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:

  • 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 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.

Lines 2-33:

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

  • Lines 5-10: 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 11-27: Show that the sponsor chose to represent summary statistics for male and female subjects in 2 separate displays within the output.
Lines 34-64:

Show the definition of 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 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 51-58: Show that the sponsor chose to represent all results for the output in a single display.

YAML Example
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:
      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: TEAE_Summ
      version: 1
      displayTitle: Overall Summary of Treatment-Emergent Adverse Events
      ...
  categoryIds:
    ...
  documentRefs:
    ...
  programmingCode:
    ...
...
  • No labels