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This example shows the definition and results for a single analysis, "Summary of Subjects with TEAEs by Treatment and Sex, 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.

Xfancy
classrowcaps
Lines 1-3118:

Show the definitions definition of the 2 single subject grouping factors referenced by the analysis, both of which are not data-driven (dataDriven = false, shown on lines 3 and 17):

Lines 2-18: Show the definition of the "Treatment" grouping factor, which has 3

: 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 lines 3).

Lines 19-3127:

Show the definition of the

"Sex" grouping factor, which has 2 groups: "Male" and "Female".
Lines 32-44:

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 method referenced by
  • the
analysis, "Summary by group of a categorical variable", which has 2 operations:
  • "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 24-27Lines 36-39: Show the definition of the "Count of subjects" operationPreferred Term" data grouping factor, for which group values are found in the AEDECOD variable specified in the groupingVariable attribute on line 27.
Lines 28-40-44:

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

  • Lines 36-39: Show the definition of the "Count of "Percent of subjects" operation.
  • Lines 40-44: Show the definition of the "Percent of subjects" operation.
Lines 42-57 46-58:

Show the definition of the analysis:

  • Lines 49-50: Show that this is an analysis of the USUBJID variable in the ADSL dataset.
  • Line 51: Shows the reference to the "Summary by group of a categorical variable" method.
  • Lines 52-58: Show the references to the 2 grouping factors, both of which are marked as producing a result for each group in the grouping factor (resultsByGroup = true, shown on lines 54 and 57).
Lines 5958-155178

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

  • The identifier value of the statistical operation performed 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 the groupingId and groupId attributes) 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 39 and 43.35 and 39.
Code Block
titleYAML Example
linenumberstrue
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
Code Block
titleYAML Example
linenumberstrue
analysisGroupings:
- id: AnlsGrouping_01_Trt
      dataDrivengroupId: falseAnlsGrouping_01_Trt_1
  label: Treatment
  groupingVariable: TRT01A
  groups:
  - groupingId: AnlsGrouping_06_Soc
      groupValue: CARDIAC DISORDERS
    - idgroupingId: AnlsGrouping_0107_Trt_1Pt
      labelgroupValue: ATRIAL PlaceboFIBRILLATION
    orderrawValue: '1'
    ...formattedValue: '1'
  - idoperationId: AnlsGroupingMth01_CatVar_01Summ_TrtByGrp_2
    label: Xanomeline Low Dose_pct
    orderresultGroups: 2 
    ...
  - idgroupingId: AnlsGrouping_01_Trt_3
    label: Xanomeline High Dose
    order: 3  groupId: AnlsGrouping_01_Trt_1
    ...
dataGroupings:
- idgroupingId: AnlsGrouping_06_Soc
  dataDriven:  true
  labelgroupValue: SystemCARDIAC OrganDISORDERS
 Class
  groupingVariable: AESOC
- idgroupingId: AnlsGrouping_07_Pt
   dataDriven: true
  labelgroupValue: PreferredATRIAL TermFIBRILLATION
  groupingVariable: AEDECOD
methods:
- id: Mth01_CatVar_Summ_ByGrp rawValue: '1.1628'
  name: Summary byformattedValue: group( of a categorical variable 1.2)
  operations:
  - idoperationId: Mth01_CatVar_Summ_ByGrp_1_n
    nameresultGroups:
 Count of subjects
 -   labelgroupingId: nAnlsGrouping_01_Trt
    resultPattern: XXX
  - idgroupId: Mth01AnlsGrouping_CatVar01_Summ_ByGrp_2_pctTrt_1
    name: Percent of subjects
    label: '%'    
- groupingId: AnlsGrouping_06_Soc
      resultPatterngroupValue: ( XX.X)GASTROINTESTINAL DISORDERS
    ...
analyses:
- idgroupingId: An07AnlsGrouping_10_SocPt_Summ_ByTrt07_Pt
  name: Summary of Subjects withgroupValue: TEAEsDIARRHOEA
 by Treatment, System Organ Class and Preferred Term
  version: 1
  dataset: ADAE
  variable: USUBJID
  methodId rawValue: '9'
    formattedValue: '9'
  - operationId: Mth01_CatVar_Summ_ByGrp_2_pct
  orderedGroupings:
  - orderresultGroups:
 1
   - resultsByGroupgroupingId: true
AnlsGrouping_01_Trt
      groupingIdgroupId: AnlsGrouping_01_Trt_1
    - ordergroupingId: 2AnlsGrouping_06_Soc
     resultsByGroup groupValue: GASTROINTESTINAL trueDISORDERS
    - groupingId: AnlsGrouping_0607_SocPt
     - ordergroupValue: 3DIARRHOEA
    resultsByGrouprawValue: true'10.4651'
    groupingIdformattedValue: AnlsGrouping_07_Pt
  results:  ( 10.5)
  - operationId: Mth01_CatVar_Summ_ByGrp_1_n
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_12
    - 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_12
    - groupingId: AnlsGrouping_06_Soc
      groupValue: CARDIAC DISORDERS
    - groupingId: AnlsGrouping_07_Pt
      groupValue: ATRIAL FIBRILLATION
    rawValue: '1.16281905'
    formattedValue: (  1.2)
  - operationId: Mth01_CatVar_Summ_ByGrp_1_n
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_12
    - groupingId: AnlsGrouping_06_Soc
      groupValue: CARDIACGASTROINTESTINAL DISORDERS
    - groupingId: AnlsGrouping_07_Pt
      groupValue: ATRIAL FLUTTERDIARRHOEA
    rawValue: '04'
    formattedValue: '04'
  - operationId: Mth01_CatVar_Summ_ByGrp_2_pct
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_12
    - groupingId: AnlsGrouping_06_Soc
      groupValue: CARDIACGASTROINTESTINAL DISORDERS
    - groupingId: AnlsGrouping_07_Pt
      groupValue: ATRIAL FLUTTERDIARRHOEA
    rawValue: '04.7619'
    formattedValue: (  04.08)
  - operationId: Mth01_CatVar_Summ_ByGrp_1_n
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_13
    - groupingId: AnlsGrouping_06_Soc
      groupValue: CONGENITAL, FAMILIAL AND GENETICCARDIAC DISORDERS
    - groupingId: AnlsGrouping_07_Pt
      groupValue: VENTRICULARATRIAL SEPTAL DEFECTFIBRILLATION
    rawValue: '03'
    formattedValue: '03'
  - operationId: Mth01_CatVar_Summ_ByGrp_2_pct
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_13
    - groupingId: AnlsGrouping_06_Soc
      groupValue: CONGENITAL, FAMILIAL AND GENETICCARDIAC DISORDERS
    - groupingId: AnlsGrouping_07_Pt
      groupValue: VENTRICULARATRIAL SEPTAL DEFECTFIBRILLATION
    rawValue: '03.5714'
    formattedValue: (  03.06)
  - operationId: Mth01_CatVar_Summ_ByGrp_1_n
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_13
    - groupingId: AnlsGrouping_06_Soc
      groupValue: EAR AND LABYRINTHGASTROINTESTINAL DISORDERS
    - groupingId: AnlsGrouping_07_Pt
      groupValue: CERUMEN IMPACTIONDIARRHOEA
    rawValue: '04'
    formattedValue: '04'
  - operationId: Mth01_CatVar_Summ_ByGrp_2_pct
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_13
    - groupingId: AnlsGrouping_06_Soc
      groupValue: EAR AND LABYRINTHGASTROINTESTINAL DISORDERS
    - groupingId: AnlsGrouping_07_Pt
      groupValue: CERUMEN IMPACTIONDIARRHOEA
    rawValue: '04.7619'
    formattedValue: (  04.08)
    ...
 ...

The results for this analysis could be represented in tabular format as shown in the following table, where the groupingId, groupId and groupId groupValue values from the 2 3 two instances of the ResultGroup class found in the resultGroups attribute for each each result are represented in separate pairs of columns ("groupingId1"/"groupId1", "groupingId2"/"groupValue2" and "groupingId2groupingId3"/"groupId2groupValue3") so that each result is represented on a single row:

33
Xfancy
classdataset
operation_id
Dataset2
operationId
groupingId1groupId1groupingId2groupValue2
groupId2
groupingId3groupValue3rawValueformattedValue
Mth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_1AnlsGrouping_
02_Sex
06_SocCARDIAC DISORDERSAnlsGrouping_
02_Sex_1
33
07_PtATRIAL FIBRILLATION11
Mth01_CatVar_Summ_ByGrp_
1
2_
n
pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_1AnlsGrouping_
02_Sex
06_SocCARDIAC DISORDERSAnlsGrouping_
02_Sex_25353
07_PtATRIAL FIBRILLATION1.1628(  1.2)
Mth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt
_2
_1AnlsGrouping_06_SocGASTROINTESTINAL DISORDERSAnlsGrouping_
02
07_
SexAnlsGrouping_02_Sex_13434
PtDIARRHOEA99
Mth01_CatVar_Summ_ByGrp_
1
2_
n
pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_
2
1AnlsGrouping_
02_Sex
06_SocGASTROINTESTINAL DISORDERSAnlsGrouping_
02_Sex_25050
07_PtDIARRHOEA10.4651( 10.5)
Mth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_
3
2AnlsGrouping_
02_Sex
06_SocCARDIAC DISORDERSAnlsGrouping_
02_Sex_14444
07_PtATRIAL FIBRILLATION11
Mth01_CatVar_Summ_ByGrp_
1
2_
n
pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_
3
2AnlsGrouping_
02_Sex
06_SocCARDIAC DISORDERSAnlsGrouping_
02_Sex_24040
07_PtATRIAL FIBRILLATION1.1905(  1.2)
Mth01_CatVar_Summ_ByGrp_
2
1_
pct
nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_
1
2AnlsGrouping_
02_Sex
06_SocGASTROINTESTINAL DISORDERSAnlsGrouping_
02_Sex_138.3720930232558
07_PtDIARRHOEA44
( 38.4)
Mth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_
1
2AnlsGrouping_
02_Sex
06_SocGASTROINTESTINAL DISORDERSAnlsGrouping_
02_Sex_261.6279069767442
07_PtDIARRHOEA4.7619(  4.8
( 61.6
)
Mth01_CatVar_Summ_ByGrp_
2
1_
pct
nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_
2
3AnlsGrouping_
02_Sex
06_SocCARDIAC DISORDERSAnlsGrouping_
02_Sex_140.4761904761905
07_PtATRIAL FIBRILLATION33
( 40.5)
Mth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_
2
3AnlsGrouping_
02_Sex
06_SocCARDIAC DISORDERSAnlsGrouping_
02_Sex_259.5238095238095
07_PtATRIAL FIBRILLATION3.5714(  3.6
( 59.5
)
Mth01_CatVar_Summ_ByGrp_
2
1_
pct
nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_3AnlsGrouping_
02_Sex
06_SocGASTROINTESTINAL DISORDERSAnlsGrouping_
02_Sex_152.3809523809524
07_PtDIARRHOEA44
( 52.4)
Mth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_3AnlsGrouping_
02_Sex
06_SocGASTROINTESTINAL DISORDERSAnlsGrouping
_02
_
Sex
07_
2
PtDIARRHOEA
47
4.
6190476190476
7619(
47
  4.
6
8)

Alternatively, to aid readability, each of the identifier values could be used to retrieve and include additional descriptive information from the definitions of the operations, grouping factors, and predefined groups:

dataset2
Xfancy
class
dataset
operationId
operation_idoperation_labelgroupingId1grouping_label1groupId1group_label1groupingId2grouping_label2groupValue2
groupId2
groupingId3
group
grouping_
label2
label3groupValue3rawValueformattedValue
Mth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_1PlaceboAnlsGrouping_
02_SexSex
06_SocSystem Organ ClassCARDIAC DISORDERSAnlsGrouping_
02_Sex_1
Male33
07_PtPreferred TermATRIAL FIBRILLATION11
33
Mth01_CatVar_Summ_ByGrp_
1
2_
n
pct
n
%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_1PlaceboAnlsGrouping_
02_SexSex
06_SocSystem Organ ClassCARDIAC DISORDERSAnlsGrouping_
02_Sex_2Female53
07_PtPreferred TermATRIAL FIBRILLATION1.1628(  1.2)
53
Mth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_
2
1
Xanomeline Low Dose
PlaceboAnlsGrouping_
02_SexSex
06_SocSystem Organ ClassGASTROINTESTINAL DISORDERSAnlsGrouping_
02_Sex_1Male34
07_PtPreferred TermDIARRHOEA99
34
Mth01_CatVar_Summ_ByGrp_
1
2_
n
pct
n
%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_
2
1
Xanomeline Low Dose
PlaceboAnlsGrouping_
02_SexSex
06_SocSystem Organ ClassGASTROINTESTINAL DISORDERSAnlsGrouping_
02_Sex_2Female50
07_PtPreferred TermDIARRHOEA10.4651( 10.5)
50
Mth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_
3
2Xanomeline
High
Low DoseAnlsGrouping_
02_SexSex
06_SocSystem Organ ClassCARDIAC DISORDERSAnlsGrouping_
02_Sex_1Male4444
07_PtPreferred TermATRIAL FIBRILLATION11
Mth01_CatVar_Summ_ByGrp_
1
2_
n
pct
n
%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_
3
2Xanomeline
High
Low DoseAnlsGrouping_
02_SexSex
06_SocSystem Organ ClassCARDIAC DISORDERSAnlsGrouping_
02_Sex_2Female4040
07_PtPreferred TermATRIAL FIBRILLATION1.1905(  1.2)
Mth01_CatVar_Summ_ByGrp_
2
1_
pct
n
%
nAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_
1
2
Placebo
Xanomeline Low DoseAnlsGrouping_
02_SexSex
06_SocSystem Organ ClassGASTROINTESTINAL DISORDERSAnlsGrouping_
02_Sex_1Male38.3720930232558
07_PtPreferred TermDIARRHOEA44
( 38.4)
Mth01_CatVar_Summ_ByGrp_2_pct%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_
1
2
Placebo
Xanomeline Low DoseAnlsGrouping_
02_SexSex
06_SocSystem Organ ClassGASTROINTESTINAL DISORDERSAnlsGrouping_
02_Sex_2Female61.6279069767442
07_PtPreferred TermDIARRHOEA4.7619(  4.8
( 61.6
)
Mth01_CatVar_Summ_ByGrp_
2
1_
pct
n
%
nAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_
2
3Xanomeline
Low
High DoseAnlsGrouping_
02_SexSex
06_SocSystem Organ ClassCARDIAC DISORDERSAnlsGrouping_
02_Sex_1Male40.4761904761905
07_PtPreferred TermATRIAL FIBRILLATION33
( 40.5)
Mth01_CatVar_Summ_ByGrp_2_pct%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_
2
3Xanomeline
Low
High DoseAnlsGrouping_
02_SexSex
06_SocSystem Organ ClassCARDIAC DISORDERSAnlsGrouping_
02_Sex_2Female59.5238095238095
07_PtPreferred TermATRIAL FIBRILLATION3.5714(  3.6
( 59.5
)
Mth01_CatVar_Summ_ByGrp_
2
1_
pct
n
%
nAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_3Xanomeline High DoseAnlsGrouping_
02_SexSex
06_SocSystem Organ ClassGASTROINTESTINAL DISORDERSAnlsGrouping_
02_Sex_1Male52.3809523809524( 52.4)
07_PtPreferred TermDIARRHOEA44
Mth01_CatVar_Summ_ByGrp_2_pct%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_3Xanomeline High DoseAnlsGrouping_
02_SexSex
06_SocSystem Organ ClassGASTROINTESTINAL DISORDERSAnlsGrouping_
02_Sex_2Female47.6190476190476( 47.6)
07_PtPreferred TermDIARRHOEA4.7619(  4.8)
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