This example shows use of either an existing controlled term or a sponsor-defined term for each of the attributes associated with extensible enumerations:
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| Lines 2-14: | Show the "Percent of subjects" operation of the "Summary by group of a categorical variable" analysis method, which 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 |
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| class contain a controlledTerm with a permissible value from the OperationRoleEnum enumeration. |
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the "Comparison of Subjects with TEAEs by Treatment - Placebo vs Low Dose" analysis: |
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- Lines 21-22: The reason attribute contains a sponsorTermId
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- with the identifier value of a sponsor term defined in the terminology extension for the AnalysisReasonEnum enumerator (as shown in the example in
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- Lines 23-24: The purpose attribute contain controlledTerm with a permissible value from the AnalysisPurposeEnum enumeration.
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| Lines 27-37: | Show the "Summary of Demographics" output, which has two file specifications and the fileType attribute for: - Lines 32-33: The first file specification contains
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- with a permissible value from the OutputFileTypeEnum enumeration.
- Lines 36-37: The second file specification contains
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- with the identifier value of a sponsor term defined in the terminology extension for the OutputFileTypeEnum enumerator (as shown in the example in
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| markdown |
```
methods:
- id: Mth01_CatVar_Summ_ByGrp
name: Summary by group of a categorical variable
operations:
- id: Mth01_CatVar_Summ_ByGrp_2_pct
name: Percent of subjects
referencedOperationRelationships:
- id: Mth01_CatVar_Summ_ByGrp_2_pct_NUM
referencedOperationRole:
controlledTerm: NUMERATOR
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- id: Mth01_CatVar_Summ_ByGrp_2_pct_DEN
referencedOperationRole:
controlledTerm: DENOMINATOR
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analyses:
- id: An07_01_TEAE_Comp_ByTrt_PlacLow
name: Comparison of Subjects with TEAEs by Treatment - Placebo vs Low Dose
reason:
sponsorTermId: SPANREAS1
purpose:
controlledTerm: SECONDARY OUTCOME MEASURE
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outputs:
- id: Out14-1-1
name: Summary of Demographics
version: 1
fileSpecifications:
- name: t14-1-1-demog
fileType:
controlledTerm: rtf
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- name: t14-1-1-demog
fileType:
sponsorTermId: SPFTYPE_ODT
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``` |