This example shows the definition of 2 data 4 grouping factors, each of which is represented as an instance of the DataGroupingFactor GroupingFactor class within the dataGroupingsanalysisGroupings attribute of the reporting event.
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| Lines 2-29: | Show the attributes of the instance of the GroupingFactor class for the first grouping factor, "Sex" (line 3), which is defined as being based on the ADSL SEX grouping variable (lines 4 and 5). The grouping factor is not data-driven (line 6), so the groups attribute is included (line 7) and contains 2 predefined groups, each specified as a simple condition represented as an instance of the Group class: - Lines 8-17: Show the first predefined group (order = 1), which is identified as "AnlsGrouping_05_Sex_1", named as "Female" (line 9), labeled as "F" (line 10), and contains a simple condition specifying that the value of the SEX variable in the ADSL dataset is equal to "F", which could be expressed as:
- Lines 18-27: Show the second predefined group (order = 2), which is identified as "AnlsGrouping_05_Sex_2", named as "Male" (line 20), labeled as "M" (line 21), and contains a simple condition specifying that the value of the SEX variable in the ADSL dataset is equal to "M", which could be expressed as:
| | Lines 30-34: | Show the attributes of the instance of the GroupingFactor class for the second grouping factor, "Country" (line 31), which is defined as being based on the ADSL COUNTRY grouping variable (lines 32 and 33). The grouping factor is data-driven (line 34), so the groups attribute is not included; the groups within this grouping factor are derived from the distinct values in the ADSL COUNTRY variable. | | Lines 35-60: | Show the attributes of the instance of the DataGroupingFactor GroupingFactor class for the first subject grouping factor, "Vital Signs Parameter" (line 336), which is defined as being based on the ADVS PARAMCD grouping variable (line 4lines 37 and 38). The grouping factor is not data-driven (line 539), so the groups attribute is included (line 640) and contains 2 predefined groups, each specified as a simple condition represented as an instance of the DataGroup Group class: - Lines 741-1650: Show the first predefined group (order = 1), which is identified as "DataGroupingAnlsGrouping_0103_Param_1", labeled named as "Systolic Blood Pressure (mmHg)" (line 42), and contains a simple condition specifying that the value of the PARAMCD variable in the ADVS dataset is equal to "SYSBP", which could be expressed as:
- Lines 1751-2660: Show the second predefined group (order = 2), which is identified as "DataGroupingAnlsGrouping_0103_Param_2", labeled named as "Diastolic Blood Pressure (mmHg)" (line 52), and contains a simple condition specifying that that the value of the TRT01A PARAMCD variable in the ADSL ADVS dataset is equal to "Xanomeline Low DoseDIABP", which could be expressed as:
| | Lines 2761-3065: | Show the attributes of the instance of the DataGroupingFactor GroupingFactor class for the second subject grouping factor, "System Organ Class" (line 2862), which is defined as being based on the ADAE AESOC grouping variable (line 29lines 63 and 64). The grouping factor is data-driven (line 3065), so the groups attribute is not included; the groups within this data grouping factor are derived from the distinct values in the AESOC variable. |
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| title | YAML Example |
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dataGroupingsanalysisGroupings:
- id: DataGroupingAnlsGrouping_01_ParamSex
name: Sex
groupingDataset: ADSL
groupingVariable: SEX
dataDriven: false
groups:
- id: AnlsGrouping_01_Sex_1
name: Female
label: F
level: 1
order: 1
condition:
dataset: ADSL
variable: SEX
comparator: EQ
value:
- F
- id: AnlsGrouping_01_Sex_2
name: Male
label: M
level: 1
order: 2
condition:
dataset: ADSL
variable: SEX
comparator: EQ
value:
- M
- id: AnlsGrouping_02_Cntry
name: Country
GroupingDataset: ADSL
groupingVariable: COUNTRY
dataDriven: true
- id: AnlsGrouping_03_Param
name: Vital Signs Parameter
groupingDataset: ADVS
groupingVariable: PARAMCD
groupsdataDriven: false
groups:
- id: DataGroupingAnlsGrouping_0103_Param_1
labelname: Systolic Blood Pressure (mmHg)
level: 1
order: 1
condition:
dataset: ADVS
variable: PARAMCD
comparator: EQ
value:
- SYSBP
- id: DataGroupingAnlsGrouping_0103_Param_2
labelname: Diastolic Blood Pressure (mmHg)
level: 1
order: 2
condition:
dataset: ADVS
variable: PARAMCD
comparator: EQ
value:
- DIABP
- id: DataGroupingAnlsGrouping_0204_Soc
labelname: System Organ Class
groupingDataset: ADAE
groupingVariable: AESOC
dataDriven: true |
These data grouping factors and their predefined groups could be represented in tabular form as shown in the following table where each instance of the DataGroup Group class is represented on a separate line, with attribute values for the related instance of the DataGroupingFactor 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 shown with values only shown included for the DataGroupingFactor GroupingFactor attributes.
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| id | name | labelgroupingDataset | groupingVariable | dataDriven | group_id | group_name | group_label | level | order | dataset | variable | comparator | value |
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| AnlsGrouping_01_Sex | Sex | ADSL | SEX | FALSE | AnlsGrouping_01_Sex_1 | Female | F | 1 | 1 | ADSL | SEX | EQ | F | | AnlsGrouping_01_Sex | Sex | ADSL | SEX | FALSE | AnlsGrouping_01_Sex_2 | Male | M | 1 | 2 | ADSL | SEX | EQ | M | | AnlsGrouping_02_Cntry | Country | ADSL | COUNTRY | TRUE |
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| | AnlsGrouping_03_DataGrouping_01_Param | Vital Signs Parameter | ADVS | PARAMCD | FALSE | DataGroupingAnlsGrouping_0103_Param_1 | Systolic Blood Pressure (mmHg) |
| 1 | 1 | ADVS | PARAMCD | EQ | SYSBP | | DataGroupingAnlsGrouping_0103_Param | Vital Signs Parameter | ADVS | PARAMCD | FALSE | DataGroupingAnlsGrouping_0103_Param_2 | Diastolic Blood Pressure (mmHg) |
| 1 | 2 | ADVS | PARAMCD | EQ | DIABP | | DataGroupingAnlsGrouping_0204_Soc | System Organ Class | ADAE | AESOC | TRUE |
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