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Comment: Changed "labeled" to "named" for assignment of values in the name attribute and added examples of the use of label (GitHub #217)

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  • display within the displays attribute: refer to the OutputDisplay section for a full example of a display specification.
  • categoryIds: refer to the AnalysisOutputCategorization section for examples of the categorization of outputs.
  • documentRefs: refer to the DocumentReference section for examples of informational documentation document references specified for an output.
  • programmingCode: refer to the AnalysisOutputProgrammingCode section for examples of the representation of programming code for analyses and outputs.
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Lines 2-3033:

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

  • Lines 5-910: Show that the results for the output are represented in a single PDF file, which the sponsor named as "Table 14.1.1 Demographics" (line 6) and labeled as "t14-1-1-demog" (line 7). 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 11-2427: Show that the sponsor chose to represent summary statistics for male and female subjects in 2 separate displays within the output.
Lines 3134-5864:

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

  • Lines 34-44Show that the results for the output are represented in 2 files (1 in RTF format and 1 in PDF format), which the sponsor labeled named as "t14-3-1-1-teae-summ (RTF)" and "t14-3-1-1-teae-summ (PDF)". The sponsor chose to label both files as "t14-3-1-1-teae-summ" (lines 39 and 45). 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 4551-5258: Show that the sponsor chose to represent all results for the output in a single display.
Code Block
titleYAML Example
linenumberstrue
outputs:
- id: Out14-1
  name: Summary of Demographics
  version: 1
  fileSpecifications:
  - name: Table 14.1.1 Demographics
    label: t14-1-1-demog
    fileType:
      controlledTerm: pdf
    location: ./outputs/t14-1-1-demog.pdf
  displays:
  - order: 1
    display:
      id: Disp14-1-1
      name: Demographics - Male
      label: Demog-M
      version: 1
      displayTitle: Summary of Demographics (Male)
      ...
  - order: 2
    display:
      id: Disp14-1-2
      name: Demographics - Female
      label: Demog-F
      version: 1
      displayTitle: Summary of Demographics (Female)
      ...
  categoryIds:
    ...
  documentRefs:
    ...
  programmingCode:
    ...
- id: Out14-3-1-1
  name: Overall Summary of Treatment-Emergent Adverse Events
  version: 1
  fileSpecifications:
  - name: t14-3-1-1-teae-summ (RTF)
    label: t14-3-1-1-teae-summ
   fileType fileType:
      controlledTerm: rtf
    location: ./outputs/t14-3-1-1-teae-summ.rtf
    style: '{fontsize: small}'
  - name: t14-3-1-1-teae-summ (PDF)
    label: t14-3-1-1-teae-summ
    fileType:
      controlledTerm: pdf
    location: ./outputs/t14-3-1-1-teae-summ.pdf
    style: '{fontsize: small}' 
  displays:
  - order: 1
    display:
      id: Disp14-3-1-1
      name: TEAE Summary
      label: AETEAE_Summ
      version: 1
      displayTitle: Overall Summary of Treatment-Emergent Adverse Events
      ...
  categoryIds:
    ...
  documentRefs:
    ...
  programmingCode:
    ...
...