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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. This categorization and its sub-categorizations are represented—with identifier values assigned form both categorizations and categories—in the reporting event's analysisOutputCategorizations attribute. In these line captions, categorization labels are shown in bold and category labels are shown in italics.:

Lines 2-4:
  • Analysis Data Class (categorization)
Lines 5-7:
    • Subject-level (category of "Analysis Data Class")
Lines 8-10:
      • Subject-level Data Type (sub-categorization of "Subject-level")
Lines 11-12:
        • Demographics (category of "Subject-level Data Type")
Lines 13-15:
    • Events (category of "Analysis Data Class")
Lines 16-18:
      • Events Data Type (sub-categorization of "Events")
Lines 19-20:
        • Adverse Events (category of "Events Data Type")
Lines 21-22:
        • Clinical Events (category of "Events Data Type")
Lines 23-24:
        • Disposition (category of "Events Data Type")
Lines 25-27:
      • Events Analysis Type (sub-categorization of "Events")
Lines 28-29:
        • Occurrence (category of "Events Analysis Type")
Lines 30-31:
        • Time-to-Event (category of "Events Analysis Type")
Lines 32-34:
    • Findings (category of "Analysis Data Class")
Lines 35-37:
      • Findings Data Type (sub-categorization of "Findings")
Lines 38-39:
        • Vital Signs (category of "Findings Data Type")
Lines 40-41:
        • Laboratory Tests (category of "Findings Data Type")
Lines 42-44:
      • Findings Analysis Type (sub-categorization of "Findings")
Lines 45-46:
        • Change from Baseline (category of "Findings Analysis Type")
Lines 47-48:
        • Shift Table (category of "Findings Analysis Type")

YAML Example
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:

Lines 4-6:Show that the "Summary of Age by Treatment" analysis was categorized as:
  • Subject-level (category of "Analysis Data Class")
  • Demographics (category of "Subject-level Data Type") 
Lines 12-15:

Show the "Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs" output was categorized as:

  • Findings (category of "Analysis Data Class")
  • Vital Signs (category of "Findings Data Type")
  • Shift Table (category of "Findings Analysis Type")

YAML Example
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
  ...
  • No labels