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 examples of informational 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 2-30: | 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.
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| title | YAML Example |
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| linenumbers | true |
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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
...
... |