This example shows the specification of an analysis method that contains 2 operations, 1 of which is a dependent operation. The definitions of 2 analyses are also includeincluded, 1 of which is an analysis that uses the example method and the other is the analysis that produces some of the results used by the dependent operation.
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| Lines 2-1132: | Show the "Summary by group of a categorical variable" analysis method, which has a single documentation document reference indicating that relevant information can be found on pages 9 and 11 of the reference document identified as "CDISCPILOT01_SAP". | | Lines 15-32: | Show the "Summary of Change from Baseline by Treatment, Parameter and Visit" analysis, which has document references for 2 reference documents, indicating that: - Lines 18-27: In the reference document identified as "CDISCPILOT01_SAP", relevant information can be found on pages 9 and 17. The sponsor created 2 page separate page references in order to assign a specific label to each.
- Lines 28-32: In the reference document identified as "CDISCPILOT01_CSR", relevant information can be found at the named destination "Table 14-7.02". The sponsor chose not to specify a label for this page reference.
| | Lines 36-44: | Show the "Summary of Demographics" output, which has a single documentation document reference indicating that relevant information can be found on pages 46 to 48 of the reference document identified as "CDISCPILOT01_CSR". | contains 2 operations: - Lines 8-12: Show the definition of the "Count of subjects" operation.
- Lines 13-32: Show the definition of the "Percent of subjects" operation, which is a dependent operation; it references the results of 2 other operations to act as the numerator and denominator in the calculation of the percentage:
- Lines 19-25: Show the definition of the referenced operation relationship that specifies that the results of the operation identified as "Mth01_CatVar_Summ_ByGrp_1_n" (line 22) act as the numerator (lines 20-21) in the calculation of the percentage. The analysisId attribute is not included, which indicates that the referenced analysis identifier differs depending on the analysis that uses this operation (so this referenced analysis identifier must be specified in the definition of any analysis that uses this operation). The description (lines 23-25) indicates the type of analysis that can provide the numerator for the calculation.
- Lines 26-32: Show the definition of the referenced operation relationship that specifies that the results of the operation identified as "Mth01_CatVar_Count_ByGrp_1_n" (line 29) act as the denominator (lines 27-28) in the calculation of the percentage. Again, the analysisId attribute is not included, which indicates that the referenced analysis identifier differs depending on the analysis that performs this operation (so this referenced analysis identifier must also be specified in the definition of any analysis that uses this operation). The description (lines 30-32) indicates the type of analysis that can provide the denominator for the calculation.
| | Lines 35-45: | Show the definition of the "Summary of Subjects by Treatment" analysis, which is identified as "An01_05_SAF_Summ_ByTrt". This analysis definition is included in the example because it uses the method identified as "Mth01_CatVar_Count_ByGrp", which contains the referenced operation that provides the denominator for the calculation of the percentage, as described above and referenced as "Mth01_CatVar_Count_ByGrp_1_n" on line 27. The definition of the method identified as "Mth01_CatVar_Count_ByGrp" is shown in Example 1 in the AnalysisMethod section. | | Lines 46-65: | Show the definition of "Summary of Subjects by Treatment and Age Group" analysis, which is identified as "An03_02_AgeGrp_Summ_ByTrt" (line 46) and includes 2 referenced analysis operations: - Lines 61-62: Show that the analysis identified as "An03_02_AgeGrp_Summ_ByTrt" (line 62)—i.e., this same analysis—provides the results used as the numerator in the "Percent of subjects" operation (as specified in the referenced operation relationship identified as "Mth01_CatVar_Summ_ByGrp_2_pct_NUM" (line 61) whose definition is shown on lines 19-25).
- Lines 63-64: Show that the analysis identified as "An01_05_SAF_Summ_ByTrt" (line 64)—i.e., the analysis defined on lines 35-45—provides the results used as the denominator in the "Percent of subjects" operation (as specified in the referenced operation relationship identified as "Mth01_CatVar_Summ_ByGrp_2_pct_DEN" (line 63) whose definition is shown on lines 26-32).
| Lines 45-49: | Show the "Overall Summary of Treatment-Emergent Adverse Events" output, which has a single documentation document reference indicating that relevant information can be found in the reference document identified as "AE_Summary_Table_Shell". No page reference was specified, which indicates that the whole reference document contains relevant information. |
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| title | YAML Example |
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| linenumbers | true |
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methods:
- id: Mth01_CatVar_Summ_ByGrp
name: Summary by group of a categorical variable
label: Grouped summary of categorical variable
description: Descriptive summary statistics across groups for a categorical variable,
based on subject occurrence
label: Grouped summary of categorical variable
operations:
- id: Mth01_CatVar_Summ_ByGrp_1_n
name: Count of subjects
label: n
order: 1
resultPattern: XXX
- id: Mth01_CatVar_Summ_ByGrp_2_pct
name: Percent of subjects
label: '%'
order: 2
resultPattern: ( XX.X)
referencedOperationRelationships:
- id: Mth01_CatVar_Summ_ByGrp_2_pct_NUM
referencedOperationRole:
controlledTerm: NUMERATOR
operationId: Mth01_CatVar_Summ_ByGrp_1_n
description: The count operation whose result provides the numerator for calculation
of the percentage. The referenced analysis should be the analysis that contains
this percent operation.
- id: Mth01_CatVar_Summ_ByGrp_2_pct_DEN
referencedOperationRole:
controlledTerm: DENOMINATOR
operationId: Mth01_CatVar_Count_ByGrp_1_n
description: The count operation whose result provides the denominator for calculation
of the percentage. The referenced analysis should have the same analysis set
and subject grouping(s) as the analysis containing this percent operation.
...
analyses:
- id: An01_05_SAF_Summ_ByTrt
version: 1
name: Summary of Subjects by Treatment
methodId: Mth01_CatVar_Count_ByGrp
dataset: ADSL
variable: USUBJID
analysisSetId: AnalysisSet_02_SAF
orderedGroupings:
- order: 1
resultsByGroup: true
groupingId: AnlsGrouping_01_Trt
- id: An03_02_AgeGrp_Summ_ByTrt
version: 1
name: Summary of Subjects by Treatment and Age Group
methodId: Mth01_CatVar_Summ_ByGrp
dataset: ADSL
variable: USUBJID
analysisSetId: AnalysisSet_02_SAF
orderedGroupings:
- order: 1
resultsByGroup: true
groupingId: AnlsGrouping_01_Trt
- order: 2
resultsByGroup: true
groupingId: AnlsGrouping_03_AgeGp
referencedAnalysisOperations:
- referencedOperationRelationshipId: Mth01_CatVar_Summ_ByGrp_2_pct_NUM
analysisId: An03_02_AgeGrp_Summ_ByTrt
- referencedOperationRelationshipId: Mth01_CatVar_Summ_ByGrp_2_pct_DEN
analysisId: An01_05_SAF_Summ_ByTrt
...
... |