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.
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| Lines 1-3129: | Show the definitions definition of the 2 3 grouping factors referenced by the analysis, both of which are not data-driven (dataDriven = false, shown on lines 3 and 17):. - Lines 2-19: Show the Lines 2-18: Show the definition of the "Treatment" 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 6).
- Lines 1920-3124: Show the definition of the "SexSystem Organ Class" grouping factor, which has 2 groups: "Male" and "Female".for which group values are found in the ADAE AESOC variable specified in the groupingDataset and groupingVariable attributes on lines 22 and 23. This grouping factor is data-driven (dataDriven = true on line 24).
- Lines 25-29: Show the definition of the "Preferred Term" grouping factor, for which group values are found in the ADAE AEDECOD variable specified in the groupingDataset and groupingVariable attributes on lines 27 and 28. This grouping factor is data-driven (dataDriven = true on line 29).
| | Lines 31-44: | Show the definition of the method referenced by the analysis, "Summary by group of a categorical variable", which has 2 operations: | Lines 32-44: | 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 subjects" operation.
- Lines 40-44: Show the definition of the "Count of subjects" operation.
- Lines 39-43: Show the definition of the "Percent of subjects" operation.
| | Lines 46-5861: | 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 52-5861: Show the references to the 2 3 grouping factors, both of which are marked as producing a result for each group in the grouping factor (resultsByGroup = true, shown on lines 54, 57 and 5760).
| | Lines 5962-155183 | 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, which is in the 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 and groupId attributes)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 39 38 and 43.
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analysisGroupings:
- id: AnlsGrouping_01_Trt
dataDrivenname: falseTreatment
labelgroupingDataset: TreatmentADSL
groupingVariable: TRT01A
dataDriven: false
groups:
- id: AnlsGrouping_01_Trt_1
labelname: Placebo
order: 1
...
- id: AnlsGrouping_01_Trt_2
labelname: Xanomeline Low Dose
order: 2
...
- id: AnlsGrouping_01_Trt_3
labelname: Xanomeline High Dose
order: 3
...
dataGroupings:
- id: AnlsGrouping_06_Soc
dataDriven: true
labelname: System Organ Class
groupingVariablegroupingDataset: AESOCADAE
- groupingVariable: AESOC
dataDriven: true
- id: AnlsGrouping_07_Pt
dataDrivenname: Preferred trueTerm
labelgroupingDataset: Preferred TermADAE
groupingVariable: AEDECOD
dataDriven: true
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
order: 1
resultPattern: XXX
- id: Mth01_CatVar_Summ_ByGrp_2_pct
name: Percent of subjects
label: '%'
order: 2
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: CARDIACGASTROINTESTINAL DISORDERS
- groupingId: AnlsGrouping_07_Pt
groupValue: ATRIAL FLUTTERDIARRHOEA
rawValue: '09'
formattedValue: '09'
- operationId: Mth01_CatVar_Summ_ByGrp_2_pct
resultGroups:
- groupingId: AnlsGrouping_01_Trt
groupId: AnlsGrouping_01_Trt_1
- groupingId: AnlsGrouping_06_Soc
groupValue: CARDIACGASTROINTESTINAL DISORDERS
- groupingId: AnlsGrouping_07_Pt
groupValue: ATRIAL FLUTTERDIARRHOEA
rawValue: '010.4651'
formattedValue: ( 010.05)
- operationId: Mth01_CatVar_Summ_ByGrp_1_n
resultGroups:
- groupingId: AnlsGrouping_01_Trt
groupId: AnlsGrouping_01_Trt_12
- groupingId: AnlsGrouping_06_Soc
groupValue: CONGENITAL, FAMILIAL AND GENETICCARDIAC DISORDERS
- groupingId: AnlsGrouping_07_Pt
groupValue: VENTRICULARATRIAL SEPTAL DEFECTFIBRILLATION
rawValue: '01'
formattedValue: '01'
- operationId: Mth01_CatVar_Summ_ByGrp_2_pct
resultGroups:
- groupingId: AnlsGrouping_01_Trt
groupId: AnlsGrouping_01_Trt_12
- groupingId: AnlsGrouping_06_Soc
groupValue: CONGENITAL, FAMILIAL AND GENETICCARDIAC DISORDERS
- groupingId: AnlsGrouping_07_Pt
groupValue: VENTRICULARATRIAL SEPTAL DEFECTFIBRILLATION
rawValue: '01.1905'
formattedValue: ( 01.02)
- operationId: Mth01_CatVar_Summ_ByGrp_1_n
resultGroups:
- groupingId: AnlsGrouping_01_Trt
groupId: AnlsGrouping_01_Trt_12
- groupingId: AnlsGrouping_06_Soc
groupValue: EARGASTROINTESTINAL AND LABYRINTH DISORDERS
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_12
- 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 and groupId values from the 2 two instances of the ResultGroup class found in the resultGroups attribute for each each result are represented in separate pairs of columns ("groupingId1"/"groupId1" and "groupingId2"/"groupId2") so that each result is represented on a single row:
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 value of the id attribute of the analysis is shown in the "analysisId" column and 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:
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| analysisId | operationId | groupingId1 | groupId1 | groupingId2 | groupValue2 | groupingId3 | groupValue3 | rawValue | formattedValue |
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| An07_10_SocPt_Summ_ByTrt | Mth01_CatVar_Summ_ByGrp_1_n | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_1 | AnlsGrouping_06_Soc | CARDIAC DISORDERS | AnlsGrouping_07_Pt | ATRIAL FIBRILLATION | 1 | 1 | | An07_10_SocPt_Summ_ByTrt | Mth01_CatVar_Summ_ByGrp_2_pct | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_1 | AnlsGrouping_06_Soc | CARDIAC DISORDERS | AnlsGrouping_07_Pt | ATRIAL FIBRILLATION | 1.1628 | ( 1.2) | | An07_10_SocPt_Summ_ByTrt | Mth01_CatVar_Summ_ByGrp_1_n | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_1 | AnlsGrouping_06_Soc | GASTROINTESTINAL DISORDERS | AnlsGrouping_07_Pt | DIARRHOEA | 9 | 9 | | An07_10_SocPt_Summ_ByTrt | Mth01_CatVar_Summ_ByGrp_2_pct | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_1 | AnlsGrouping_06_Soc | GASTROINTESTINAL DISORDERS | AnlsGrouping_07_Pt | DIARRHOEA | 10.4651 | ( 10.5) | | An07_10_SocPt_Summ_ByTrt |
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| operationId | groupingId1 | groupId1 | groupingId2 | groupId2 | rawValue | formattedValue | Mth01_CatVar_Summ_ByGrp_1_n | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_12 | AnlsGrouping_02_Sex06_Soc | CARDIAC DISORDERS | AnlsGrouping_0207_Sex_1 | 33 | 33 | Mth01_CatVar_Summ_ByGrp_1_n | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_1 | AnlsGrouping_02_Sex | AnlsGrouping_02_Sex_2 | 53 | Pt | ATRIAL FIBRILLATION | 1 | 1 |
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| An07_10_SocPt_Summ_ByTrt53 | Mth01_CatVar_Summ_ByGrp_12_npct | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_2 | AnlsGrouping_02_Sex06_Soc | CARDIAC DISORDERS | AnlsGrouping_02_Sex_1 | 34 | 07_Pt | ATRIAL FIBRILLATION | 1.1905 | ( 1.2) | | An07_10_SocPt_Summ_ByTrt34 | Mth01_CatVar_Summ_ByGrp_1_n | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_2 | AnlsGrouping_06_Soc | GASTROINTESTINAL DISORDERS | AnlsGrouping_02_Sex | AnlsGrouping_02_Sex_2 | 50 | 07_Pt | DIARRHOEA | 4 | 4 | | An07_10_SocPt_Summ_ByTrt50 | Mth01_CatVar_Summ_ByGrp_12_npct | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_32 | AnlsGrouping_02_Sex06_Soc | GASTROINTESTINAL DISORDERS | AnlsGrouping_02_Sex_1 | 44 | 07_Pt | DIARRHOEA | 4.7619 | ( 4.8) | | An07_10_SocPt_Summ_ByTrt44 | Mth01_CatVar_Summ_ByGrp_1_n | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_3_3 | AnlsGrouping_06_Soc | CARDIAC DISORDERS | AnlsGrouping_02_Sex | AnlsGrouping_02_Sex_2 | 40 | 07_Pt | ATRIAL FIBRILLATION | 3 | 3 | | An07_10_SocPt_Summ_ByTrt40 | Mth01_CatVar_Summ_ByGrp_2_pct | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_13 | AnlsGrouping_02_Sex06_Soc | CARDIAC DISORDERS | AnlsGrouping_02_Sex_1 | 38.3720930232558 | 07_Pt | ATRIAL FIBRILLATION | 3.5714 | ( 3.6) | | An07_10_SocPt_Summ_ByTrt( 38.4) | Mth01_CatVar_Summ_ByGrp_21_pctn | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_13 | AnlsGrouping_02_Sex06_Soc | GASTROINTESTINAL DISORDERS | AnlsGrouping_02_Sex_2 | 61.6279069767442 | 07_Pt | DIARRHOEA | 4 | 4 | | An07_10_SocPt_Summ_ByTrt( 61.6) | Mth01_CatVar_Summ_ByGrp_2_pct | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_23 | AnlsGrouping_02_Sex06_Soc | GASTROINTESTINAL DISORDERS | AnlsGrouping_02_Sex_1 | 40.4761904761905 | ( 40.5) | | Mth01_CatVar_Summ_ByGrp_2_pct | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_2 | AnlsGrouping_02_Sex | AnlsGrouping_02_Sex_2 | 59.5238095238095 | ( 59.5) | | 07_Pt | DIARRHOEA | 4.7619 | ( 4.8) |
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Alternatively, to aid readability, each of the identifier values could be used to retrieve and include the name or label (or any other descriptive information) from the definitions of the operations, grouping factors, and predefined groups:
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| analysisId | operationId | operation_label | groupingId1 | grouping_name1 | groupId1 | group_name1 | groupingId2 | grouping_name2 | groupValue2 | groupingId3 | grouping_name3 | groupValue3 | rawValue | formattedValue |
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| An07_10_SocPt_Summ_ByTrt | Mth01_CatVar_Summ_ByGrp_2_pct | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_3 | AnlsGrouping_02_Sex | AnlsGrouping_02_Sex_1 | 52.3809523809524 | ( 52.4) | Mth01_CatVar_Summ_ByGrp_21_pctn | n | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_3 | AnlsGrouping_02_Sex | AnlsGrouping_02_Sex_2 | 47.6190476190476 | ( 47.6) |
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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 groups:
| _1 | Placebo | AnlsGrouping_06_Soc | System Organ Class | CARDIAC DISORDERS | AnlsGrouping_07_Pt | Preferred Term | ATRIAL FIBRILLATION | 1 | 1 | | An07_10_SocPt_Summ_ByTrt |
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| operationId | operation_label | groupingId1 | grouping_label1 | groupId1 | group_label1 | groupingId2 | grouping_label2 | groupId2 | group_label2 | rawValue | formattedValue | Mth01_CatVar_Summ_ByGrp_12_npctn | % | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_1_1 | Placebo | AnlsGrouping_06_Soc | System Organ Class | CARDIAC DISORDERS | AnlsGrouping_07_Pt | Preferred Term | ATRIAL FIBRILLATION | 1.1628 | ( 1.2) |
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| An07_10_SocPt_Summ_ByTrt | Placebo | AnlsGrouping_02_Sex | Sex | AnlsGrouping_02_Sex_1 | Male | 33 | 33 | Mth01_CatVar_Summ_ByGrp_1_n | n | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_1 | Placebo | AnlsGrouping_02_Sex | Sex | AnlsGrouping_02_Sex_2 | Female | 53 | 06_Soc | System Organ Class | GASTROINTESTINAL DISORDERS | AnlsGrouping_07_Pt | Preferred Term | DIARRHOEA | 9 | 9 | | An07_10_SocPt_Summ_ByTrt53 | Mth01_CatVar_Summ_ByGrp_12_npctn | % | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_21 | Xanomeline Low DosePlacebo | AnlsGrouping_02_SexSex06_Soc | System Organ Class | GASTROINTESTINAL DISORDERS | AnlsGrouping_02_Sex_1 | Male | 34 | 07_Pt | Preferred Term | DIARRHOEA | 10.4651 | ( 10.5) | | An07_10_SocPt_Summ_ByTrt34 | Mth01_CatVar_Summ_ByGrp_1_n | n | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_2 | Xanomeline Low Dose | AnlsGrouping_0206_SexSoc | Sex | AnlsGrouping_02_Sex_2 | Female | 50 | 50 | Mth01_CatVar_Summ_ByGrp_1_n | System Organ Class | CARDIAC DISORDERSn | AnlsGrouping_0107_TrtPt | Treatment | AnlsGrouping_01_Trt_3 | Xanomeline High Dose | AnlsGrouping_02_Sex | Sex | AnlsGrouping_02_Sex_1 | Male | 44 | Preferred Term | ATRIAL FIBRILLATION | 1 | 1 | | An07_10_SocPt_Summ_ByTrt44 | Mth01_CatVar_Summ_ByGrp_12_npctn | % | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_32 | Xanomeline High DoseLow Dose | AnlsGrouping_06_Soc | System Organ Class | CARDIAC DISORDERS | AnlsGrouping_02_Sex | Sex | AnlsGrouping_02_Sex_2 | Female | 40 | 07_Pt | Preferred Term | ATRIAL FIBRILLATION | 1.1905 | ( 1.2) | | An07_10_SocPt_Summ_ByTrt40 | Mth01_CatVar_Summ_ByGrp_21_pctn | %n | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_12 | PlaceboXanomeline Low Dose | AnlsGrouping_02_SexSex06_Soc | System Organ Class | GASTROINTESTINAL DISORDERS | AnlsGrouping_02_Sex_1 | Male | 38.3720930232558 | 07_Pt | Preferred Term | DIARRHOEA | 4 | 4 | | An07_10_SocPt_Summ_ByTrt( 38.4) | Mth01_CatVar_Summ_ByGrp_2_pct | % | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_12 | PlaceboXanomeline Low Dose | AnlsGrouping_02_SexSex06_Soc | System Organ Class | GASTROINTESTINAL DISORDERS | AnlsGrouping_02_Sex_2 | Female | 61.6279069767442 | 07_Pt | Preferred Term | DIARRHOEA | 4.7619 | ( 4.8) | | An07_10_SocPt_Summ_ByTrt( 61.6) | Mth01_CatVar_Summ_ByGrp_21_pctn | %n | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_23 | Xanomeline Low High Dose | AnlsGrouping_02_SexSex06_Soc | System Organ Class | CARDIAC DISORDERS | AnlsGrouping_02_Sex_1 | Male | 40.4761904761905 | 07_Pt | Preferred Term | ATRIAL FIBRILLATION | 3 | 3 | | An07_10_SocPt_Summ_ByTrt( 40.5) | Mth01_CatVar_Summ_ByGrp_2_pct | % | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_23 | Xanomeline Low High Dose | AnlsGrouping_02_SexSex06_Soc | System Organ Class | CARDIAC DISORDERS | AnlsGrouping_02_Sex_2 | Female | 59.5238095238095 | 07_Pt | Preferred Term | ATRIAL FIBRILLATION | 3.5714 | ( 3.6) | | An07_10_SocPt_Summ_ByTrt( 59.5) | Mth01_CatVar_Summ_ByGrp_21_pctn | %n | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_3 | Xanomeline High Dose | AnlsGrouping_02_SexSex06_Soc | System Organ Class | GASTROINTESTINAL DISORDERS | AnlsGrouping_02_Sex_1 | Male | 52.3809523809524 | 07_Pt | Preferred Term | DIARRHOEA | 4 | 4 | | An07_10_SocPt_Summ_ByTrt( 52.4) | Mth01_CatVar_Summ_ByGrp_2_pct | % | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_3 | Xanomeline High Dose | AnlsGrouping_02_SexSex06_Soc | System Organ Class | GASTROINTESTINAL DISORDERS | AnlsGrouping_02_Sex_2 | Female | 47.6190476190476 | ( 47.6)07_Pt | Preferred Term | DIARRHOEA | 4.7619 | ( 4.8) |
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