Contains information describing any medicinal products (whether suspect or concommittant) given to or taken by the subject near the time of the adverse event occurred. Corresponds to ICH E2B(R3), G.k.

Attributes
Boolean	didEventAbate	Did the adverse event abate after the use of the suspect medication was stopped or the dose was reduced? Medwatch 3500 form question D.5; Medwatch 3500A form question C.5; Medwatch 3500B form question B.13.
Boolean	didReappear	Did the adverse event reappear after the the suspect medication was reintroduced? Medwatch 3500 form question D.8; Medwatch 3500A form question C.8; Medwatch 3500B form question B.14.
DrugDosage	drugDosage	Pointer to information describing the amount, timing, and route of administration of medicinal products (whether suspect or concommittant) given to or taken by the subject near the time of the adverse event occurred.
DrugIngredient	drugIngredient	Pointer to the active ingredient(s) of the drug. Used only if the medicinalProduct or the pharmaceuticalProduct are not known.- ICH E2B(R3), G.k.2.3.r
String	indHolderCountry	"The country where the drug was authorised when the case report is sent to that country if known." - ICH E2B(R3), G.k.3.2
String	indHolderName	"The name of the licence holder as indicated on the package." - ICH E2B(R3), G.k.3.3
«TS» PointInTime	lastFillDate
MedicinalProduct	medicinalProduct
MedicinalProductInstance	medicinalProductInstance	Medwatch 3500A form question C.1 (name), C.6 (lot), C.7 (exp date), C.9 (ndc)
Integer	nbrOfPreviousDoses
GenericMedicine	pharmaceuticalProduct
String	sig

 didEventAbate

Public Boolean didEventAbate

Did the adverse event abate after the use of the suspect medication was stopped or the dose was reduced? Medwatch 3500 form question D.5; Medwatch 3500A form question C.5; Medwatch 3500B form question B.13.

Constraints:

Properties:

Aggregation	None
Alias
Association
Association End
Class	DrugObservation
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	0
Lower Value	(0)
Multiplicity	0..1
Name	didEventAbate
Name Expression
Namespace	DrugObservation
Opposite
Owner	DrugObservation
Owning Association
Owning Template Parameter
Qualified Name	FHIM::AdverseEventReporting::DrugObservation::didEventAbate
Stereotype
Template Parameter
Type	Boolean
Upper	1
Upper Value	(1)
Visibility	Public

 didReappear

Public Boolean didReappear

Did the adverse event reappear after the the suspect medication was reintroduced? Medwatch 3500 form question D.8; Medwatch 3500A form question C.8; Medwatch 3500B form question B.14.

Constraints:

Properties:

Aggregation	None
Alias
Association
Association End
Class	DrugObservation
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	0
Lower Value	(0)
Multiplicity	0..1
Name	didReappear
Name Expression
Namespace	DrugObservation
Opposite
Owner	DrugObservation
Owning Association
Owning Template Parameter
Qualified Name	FHIM::AdverseEventReporting::DrugObservation::didReappear
Stereotype
Template Parameter
Type	Boolean
Upper	1
Upper Value	(1)
Visibility	Public

 drugDosage

Public DrugDosage drugDosage

Pointer to information describing the amount, timing, and route of administration of medicinal products (whether suspect or concommittant) given to or taken by the subject near the time of the adverse event occurred.

Constraints:

Properties:

Aggregation	None
Alias
Association	(drugDosage:DrugDosage)
Association End
Class	DrugObservation
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	0
Lower Value	(0)
Multiplicity	*
Name	drugDosage
Name Expression
Namespace	DrugObservation
Opposite
Owner	DrugObservation
Owning Association
Owning Template Parameter
Qualified Name	FHIM::AdverseEventReporting::DrugObservation::drugDosage
Stereotype
Template Parameter
Type	DrugDosage
Upper	*
Upper Value	(*)
Visibility	Public

 drugIngredient

Public DrugIngredient drugIngredient

Pointer to the active ingredient(s) of the drug. Used only if the medicinalProduct or the pharmaceuticalProduct are not known.- ICH E2B(R3), G.k.2.3.r

Constraints:

Properties:

Aggregation	None
Alias
Association	(drugIngredient:DrugIngredient)
Association End
Class	DrugObservation
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	0
Lower Value	(0)
Multiplicity	*
Name	drugIngredient
Name Expression
Namespace	DrugObservation
Opposite
Owner	DrugObservation
Owning Association
Owning Template Parameter
Qualified Name	FHIM::AdverseEventReporting::DrugObservation::drugIngredient
Stereotype
Template Parameter
Type	DrugIngredient
Upper	*
Upper Value	(*)
Visibility	Public

 indHolderCountry

Public String indHolderCountry

"The country where the drug was authorised when the case report is sent to that country if known." - ICH E2B(R3), G.k.3.2

Constraints:

Properties:

Aggregation	None
Alias
Association
Association End
Class	DrugObservation
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	0
Lower Value	(0)
Multiplicity	0..1
Name	indHolderCountry
Name Expression
Namespace	DrugObservation
Opposite
Owner	DrugObservation
Owning Association
Owning Template Parameter
Qualified Name	FHIM::AdverseEventReporting::DrugObservation::indHolderCountry
Stereotype
Template Parameter
Type	String
Upper	1
Upper Value	(1)
Visibility	Public

 indHolderName

Public String indHolderName

"The name of the licence holder as indicated on the package." - ICH E2B(R3), G.k.3.3

Constraints:

Properties:

Aggregation	None
Alias
Association
Association End
Class	DrugObservation
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	0
Lower Value	(0)
Multiplicity	0..1
Name	indHolderName
Name Expression
Namespace	DrugObservation
Opposite
Owner	DrugObservation
Owning Association
Owning Template Parameter
Qualified Name	FHIM::AdverseEventReporting::DrugObservation::indHolderName
Stereotype
Template Parameter
Type	String
Upper	1
Upper Value	(1)
Visibility	Public

 lastFillDate

Public «TS» PointInTime lastFillDate

Constraints:

Properties:

Aggregation	None
Alias
Association
Association End
Class	DrugObservation
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	0
Lower Value	(0)
Multiplicity	0..1
Name	lastFillDate
Name Expression
Namespace	DrugObservation
Opposite
Owner	DrugObservation
Owning Association
Owning Template Parameter
Qualified Name	FHIM::AdverseEventReporting::DrugObservation::lastFillDate
Stereotype
Template Parameter
Type	«TS» PointInTime
Upper	1
Upper Value	(1)
Visibility	Public

 medicinalProduct

Public MedicinalProduct medicinalProduct

Constraints:

Properties:

Aggregation	None
Alias
Association	concommittantDrugs_medicinalProduct
Association End
Class	DrugObservation
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	0
Lower Value	(0)
Multiplicity	*
Name	medicinalProduct
Name Expression
Namespace	DrugObservation
Opposite
Owner	DrugObservation
Owning Association
Owning Template Parameter
Qualified Name	FHIM::AdverseEventReporting::DrugObservation::medicinalProduct
Stereotype
Template Parameter
Type	MedicinalProduct
Upper	*
Upper Value	(*)
Visibility	Public

 medicinalProductInstance

Public MedicinalProductInstance medicinalProductInstance

Medwatch 3500A form question C.1 (name), C.6 (lot), C.7 (exp date), C.9 (ndc)

Constraints:

Properties:

Aggregation	None
Alias
Association	suspectedMedicinalProduct_medicinalProductInstance
Association End
Class	DrugObservation
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	1
Lower Value	(1)
Multiplicity	1
Name	medicinalProductInstance
Name Expression
Namespace	DrugObservation
Opposite
Owner	DrugObservation
Owning Association
Owning Template Parameter
Qualified Name	FHIM::AdverseEventReporting::DrugObservation::medicinalProductInstance
Stereotype
Template Parameter
Type	MedicinalProductInstance
Upper	1
Upper Value	(1)
Visibility	Public

 nbrOfPreviousDoses

Public Integer nbrOfPreviousDoses

Constraints:

Properties:

Aggregation	None
Alias
Association
Association End
Class	DrugObservation
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	0
Lower Value	(0)
Multiplicity	0..1
Name	nbrOfPreviousDoses
Name Expression
Namespace	DrugObservation
Opposite
Owner	DrugObservation
Owning Association
Owning Template Parameter
Qualified Name	FHIM::AdverseEventReporting::DrugObservation::nbrOfPreviousDoses
Stereotype
Template Parameter
Type	Integer
Upper	1
Upper Value	(1)
Visibility	Public

 pharmaceuticalProduct

Public GenericMedicine pharmaceuticalProduct

Constraints:

Properties:

Aggregation	None
Alias
Association	(pharmaceuticalProduct:GenericMedicine)
Association End
Class	DrugObservation
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	0
Lower Value	(0)
Multiplicity	*
Name	pharmaceuticalProduct
Name Expression
Namespace	DrugObservation
Opposite
Owner	DrugObservation
Owning Association
Owning Template Parameter
Qualified Name	FHIM::AdverseEventReporting::DrugObservation::pharmaceuticalProduct
Stereotype
Template Parameter
Type	GenericMedicine
Upper	*
Upper Value	(*)
Visibility	Public

 sig

Public String sig

Constraints:

Properties:

Aggregation	None
Alias
Association
Association End
Class	DrugObservation
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	0
Lower Value	(0)
Multiplicity	0..1
Name	sig
Name Expression
Namespace	DrugObservation
Opposite
Owner	DrugObservation
Owning Association
Owning Template Parameter
Qualified Name	FHIM::AdverseEventReporting::DrugObservation::sig
Stereotype
Template Parameter
Type	String
Upper	1
Upper Value	(1)
Visibility	Public