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

YAML Example
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.

$titleHtml
idlabelcategory_idcategory_label
Catn_01_GrpGroup of AnalysesCatn_01_Grp_1_PopPopulation Description
Catn_01_GrpGroup of AnalysesCatn_01_Grp_2_SafSafety
Catn_01_GrpGroup of AnalysesCatn_01_Grp_3_EffEfficacy
Catn_02_EstEstimand Analysis TypeCatn_02_Est_1_PrimPrimary Estimator
Catn_02_EstEstimand Analysis TypeCatn_02_Est_2_SensSensitivity Analysis
Catn_02_EstEstimand Analysis TypeCatn_02_Est_3_SuppSupplementary Analysis
$warningHtml
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".

YAML Example
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
  ...
  • No labels