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Lines 2-1131:

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 8-11: Show the definition of the "Count of subjects" operation.
  • Lines 12-30: 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 17-23: 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 20) act as the numerator (lines 18-19) 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 performs this operation (whose definition must therefore specify the referenced analysis identifier). The description (lines 21-23) indicates the type of analysis that can provide the numerator for the calculation.
    • Lines 24-30: 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 27) act as the denominator (lines 25-26) 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 (whose definition must therefore also specify the referenced analysis identifier for this relationship). The description (lines 29-30) indicates the type of analysis that can provide the denominator for the calculation.
Lines 33-43:

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 44-63:

Show the definition of "Summary of Subjects by Treatment and Age Group" analysis, which is identified as "An03_02_AgeGrp_Summ_ByTrt" (line 44) and includes 2 referenced analysis operations:

  • Lines 59-60: Show that the analysis identified as "An03_02_AgeGrp_Summ_ByTrt" (line 60)—i.e., this 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 59) whose definition is shown on lines 17-23). 
  • Lines 61-62: Show that the analysis identified as "An01_05_SAF_Summ_ByTrt" (line 62)—i.e., the analysis defined on lines 33-43—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 61) whose definition is shown on lines 24-30). 
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.
Code Block
titleYAML Example
linenumberstrue
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
  operations:
  - id: Mth01_CatVar_Summ_ByGrp_1_n
    name: Count of subjects
    label: n
    resultPattern: XXX
  - id: Mth01_CatVar_Summ_ByGrp_2_pct
    name: Percent of subjects
    label: '%'
    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
  ...
...