Model Documentation
Class: OutputDisplay
The OutputDisplay class is used:
- In the display attribute of an instance of the OrderedDisplay class representing 1 of the ordered displays within the displays attribute of an output.
- To specify text values to be used in different parts (or "sections") of the display (e.g., titles, footnotes).
ER Diagram: OutputDisplay
An instance of the OutputDisplay class is created for each display in an output and, in each instance:
- The id attribute contains the identifier value assigned for the display.
- The version attribute contains the version number of the display.
- The name attribute indicates the assigned name of the display (e.g., "Table 14.1.2", "Table 14.3.1"). The display name should be unique within the reporting event.
- The description attribute may be used to record a detailed description of the display.
- The label attribute may be used to record a short descriptive label for the display.
- The displayTitle attribute contains a textual description of the display (e.g., "Summary of Demographics and Baseline Characteristics - Safety", "Overall Summary of Treatment-Emergent Adverse Events"). The display name should also be unique within the reporting event.
- The displaySections attribute contains a list of display sections for which text values have been defined.
The following diagram indicates the display sections for which text values may be defined.
Display Sections
Within the displaySections attribute, each section of a display is represented as an instance of the DisplaySection class, which includes the following attributes:
- sectionType, which includes a value from the DisplaySectionTypeEnum enumeration (e.g., "Title", "Footnote", "Abbreviation") to indicate which section of the display contains the specified text values.
- orderedSubSections, which contains a list of ordered text value specifications (or "subsections"), each of which is represented as an instance of one of the specializations of the OrderedDisplaySubSection class:
- OrderedSubSection, which contains a new subsection specification represented in the subSection attribute as an instance of the DisplaySubSection class that contains the text value in the text attribute and an assigned identifier value in the id attribute.
- OrderedSubSectionRef, which contains, in the subSectionId attribute, the identifier of a subsection that has already been defined, either as part of a global display section (as described in the GlobalDisplaySection section) or within another display section.
In both specializations of the OrderedDisplaySubSection class, the order attribute contains an integer to order the subsection with respect to other sub-sections in the display section (i.e., "1" for the first subsection in the display section, "2" for the second subsection, and so on).
Example
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 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 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:
|
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_id | version | name | description | label | displayTitle | sectionType | order | subSection_id | subSection_text |
|---|---|---|---|---|---|---|---|---|---|
| Disp14-1-1 | 1 | Demographics - Male | A summary of demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for male subjects | Demog-M | Summary of Demographics (Male) | Header | 1 | GlobalDisp_Header_1 | Study CDISCPILOT01 |
| Disp14-1-1 | 1 | Demographics - Male | A summary of demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for male subjects | Demog-M | Summary of Demographics (Male) | Title | 1 | Disp14-1-1_Title_1 | Table 14.1.1 |
| Disp14-1-1 | 1 | Demographics - Male | A summary of demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for male subjects | Demog-M | Summary of Demographics (Male) | Title | 2 | Disp14-1-1_Title_2 | Summary of Demographics |
| Disp14-1-1 | 1 | Demographics - Male | A summary of demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for male subjects | Demog-M | Summary of Demographics (Male) | Title | 3 | Disp14-1-1_Title_3 | Male Subjects |
| Disp14-1-1 | 1 | Demographics - Male | A summary of demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for male subjects | Demog-M | Summary of Demographics (Male) | Footer | 1 | Disp14-1-1_Footer_1 | Source dataset: adsl, Generated on: DDMONYYYY:HH:MM |
| Disp14-1-1 | 1 | Demographics - Male | A summary of demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for male subjects | Demog-M | Summary of Demographics (Male) | Rowlabel Header | 1 | Disp14-1-1_RLbHd_1 | Characteristics |
| Disp14-1-2 | 1 | Demographics - Female | A summary of the demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for female subjects | Demog-F | Summary of Demographics (Female) | Header | 1 | GlobalDisp_Header_1 | Study CDISCPILOT01 |
| Disp14-1-2 | 1 | Demographics - Female | A summary of the demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for female subjects | Demog-F | Summary of Demographics (Female) | Title | 1 | Disp14-1-2_Title_1 | Table 14.1.2 |
| Disp14-1-2 | 1 | Demographics - Female | A summary of the demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for female subjects | Demog-F | Summary of Demographics (Female) | Title | 2 | Disp14-1-1_Title_2 | Summary of Demographics |
| Disp14-1-2 | 1 | Demographics - Female | A summary of the demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for female subjects | Demog-F | Summary of Demographics (Female) | Title | 3 | Disp14-1-2_Title_2 | Female Subjects |
| Disp14-1-2 | 1 | Demographics - Female | A summary of the demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for female subjects | Demog-F | Summary of Demographics (Female) | Footer | 1 | Disp14-1-1_Footer_1 | Source dataset: adsl, Generated on: DDMONYYYY:HH:MM |
| Disp14-1-2 | 1 | Summary of Demographics - Female | A summary of the demographic characteristics (age, age group, gender, ethnicity, primary race, and height) for female subjects | Demog-F | Summary of Demographics (Female) | Rowlabel Header | 1 | Disp14-1-1_RLbHd_1 | Characteristics |
| Disp14-3-1-1 | 1 | TEAE Summary | 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) | TEAE_Summ | Overall Summary of Treatment-Emergent Adverse Events | Header | 1 | GlobalDisp_Header_1 | Study CDISCPILOT01 |
| Disp14-3-1-1 | 1 | TEAE Summary | 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) | TEAE_Summ | Overall Summary of Treatment-Emergent Adverse Events | Title | 1 | Disp14-3-1-1_Title_1 | Table 14.3.1.1 |
| Disp14-3-1-1 | 1 | TEAE Summary | 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) | TEAE_Summ | Overall Summary of Treatment-Emergent Adverse Events | Title | 2 | Disp14-3-1-1_Title_2 | Overall Summary of Treatment-Emergent Adverse Events |
| Disp14-3-1-1 | 1 | TEAE Summary | 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) | TEAE_Summ | Overall Summary of Treatment-Emergent Adverse Events | Abbreviation | 1 | Disp14-3-1-1_Abbrv_1 | Note: TEAE=Treatment-Emergent Adverse Events. |
| Disp14-3-1-1 | 1 | TEAE Summary | 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) | TEAE_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. |
| Disp14-3-1-1 | 1 | TEAE Summary | 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) | TEAE_Summ | Overall Summary of Treatment-Emergent Adverse Events | Footer | 1 | Disp14-3-1-1_Footer_1 | Source dataset: adae, Generated on: DDMONYYYY:HH:MM |
| Disp14-3-1-1 | 1 | TEAE Summary | 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) | TEAE_Summ | Overall Summary of Treatment-Emergent Adverse Events | Rowlabel Header | 1 | Disp14-3-1-1_RLbHd_1 | Categories, n (%) |