This example shows the definition of 3 subject 2 grouping factors based, each of which is represented as an instance of the SubjectGroupingFactor GroupingFactor class within the analysisGroupings attribute of the reporting event.
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| Lines 2-637: | Show the attributes of the instance of the SubjectGroupingFactor GroupingFactor class for the first subject grouping factor, "Treatment" (line 3), which is defined as being based on the ADSL TRT01A grouping variable (line lines 4 and 5). The grouping factor is not data-driven (line 56), so the the groups attribute is included (line 67) and contains 3 predefined groups, each specified as a simple condition represented as an instance of the AnalysisGroup Group class: - Lines 78-1617: Show the first predefined group (order = 1), which is identified as "AnlsGrouping_0105_Trt_1", labeled named as "Placebo" (line 89), and contains a simple condition specifying that the value of the TRT01A variable in the ADSL dataset is equal to "Placebo", which could be expressed as:
- Lines 1718-2627: Show the second predefined group (order = 2), which is identified as "AnlsGrouping_0105_Trt_2", labeled named as "Xanomeline Low Dose" (line 1819), and contains a simple condition specifying that the value of the TRT01A variable in the ADSL dataset is equal to "Xanomeline Low Dose", which could be expressed as:
ADSL.TRT01A EQ 'Xanomeline Low Dose'
- Lines 2728-3637: Show the third predefined group (order = 3), which is identified as "AnlsGrouping_0105_Trt_3", labeled named as "Xanomeline High Dose" (line 2829), and contains a simple condition specifying that the value of the TRT01A variable in the ADSL dataset is equal to "Xanomeline High Dose", which could be expressed as:
ADSL.TRT01A EQ 'Xanomeline High Dose'
| | Lines 37-40:Show the attributes of the instance of the SubjectGroupingFactor class for the second subject grouping factor, "Country" (line 38), which is defined as being based on the COUNTRY grouping variable (line 39). The grouping factor is data-driven (line 40), so the groups attribute is not included; the groups within this subject grouping factor are derived from the distinct values in the COUNTRY variable.Lines 41-45-68: | Show the attributes of the instance of the SubjectGroupingFactor GroupingFactor class for the third subject grouping factor, "On Active Treatment" (line 4239). Although the groups within this grouping factor are defined as compound expressions (lines 50 49 and 5963), the grouping variable is specified as ADSL TRT01A (line 43lines 40 and 41) because all the sub-clauses subclauses of the compound expression expressions are identified as groups that are simple conditions based on the TRT01A variable. The grouping factor is not data-driven (line 4442), so the groups attribute is included (line 4543) and contains 2 predefined groups, each specified as a compound expression represented as an instance of the AnalysisGroup Group class: - Lines 4644-5457: Show the first predefined group (order = 1) in which the compound expression , which is identified as "AnlsGrouping_06_ActTrt_1", named as "Yes", and labeled as "Y". The compound expression defined for this group uses the "OR" logical operator (line 51) to combines the conditions specified in the instances of the AnalysisGroup 50) to combine 2 subclauses, each of which is represented as an instance of the ReferencedGroup class.
- Lines 52-54: Show the first subclause (level = 2, order = 1), which is a reference to the instance of the Group class identified as "AnlsGrouping_
01 53) and - 54).
- Lines 55-57: Show the second subclause (level = 2, order = 2), which is a reference to the instance of the Group class identified as "AnlsGrouping_
01 54
When these the identifier values specified the 2 subclauses are used to retrieve the definitions of the identified groups, this compound expression could be expressed as: ADSL.TRT01A EQ 'Xanomeline Low Dose' OR ADSL.TRT01A EQ 'Xanomeline High Dose'
- Lines 5558-6268: Show the second predefined group (order = 2) in which the compound expression , which is identified as "AnlsGrouping_06_ActTrt_2", named as "No", and labeled as "N". The compound expression defined for this group uses the "NOT" logical operator (line 6064) to negate the condition(s) specified by the subclause. The subclause is specified as an instance of the ReferencedGroup class, in which the subClauseId attribute references the instance of the AnalysisGroup Group class identified as "AnlsGrouping_0306_ActTrt_1" (line 6268). When the identifier values for this referenced group ("AnlsGrouping_0306_ActTrt_1") and groups it references ("AnlsGrouping_0105_Trt_2" and "AnlsGrouping_0105_Trt_2") are used to retrieve the original group definitions, this compound expression could be expressed as:
NOT (ADSL.TRT01A EQ 'Xanomeline Low Dose' OR ADSL.TRT01A EQ 'Xanomeline High Dose')
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| title | YAML Example |
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analysisGroupings:
- id: AnlsGrouping_0105_Trt
labelname: Treatment
groupingDataset: ADSL
groupingVariable: TRT01A
dataDriven: false
groups:
- id: AnlsGrouping_0105_Trt_1
labelname: Placebo
level: 1
order: 1
condition:
dataset: ADSL
variable: TRT01A
comparator: EQ
value:
- Placebo
- id: AnlsGrouping_0105_Trt_2
labelname: Xanomeline Low Dose
level: 1
order: 2
condition:
dataset: ADSL
variable: TRT01A
comparator: EQ
value:
- Xanomeline Low Dose
- id: AnlsGrouping_0105_Trt_3
labelname: Xanomeline High Dose
level: 1
order: 3
condition:
dataset: ADSL
variable: TRT01A
comparator: EQ
value:
- Xanomeline High Dose
- id: AnlsGrouping_0206_CntryActTrt
labelname: Country
On Active groupingVariable: COUNTRYTreatment
dataDriven: true
- id: AnlsGrouping_03_ActTrt
label: On Active TreatmentgroupingDataset: ADSL
groupingVariable: TRT01A
dataDriven: false
groups:
- id: AnlsGrouping_0306_ActTrt_1
name: Yes
label: Y
level: 1
order: 1
compoundExpression:
logicalOperator: OR
whereClauses:
- level: 2
order: 1
subClauseId: AnlsGrouping_0105_Trt_2
- level: 2
order: 2
subClauseId: AnlsGrouping_0105_Trt_3
- id: AnlsGrouping_0306_ActTrt_2
name: No
label: N
level: 1
order: 2
compoundExpression:
logicalOperator: NOT
whereClauses:
- level: 2
order: 1
subClauseId: AnlsGrouping_0306_ActTrt_1 |
These subject grouping factors and their predefined groups could be represented in tabular form as shown in the following table where:
- Each row represents an instance of one of the AnalysisGroup class is represented on a separate linefollowing classes, with attribute values for the related instance of the SubjectGroupingFactor GroupingFactor class represented on every row. If there are no predefined groups in the grouping factor (i.e., it is data-driven), a single row is included with values only shown for the SubjectGroupingFactor attributes.The identifier values of any predefined groups referenced in the whereClauses attribute of compound expressions are shown in a column called "subclause_id":
- Group: each predefined group is represented on a separate line (rows where level = 1).
- ReferencedGroup: for each predefined group that includes a compound expression, any subclause that references another predefined predefined group by identifier is represented on a separate row (rows where level = 2), where the identifier value of the referenced predefined group shown in the "subClauseId" column and the attribute values of the related instance of the Group class are also shown.
- Although it would be possible, in this representation, the referenced identifier values have not been used to retrieve the details of the simple conditions from the original group definitions.
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| id | name | groupingDatasetlabel | groupingVariable | dataDriven | group_id | group_name | group_label | level | order | logicalOperator | subclause_idsubClauseId | dataset | variable | comparator | value |
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| AnlsGrouping_0105_Trt | Treatment | ADSL | TRT01A | FALSE | AnlsGrouping_0105_Trt_1 | Placebo |
| 1 | 1 |
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| ADSL | TRT01A | EQ | Placebo | | AnlsGrouping_0105_Trt | Treatment | ADSL | TRT01A | FALSE | AnlsGrouping_0105_Trt_2 | Xanomeline Low Dose |
| 1 | 2 |
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| ADSL | TRT01A | EQ | Xanomeline Low Dose | | AnlsGrouping_0105_Trt | Treatment | ADSL | TRT01A | FALSE | AnlsGrouping_0105_Trt_3 | Xanomeline High Dose |
| 1 | 3 |
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| ADSL | TRT01A | EQ | Xanomeline High Dose | | AnlsGrouping_0206_CntryActTrt | Country | COUNTRY | TRUE | | ADSL | AnlsGrouping_03_ActTrt | Age Group | TRT01A | FALSE | AnlsGrouping_0306_ActTrt_1 | Yes | Y | 1 | 1 | OR |
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| | AnlsGrouping_0306_ActTrt | On Active Treatment | ADSLAge Group | TRT01A | FALSE | AnlsGrouping_0306_ActTrt_1 | Yes | Y | 2 | 1 |
| AnlsGrouping_0105_Trt_12 |
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| | AnlsGrouping_0306_ActTrt | On Active Treatment | ADSLAge Group | TRT01A | FALSE | AnlsGrouping_0306_ActTrt_1 | Yes | Y | 2 | 2 |
| AnlsGrouping_0105_Trt_23 |
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| | AnlsGrouping_0306_ActTrt | On Active Treatment | ADSLAge Group | TRT01A | FALSE | AnlsGrouping_0306_ActTrt_2 | No | N | 1 | 2 | NOT |
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| | AnlsGrouping_0306_ActTrt | On Active Treatment | ADSLAge Group | TRT01A | FALSE | AnlsGrouping_0306_ActTrt_2 | No | N | 2 | 12 |
| AnlsGrouping_0306_ActTrt_1 |
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