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This example shows use of either an existing controlled term or a sponsor-defined term for each of the attributes associated with extensible enumerations:

The "Percent of subjects" operation of the "Summary by group of a categorical variable" analysis method has 2 referenced operation relationships, which identify the operations whose results are used as the numerator and denominator in the calculation of the percentage. For both referenced operation relationships in this example, the referencedOperationRole attribute of the ReferencedOperationRelationship class contain a controlledTerm with a permissible value from the OperationRoleEnum enumeration.
For the "Comparison of Subjects with TEAEs by Treatment - Placebo vs Low Dose" analysis:
- The reason attribute contains a sponsorTermId with the identifier value of a sponsor term defined in the terminology extension for the AnalysisReasonEnum enumerator (as shown in the example in the TerminologyExtension section).
- The purpose attribute contain controlledTerm with a permissible value from the AnalysisPurposeEnum enumeration.
The "Summary of Demographics" output has two file specifications and the fileType attribute for:
- The first file specification contains a controlledTerm with a permissible value from the OutputFileTypeEnum enumeration.
- The second file specification contains a sponsorTermId with the identifier value of a sponsor term defined in the terminology extension for the OutputFileTypeEnum enumerator (as shown in the example in the TerminologyExtension section).

2 terminology extensions, with 1 sponsor term defined for the AnalysisReasonEnum enumeration and 2 sponsor terms defined for the OutputFileTypeEnum enumeration:

``` methods

terminologyExtensions:
- id:

Mth01_CatVar_Summ_ByGrp

SPANREAS

name

 enumeration:

Summary by group of a categorical variable

AnalysisReasonEnum

operations

 sponsorTerms:
  - id:

Mth01_CatVar_Summ_ByGrp_2_pct

SPANREAS1

name

submissionValue:

Percent

DEMONSTRATION

of

subjects

referencedOperationRelationships

description:

 The analysis was

-

included

id: Mth01_CatVar_Summ_ByGrp_2_pct_NUM referencedOperationRole:

in the set as an additional example to
      demonstrate both

controlledTerm:

NUMERATOR

different type of analysis and sponsor

...

terminology

- id: Mth01_CatVar_Summ_ByGrp_2_pct_DEN

for analysis

referencedOperationRole:

reason.

controlledTerm

- id:

DENOMINATOR

SPFTYPE

... ...

enumeration: OutputFileTypeEnum
  sponsorTerms:

... analyses:

- id:

An07_01_TEAE_Comp_ByTrt_PlacLow

SPFTYPE_DOCX

name:

Comparison

of

Subjects with TEAEs by Treatment - Placebo vs Low Dose

submissionValue: docx

reason:

sponsorTermId

description:

SPREAS1

Office Open

purpose:

XML Document

controlledTerm: SECONDARY OUTCOME MEASURE

Format (DOCX)

... outputs:

- id:

Out14-1-1 name: Summary of Demographics version: 1 fileSpecifications: - name: t14-1-1-demog fileType: controlledTerm: rtf ... - name: t14-1-1-demog fileType: sponsorTermId: SPFTYPE_ODT ... ... ... ```

SPFTYPE_ODT
    submissionValue: odt
    description: OpenDocument Text Format (ODT)
...

Code Blockpanel

title	YAML Example

Markdown

These terminology extensions could be represented in tabular form as:

Xfancy

class	dataset

id	enumeration	sponsorTerms
id	enumeration	id	submissionValue	description
SPANREAS	AnalysisReasonEnum	SPANREAS1	DEMONSTRATION	The analysis was included in the set as an additional example to demonstrate both a different type of analysis and sponsor terminology for analysis reason.
SPFTYPE	OutputFileTypeEnum	SPFTYPE_DOCX	docx	Office Open XML Document Format (DOCX)
SPFTYPE	OutputFileTypeEnum	SPFTYPE_ODT	odt	OpenDocument Text Format (ODT)

Xcss
.wiki-content .dataset table>tbody>tr>th{background-color: #cfcfcf;}

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