This example shows the definition of 3 analysis sets, each of which is represented as an instance of the AnalysisSet class within the analysisSets attribute of the reporting event. The first 2 analysis sets are simple conditions based on a single specified selection value for a population flag variable, and the third is a compound expression that combines the conditions defined for the first 2 analysis sets.
Lines 2-11: | Show the "Safety Population" analysis set defined as a simple condition that specifies that the value of the SAFFL variable in the ADSL dataset is equal to "Y". This condition could be expressed as:
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Lines 12-21: | Show the "Region X Population" analysis set defined as a simple condition that specifies that the value of the RGXFL variable in the ADSL dataset is equal to "Y". This condition could be expressed as:
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Lines 22-30: | Show the "Region X Safety Population" analysis set defined as a compound expression that uses the "AND" logical operator to combine the conditions specified for the "Region X Population" and "Safety Population" analysis sets (meaning that only subjects meeting both conditions are included in the analysis set ). When the references to the other analysis sets are resolved, this expression could be expressed as:
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analysisSets: - id: AnalysisSet_SAF label: Safety Population level: 1 order: 1 condition: dataset: ADSL variable: SAFFL comparator: EQ value: - Y - id: AnalysisSet_RGX label: Region X Population level: 1 order: 1 condition: dataset: ADSL variable: RGXFL comparator: EQ value: - Y - id: AnalysisSet_RGXSAF label: Region X Safety Population level: 1 order: 1 compoundExpression: logicalOperator: AND whereClauses: - AnalysisSet_RGX - AnalysisSet_SAF
These analysis sets could be represented in tabular form as shown in the following table where:
- Each instance of the AnalysisSet class is represented on a separate row.
- The values of the id and label attributes of the "AnalysisSet_RGXSAF" instance of the analysis set class have be propagated onto all rows representing subclauses defined within the analysis set.
- The identifier values of the analysis sets referenced in the whereClauses attribute of the compound expression are shown in a column called "subclause_id".
- Cells highlighted in yellow contain derived values:
- The level values are calculated as being 1 greater than that of the instance of the analysis set containing the compound expression.
- The order values are assigned according to the order of the analysis set references within the whereClauses attribute.
- The values in the dataset, variable, comparator and value columns have been retrieved from the definitions of the analysis sets using the identifier value specified in the whereClauses attribute.
Row | id | label | level | order | logicalOperator | subclause_id | dataset | variable | comparator | value |
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1 | AnalysisSet_SAF | Safety Population | 1 | 1 | ADSL | SAFFL | EQ | Y | ||
2 | AnalysisSet_RGX | Region X Population | 1 | 1 | ADSL | RGXFL | EQ | Y | ||
3 | AnalysisSet_RGXSAF | Region X Safety Population | 1 | 1 | AND | |||||
4 | AnalysisSet_RGXSAF | Region X Safety Population | 2 | 1 | AnalysisSet_RGX | ADSL | RGXFL | EQ | Y | |
5 | AnalysisSet_RGXSAF | Region X Safety Population | 2 | 2 | AnalysisSet_SAF | ADSL | SAFFL | EQ | Y |