This example shows the definitions for 3 displays, 2 within the "Summary of Demographics" output and 1 within the "Overall Summary of Treatment-Emergent Adverse Events" output.

Lines 6-44:

Show the definition of the first display in the "Summary of Demographics" output, which is shown as version 1 of the "Demographics - Male" display. The display has been assigned an identifier value of "Disp14-1-1" (line 8) and a display title of "Summary of Demographics (Male)" (line 13). The sponsor has also chosen to assign a description and label for this display (lines 11-12). One header, 3 titles, 1 footer and 1 row label header have been specified for this display:

  • Lines 15-18: Show the header, which is specified as a reference to the identifier of a subsection that has already been defined; the subsection identified as "GlobalDisp_Header_1" whose definition as "Study CDISCPILOT01" is shown in Example 1 in the GlobalDisplaySection section.
  • Lines 19-32: Show the specifications for the 3 titles, all of which are newly defined subsections.
  • Lines 33-38: Show the specification of a new subsection as the display's first footer.
  • Lines 39-44: Show the specification of a new subsection as the display's first row label header.
Lines 45-77:

Show the definition of the second display in the "Summary of Demographics" output, which is shown as version 1 of the "Demographics - Female" display. The display has been assigned an identifier value of "Disp14-1-2" (line 47) and a display title of "Summary of Demographics (Female)" (line 52). The sponsor has also chosen to assign a description and label for this display (lines 50-51). One header, 3 titles, 1 footer and 1 row label header have also been specified for this display:

  • Lines 54-57: Show the specification for the display's single header, which is defined as a reuse of the global subsection identified as "GlobalDisp_Header_1".
  • Lines 58-69: Show the specifications for the display's 3 titles:
    • The first and third titles (lines 60-63 and 66-69) are specified as subsections newly defined within this display.
    • The second title (lines 64-65) is specified as a reuse of the corresponding title defined in the "Demographics - Male" display (whose definition is shown in lines 27-28).
  • Lines 70-77: Show specification of a footer and a row label header, both as reuses of the corresponding subsections defined in the "Demographics - Male" display (whose definitions are shown on rows 37-38 and 43-44, respectively).
Lines 83-130:

Show the definition of the first display in the "Overall Summary of Treatment-Emergent Adverse Events" output, which is shown as version 1 of the "TEAE Summary" display. The display has been assigned an identifier value of "Disp14-3-1-1" (line 85) and a display title of "Overall Summary of Treatment-Emergent Adverse Events" (line 90). The sponsor has also chosen to assign a description and label for this display (lines 88-89). One header, 2 titles, 1 abbreviation, 1 footnote, 1 footer, and 1 row label header have also been specified for this display:

  • Lines 92-95: Show the header specified for the display, which is defined as a reuse of the "GlobalDisp_Header_1" global subsection.
  • Lines 96-105: Show the 2 titles specified for the display, both of which are newly defined within the display.
  • Lines 106-111: Show the specification of a new subsection as the display's first abbreviation.
  • Lines 112-118: Show the specification of a new subsection as the display's first footnote.
  • Lines 119-124: Show the specification of a new subsection as the display's first footer.
  • Lines 125-130: Show the specification of a new subsection as the display's first row label header.

YAML Example
outputs:
- id: Out14-1
  version: 1
  name: Summary of Demographics
  displays:
  - order: 1
    display:
      id: Disp14-1-1
      version: 1
      name: Demographics - Male
      description: A summary of demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for male subjects
      label: Demog-M
      displayTitle: Summary of Demographics (Male)
      displaySections:
      - sectionType: Header
        orderedSubSections:
        - order: 1
          subSectionId: GlobalDisp_Header_1
      - sectionType: Title
        orderedSubSections: 
        - order: 1
          subSection:
            id: Disp14-1-1_Title_1
            text: Table 14.1.1
        - order: 2
          subSection:
            id: Disp14-1-1_Title_2
            text: Summary of Demographics
        - order: 3
          subSection:
            id: Disp14-1-1_Title_3
            text: Male Subjects
      - sectionType: Footer
        orderedSubSections:
        - order: 1
          subSection:
            id: Disp14-1-1_Footer_1
            text: 'Source dataset: adsl, Generated on: DDMONYYYY:HH:MM'
      - sectionType: Rowlabel Header
        orderedSubSections:
        - order: 1
          subSection:
            id: Disp14-1-1_RLbHd_1
            text: Characteristics
  - order: 2
    display:
      id: Disp14-1-2
      version: 1
      name: Demographics - Female
      description: A summary of the demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for female subjects
      label: Demog-F
      displayTitle: Summary of Demographics (Female)
      displaySections:
      - sectionType: Header
        orderedSubSections:
        - order: 1
          subSectionId: GlobalDisp_Header_1
      - sectionType: Title
        orderedSubSections:
        - order: 1
          subSection:
            id: Disp14-1-2_Title_1
            text: Table 14.1.2 
        - order: 2
          subSectionId: Disp14-1-1_Title_2
        - order: 3
          subSection:
            id: Disp14-1-2_Title_2
            text: Female Subjects
      - sectionType: Footer
        orderedSubSections:
        - order: 1
          subSectionId: Disp14-1-1_Footer_1
      - sectionType: Rowlabel Header
        orderedSubSections:
        - order: 1
          subSectionId: Disp14-1-1_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: TEAE Summary
      description: A summary of treatment-emergent AEs of different types (overall, related, serious, related serious, leading to death, related leading to death, leading to dose modification, and leading to treatment discontinuation) 
      label: TEAE_Summ
      displayTitle: Overall Summary of Treatment-Emergent Adverse Events
      displaySections:
      - sectionType: Header
        orderedSubSections:
        - order: 1
          subSectionId: GlobalDisp_Header_1
      - sectionType: Title
        orderedSubSections:
        - order: 1
          subSection:
            id: Disp14-3-1-1_Title_1
            text: Table 14.3.1.1
        - order: 2
          subSection:
            id: Disp14-3-1-1_Title_2
            text: Overall Summary of Treatment-Emergent Adverse Events
      - sectionType: Abbreviation
        orderedSubSections:
        - order: 1
          subSection:
            id: Disp14-3-1-1_Abbrv_1
            text: 'Note: TEAE=Treatment-Emergent Adverse Events.'
      - sectionType: Footnote
        orderedSubSections:
        - order: 1
          subSection:
            id: Disp14-3-1-1_Fnote_1
            text: '[a] Dose Modification includes Dose Reduced; Drug Interrupted in
              the AE action taken with study treatment.'
      - sectionType: Footer
        orderedSubSections:
        - order: 1
          subSection:
            id: Disp14-3-1-1_Footer_1
            text: 'Source dataset: adae, Generated on: DDMONYYYY:HH:MM'
      - sectionType: Rowlabel Header
        orderedSubSections:
        - order: 1
          subSection:
            id: Disp14-3-1-1_RLbHd_1
            text: Categories, n (%) 
  ...
...

These display section specifications could be represented in tabular form as follows, where:

  • The subSection_id column is populated with values of both the id attribute of the OrderedSubSection class (in plain text) and the subSectionId attribute of the OrderedSubSectionRef class (in italics), and
  • The italicized values in the cells highlighted in blue in the subSection_text column have been retrieved from the original definition using the subSectionId value. 

display_idversionnamedescriptionlabeldisplayTitlesectionTypeordersubSection_idsubSection_text
Disp14-1-11Demographics - MaleA summary of demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for male subjectsDemog-MSummary of Demographics (Male)Header1GlobalDisp_Header_1Study CDISCPILOT01
Disp14-1-11Demographics - MaleA summary of demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for male subjectsDemog-MSummary of Demographics (Male)Title1Disp14-1-1_Title_1Table 14.1.1
Disp14-1-11Demographics - MaleA summary of demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for male subjectsDemog-MSummary of Demographics (Male)Title2Disp14-1-1_Title_2Summary of Demographics
Disp14-1-11Demographics - MaleA summary of demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for male subjectsDemog-MSummary of Demographics (Male)Title3Disp14-1-1_Title_3Male Subjects
Disp14-1-11Demographics - MaleA summary of demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for male subjectsDemog-MSummary of Demographics (Male)Footer1Disp14-1-1_Footer_1Source dataset: adsl, Generated on: DDMONYYYY:HH:MM
Disp14-1-11Demographics - MaleA summary of demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for male subjectsDemog-MSummary of Demographics (Male)Rowlabel Header1Disp14-1-1_RLbHd_1Characteristics
Disp14-1-21Demographics - FemaleA summary of the demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for female subjectsDemog-FSummary of Demographics (Female)Header1GlobalDisp_Header_1Study CDISCPILOT01
Disp14-1-21Demographics - FemaleA summary of the demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for female subjectsDemog-FSummary of Demographics (Female)Title1Disp14-1-2_Title_1Table 14.1.2
Disp14-1-21Demographics - FemaleA summary of the demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for female subjectsDemog-FSummary of Demographics (Female)Title2Disp14-1-1_Title_2Summary of Demographics
Disp14-1-21Demographics - FemaleA summary of the demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for female subjectsDemog-FSummary of Demographics (Female)Title3Disp14-1-2_Title_2Female Subjects
Disp14-1-21Demographics - FemaleA summary of the demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for female subjectsDemog-FSummary of Demographics (Female)Footer1Disp14-1-1_Footer_1Source dataset: adsl, Generated on: DDMONYYYY:HH:MM
Disp14-1-21Summary of Demographics - FemaleA summary of the demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for female subjectsDemog-FSummary of Demographics (Female)Rowlabel Header1Disp14-1-1_RLbHd_1Characteristics
Disp14-3-1-11TEAE SummaryA summary of treatment-emergent AEs of different types (overall, related, serious, related serious, leading to death, related leading to death, leading to dose modification, and leading to treatment discontinuation)TEAE_SummOverall Summary of Treatment-Emergent Adverse EventsHeader1GlobalDisp_Header_1Study CDISCPILOT01
Disp14-3-1-11TEAE SummaryA summary of treatment-emergent AEs of different types (overall, related, serious, related serious, leading to death, related leading to death, leading to dose modification, and leading to treatment discontinuation)TEAE_SummOverall Summary of Treatment-Emergent Adverse EventsTitle1Disp14-3-1-1_Title_1Table 14.3.1.1
Disp14-3-1-11TEAE SummaryA summary of treatment-emergent AEs of different types (overall, related, serious, related serious, leading to death, related leading to death, leading to dose modification, and leading to treatment discontinuation)TEAE_SummOverall Summary of Treatment-Emergent Adverse EventsTitle2Disp14-3-1-1_Title_2Overall Summary of Treatment-Emergent Adverse Events
Disp14-3-1-11TEAE SummaryA summary of treatment-emergent AEs of different types (overall, related, serious, related serious, leading to death, related leading to death, leading to dose modification, and leading to treatment discontinuation)TEAE_SummOverall Summary of Treatment-Emergent Adverse EventsAbbreviation1Disp14-3-1-1_Abbrv_1Note: TEAE=Treatment-Emergent Adverse Events.
Disp14-3-1-11TEAE SummaryA summary of treatment-emergent AEs of different types (overall, related, serious, related serious, leading to death, related leading to death, leading to dose modification, and leading to treatment discontinuation)TEAE_SummOverall Summary of Treatment-Emergent Adverse EventsFootnote1Disp14-3-1-1_Fnote_1[a] Dose Modification includes Dose Reduced; Drug Interrupted in the AE action taken with study treatment.
Disp14-3-1-11TEAE SummaryA summary of treatment-emergent AEs of different types (overall, related, serious, related serious, leading to death, related leading to death, leading to dose modification, and leading to treatment discontinuation)TEAE_SummOverall Summary of Treatment-Emergent Adverse EventsFooter1Disp14-3-1-1_Footer_1Source dataset: adae, Generated on: DDMONYYYY:HH:MM
Disp14-3-1-11TEAE SummaryA summary of treatment-emergent AEs of different types (overall, related, serious, related serious, leading to death, related leading to death, leading to dose modification, and leading to treatment discontinuation)TEAE_SummOverall Summary of Treatment-Emergent Adverse EventsRowlabel Header1Disp14-3-1-1_RLbHd_1Categories, n (%)

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