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This example shows the definitions for 2 outputs. To illustrate the structure of an output specification, all attributes in the Output class are represented for both outputs but, for brevity, some or all of the details have been omitted for the following attributes:

Lines 2-30:

Show the "Summary of Demographics" output, in which:

  • Lines 5-9: Show that the results for the output are represented in a single PDF file, which the sponsor labeled as "t14-1-1-demog". The file (t14-1-1-demog.pdf) is located in the "outputs" sub-folder of the folder that contains the reporting event file.
  • Lines 10-24: Show that the sponsor chose to represent summary statistics for male and female subjects in 2 separate displays within the output.
Lines 31-58:

Show the "Overall Summary of Treatment-Emergent Adverse Events" output, in which:

  • Lines 34-44: Show that the results for the output are represented in 2 files (1 in RTF format and 1 in PDF format), which the sponsor labeled as "t14-3-1-1-teae-summ (RTF)" and "t14-3-1-1-teae-summ (PDF)". Both files are located in the "outputs" sub-folder of the folder that contains the reporting event file. For both files, the sponsor also used the style attribute to record a formatting element that was meaningful to their implementation system.
  • Lines 45-52: Show that the sponsor chose to represent all results for the output in a single display.

YAML Example
outputs:
- id: Out14-1
  version: 1
  name: Summary of Demographics
  displays:
  - order: 1
    display:
      id: Disp14-1-1
      version: 1
      name: Demog-M
      displayTitle: Summary of Demographics (Male)
      displaySections:
      - sectionType: Title
        orderedSubSections:
        - order: 1
          subSectionId: GlobalDisp_Title_1
        - order: 2
          subSection:
            id: Disp14-1_Title_1
            text: Table 14.1.1
        - order: 3
          subSection:
            id: Disp14-1_Title_2
            text: Summary of Demographics
        - order: 4
          subSection:
            id: Disp14-1_Title_3
            text: Male Subjects
      - sectionType: Footnote
        orderedSubSections:
        - order: 1
          subSection:
            id: Disp14-1_Fnote_1
            text: 'Source dataset: adsl, Generated on: DDMONYYYY:HH:MM'
      - sectionType: Rowlabel Header
        orderedSubSections:
        - order: 1
          subSection:
            id: Disp14-1_RLbHd_1
            text: Characteristics
  - order: 2
    display:
      id: Disp14-1-2
      version: 1
      name: Demog-F
      displayTitle: Summary of Demographics (Female)
      displaySections:
      - sectionType: Title
        orderedSubSections:
        - order: 1
          subSectionId: GlobalDisp_Title_1
        - order: 2
          subSectionId: Disp14-1_Title_1
        - order: 3
          subSectionId: Disp14-1_Title_2
        - order: 4
          subSection:
            id: Disp14-1_Title_4
            text: Female Subjects
      - sectionType: Footnote
        orderedSubSections:
        - order: 1
          subSectionId: Disp14-1_Fnote_1
      - sectionType: Rowlabel Header
        orderedSubSections:
        - order: 1
          subSectionId: Disp14-1_RLbHd_1
   ...
- id: Out14-3-1-1
  version: 1
  name: Overall Summary of Treatment-Emergent Adverse Events
  displays:
  - order: 1
    display:
      id: Disp14-3-1-1
      version: 1
      name: AE_Summ
      displayTitle: Overall Summary of Treatment-Emergent Adverse Events
  ...
...
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