AdverseEventReporting
Class RelevantPastDrugHistory

This class details "relevant drugs previously administered and which have been stopped before the Adverse Event onset. It does not concern drugs taken concomitantly or drugs which might have potentially been involved in the current reaction(s)/event(s). Medical judgment should be exercised in [determining which drug(s) to include]. Medications that have been stopped might be considered suspect based on the elimination half-life of the drug and the known pharmacodynamic effects of the drug in a particular patient (for example, a patient with known renal or liver impairment).... The information provided here can also include previous experience with similar drugs." - ICH E2B(R3), D.8.r.

Attributes
«CS» Code indication indication

"The indication of the medicinal product." - ICH E2B(R3), D.8.r.6a and D.8.r.6b; D.10.8.r.6a and D.10.8.r.6b (MedDRA code and version)

«EntryPoint» MedicationList medicationList medicationList
«CS» Code previousReaction previousReaction

"Describes previous experience with the drug described [in the medication list]" - ICH E2B(R3), D.8.r.7a and D.8.r.7b; D.10.8.r.7a and D.10.8.r.7b (MedDRA code and version)


Properties:

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

Attribute Details

 indication
Public «CS» Code indication

"The indication of the medicinal product." - ICH E2B(R3), D.8.r.6a and D.8.r.6b; D.10.8.r.6a and D.10.8.r.6b (MedDRA code and version)

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassRelevantPastDrugHistory
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
Nameindication
Name Expression
NamespaceRelevantPastDrugHistory
Opposite
OwnerRelevantPastDrugHistory
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::RelevantPastDrugHistory::indication
Stereotype
Template Parameter
Type«CS» Code
Upper1
Upper Value(1)
VisibilityPublic


 medicationList
Public «EntryPoint» MedicationList medicationList
Constraints:
Properties:

AggregationNone
Alias
Association(medicationList:MedicationList)
Association End
ClassRelevantPastDrugHistory
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
NamemedicationList
Name Expression
NamespaceRelevantPastDrugHistory
Opposite
OwnerRelevantPastDrugHistory
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::RelevantPastDrugHistory::medicationList
Stereotype
Template Parameter
Type«EntryPoint» MedicationList
Upper1
Upper Value(1)
VisibilityPublic


 previousReaction
Public «CS» Code previousReaction

"Describes previous experience with the drug described [in the medication list]" - ICH E2B(R3), D.8.r.7a and D.8.r.7b; D.10.8.r.7a and D.10.8.r.7b (MedDRA code and version)

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassRelevantPastDrugHistory
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
NamepreviousReaction
Name Expression
NamespaceRelevantPastDrugHistory
Opposite
OwnerRelevantPastDrugHistory
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::RelevantPastDrugHistory::previousReaction
Stereotype
Template Parameter
Type«CS» Code
Upper1
Upper Value(1)
VisibilityPublic