This example shows an instance of the DataSubset specialization of the WhereClause class that defines a compound expression for "Treatment-emergent adverse events resulting in death". The compound expression specifies that the value of the TRTEMFL variable in the ADAE dataset is equal to "Y" and either the value of the AESDTH variable in the ADAE dataset is equal to "Y" or the value of the AEOUT variable in the ADAE dataset is equal to "FATAL", which could be expressed as:

  • ADAE.TRTEMFL EQ 'Y' AND (ADAE.AESDTH EQ 'Y' OR ADAE.AEOUT EQ 'FATAL') 

Lines 1-5:

Show the attributes of the DataSubset specialization of the WhereClause class:

  • level is assigned as "1" because this is the "top" level of the specification of the selection criterion.
  • order is "1" because level is "1" and this is not a specialization of the Group class.
  • The presence of the compoundExpression attribute indicates that a compound expression is being defined.
Lines 6-7:

Show the attributes of an instance of the CompoundSubsetExpression specialization of the WhereClauseCompoundExpression class (because this is a compound expression within a DataSubset class):

  • The value of the logicalOperator attribute is "AND" which indicates that both subclauses specified in the whereClauses attribute have to be satisfied.
  • The whereClause attribute contains 2 subclauses, both represented as instances of the WhereClause class (because these are subclauses within a CompoundSubsetExpression class) with "2" as the value of the level attribute (1 greater than the level of the DataSubset class specifying this compound expression):
    • Lines 8-10: Show the first subclause (order = 1) defined as a simple condition.
    • Lines 18-18: Show the second subclause (order = 2) defined as another compound expression. 
Lines 19-20:

Show the attributes of an instance of the WhereClauseCompoundExpression class (because this is a compound expression within a WhereClause class):

  • The value of the logicalOperator attribute is "OR" which indicates that either of the subclauses specified in the whereClauses attribute has to be satisfied.
  • The whereClause attribute contains two subclauses, both of which are simple conditions represented as instances of the WhereClause class (because these are subclauses within a WhereClauseCompoundExpression class) with "3" as the value of the level attribute (1 greater than the level of the WhereClause class specifying this compound expression). The values of the order attribute are "1" and "2" to order the subclauses within this level.

YAML Example
id: DSS-TEAE-DTH
label: Treatment-emergent adverse events resulting in death
level: 1
order: 1
compoundExpression:
  logicalOperator: AND
  whereClauses:
  - level: 2
    order: 1
    condition:
      dataset: ADAE
      variable: TRTEMFL
      comparator: EQ
      value:
      - Y
  - level: 2
    order: 2
    compoundExpression:
      logicalOperator: OR
      whereClauses:
      - level: 3
        order: 1
        condition:
          dataset: ADAE
          variable: AESDTH
          comparator: EQ
          value:
          - Y
      - level: 3
        order: 2
        condition:
          dataset: ADAE
          variable: AEOUT
          comparator: EQ
          value:
          - FATAL

This compound expression could be represented in tabular form as shown in the following table where:

  • Each instance of the WhereClause class (and its DataSubset specialization) is represented on a separate row.
  • The values of the id and label attributes of the DataSubset class have be propagated onto all rows representing subclauses within the defined data subset.

$titleHtml
idlabellevelorderlogicalOperatordatasetvariablecomparatorvalue
DSS-TEAE-DTHTreatment-emergent adverse events resulting in death11AND



DSS-TEAE-DTHTreatment-emergent adverse events resulting in death21
AEAETRTEMFLEQY
DSS-TEAE-DTHTreatment-emergent adverse events resulting in death22OR



DSS-TEAE-DTHTreatment-emergent adverse events resulting in death31
AEAEAESDTHEQY
DSS-TEAE-DTHTreatment-emergent adverse events resulting in death32
AEAEAEOUTEQFATAL
$warningHtml

  • No labels