variable. The grouping factor is not data-driven (line 44), so the groups attribute is included (line 45) and contains 2 predefined groups, each specified as a compound expression represented as an instance of the AnalysisGroup class:
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analysisGroupings: - id: AnlsGrouping_01_Trt label: Treatment groupingVariable: TRT01A dataDriven: false groups: - id: AnlsGrouping_01_Trt_1 label: Placebo level: 1 order: 1 condition: dataset: ADSL variable: TRT01A comparator: EQ value: - Placebo - id: AnlsGrouping_01_Trt_2 label: Xanomeline Low Dose level: 1 order: 2 condition: dataset: ADSL variable: TRT01A comparator: EQ value: - Xanomeline Low Dose - id: AnlsGrouping_01_Trt_3 label: Xanomeline High Dose level: 1 order: 3 condition: dataset: ADSL variable: TRT01A comparator: EQ value: - Xanomeline High Dose - id: AnlsGrouping_02_Cntry label: Country groupingVariable: COUNTRY dataDriven: true - id: AnlsGrouping_03_ActTrt label: On Active Treatment groupingVariable: TRT01A dataDriven: false groups: - id: AnlsGrouping_03_ActTrt_1 label: Y level: 1 order: 1 compoundExpression: logicalOperator: OR whereClauses: - AnlsGrouping_01_Trt_2 - AnlsGrouping_01_Trt_3 - id: AnlsGrouping_03_ActTrt_2 label: N level: 1 order: 2 compoundExpression: logicalOperator: NOT whereClauses: - AnlsGrouping_03_ActTrt_1
These subject grouping factors and their predefined groups could be represented in tabular form as shown in the following table where:
- Each instance of the AnalysisGroup class is represented on a separate line, with attribute values for the related instance of the SubjectGroupingFactor class represented on every row. If there are no predefined groups in the grouping factor (i.e., it is data-driven), a single row is included with values only shown for the SubjectGroupingFactor attributes.
- The identifier values of any predefined groups referenced in the whereClauses attribute of compound expressions are shown in a column called "subclause_id".
- Although it would be possible, in this representation, the referenced identifier values have not been used to retrieve the details of the simple conditions from the original group definitions.
id | label | groupingVariable | dataDriven | group_id | group_label | level | order | logicalOperator | subclause_id | dataset | variable | comparator | value |
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AnlsGrouping_01_Trt | Treatment | TRT01A | FALSE | AnlsGrouping_01_Trt_1 | Placebo | 1 | 1 | ADSL | TRT01A | EQ | Placebo | ||
AnlsGrouping_01_Trt | Treatment | TRT01A | FALSE | AnlsGrouping_01_Trt_2 | Xanomeline Low Dose | 1 | 2 | ADSL | TRT01A | EQ | Xanomeline Low Dose | ||
AnlsGrouping_01_Trt | Treatment | TRT01A | FALSE | AnlsGrouping_01_Trt_3 | Xanomeline High Dose | 1 | 3 | ADSL | TRT01A | EQ | Xanomeline High Dose | ||
AnlsGrouping_02_Cntry | Country | COUNTRY | TRUE | ||||||||||
AnlsGrouping_03_ActTrt | Age Group | TRT01A | FALSE | AnlsGrouping_03_ActTrt_1 | Y | 1 | 1 | OR | |||||
AnlsGrouping_03_ActTrt | Age Group | TRT01A | FALSE | AnlsGrouping_03_ActTrt_1 | Y | 2 | 1 | AnlsGrouping_01_Trt_1 | |||||
AnlsGrouping_03_ActTrt | Age Group | TRT01A | FALSE | AnlsGrouping_03_ActTrt_1 | Y | 2 | 2 | AnlsGrouping_01_Trt_2 | |||||
AnlsGrouping_03_ActTrt | Age Group | TRT01A | FALSE | AnlsGrouping_03_ActTrt_2 | N | 1 | 2 | NOT | |||||
AnlsGrouping_03_ActTrt | Age Group | TRT01A | FALSE | AnlsGrouping_03_ActTrt_2 | N | 1 | 2 | AnlsGrouping_03_ActTrt_1 |