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Model Documentation

The OperationResult class is used in the results attribute of an analysis to represent the results of the analysis.

ER Diagram: OperationResult

An instance of the OperationResult is created for each individual "statistic" value generated by the analysis. There will be at least 1 instance for each statistical operation defined for the method associated with the analysis (i.e., specified in the methodId attribute of the analysis). For analyses in which at least 1 "results-by-group" grouping factor (i.e., a grouping factor that is referenced in the orderedGrouping attribute of the analysis and is indicated as producing a result for every group by having a value of "true" in the resultsByGroup attribute of its instance of the OrderedGroupingFactor class), there will be 1 instance for each combination of statistical operation and groups within each results-by-group grouping factor. For example:

  • In a simple analysis for "Count of subjects in the safety population", where the associated analysis method only has a single operation (i.e., "Count of subjects") and there are no results-by-group grouping factors, there will only be 1 result value (i.e., only one instance of the OperationResult class).
  • In an analysis for "Summary of subjects by treatment and sex", where the analysis method has 2 operations (i.e., "Count of subjects" and "Percent of subjects") and there are 2 results-by-group grouping factors:
    • "Treatment" with 3 groups: "Placebo", "Drug A", and "Drug B"
    • "Sex" with 2 groups: "Male" and "Female"

There will be a total of 12 individual result values (i.e., 12 instances of the OperationResult class); 1 for each combination of operation, treatment group and sex group:

OperationTreatmentSex
Count of subjectsPlaceboMale
Count of subjectsPlaceboFemale
Count of subjectsDrug AMale
Count of subjectsDrug AFemale
Count of subjectsDrug BMale
Count of subjectsDrug BFemale
Percent of subjectsPlaceboMale
Percent of subjectsPlaceboFemale
Percent of subjectsDrug AMale
Percent of subjectsDrug AFemale
Percent of subjectsDrug BMale
Percent of subjectsDrug BFemale
In each instance of the OperationResult class:

  • The operationId attribute contains the identifier value for the operation that generated the result (i.e., 1 of the operations defined in the method associated with the analysis).
  • The resultGroups attribute may contain references to the grouping factor(s)/group(s) associated with the result (see below).
  • The rawValue attribute contains the raw result value generated by the statistical operation, with no formatting or rounding applied.
  • The formattedValue attribute contains the result value formatted according to the pattern specified in the resultPattern attribute of the operation referenced by the operationId attribute value.

The resultGroups attribute is used to associate the result value with any grouping factors defined for the analysis. The association with each grouping factor is represented as an instance of the ResultGroup class, in which:

  • The groupingId attribute contains the identifier value for the subject or data grouping factor.
  • For results-by-group grouping factors, the specific group associated with the result is indicated by the value of either:
    • The groupId attribute, which contains the identifier value for a predefined group within the grouping factor, or
    • The groupValue attribute, which contains 1 of the data values from the grouping variable. The groupValue attribute is used for data-driven grouping factors (i.e., where the value for the dataDriven attribute of the grouping factor is "true"), which do not have predefined groups.

Example

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Example

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Example


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