AdverseEventReporting
Class ProductEventAssessment

An assessment of whether the reaction / adverse event may have been caused by or exacerbated by the product cited by the owning ProductEventRelationship class.

Attributes
String method method

"The method of the assessment provided in G.k.9.i.2.r.3.For example global introspection, algorithm, Bayesian calculation, etc." - ICH E2B(R3), G.k.9.i.2.r.2.

String result result

"The result of the assessment for relatedness. The value will depend on the method used for the assessment" - ICH E2B(R3), G.k.9.i.2.r.3.

String source source

"The source of the assessment provided in G.k.9.i.2.r.3." - ICH E2B(R3), G.k.9.i.2.r.1.


Properties:

Alias
Classifier Behavior
Is Abstractfalse
Is Activefalse
Is Leaffalse
Keywords
NameProductEventAssessment
Name Expression
NamespaceAdverseEventReporting
Owned Template Signature
OwnerAdverseEventReporting
Owning Template Parameter
PackageAdverseEventReporting
Qualified NameFHIM::AdverseEventReporting::ProductEventAssessment
Representation
Stereotype
Template Parameter
VisibilityPublic

Attribute Details

 method
Public String method

"The method of the assessment provided in G.k.9.i.2.r.3.For example global introspection, algorithm, Bayesian calculation, etc." - ICH E2B(R3), G.k.9.i.2.r.2.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassProductEventAssessment
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
Namemethod
Name Expression
NamespaceProductEventAssessment
Opposite
OwnerProductEventAssessment
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::ProductEventAssessment::method
Stereotype
Template Parameter
TypeString
Upper1
Upper Value(1)
VisibilityPublic


 result
Public String result

"The result of the assessment for relatedness. The value will depend on the method used for the assessment" - ICH E2B(R3), G.k.9.i.2.r.3.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassProductEventAssessment
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
Nameresult
Name Expression
NamespaceProductEventAssessment
Opposite
OwnerProductEventAssessment
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::ProductEventAssessment::result
Stereotype
Template Parameter
TypeString
Upper1
Upper Value(1)
VisibilityPublic


 source
Public String source

"The source of the assessment provided in G.k.9.i.2.r.3." - ICH E2B(R3), G.k.9.i.2.r.1.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassProductEventAssessment
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
Namesource
Name Expression
NamespaceProductEventAssessment
Opposite
OwnerProductEventAssessment
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::ProductEventAssessment::source
Stereotype
Template Parameter
TypeString
Upper1
Upper Value(1)
VisibilityPublic