Model Documentation

Class: DataSubset

The DataSubset class is used in the reporting event's dataSubsets attribute to specify any additional data subsets that are used to restrict the subjects or records that are included in any given analysis, but are not considered to be defined analysis sets (e.g., subjects with a non-missing baseline value, or inclusion of only treatment-emergent adverse events in an AE summary analysis). Once a data subset has been defined in the reporting event's dataSubsets attribute, it can be used for any analysis by specifying its identifier value in the dataSubsetId attribute of the instance of the Analysis class that represents the analysis, as described in the Analysis section.

ER Diagram: DataSubset

Each data subset is defined as an instance of the DataSubset class, in which:

  • The id attribute contains the assigned identifier value for the data subset.
  • The name attribute contains the assigned name for the data subset (e.g., "Treatment-Emergent Adverse Events").
  • The description attribute may be used to record a detailed description of the data subject.
  • The label attribute may be used to record a short description of the data subset (e.g., "TEAE").
  • The level and order attributes are both assigned a value of "1".
  • Either:

Or:

    • The compoundExpression attribute contains the definition of a compound expression represented as an instance of the CompoundSubsetExpression class, in which:
      • The logicalOperator attribute contains a value from the ExpressionLogicalOperatorEnum enumeration.
      • The whereClauses attribute contains 1 or more subclauses being combined or negated by the specified logical operator. Each subclause is represented as one of the following:
        • A where clause represented as an instance of the WhereClause class, with the subclause expressed using either the condition or compoundExpression attribute.
        • A reference to another defined data subset represented as an instance of the ReferencedDataSubset class, in which the subClauseId attribute contains the identifier value of the referenced data subset.

Refer to the WhereClauseCompoundExpression section for more information about compound expressions, including examples of data subsets defined as a compound expressions.

Example

This example shows the definition of 2 data subsets, each of which is a based on a simple condition represented as an instance of the DataSubset class within the dataSubets attribute of the reporting event.

Lines 2-12:

Show the "Treatment-Emergent Adverse Events" data subset defined as a simple condition (line 7) that specifies that the value of the TRTEMFL variable in the ADAE dataset is equal to "Y". This condition could be expressed as:

  • ADAE.TRTEMFL EQ 'Y'

The sponsor chose to assign a label of "TEAE" for this data subset (line 4).

Lines 13-32:

Show the "Related Treatment-Emergent Adverse Events" data subset, which the sponsor chose to label as "Related TEAE" (line 15). This data subset is defined as a compound expression (line 18) that combines 2 subclauses using the "AND" logical operator (line 19).

Lines 21-23: Show the first subclause defined as an instance of the ReferencedDataSubset class that references the instance of the DataSubset class identified as "Dss01_TEAE" (line 22).

Lines 24-32: Show the second subclause defined as a simple condition that specifies that the value of the AEREL variable in the ADAE dataset is either "POSSIBLE" or "PROBABLE". This subclause condition could be expressed as:

    • ADAE.AEREL IN ('POSSIBLE', 'PROBABLE')

When the condition for the data subset referenced by the first subclause is retrieved and combined with the condition for the second subclause using the specified logical operator, this compound expression could be expressed as:

  • ADAE.TRTEMFL EQ 'Y' AND ADAE.AEREL IN ('POSSIBLE', 'PROBABLE')
Lines 33-42:

Show the "Vital Signs Analysis Records" data subset defined as a simple condition (line 37) that specifies that the value of the ANL01FL variable in the ADVS dataset is equal to "Y". This condition could be expressed as:

  • ADVS.ANL01FL EQ 'Y'

The sponsor chose not to assign a label for this data subset.

YAML Example
dataSubsets:
- id: Dss01_TEAE
  name: Treatment-Emergent Adverse Events
  label: TEAE
  level: 1
  order: 1
  condition:
    dataset: ADAE
    variable: TRTEMFL
    comparator: EQ
    value:
    - Y
- id: Dss02_RelTEAE
  name: Related Treatment-Emergent Adverse Events
  label: Related TEAE
  level: 1
  order: 1
  compoundExpression:
    logicalOperator: AND
    whereClauses:
    - level: 2
      order: 1
      subClauseId: Dss01_TEAE
    - level: 2
      order: 2
      condition:
        dataset: ADAE
        variable: AEREL
        comparator: IN
        value:
        - POSSIBLE
        - PROBABLE
- id: Dss09_VS_AnRec
  name: Vital Signs Analysis Records
  level: 1
  order: 1
  condition:
    dataset: ADVS
    variable: ANL01FL
    comparator: EQ
    value:
    - Y

These data subsets could be represented in tabular form as shown in the following table where each data subset and subclause is represented on a separate row, and multiple condition values are represented as a pipe (|)-delimited list.

$titleHtml
idnamelabellevelorderlogicalOperatorsubClauseIddatasetvariablecomparatorvalue
Dss01_TEAETreatment-Emergent Adverse EventsTEAE11

ADAETRTEMFLEQY
Dss02_RelTEAERelated Treatment-Emergent Adverse EventsRelated TEAE11AND




Dss02_RelTEAERelated Treatment-Emergent Adverse EventsRelated TEAE21
Dss01_TEAE



Dss02_RelTEAERelated Treatment-Emergent Adverse EventsRelated TEAE22

ADAEAERELINPOSSIBLE|PROBABLE
Dss09_VS_AnRecVital Signs Analysis Records
11

ADVSANL01FLEQY
$warningHtml

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