In this example, the sponsor defined 2 categorizations, each of which had 3 categories:
- Group of Analyses
- Population Description
- Safety
- Efficacy
- Estimand Analysis Type
- Primary Estimator
- Sensitivity Analysis
- Supplemental Analysis
These categorizations are represented—with identifier values assigned form both categorizations and categories—in the reporting event's analysisOutputCategorizations attribute:
In the same reporting event, both analyses and outputs were categorized by specifying one or more of the defined category identifier values in the categoryIds attribute:
- Both the "Summary of Subjects by Treatment" analysis and the "Summary of Demographics" output were categorized as "Population Description".
- The "Comparison of Change in Clinical Characteristic X by Treatment" analysis was categorized as both "Efficacy" and "Primary Estimand".
- The "Change in Clinical Characteristic X" output was categorized as "Efficacy".