AdverseEventReporting
Class ReportSubjectObservation

Attributes
«CS» Code ageGroup ageGroup

If the patient's date of birth is not known, this property is used to provide a characterization of the age of the person at the time of the first reaction or event. From ICH E2B(R3), D.2.3. Possible values include: Foetus; Neonate (Preterm and Term newborns); Infant; Child; Adolescent; Adult; Elderly.

«CS» Code autopsyDeterminedCauseOfDeath autopsyDeterminedCauseOfDeath

"The autopsy-determined cause of death." - ICH E2B(R3), D.9.4.r.1a and D.9.4.r.1b (MedDRA code and version). Note that this property can repeat.

String autopsyDeterminedCauseOfDeathText autopsyDeterminedCauseOfDeathText

"The original reporter's words and/or short phrases used to describe the autopsy-determined cause of death." - ICH E2B(R3), D.9.4.r.2. Note that this property can repeat.

«TS» PointInTime dateOfDeath dateOfDeath

The reported date of death of the patient. An imprecise date can be used if the exact date is not known. Note that this property can be derived from the person's demographics information. See ICH E2B(R3), D.9.1.

Date that the patient died as an outcome attributed to the Adverse Event. Medwatch 3500A form question A.2, box 1.

«PQ» TimeQuantity gestationalAgeAtOnset gestationalAgeAtOnset

If the reaction or adverse event affected an unborn child, this property is used to convey the gestational period (age) of the fetus at the time of the first reaction or event. Note that the units could include trimester as well as days, weeks, or months. From ICH E2B(R3), D.2.2.1.a and D.2.2.1b.

«CS» Code reportedCauseOfDeath reportedCauseOfDeath

"The reported cause of death." - ICH E2B(R3), D.9.2.r.1a and D.9.2.r.1b (MedDRA code and version). Note that this property can repeat.

String reportedCauseOfDeathText reportedCauseOfDeathText

"The original reporter's words and/or short phrases used to describe the cause of death." - ICH E2B(R3), D.9.2.r.2. Note that this property can repeat.

Attributes inherited from FHIM::AdverseEventReporting::AbstractReportSubjectObservation FHIM::AdverseEventReporting::AbstractReportSubjectObservation
ageAtOnset ageAtOnset, dateOfBirth dateOfBirth, initials initials, race race, releventMedicalHistoryText releventMedicalHistoryText, sex sex, releventMedicalHistory releventMedicalHistory, relevantPastDrugHistory relevantPastDrugHistory, heightObservation heightObservation, weightObservation weightObservation, lastMenstrualPeriodObservation lastMenstrualPeriodObservation, relevantLabTest relevantLabTest

Properties:

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

Attribute Details

 ageGroup
Public «CS» Code ageGroup

If the patient's date of birth is not known, this property is used to provide a characterization of the age of the person at the time of the first reaction or event. From ICH E2B(R3), D.2.3. Possible values include: Foetus; Neonate (Preterm and Term newborns); Infant; Child; Adolescent; Adult; Elderly.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassReportSubjectObservation
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
NameageGroup
Name Expression
NamespaceReportSubjectObservation
Opposite
OwnerReportSubjectObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::ReportSubjectObservation::ageGroup
Stereotype
Template Parameter
Type«CS» Code
Upper1
Upper Value(1)
VisibilityPublic


 autopsyDeterminedCauseOfDeath
Public «CS» Code autopsyDeterminedCauseOfDeath

"The autopsy-determined cause of death." - ICH E2B(R3), D.9.4.r.1a and D.9.4.r.1b (MedDRA code and version). Note that this property can repeat.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassReportSubjectObservation
Datatype
Default
Default Value
Is Compositefalse
Is Derivedtrue
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity*
NameautopsyDeterminedCauseOfDeath
Name Expression
NamespaceReportSubjectObservation
Opposite
OwnerReportSubjectObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::ReportSubjectObservation::autopsyDeterminedCauseOfDeath
Stereotype
Template Parameter
Type«CS» Code
Upper*
Upper Value(*)
VisibilityPublic


 autopsyDeterminedCauseOfDeathText
Public String autopsyDeterminedCauseOfDeathText

"The original reporter's words and/or short phrases used to describe the autopsy-determined cause of death." - ICH E2B(R3), D.9.4.r.2. Note that this property can repeat.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassReportSubjectObservation
Datatype
Default
Default Value
Is Compositefalse
Is Derivedtrue
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity*
NameautopsyDeterminedCauseOfDeathText
Name Expression
NamespaceReportSubjectObservation
Opposite
OwnerReportSubjectObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::ReportSubjectObservation::autopsyDeterminedCauseOfDeathText
Stereotype
Template Parameter
TypeString
Upper*
Upper Value(*)
VisibilityPublic


 dateOfDeath
Public «TS» PointInTime dateOfDeath

The reported date of death of the patient. An imprecise date can be used if the exact date is not known. Note that this property can be derived from the person's demographics information. See ICH E2B(R3), D.9.1.

Date that the patient died as an outcome attributed to the Adverse Event. Medwatch 3500A form question A.2, box 1.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassReportSubjectObservation
Datatype
Default
Default Value
Is Compositefalse
Is Derivedtrue
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NamedateOfDeath
Name Expression
NamespaceReportSubjectObservation
Opposite
OwnerReportSubjectObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::ReportSubjectObservation::dateOfDeath
Stereotype
Template Parameter
Type«TS» PointInTime
Upper1
Upper Value(1)
VisibilityPublic


 gestationalAgeAtOnset
Public «PQ» TimeQuantity gestationalAgeAtOnset

If the reaction or adverse event affected an unborn child, this property is used to convey the gestational period (age) of the fetus at the time of the first reaction or event. Note that the units could include trimester as well as days, weeks, or months. From ICH E2B(R3), D.2.2.1.a and D.2.2.1b.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassReportSubjectObservation
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
NamegestationalAgeAtOnset
Name Expression
NamespaceReportSubjectObservation
Opposite
OwnerReportSubjectObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::ReportSubjectObservation::gestationalAgeAtOnset
Stereotype
Template Parameter
Type«PQ» TimeQuantity
Upper1
Upper Value(1)
VisibilityPublic


 reportedCauseOfDeath
Public «CS» Code reportedCauseOfDeath

"The reported cause of death." - ICH E2B(R3), D.9.2.r.1a and D.9.2.r.1b (MedDRA code and version). Note that this property can repeat.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassReportSubjectObservation
Datatype
Default
Default Value
Is Compositefalse
Is Derivedtrue
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity*
NamereportedCauseOfDeath
Name Expression
NamespaceReportSubjectObservation
Opposite
OwnerReportSubjectObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::ReportSubjectObservation::reportedCauseOfDeath
Stereotype
Template Parameter
Type«CS» Code
Upper*
Upper Value(*)
VisibilityPublic


 reportedCauseOfDeathText
Public String reportedCauseOfDeathText

"The original reporter's words and/or short phrases used to describe the cause of death." - ICH E2B(R3), D.9.2.r.2. Note that this property can repeat.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassReportSubjectObservation
Datatype
Default
Default Value
Is Compositefalse
Is Derivedtrue
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity*
NamereportedCauseOfDeathText
Name Expression
NamespaceReportSubjectObservation
Opposite
OwnerReportSubjectObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::ReportSubjectObservation::reportedCauseOfDeathText
Stereotype
Template Parameter
TypeString
Upper*
Upper Value(*)
VisibilityPublic