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This example shows the definition and results for a single analysis, "Summary of Subjects with TEAEs by Treatment, System Organ Class and Preferred Term", including the definitions of the grouping factors and method referenced by the analysis. This example illustrates the use of the groupingId and groupValue attributes of the ResultGroup class to associate results with groups in data-driven, results-by-group groupings.

Lines 1-18:

Show the definition of the single subject grouping factors referenced by the analysis: the "Treatment" subject grouping factor, which has 3 groups: "Placebo", "Xanomeline Low Dose", and "Xanomeline High Dose". This grouping factor is not data-driven (dataDriven = false on line 3).

Lines 19-27:

Show the definition of the 2 data grouping factors referenced by the analysis, both of which are data-driven (dataDriven = true, as shown on lines 21 and 25).

  • Lines 20-23: Show the definition of the "System Organ Class" data grouping factor, for which group values are found in the AESOC variable specified in the groupingVariable attribute on line 23.
  • Lines 24-27: Show the definition of the "Preferred Term" data grouping factor, for which group values are found in the AEDECOD variable specified in the groupingVariable attribute on line 27.
Lines 28-40:

Show the definition of the method referenced by the analysis, "Summary by group of a categorical variable", which has 2 operations:

  • Lines 32-35: Show the definition of the "Count of subjects" operation.
  • Lines 36-40: Show the definition of the "Percent of subjects" operation.
Lines 42-57:

Show the definition of the analysis:

  • Lines 45-46: Show that this is an analysis of the USUBJID variable in the ADSL dataset.
  • Line 47: Shows the reference to the "Summary by group of a categorical variable" method.
  • Lines 48-57: Show the references to the 3 grouping factors, both of which are marked as producing a result for each group in the grouping factor (resultsByGroup = true, shown on lines 50, 53 and 56).
Lines 58-178

Show a list of a subset of the results for the analysis. Each entry in the list (starting with the operationId attribute preceded by a hyphen) represents an instance of the OperationResult class and contains:

  • The identifier value of the statistical operation performed, which is in the operationId attribute.
  • In the resultGroups attribute, a reference to both grouping factor groups associated with the result (indicated by the values of the groupingId attribute and:
    • groupId for the "Treatment" grouping factor (which has predefined groups)
    • groupValue for the other 2 data-driven groupings factors.
  • The raw result value in the rawValue attribute, and
  • In the formattedValue attribute, the result value formatted according to the pattern specified in the resultPattern attribute of the operation referenced by the operationId value. The specified patterns are shown on rows 35 and 39.

YAML Example
analysisGroupings:
- id: AnlsGrouping_01_Trt
  dataDriven: false
  label: Treatment
  groupingVariable: TRT01A
  groups:
  - id: AnlsGrouping_01_Trt_1
    label: Placebo
    order: 1
    ...
  - id: AnlsGrouping_01_Trt_2
    label: Xanomeline Low Dose
    order: 2 
    ...
  - id: AnlsGrouping_01_Trt_3
    label: Xanomeline High Dose
    order: 3 
    ...
dataGroupings:
- id: AnlsGrouping_06_Soc
  dataDriven: true
  label: System Organ Class
  groupingVariable: AESOC
- id: AnlsGrouping_07_Pt
  dataDriven: true
  label: Preferred Term
  groupingVariable: AEDECOD
methods:
- id: Mth01_CatVar_Summ_ByGrp
  name: Summary by group of a categorical variable
  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)
    ...
analyses:
- id: An07_10_SocPt_Summ_ByTrt
  name: Summary of Subjects with TEAEs by Treatment, System Organ Class and Preferred Term
  version: 1
  dataset: ADAE
  variable: USUBJID
  methodId: Mth01_CatVar_Summ_ByGrp
  orderedGroupings:
  - order: 1
    resultsByGroup: true
    groupingId: AnlsGrouping_01_Trt
  - order: 2
    resultsByGroup: true
    groupingId: AnlsGrouping_06_Soc
  - order: 3
    resultsByGroup: true
    groupingId: AnlsGrouping_07_Pt
  results:
  - operationId: Mth01_CatVar_Summ_ByGrp_1_n
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_1
    - groupingId: AnlsGrouping_06_Soc
      groupValue: CARDIAC DISORDERS
    - groupingId: AnlsGrouping_07_Pt
      groupValue: ATRIAL FIBRILLATION
    rawValue: '1'
    formattedValue: '1'
  - operationId: Mth01_CatVar_Summ_ByGrp_2_pct
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_1
    - groupingId: AnlsGrouping_06_Soc
      groupValue: CARDIAC DISORDERS
    - groupingId: AnlsGrouping_07_Pt
      groupValue: ATRIAL FIBRILLATION
    rawValue: '1.1628'
    formattedValue: (  1.2)
  - operationId: Mth01_CatVar_Summ_ByGrp_1_n
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_1
    - groupingId: AnlsGrouping_06_Soc
      groupValue: GASTROINTESTINAL DISORDERS
    - groupingId: AnlsGrouping_07_Pt
      groupValue: DIARRHOEA
    rawValue: '9'
    formattedValue: '9'
  - operationId: Mth01_CatVar_Summ_ByGrp_2_pct
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_1
    - groupingId: AnlsGrouping_06_Soc
      groupValue: GASTROINTESTINAL DISORDERS
    - groupingId: AnlsGrouping_07_Pt
      groupValue: DIARRHOEA
    rawValue: '10.4651'
    formattedValue: ( 10.5)
  - operationId: Mth01_CatVar_Summ_ByGrp_1_n
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_2
    - groupingId: AnlsGrouping_06_Soc
      groupValue: CARDIAC DISORDERS
    - groupingId: AnlsGrouping_07_Pt
      groupValue: ATRIAL FIBRILLATION
    rawValue: '1'
    formattedValue: '1'
  - operationId: Mth01_CatVar_Summ_ByGrp_2_pct
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_2
    - groupingId: AnlsGrouping_06_Soc
      groupValue: CARDIAC DISORDERS
    - groupingId: AnlsGrouping_07_Pt
      groupValue: ATRIAL FIBRILLATION
    rawValue: '1.1905'
    formattedValue: (  1.2)
  - operationId: Mth01_CatVar_Summ_ByGrp_1_n
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_2
    - groupingId: AnlsGrouping_06_Soc
      groupValue: GASTROINTESTINAL DISORDERS
    - groupingId: AnlsGrouping_07_Pt
      groupValue: DIARRHOEA
    rawValue: '4'
    formattedValue: '4'
  - operationId: Mth01_CatVar_Summ_ByGrp_2_pct
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_2
    - groupingId: AnlsGrouping_06_Soc
      groupValue: GASTROINTESTINAL DISORDERS
    - groupingId: AnlsGrouping_07_Pt
      groupValue: DIARRHOEA
    rawValue: '4.7619'
    formattedValue: (  4.8)
  - operationId: Mth01_CatVar_Summ_ByGrp_1_n
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_3
    - groupingId: AnlsGrouping_06_Soc
      groupValue: CARDIAC DISORDERS
    - groupingId: AnlsGrouping_07_Pt
      groupValue: ATRIAL FIBRILLATION
    rawValue: '3'
    formattedValue: '3'
  - operationId: Mth01_CatVar_Summ_ByGrp_2_pct
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_3
    - groupingId: AnlsGrouping_06_Soc
      groupValue: CARDIAC DISORDERS
    - groupingId: AnlsGrouping_07_Pt
      groupValue: ATRIAL FIBRILLATION
    rawValue: '3.5714'
    formattedValue: (  3.6)
  - operationId: Mth01_CatVar_Summ_ByGrp_1_n
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_3
    - groupingId: AnlsGrouping_06_Soc
      groupValue: GASTROINTESTINAL DISORDERS
    - groupingId: AnlsGrouping_07_Pt
      groupValue: DIARRHOEA
    rawValue: '4'
    formattedValue: '4'
  - operationId: Mth01_CatVar_Summ_ByGrp_2_pct
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_3
    - groupingId: AnlsGrouping_06_Soc
      groupValue: GASTROINTESTINAL DISORDERS
    - groupingId: AnlsGrouping_07_Pt
      groupValue: DIARRHOEA
    rawValue: '4.7619'
    formattedValue: (  4.8)
    ...
 ...

The results for this analysis could be represented in tabular format as shown in the following table, where the groupingId and groupId or groupValue values from the 3 instances of the ResultGroup class found in the resultGroups attribute for each result are represented in separate pairs of columns ("groupingId1"/"groupId1", "groupingId2"/"groupValue2" and "groupingId3"/"groupValue3") so that each result is represented on a single row:

operationIdgroupingId1groupId1groupingId2groupValue2groupingId3groupValue3rawValueformattedValue
Mth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_1AnlsGrouping_06_SocCARDIAC DISORDERSAnlsGrouping_07_PtATRIAL FIBRILLATION11
Mth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_1AnlsGrouping_06_SocCARDIAC DISORDERSAnlsGrouping_07_PtATRIAL FIBRILLATION1.1628(  1.2)
Mth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_1AnlsGrouping_06_SocGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtDIARRHOEA99
Mth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_1AnlsGrouping_06_SocGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtDIARRHOEA10.4651( 10.5)
Mth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_2AnlsGrouping_06_SocCARDIAC DISORDERSAnlsGrouping_07_PtATRIAL FIBRILLATION11
Mth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_2AnlsGrouping_06_SocCARDIAC DISORDERSAnlsGrouping_07_PtATRIAL FIBRILLATION1.1905(  1.2)
Mth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_2AnlsGrouping_06_SocGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtDIARRHOEA44
Mth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_2AnlsGrouping_06_SocGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtDIARRHOEA4.7619(  4.8)
Mth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_3AnlsGrouping_06_SocCARDIAC DISORDERSAnlsGrouping_07_PtATRIAL FIBRILLATION33
Mth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_3AnlsGrouping_06_SocCARDIAC DISORDERSAnlsGrouping_07_PtATRIAL FIBRILLATION3.5714(  3.6)
Mth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_3AnlsGrouping_06_SocGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtDIARRHOEA44
Mth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_3AnlsGrouping_06_SocGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtDIARRHOEA4.7619(  4.8)
Alternatively, to aid readability, each of the identifier values could be used to retrieve and include the label (or any other descriptive information) from the definitions of the operations, grouping factors, and predefined groups:
operationIdoperation_labelgroupingId1grouping_label1groupId1group_label1groupingId2grouping_label2groupValue2groupingId3grouping_label3groupValue3rawValueformattedValue
Mth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_1PlaceboAnlsGrouping_06_SocSystem Organ ClassCARDIAC DISORDERSAnlsGrouping_07_PtPreferred TermATRIAL FIBRILLATION11
Mth01_CatVar_Summ_ByGrp_2_pct%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_1PlaceboAnlsGrouping_06_SocSystem Organ ClassCARDIAC DISORDERSAnlsGrouping_07_PtPreferred TermATRIAL FIBRILLATION1.1628(  1.2)
Mth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_1PlaceboAnlsGrouping_06_SocSystem Organ ClassGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtPreferred TermDIARRHOEA99
Mth01_CatVar_Summ_ByGrp_2_pct%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_1PlaceboAnlsGrouping_06_SocSystem Organ ClassGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtPreferred TermDIARRHOEA10.4651( 10.5)
Mth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_2Xanomeline Low DoseAnlsGrouping_06_SocSystem Organ ClassCARDIAC DISORDERSAnlsGrouping_07_PtPreferred TermATRIAL FIBRILLATION11
Mth01_CatVar_Summ_ByGrp_2_pct%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_2Xanomeline Low DoseAnlsGrouping_06_SocSystem Organ ClassCARDIAC DISORDERSAnlsGrouping_07_PtPreferred TermATRIAL FIBRILLATION1.1905(  1.2)
Mth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_2Xanomeline Low DoseAnlsGrouping_06_SocSystem Organ ClassGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtPreferred TermDIARRHOEA44
Mth01_CatVar_Summ_ByGrp_2_pct%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_2Xanomeline Low DoseAnlsGrouping_06_SocSystem Organ ClassGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtPreferred TermDIARRHOEA4.7619(  4.8)
Mth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_3Xanomeline High DoseAnlsGrouping_06_SocSystem Organ ClassCARDIAC DISORDERSAnlsGrouping_07_PtPreferred TermATRIAL FIBRILLATION33
Mth01_CatVar_Summ_ByGrp_2_pct%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_3Xanomeline High DoseAnlsGrouping_06_SocSystem Organ ClassCARDIAC DISORDERSAnlsGrouping_07_PtPreferred TermATRIAL FIBRILLATION3.5714(  3.6)
Mth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_3Xanomeline High DoseAnlsGrouping_06_SocSystem Organ ClassGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtPreferred TermDIARRHOEA44
Mth01_CatVar_Summ_ByGrp_2_pct%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_3Xanomeline High DoseAnlsGrouping_06_SocSystem Organ ClassGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtPreferred TermDIARRHOEA4.7619(  4.8)

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