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 ). |
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" analysis set class have be propagated onto all rows representing sub-clauses 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 |
---|---|---|---|---|---|---|---|---|---|---|
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 |