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: - Population Description
- Safety
- Efficacy
| | Lines 12-19: | Show the "Estimand Analysis Type" categorization with 3 categories: - Primary Estimator
- Sensitivity Analysis
- Supplemental Analysis
|
|
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 |
These categorization and category definitions could be represented in tabular form as shown in the following table where:
- Each instance of the AnalysisOutputCategory class is shown on a separate line, with values for the id and label attributes shown in the category_id and category_label columns, respectively.
- Attribute values each instance of the AnalysisOutputCategorization class are represented on each of the rows for the categories in the categorization.
| id | label | category_id | category_label |
|---|
| Catn_01_Grp | Group of Analyses | Catn_01_Grp_1_Pop | Population Description | | Catn_01_Grp | Group of Analyses | Catn_01_Grp_2_Saf | Safety | | Catn_01_Grp | Group of Analyses | Catn_01_Grp_3_Eff | Efficacy | | Catn_02_Est | Estimand Analysis Type | Catn_02_Est_1_Prim | Primary Estimator | | Catn_02_Est | Estimand Analysis Type | Catn_02_Est_2_Sens | Sensitivity Analysis | | Catn_02_Est | Estimand Analysis Type | Catn_02_Est_3_Supp | 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
... |