In this example, the sponsor defined 2 categorizations, which are represented—with identifier values assigned for both categorizations and categories—in the reporting event's analysisOutputCategorizations attribute:
| Lines 2-10: | Show the "Group of Analyses" categorization with 3 categories:
|
| Lines 12-19: | Show the "Estimand Analysis Type" categorization with 3 categories:
|
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 by specifying one or more of the defined category identifier values in the categoryIds attribute:
| Lines 5, 18: | Show that both the "Summary of Subjects by Treatment" analysis and the "Summary of Demographics" output were categorized as "Population Description". |
| Lines 10-11: | Show that the "Comparison of Change in Clinical Characteristic X by Treatment" analysis was categorized as both "Efficacy" and "Primary Estimand". |
| Line 23: | Shows that the "Change in Clinical Characteristic X" output was categorized as "Efficacy". |
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 ... ... outputs: - 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 ...