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:3 displays, 2 within the "Summary of Demographics" output and 1 within the "Overall Summary of Treatment-Emergent Adverse Events" output.
| Xfancy |
|---|
|
| Lines 26-3040: | Show the definition of the first display in the "Summary of Demographics" output, in whichwhich is shown as version 1 of the "Demog-M" display. The display has been assigned an identifier value of "Disp14-1-1" and a display title of "Summary of Demographics (Male)". Four titles, 1 footnote and 1 row label header have been specified for this display: - Lines 515-916: Show the first title specified as a reference to the identifier of a sub-section 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.
- has already been defined; the sub-section identified as "GlobalDisp_Title_1" whose definition as "Study CDISCPILOT01" is shown in Example 1 in the GlobalDisplaySection section.
- Lines 17-28: Show the specifications for the second, third and fourth titles, all of which are newly defined sub-sections.
- Lines 29-34: Show the specification of a new sub-section as the display's first footnote.
- Lines 35-40: Show the specification of a new sub-section as the display's first row label header.
| | Lines 41-67: | Show the definition of the second display in the "Summary of Demographics" output, which is shown as version 1 of the "Demog-F" display. The display has been assigned an identifier value of "Disp14-1-2" and a display title of "Summary of Demographics (Female)". Four titles, 1 footnote and 1 row label header have also been specified for this display: - Lines 50-55: Show the first three titles specified as references to the identifiers of a sub-sections that have already been defined:
- The global sub-section identified as "GlobalDisp_Title_1" is reused as the first title.
- The second and third titles are specified as reuses of the corresponding titles defined in the "Demog-M" display (as shown in lines 19-20 and 23-24).
- Lines 56-59: Show the specification for fourth title, which is newly defined within this display.
- Lines 60-67: Show specification of a footnote and a row label header, both as reuses of the corresponding sub-sections defined in the "Demog-M" display.
| | Lines 72-113: | Show the definition of the first display in the | Lines 31-58: | Show the "Overall Summary of Treatment-Emergent Adverse Events" output, which is shown as version 1 of the "AE_Summ" display. The display has been assigned an identifier value of "Disp14-3-1-1 a display title of "Overall Summary of Treatment-Emergent Adverse Events". Three titles, 1 abbreviation, 2 footnotes and 1 row label header have also been specified for this display: - Lines 97-90: Show the 3 titles specified for the display, the first as a reuse of the "GlobalDisp_Title_1" global sub-section, and the second and third as newly defined within the display.
- Lines 91-96: Show the specification of a new sub-section as the display's first abbreviation.
- Lines 97-107: Show the specifications for the first and second, both of which are newly defined sub-sections.
- Lines 108-113: Show the specification of a new sub-section as the display's first row label header
|
|
| Code Block |
|---|
| title | YAML Example |
|---|
| linenumbers | true |
|---|
|
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: Disp14-1-1_Title_1
text: Table 14.1.1
- order: 3
subSection:
id: Disp14-1-1_Title_2
text: Summary of Demographics
- order: 4
subSection:
id: Disp14-1-1_Title_3
text: Male Subjects
- sectionType: Footnote
orderedSubSections:
- order: 1
subSection:
id: Disp14-1-1_Fnote_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: Demog-F
displayTitle: Summary of Demographics (Female)
displaySections:
- sectionType: Title
orderedSubSections:
- order: 1
subSectionId: GlobalDisp_Title_1
- ordersubSection:
2
subSectionIdid: Disp14-1-2_Title_1
text: Table 14.1.2
- order: 3
subSectionId: Disp14-1-1_Title_2
- order: 4
subSection:
id: Disp14-1-2_Title_42
text: Female Subjects
- sectionType: Footnote
orderedSubSections:
- order: 1
subSectionId: Disp14-1-1_Fnote_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: AE_Summ
displayTitle: Overall Summary of Treatment-Emergent Adverse Events
displaySections:
- sectionType: Title
orderedSubSections:
- order: 1
subSectionId: GlobalDisp_Title_1
- order: 2
subSection:
id: Disp14-3-1-1_Title_1
text: Table 14.3.1.1
- order: 3
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.'
- order: 2
subSection:
id: Disp14-3-1-1_Fnote_2
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 (%)
...
... |
This display section specifications could be represented in tabular form as:
| Xfancy |
|---|
|
| output_id | display_id | version | name | displayTitle | sectionType | order | subSection_id | subSection_text | subSectionId |
|---|
| Out14-1 | Disp14-1-1 | 1 | Demog-M | Summary of Demographics (Male) | Title | 1 |
|
| GlobalDisp_Title_1 | | Out14-1 | Disp14-1-1 | 1 | Demog-M | Summary of Demographics (Male) | Title | 2 | Disp14-1-1_Title_1 | Table 14.1.1 |
| | Out14-1 | Disp14-1-1 | 1 | Demog-M | Summary of Demographics (Male) | Title | 3 | Disp14-1-1_Title_2 | Summary of Demographics |
| | Out14-1 | Disp14-1-1 | 1 | Demog-M | Summary of Demographics (Male) | Title | 4 | Disp14-1-1_Title_3 | Male Subjects |
| | Out14-1 | Disp14-1-1 | 1 | Demog-M | Summary of Demographics (Male) | Footnote | 1 | Disp14-1-1_Fnote_1 | Source dataset: adsl, Generated on: DDMONYYYY:HH:MM |
| | Out14-1 | Disp14-1-1 | 1 | Demog-M | Summary of Demographics (Male) | Rowlabel Header | 1 | Disp14-1-1_RLbHd_1 | Characteristics |
| | Out14-1 | Disp14-1-2 | 1 | Demog-F | Summary of Demographics (Female) | Title | 1 |
|
| GlobalDisp_Title_1 | | Out14-1 | Disp14-1-2 | 1 | Demog-F | Summary of Demographics (Female) | Title | 2 | Disp14-1-2_Title_1 | Table 14.1.2 |
| | Out14-1 | Disp14-1-2 | 1 | Demog-F | Summary of Demographics (Female) | Title | 3 |
|
| Disp14-1-1_Title_2 | | Out14-1 | Disp14-1-2 | 1 | Demog-F | Summary of Demographics (Female) | Title | 4 | Disp14-1-2_Title_2 | Female Subjects |
| | Out14-1 | Disp14-1-2 | 1 | Demog-F | Summary of Demographics (Female) | Footnote | 1 |
|
| Disp14-1-1_Fnote_1 | | Out14-1 | Disp14-1-2 | 1 | Demog-F | Summary of Demographics (Female) | Rowlabel Header | 1 | Disp14-1-1_RLbHd_1 |
|
| | Out14-3-1-1 | Disp14-3-1-1 | 1 | AE_Summ | Overall Summary of Treatment-Emergent Adverse Events | Title | 1 |
|
| GlobalDisp_Title_1 | | Out14-3-1-1 | Disp14-3-1-1 | 1 | AE_Summ | Overall Summary of Treatment-Emergent Adverse Events | Title | 2 | Disp14-3-1-1_Title_1 | Table 14.3.1.1 |
| | Out14-3-1-1 | Disp14-3-1-1 | 1 | AE_Summ | Overall Summary of Treatment-Emergent Adverse Events | Title | 3 | Disp14-3-1-1_Title_2 | Overall Summary of Treatment-Emergent Adverse Events |
| | Out14-3-1-1 | Disp14-3-1-1 | 1 | AE_Summ | Overall Summary of Treatment-Emergent Adverse Events | Abbreviation | 1 | Disp14-3-1-1_Abbrv_1 | Note: TEAE=Treatment-Emergent Adverse Events. |
| | Out14-3-1-1 | Disp14-3-1-1 | 1 | AE_Summ | Overall Summary of Treatment-Emergent Adverse Events | Footnote | 1 | Disp14-3-1-1_Fnote_1 | [a] Dose Modification includes Dose Reduced; Drug Interrupted in the AE action taken with study treatment. |
| | Out14-3-1-1 | Disp14-3-1-1 | 1 | AE_Summ | Overall Summary of Treatment-Emergent Adverse Events | Footnote | 2 | Disp14-3-1-1_Fnote_2 | Source dataset: adae, Generated on: DDMONYYYY:HH:MM |
| | Out14-3-1-1 | Disp14-3-1-1 | 1 | AE_Summ | Overall Summary of Treatment-Emergent Adverse Events | Rowlabel Header | 1 | Disp14-3-1-1_RLbHd_1 | Categories, n (%) |
|
|