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.
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| 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 lines 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 36-39: Show the definition of the "Count of subjects" operation.
- Lines 40-44: Show the definition of the "Percent of subjects" operation.
| | Lines 42-57: | 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 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 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.
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| title | YAML Example |
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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, groupId and groupValue values from the 3 two 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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| operationId | groupingId1 | groupId1 | groupingId2 | groupValue2 | groupingId3 | groupValue3 | rawValue | formattedValue |
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| 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 | | 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) | | Mth01_CatVar_Summ_ByGrp_1_n | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_1 | AnlsGrouping_06_Soc | GASTROINTESTINAL DISORDERS | AnlsGrouping_07_Pt | DIARRHOEA | 9 | 9 | | 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) | | Mth01_CatVar_Summ_ByGrp_1_n | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_2 | AnlsGrouping_06_Soc | CARDIAC DISORDERS | AnlsGrouping_07_Pt | ATRIAL FIBRILLATION | 1 | 1 | | Mth01_CatVar_Summ_ByGrp_2_pct | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_2 | AnlsGrouping_06_Soc | CARDIAC DISORDERS | AnlsGrouping_07_Pt | ATRIAL FIBRILLATION | 1.1905 | ( 1.2) | | Mth01_CatVar_Summ_ByGrp_1_n | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_2 | AnlsGrouping_06_Soc | GASTROINTESTINAL DISORDERS | AnlsGrouping_07_Pt | DIARRHOEA | 4 | 4 | | Mth01_CatVar_Summ_ByGrp_2_pct | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_2 | AnlsGrouping_06_Soc | GASTROINTESTINAL DISORDERS | AnlsGrouping_07_Pt | DIARRHOEA | 4.7619 | ( 4.8) | | Mth01_CatVar_Summ_ByGrp_1_n | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_3 | AnlsGrouping_06_Soc | CARDIAC DISORDERS | AnlsGrouping_07_Pt | ATRIAL FIBRILLATION | 3 | 3 | | Mth01_CatVar_Summ_ByGrp_2_pct | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_3 | AnlsGrouping_06_Soc | CARDIAC DISORDERS | AnlsGrouping_07_Pt | ATRIAL FIBRILLATION | 3.5714 | ( 3.6) | | Mth01_CatVar_Summ_ByGrp_1_n | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_3 | AnlsGrouping_06_Soc | GASTROINTESTINAL DISORDERS | AnlsGrouping_07_Pt | DIARRHOEA | 4 | 4 | | Mth01_CatVar_Summ_ByGrp_2_pct | AnlsGrouping_01_Trt | AnlsGrouping_01_Trt_3 | AnlsGrouping_06_Soc | GASTROINTESTINAL DISORDERS | AnlsGrouping_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 additional descriptive information from the definitions of the operations, grouping factors, and predefined groups:
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| operationId | operation_label | groupingId1 | grouping_label1 | groupId1 | group_label1 | groupingId2 | grouping_label2 | groupValue2 | groupingId3 | grouping_label3 | groupValue3 | rawValue | formattedValue |
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| Mth01_CatVar_Summ_ByGrp_1_n | n | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_1 | Placebo | AnlsGrouping_06_Soc | System Organ Class | CARDIAC DISORDERS | AnlsGrouping_07_Pt | Preferred Term | ATRIAL FIBRILLATION | 1 | 1 | | Mth01_CatVar_Summ_ByGrp_2_pct | % | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_1 | Placebo | AnlsGrouping_06_Soc | System Organ Class | CARDIAC DISORDERS | AnlsGrouping_07_Pt | Preferred Term | ATRIAL FIBRILLATION | 1.1628 | ( 1.2) | | Mth01_CatVar_Summ_ByGrp_1_n | n | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_1 | Placebo | AnlsGrouping_06_Soc | System Organ Class | GASTROINTESTINAL DISORDERS | AnlsGrouping_07_Pt | Preferred Term | DIARRHOEA | 9 | 9 | | Mth01_CatVar_Summ_ByGrp_2_pct | % | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_1 | Placebo | AnlsGrouping_06_Soc | System Organ Class | GASTROINTESTINAL DISORDERS | AnlsGrouping_07_Pt | Preferred Term | DIARRHOEA | 10.4651 | ( 10.5) | | Mth01_CatVar_Summ_ByGrp_1_n | n | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_2 | Xanomeline Low Dose | AnlsGrouping_06_Soc | System Organ Class | CARDIAC DISORDERS | AnlsGrouping_07_Pt | Preferred Term | ATRIAL FIBRILLATION | 1 | 1 | | Mth01_CatVar_Summ_ByGrp_2_pct | % | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_2 | Xanomeline Low Dose | AnlsGrouping_06_Soc | System Organ Class | CARDIAC DISORDERS | AnlsGrouping_07_Pt | Preferred Term | ATRIAL FIBRILLATION | 1.1905 | ( 1.2) | | Mth01_CatVar_Summ_ByGrp_1_n | n | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_2 | Xanomeline Low Dose | AnlsGrouping_06_Soc | System Organ Class | GASTROINTESTINAL DISORDERS | AnlsGrouping_07_Pt | Preferred Term | DIARRHOEA | 4 | 4 | | Mth01_CatVar_Summ_ByGrp_2_pct | % | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_2 | Xanomeline Low Dose | AnlsGrouping_06_Soc | System Organ Class | GASTROINTESTINAL DISORDERS | AnlsGrouping_07_Pt | Preferred Term | DIARRHOEA | 4.7619 | ( 4.8) | | Mth01_CatVar_Summ_ByGrp_1_n | n | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_3 | Xanomeline High Dose | AnlsGrouping_06_Soc | System Organ Class | CARDIAC DISORDERS | AnlsGrouping_07_Pt | Preferred Term | ATRIAL FIBRILLATION | 3 | 3 | | Mth01_CatVar_Summ_ByGrp_2_pct | % | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_3 | Xanomeline High Dose | AnlsGrouping_06_Soc | System Organ Class | CARDIAC DISORDERS | AnlsGrouping_07_Pt | Preferred Term | ATRIAL FIBRILLATION | 3.5714 | ( 3.6) | | Mth01_CatVar_Summ_ByGrp_1_n | n | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_3 | Xanomeline High Dose | AnlsGrouping_06_Soc | System Organ Class | GASTROINTESTINAL DISORDERS | AnlsGrouping_07_Pt | Preferred Term | DIARRHOEA | 4 | 4 | | Mth01_CatVar_Summ_ByGrp_2_pct | % | AnlsGrouping_01_Trt | Treatment | AnlsGrouping_01_Trt_3 | Xanomeline High Dose | AnlsGrouping_06_Soc | System Organ Class | GASTROINTESTINAL DISORDERS | AnlsGrouping_07_Pt | Preferred Term | DIARRHOEA | 4.7619 | ( 4.8) |
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