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Model Documentation

Class: OperationResult

The OperationResult class is used in the results attribute of an analysis to represent the results of the analysis.

ER Diagram: OperationResult

An instance of the OperationResult is created for each individual "statistic" value generated by the analysis. There will be at least 1 instance for each statistical operation defined for the method associated with the analysis (i.e., specified in the methodId attribute of the analysis). For analyses in which at least 1 "results-by-group" grouping factor (i.e., a grouping factor that is referenced in the orderedGrouping attribute of the analysis and is indicated as producing a result for every group by having a value of "true" in the resultsByGroup attribute of its instance of the OrderedGroupingFactor class), there will be 1 instance for each combination of statistical operation and groups within each results-by-group grouping factor. For example:

  • In a simple analysis for "Count of subjects in the safety population", where the associated analysis method only has a single operation (i.e., "Count of subjects") and there are no results-by-group grouping factors, there will only be 1 result value (i.e., only one instance of the OperationResult class).
  • In an analysis for "Summary of subjects by treatment and sex", where the analysis method has 2 operations (i.e., "Count of subjects" and "Percent of subjects") and there are 2 results-by-group grouping factors:
    • "Treatment" with 3 groups: "Placebo", "Drug A", and "Drug B"
    • "Sex" with 2 groups: "Male" and "Female"

There will be a total of 12 individual result values (i.e., 12 instances of the OperationResult class); 1 for each combination of operation, treatment group and sex group:

OperationTreatmentSex
Count of subjectsPlaceboMale
Count of subjectsPlaceboFemale
Count of subjectsDrug AMale
Count of subjectsDrug AFemale
Count of subjectsDrug BMale
Count of subjectsDrug BFemale
Percent of subjectsPlaceboMale
Percent of subjectsPlaceboFemale
Percent of subjectsDrug AMale
Percent of subjectsDrug AFemale
Percent of subjectsDrug BMale
Percent of subjectsDrug BFemale
In each instance of the OperationResult class:

  • The operationId attribute contains the identifier value for the operation that generated the result (i.e., 1 of the operations defined in the method associated with the analysis).
  • The resultGroups attribute may contain references to the grouping factor(s)/group(s) associated with the result (see below).
  • The rawValue attribute contains the raw result value generated by the statistical operation, with no formatting or rounding applied.
  • The formattedValue attribute contains the result value formatted according to the pattern specified in the resultPattern attribute of the operation referenced by the operationId attribute value.

The resultGroups attribute is used to associate the result value with any grouping factors defined for the analysis. The association with each grouping factor is represented as an instance of the ResultGroup class, in which:

  • The groupingId attribute contains the identifier value for the subject or data grouping factor.
  • For results-by-group grouping factors, the specific group associated with the result is indicated by the value of either:
    • The groupId attribute, which contains the identifier value for a predefined group within the grouping factor, or
    • The groupValue attribute, which contains 1 of the data values from the grouping variable. The groupValue attribute is used for data-driven grouping factors (i.e., where the value for the dataDriven attribute of the grouping factor is "true"), which do not have predefined groups.

In the following examples, only the attributes necessary to illustrate the representation of results using the OperationResult class have been included. References to additional information such as analysis sets and data subsets have been excluded from the example analysis definitions.

Example

This example shows the definition and results for a single analysis, "Summary of Subjects by Treatment and Sex", including the definitions of the grouping factors and method referenced by the analysis. This example illustrates the use of the groupingId and groupId attributes of the ResultGroup class to associate results with groups in results-by-group grouping factors with predefined groups.

Lines 1-33:

Show the definitions of the 2 grouping factors referenced by the analysis, both of which are not data-driven (dataDriven = false, shown on lines 6 and 24):

  • Lines 2-19: Show the definition of the "Treatment" grouping factor, which has 3 groups: "Placebo", "Xanomeline Low Dose", and "Xanomeline High Dose".
  • Lines 20-33: Show the definition of the "Sex" grouping factor, which has 2 groups: "Male" and "Female".
Lines 34-48:

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

  • Lines 38-42: Show the definition of the "Count of subjects" operation.
  • Lines 43-47: Show the definition of the "Percent of subjects" operation.
Lines 49-62:

Show the definition of the analysis:

  • Lines 53-54: Show that this is an analysis of the USUBJID variable in the ADSL dataset.
  • Line 55: Shows the reference to the "Summary by group of a categorical variable" method.
  • Lines 56-62: 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 58 and 61).
Lines 63-161

Show the list of 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 and groupId attributes)
  • 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 42 and 47.

YAML Example
analysisGroupings:
- id: AnlsGrouping_01_Trt
  name: Treatment
  groupingDataset: ADSL
  groupingVariable: TRT01A
  dataDriven: false
  groups:
  - id: AnlsGrouping_01_Trt_1
    name: Placebo
    order: 1
    ...
  - id: AnlsGrouping_01_Trt_2
    name: Xanomeline Low Dose
    order: 2 
    ...
  - id: AnlsGrouping_01_Trt_3
    name: Xanomeline High Dose
    order: 3 
    ...
- id: AnlsGrouping_02_Sex
  name: Sex
  groupingDataset: ADSL
  groupingVariable: SEX
  dataDriven: false
  groups:
  - id: AnlsGrouping_02_Sex_1
    name: Male
    order: 1
    ...
  - id: AnlsGrouping_02_Sex_2
    name: Female
    order: 2
    ...
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: An03_03_Sex_Summ_ByTrt
  name: Summary of Subjects by Treatment and Sex
  version: 1
  dataset: ADSL
  variable: USUBJID
  methodId: Mth01_CatVar_Summ_ByGrp
  orderedGroupings:
  - order: 1
    resultsByGroup: true
    groupingId: AnlsGrouping_01_Trt
  - order: 2
    resultsByGroup: true
    groupingId: AnlsGrouping_02_Sex
  results:
  - operationId: Mth01_CatVar_Summ_ByGrp_1_n
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_1
    - groupingId: AnlsGrouping_02_Sex
      groupId: AnlsGrouping_02_Sex_1
    rawValue: '33'
    formattedValue: '33'
  - operationId: Mth01_CatVar_Summ_ByGrp_1_n
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_1
    - groupingId: AnlsGrouping_02_Sex
      groupId: AnlsGrouping_02_Sex_2
    rawValue: '53'
    formattedValue: '53'
  - operationId: Mth01_CatVar_Summ_ByGrp_1_n
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_2
    - groupingId: AnlsGrouping_02_Sex
      groupId: AnlsGrouping_02_Sex_1
    rawValue: '34'
    formattedValue: '34'
  - operationId: Mth01_CatVar_Summ_ByGrp_1_n
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_2
    - groupingId: AnlsGrouping_02_Sex
      groupId: AnlsGrouping_02_Sex_2
    rawValue: '50'
    formattedValue: '50'
  - operationId: Mth01_CatVar_Summ_ByGrp_1_n
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_3
    - groupingId: AnlsGrouping_02_Sex
      groupId: AnlsGrouping_02_Sex_1
    rawValue: '44'
    formattedValue: '44'
  - operationId: Mth01_CatVar_Summ_ByGrp_1_n
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_3
    - groupingId: AnlsGrouping_02_Sex
      groupId: AnlsGrouping_02_Sex_2
    rawValue: '40'
    formattedValue: '40'
  - operationId: Mth01_CatVar_Summ_ByGrp_2_pct
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_1
    - groupingId: AnlsGrouping_02_Sex
      groupId: AnlsGrouping_02_Sex_1
    rawValue: '38.372093023255815'
    formattedValue: ( 38.4)
  - operationId: Mth01_CatVar_Summ_ByGrp_2_pct
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_1
    - groupingId: AnlsGrouping_02_Sex
      groupId: AnlsGrouping_02_Sex_2
    rawValue: '61.627906976744185'
    formattedValue: ( 61.6)
  - operationId: Mth01_CatVar_Summ_ByGrp_2_pct
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_2
    - groupingId: AnlsGrouping_02_Sex
      groupId: AnlsGrouping_02_Sex_1
    rawValue: '40.476190476190474'
    formattedValue: ( 40.5)
  - operationId: Mth01_CatVar_Summ_ByGrp_2_pct
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_2
    - groupingId: AnlsGrouping_02_Sex
      groupId: AnlsGrouping_02_Sex_2
    rawValue: '59.523809523809526'
    formattedValue: ( 59.5)
  - operationId: Mth01_CatVar_Summ_ByGrp_2_pct
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_3
    - groupingId: AnlsGrouping_02_Sex
      groupId: AnlsGrouping_02_Sex_1
    rawValue: '52.38095238095238'
    formattedValue: ( 52.4)
  - operationId: Mth01_CatVar_Summ_ByGrp_2_pct
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
      groupId: AnlsGrouping_01_Trt_3
    - groupingId: AnlsGrouping_02_Sex
      groupId: AnlsGrouping_02_Sex_2
    rawValue: '47.61904761904762'
    formattedValue: ( 47.6)
  ...
 ...

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 values from the 2 instances of the ResultGroup class found in the resultGroups attribute for each result are represented in separate pairs of columns ("groupingId1"/"groupId1" and "groupingId2"/"groupId2") so that each result is represented on a single row:

$titleHtml
analysisIdoperationIdgroupingId1groupId1groupingId2groupId2rawValueformattedValue
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_1AnlsGrouping_02_SexAnlsGrouping_02_Sex_13333
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_1AnlsGrouping_02_SexAnlsGrouping_02_Sex_25353
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_2AnlsGrouping_02_SexAnlsGrouping_02_Sex_13434
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_2AnlsGrouping_02_SexAnlsGrouping_02_Sex_25050
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_3AnlsGrouping_02_SexAnlsGrouping_02_Sex_14444
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_3AnlsGrouping_02_SexAnlsGrouping_02_Sex_24040
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_1AnlsGrouping_02_SexAnlsGrouping_02_Sex_138.3720930232558( 38.4)
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_1AnlsGrouping_02_SexAnlsGrouping_02_Sex_261.6279069767442( 61.6)
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_2AnlsGrouping_02_SexAnlsGrouping_02_Sex_140.4761904761905( 40.5)
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_2AnlsGrouping_02_SexAnlsGrouping_02_Sex_259.5238095238095( 59.5)
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_3AnlsGrouping_02_SexAnlsGrouping_02_Sex_152.3809523809524( 52.4)
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_3AnlsGrouping_02_SexAnlsGrouping_02_Sex_247.6190476190476( 47.6)
$warningHtml
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 groups:
$titleHtml
analysisIdoperationIdoperation_labelgroupingId1grouping_name1groupId1group_name1groupingId2grouping_name2groupId2group_name2rawValueformattedValue
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_1PlaceboAnlsGrouping_02_SexSexAnlsGrouping_02_Sex_1Male3333
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_1PlaceboAnlsGrouping_02_SexSexAnlsGrouping_02_Sex_2Female5353
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_2Xanomeline Low DoseAnlsGrouping_02_SexSexAnlsGrouping_02_Sex_1Male3434
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_2Xanomeline Low DoseAnlsGrouping_02_SexSexAnlsGrouping_02_Sex_2Female5050
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_3Xanomeline High DoseAnlsGrouping_02_SexSexAnlsGrouping_02_Sex_1Male4444
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_3Xanomeline High DoseAnlsGrouping_02_SexSexAnlsGrouping_02_Sex_2Female4040
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pct%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_1PlaceboAnlsGrouping_02_SexSexAnlsGrouping_02_Sex_1Male38.3720930232558( 38.4)
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pct%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_1PlaceboAnlsGrouping_02_SexSexAnlsGrouping_02_Sex_2Female61.6279069767442( 61.6)
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pct%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_2Xanomeline Low DoseAnlsGrouping_02_SexSexAnlsGrouping_02_Sex_1Male40.4761904761905( 40.5)
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pct%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_2Xanomeline Low DoseAnlsGrouping_02_SexSexAnlsGrouping_02_Sex_2Female59.5238095238095( 59.5)
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pct%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_3Xanomeline High DoseAnlsGrouping_02_SexSexAnlsGrouping_02_Sex_1Male52.3809523809524( 52.4)
An03_03_Sex_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pct%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_3Xanomeline High DoseAnlsGrouping_02_SexSexAnlsGrouping_02_Sex_2Female47.6190476190476( 47.6)
$warningHtml

Example

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 1-29:

Show the definition of the 3 grouping factors referenced by the analysis.

  • Lines 2-19: 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 20-24: Show the definition of the "System Organ Class" grouping factor, 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 34-38: Show the definition of the "Count of subjects" operation.
  • Lines 39-43: Show the definition of the "Percent of subjects" operation.
Lines 46-61:

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 52-61: 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 54, 57 and 60).
Lines 62-183

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 38 and 43.

YAML Example
analysisGroupings:
- id: AnlsGrouping_01_Trt
  name: Treatment
  groupingDataset: ADSL
  groupingVariable: TRT01A
  dataDriven: false
  groups:
  - id: AnlsGrouping_01_Trt_1
    name: Placebo
    order: 1
    ...
  - id: AnlsGrouping_01_Trt_2
    name: Xanomeline Low Dose
    order: 2 
    ...
  - id: AnlsGrouping_01_Trt_3
    name: Xanomeline High Dose
    order: 3 
    ...
- id: AnlsGrouping_06_Soc
  name: System Organ Class
  groupingDataset: ADAE
  groupingVariable: AESOC
  dataDriven: true
- id: AnlsGrouping_07_Pt
  name: Preferred Term
  groupingDataset: ADAE
  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: 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 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:

analysisIdoperationIdgroupingId1groupId1groupingId2groupValue2groupingId3groupValue3rawValueformattedValue
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_1AnlsGrouping_06_SocCARDIAC DISORDERSAnlsGrouping_07_PtATRIAL FIBRILLATION11
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_1AnlsGrouping_06_SocCARDIAC DISORDERSAnlsGrouping_07_PtATRIAL FIBRILLATION1.1628(  1.2)
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_1AnlsGrouping_06_SocGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtDIARRHOEA99
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_1AnlsGrouping_06_SocGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtDIARRHOEA10.4651( 10.5)
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_2AnlsGrouping_06_SocCARDIAC DISORDERSAnlsGrouping_07_PtATRIAL FIBRILLATION11
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_2AnlsGrouping_06_SocCARDIAC DISORDERSAnlsGrouping_07_PtATRIAL FIBRILLATION1.1905(  1.2)
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_2AnlsGrouping_06_SocGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtDIARRHOEA44
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_2AnlsGrouping_06_SocGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtDIARRHOEA4.7619(  4.8)
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_3AnlsGrouping_06_SocCARDIAC DISORDERSAnlsGrouping_07_PtATRIAL FIBRILLATION33
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pctAnlsGrouping_01_TrtAnlsGrouping_01_Trt_3AnlsGrouping_06_SocCARDIAC DISORDERSAnlsGrouping_07_PtATRIAL FIBRILLATION3.5714(  3.6)
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nAnlsGrouping_01_TrtAnlsGrouping_01_Trt_3AnlsGrouping_06_SocGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtDIARRHOEA44
An07_10_SocPt_Summ_ByTrtMth01_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 name or label (or any other descriptive information) from the definitions of the operations, grouping factors, and predefined groups:
analysisIdoperationIdoperation_labelgroupingId1grouping_name1groupId1group_name1groupingId2grouping_name2groupValue2groupingId3grouping_name3groupValue3rawValueformattedValue
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_1PlaceboAnlsGrouping_06_SocSystem Organ ClassCARDIAC DISORDERSAnlsGrouping_07_PtPreferred TermATRIAL FIBRILLATION11
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pct%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_1PlaceboAnlsGrouping_06_SocSystem Organ ClassCARDIAC DISORDERSAnlsGrouping_07_PtPreferred TermATRIAL FIBRILLATION1.1628(  1.2)
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_1PlaceboAnlsGrouping_06_SocSystem Organ ClassGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtPreferred TermDIARRHOEA99
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pct%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_1PlaceboAnlsGrouping_06_SocSystem Organ ClassGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtPreferred TermDIARRHOEA10.4651( 10.5)
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_2Xanomeline Low DoseAnlsGrouping_06_SocSystem Organ ClassCARDIAC DISORDERSAnlsGrouping_07_PtPreferred TermATRIAL FIBRILLATION11
An07_10_SocPt_Summ_ByTrtMth01_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)
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_2Xanomeline Low DoseAnlsGrouping_06_SocSystem Organ ClassGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtPreferred TermDIARRHOEA44
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pct%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_2Xanomeline Low DoseAnlsGrouping_06_SocSystem Organ ClassGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtPreferred TermDIARRHOEA4.7619(  4.8)
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_3Xanomeline High DoseAnlsGrouping_06_SocSystem Organ ClassCARDIAC DISORDERSAnlsGrouping_07_PtPreferred TermATRIAL FIBRILLATION33
An07_10_SocPt_Summ_ByTrtMth01_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)
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_1_nnAnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_3Xanomeline High DoseAnlsGrouping_06_SocSystem Organ ClassGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtPreferred TermDIARRHOEA44
An07_10_SocPt_Summ_ByTrtMth01_CatVar_Summ_ByGrp_2_pct%AnlsGrouping_01_TrtTreatmentAnlsGrouping_01_Trt_3Xanomeline High DoseAnlsGrouping_06_SocSystem Organ ClassGASTROINTESTINAL DISORDERSAnlsGrouping_07_PtPreferred TermDIARRHOEA4.7619(  4.8)

Example

This example shows the definition and results for a single analysis, "Comparison of Age by Treatment", including the definitions of the grouping factor and method referenced by the analysis. This example illustrates the use of just the groupingId attribute of the ResultGroup class to associate a result with a grouping factor that does not generate a result for each group in the grouping factor.

Lines 1-19:

Show the definition of the single grouping factor referenced by the analysis: 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 21-29:

Show the definition of the method referenced by the analysis, "Analysis of variance group comparison for a continuous variable", which has a single operation ("P-value").

Lines 31-40:

Show the definition of the analysis:

  • Lines 34-35: Show that this is an analysis of the AGE variable in the ADSL dataset.
  • Line 36: Shows the reference to the "Analysis of variance group comparison for a continuous variable" method.
  • Lines 37-40: Show the reference to the single grouping factor, which is marked as not producing a result for each group in the grouping factor (resultsByGroup = false, shown on line 39).
Lines 41-46

Show the single result for the analysis, represented as an instance of the OperationResult class containing:

  • The identifier value of the statistical operation performed, which is in the operationId attribute.
  • In the resultGroups attribute, a reference to the only grouping factor group associated with the result (indicated by the value of the groupingId attribute). The association to the "Treatment" grouping factor can be used as an indication that this is a treatment-related result.
  • 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 pattern is shown on row 28.

YAML Example
analysisGroupings:
- id: AnlsGrouping_01_Trt
  name: Treatment
  groupingDataset: ADSL
  groupingVariable: TRT01A
  dataDriven: false
  groups:
  - id: AnlsGrouping_01_Trt_1
    name: Placebo
    order: 1
    ...
  - id: AnlsGrouping_01_Trt_2
    name: Xanomeline Low Dose
    order: 2 
    ...
  - id: AnlsGrouping_01_Trt_3
    name: Xanomeline High Dose
    order: 3 
    ...
methods:
- id: Mth04_ContVar_Comp_Anova
  name: Analysis of variance group comparison for a continuous variable
  operations:
  - id: Mth04_ContVar_Comp_Anova_1_pval
    name: P-value
    label: p-value
    order: 1
    resultPattern: X.XXXX
  ...
analyses:
- id: An03_01_Age_Comp_ByTrt
  name: Comparison of Age by Treatment
  version: 1
  dataset: ADSL
  variable: AGE
  methodId: Mth04_ContVar_Comp_Anova
  orderedGroupings:
  - order: 1
    resultsByGroup: false
    groupingId: AnlsGrouping_01_Trt
  results:
  - operationId: Mth04_ContVar_Comp_Anova_1_pval
    resultGroups:
    - groupingId: AnlsGrouping_01_Trt
    rawValue: '0.5934357753'
    formattedValue: '0.5934'
  ...
...

The result 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:

$titleHtml
analysisIdoperationIdgroupingIdrawValueformattedValue
An03_01_Age_Comp_ByTrtMth04_ContVar_Comp_Anova_1_pvalAnlsGrouping_01_Trt0.59343577530.5934
$warningHtml
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 operation and grouping factor:
$titleHtml
analysisIdoperationIdoperation_labelgroupingIdgrouping_namerawValueformattedValue
An03_01_Age_Comp_ByTrtMth04_ContVar_Comp_Anova_1_pvalp-valueAnlsGrouping_01_TrtTreatment0.59343577530.5934
$warningHtml

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