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In this example, the sponsor defined a top-level "Analysis Data Class" categorization, with one or more sub-categorizations for each of the data class categories. In this list, categorization labels are shown in bold and category labels are shown in italics.:

  • Analysis Data Class
    • Subject-level
      • Subject-level Data Type (sub-categorization of "Subject-level")
        • Demographics
    • Events
      • Events Data Type (sub-categorization of "Events")
        • Adverse Events
        • Clinical Events
        • Disposition
      • Events Analysis Type (sub-categorization of "Events")
        • Occurrence
        • Time-to-Event
    • Findings
      • Findings Data Type (sub-categorization of "Findings")
        • Vital Signs
        • Laboratory Tests
      • Findings Analysis Type (sub-categorization of "Findings")
        • Change from Baseline
        • Shift Table

This categorization and its sub-categorizations are represented—with identifier values assigned form both categorizations and categories—in the reporting event's analysisOutputCategorizations attribute:

analysisOutputCategorizations:
- id: Catn_02_DClass
  label: Analysis Data Class
  categories:
  - id: Catn_02_Dclass_1_Sbj
    label: Subject-level
    subCategorizations:
    - id: Catn_03_SbjDType
      label: Subject-level Data Type
      categories:
      - id: Catn_03_SbjDType_1_Dm
        label: Demographics
  - id: Catn_02_Dclass_2_Evt
    label: Events
    subCategorizations:
    - id: Catn_04_EvtDType
      label: Events Data Type
      categories:
      - id: Catn_04_EvtDType_1_Ae
        label: Adverse Events
      - id: Catn_04_EvtDType_2_Ce
        label: Clinical Events
      - id: Catn_04_EvtDType_3_Ds
        label: Disposition
    - id: Catn_05_EvtAType
      label: Events Analysis Type
      categories:
      - id: Catn_05_EvtAType_1_Occ
        label: Occurrence
      - id: Catn_05_EvtAType_2_Tte
        label: Time-to-Event
  - id: Catn_02_Dclass_3_Fnd
    label: Findings
    subCategorizations:
    - id: Catn_06_FndDType
      label: Findings Data Type
      categories:
      - id: Catn_06_FndDType_1_Vs
        label: Vital Signs
      - id: Catn_06_FndDType_2_Lb
        label: Laboratory Tests
    - id: Catn_07_FndAType
      label: Findings Analysis Type
      categories:
      - id: Catn_07_FndAType_1_Chg
        label: Change from Baseline
      - id: Catn_07_FndAType_2_Sft
        label: Shift Table

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:

  • The "Summary of Age by Treatment" analysis was categorized as:
    • "Subject-level" (Analysis Data Class) and
    • "Demographics" (Subject-level Data Type).
  • The "Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs" output was categorized as:
    • "Findings" (Analysis Data Class),
    • "Vital Signs" (Findings Data Type), and
    • "Shift Table" (Findings Analysis Type).
analyses:
- id: An03_01_Age_Summ_ByTrt
  name: Summary of Age by Treatment
  categoryIds:
  - Catn_02_Dclass_1_Sbj
  - Catn_03_SbjDType_1_Dm
  ...
...
outputs:
- id: Out14-3-3-1a
  name: Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs
  categoryIds:
   - Catn_02_Dclass_3_Fnd
   - Catn_06_FndDType_1_Vs
   - Catn_07_FndAType_2_Sft
  ...
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