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 events analysisOutputCategorizations attribute:
analysisOutputCategorizations:
- id: Catn_01_Grp
label: Group of Analyses
categories:
- id: Catn_01_Grp_1_Pop
label: Population Description
- id: Catn_01_Grp_2_Saf
label: Safety
- id: Catn_01_Grp_3_Eff
label: Efficacy
- id: Catn_02_Est
label: Estimand Analysis Type
categories:
- id: Catn_02_Est_1_Prim
label: Primary Estimator
- id: Catn_02_Est_2_Sens
label: Sensitivity Analysis
- id: Catn_02_Est_3_Supp
label: Supplementary Analysis
In the same reporting event, both analyses and outputs were categorized using one or more of the defined category identifier values:
analyses:
- id: An01_05_SAF_Summ_ByTrt
name: Summary of Subjects by Treatment
categoryIds:
- Catn_01_Grp_1_Pop
...
- id: An02_03_SAF_Summ_ByTrt
name: Comparison of Change in Clinical Characteristic X by Treatment
categoryIds:
- Catn_01_Grp_3_Eff
- Catn_02_Est_1_Prim
...
...
- id: Out14-1-5
name: Summary of Demographics
categoryIds:
- Catn_01_Grp_1_Pop
...
- id: Out14-2-3
name: Change in Clinical Characteristic X
categoryIds:
- Catn_01_Grp_3_Eff
...
- Both the "Summary of Subjects by Treatment" analysis and the "Summary of Demographics" output where 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".