analysisOutputCategorizations: Simple

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:

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".