AdverseEventReporting
Class ProductEventRelationship

This class links a reaction or adverse event with the various medical products (medical devices and/or drugs) that were being used by the patient, and provides an assessment of whether the reaction / adverse event may have been caused by or exacerbated by the product.

Attributes
«CS» Code didReactionRecur didReactionRecur

"Indicates both if the patient was rechallenged with the drug and the known outcome. This data element should not be coded if it was not reported whether or not a rechallenge was done." - ICH E2B(R3), G.k.9.i.4. Possible values include: Yes-Yes (rechallenge was done, reaction recurred); Yes-No (rechallenge was done, reaction did not recur); Yes-Unk (rechallenge was done, outcome unknown); No–N/A (no rechallenge was done, recurrence is not applicable).

ProductEventAssessment productEventAssessment productEventAssessment

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

ReactionOrEvent reactionOrEvent reactionOrEvent

Pointer to the ReactionOrEvent for which an assessment of the causal relationship to the Drug is being made.

"Captures a technical reference within the message that is used to identify which reaction / event in Section E.i is being assessed. This is not a user entered element." - ICH E2B(R3), G.k.9.i.1.

«PQ» TimeQuantity timeFromAdminStart timeFromAdminStart

"The interval of time between the start of drug administration and the onset of the reaction. Even when other dates are provided, this data element is useful also to be transmitted for circumstances where, for example the interval is very short minutes, such as in anaphylaxis, or in which only imprecise dates are known but more information concerning the interval is known. If the sender wants to provide time intervals as well as dates, then the date of the first day of administration should be counted as Day 1 of the interval." - ICH E2B(R3), G.k.9.i.3.1a and G.k.9.i.3.1b. Note that ICH requires that the unit of time measurement should come from UCUM.

«PQ» TimeQuantity timeFromAdminStop timeFromAdminStop

"The interval of time between the end of drug administration and the onset of the reaction. Even when other dates are provided, this data element is useful also to be transmitted for circumstances where, for e.g. the interval is very short minutes, such as in anaphylaxis, or in which only imprecise dates are known but more information concerning the interval is known. If the sender wants to provide time intervals as well as dates, then the date of the last day of administration should be counted as Day 1 of the interval." - ICH E2B(R3), G.k.9.i.3.2a and G.k.9.i.3.2b. Note that ICH requires that the unit of time measurement should come from UCUM.


Properties:

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

Attribute Details

 didReactionRecur
Public «CS» Code didReactionRecur

"Indicates both if the patient was rechallenged with the drug and the known outcome. This data element should not be coded if it was not reported whether or not a rechallenge was done." - ICH E2B(R3), G.k.9.i.4. Possible values include: Yes-Yes (rechallenge was done, reaction recurred); Yes-No (rechallenge was done, reaction did not recur); Yes-Unk (rechallenge was done, outcome unknown); No–N/A (no rechallenge was done, recurrence is not applicable).

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassProductEventRelationship
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
NamedidReactionRecur
Name Expression
NamespaceProductEventRelationship
Opposite
OwnerProductEventRelationship
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::ProductEventRelationship::didReactionRecur
Stereotype
Template Parameter
Type«CS» Code
Upper1
Upper Value(1)
VisibilityPublic


 productEventAssessment
Public ProductEventAssessment productEventAssessment

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

Constraints:
Properties:

AggregationNone
Alias
Association(productEventAssessment:ProductEventAssessment)
Association End
ClassProductEventRelationship
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)
Multiplicity*
NameproductEventAssessment
Name Expression
NamespaceProductEventRelationship
Opposite
OwnerProductEventRelationship
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::ProductEventRelationship::productEventAssessment
Stereotype
Template Parameter
TypeProductEventAssessment
Upper*
Upper Value(*)
VisibilityPublic


 reactionOrEvent
Public ReactionOrEvent reactionOrEvent

Pointer to the ReactionOrEvent for which an assessment of the causal relationship to the Drug is being made.

"Captures a technical reference within the message that is used to identify which reaction / event in Section E.i is being assessed. This is not a user entered element." - ICH E2B(R3), G.k.9.i.1.

Constraints:
Properties:

AggregationNone
Alias
Association(reactionOrEvent:ReactionOrEvent)
Association End
ClassProductEventRelationship
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower1
Lower Value(1)
Multiplicity1
NamereactionOrEvent
Name Expression
NamespaceProductEventRelationship
Opposite
OwnerProductEventRelationship
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::ProductEventRelationship::reactionOrEvent
Stereotype
Template Parameter
TypeReactionOrEvent
Upper1
Upper Value(1)
VisibilityPublic


 timeFromAdminStart
Public «PQ» TimeQuantity timeFromAdminStart

"The interval of time between the start of drug administration and the onset of the reaction. Even when other dates are provided, this data element is useful also to be transmitted for circumstances where, for example the interval is very short minutes, such as in anaphylaxis, or in which only imprecise dates are known but more information concerning the interval is known. If the sender wants to provide time intervals as well as dates, then the date of the first day of administration should be counted as Day 1 of the interval." - ICH E2B(R3), G.k.9.i.3.1a and G.k.9.i.3.1b. Note that ICH requires that the unit of time measurement should come from UCUM.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassProductEventRelationship
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
NametimeFromAdminStart
Name Expression
NamespaceProductEventRelationship
Opposite
OwnerProductEventRelationship
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::ProductEventRelationship::timeFromAdminStart
Stereotype
Template Parameter
Type«PQ» TimeQuantity
Upper1
Upper Value(1)
VisibilityPublic


 timeFromAdminStop
Public «PQ» TimeQuantity timeFromAdminStop

"The interval of time between the end of drug administration and the onset of the reaction. Even when other dates are provided, this data element is useful also to be transmitted for circumstances where, for e.g. the interval is very short minutes, such as in anaphylaxis, or in which only imprecise dates are known but more information concerning the interval is known. If the sender wants to provide time intervals as well as dates, then the date of the last day of administration should be counted as Day 1 of the interval." - ICH E2B(R3), G.k.9.i.3.2a and G.k.9.i.3.2b. Note that ICH requires that the unit of time measurement should come from UCUM.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassProductEventRelationship
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
NametimeFromAdminStop
Name Expression
NamespaceProductEventRelationship
Opposite
OwnerProductEventRelationship
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::ProductEventRelationship::timeFromAdminStop
Stereotype
Template Parameter
Type«PQ» TimeQuantity
Upper1
Upper Value(1)
VisibilityPublic