AdverseEventReporting
Class AbstractReportSubjectObservation

This class contains demographic observations made about a Patient at a given point of time. Each of the properties in the class exist in the Patient or Person classes. They are repeated here to emphasize that they are point-in-time observations that are needed for a particular report. Note that each of these properties are marked as derived - all of the properties can be calculated from the Patient and Person classes.

Attributes
«PQ» TimeQuantity ageAtOnset ageAtOnset

This property contains age of the person in question at the time that the event occured. Note that if the person's date of birth is known, this property can be derived from the patient's Person demographics information. However, in general, this property is used only when the date of birth is not known, thereby conveying the approximate age of the person at the time of the first reaction or event.

If the person in question is the patient, this is their age when the event or reaction first occurred to them. See ICH E2B(R3), D.2.2.a and D.2.2b.
If the person in question is a parent (typically the mother) of the patient, this is their age at the time that the event or reaction first occurred to the child or fetus. ICH E2B(R3), D.10.2.2a and D.10.2.2b.
If the person in question is a sibling of the patient, this is their age when the date/time the event or reaction first occurred to the sibling. Note that ICH does not include siblings.

Medwatch 3500 form question A.2.a; Medwatch 3500A form question A.2.a; Medwatch 3500B form question D.3.a; VAERS-1 form question 4.

«TS» PointInTime dateOfBirth dateOfBirth

The date of birth of the person in question, which would be used to calculate their age at time that the adverse event or reaction occurred. Note that this property can be derived from the person's demographics information.

If the person in question is the patient, see ICH E2B(R3), D.2.1
If the person in question is a parent (typically the mother) of the patient, see ICH E2B(R3), D.10.2.1
It is noted that ICH does not support sibling information.

Medwatch 3500 form question A.2.b; Medwatch 3500A form question A.2.b; Medwatch 3500B form question D.3.b; VAERS-1 form question 3.

HeightObservation heightObservation heightObservation

Pointer to the reported height in centimeters of the person in question at the time that the adverse event or reaction first occured.

If the person in question is the patient, this is their reported height when the event or reaction first occurred to them. See ICH E2B(R3), D.4.
If the person in question is a parent (typically the mother) of the patient, this is the reported height of the parent at the time that the event or reaction first occurred to the child or fetus. See ICH E2B(R3), D.10.5.
If the person in question is a sibling of the patient, this property will likely not be used.

String initials initials

The first letter of each part of a proper name. This property stores the initials of a person's name, which is used in research studies to identify the patient without divulging the person's entire name. Note that this property can be derived from the patient's Person demographics information.
Medwatch 3500B form question D.1.

LastMenstrualPeriodStartDate lastMenstrualPeriodObservation lastMenstrualPeriodObservation

Pointer to a Clinical Observation of when the patient's last menstrual period began, if applicable.

«CS» Code race race

The patient's race. Note that this property can be derived from the patient's Person demographics information.
Medwatch 3500B form question D.5.

RelevantLabResult relevantLabTest relevantLabTest

Pointer to laboratory test information pertinent to understanding the case.

RelevantPastDrugHistory relevantPastDrugHistory relevantPastDrugHistory

Pointer to relevant drugs previously administered and which have been stopped before the Adverse Event onset.

ReleventMedicalHistory releventMedicalHistory releventMedicalHistory

Pointer to information pertinent to understanding the case (such as diseases, conditions such as pregnancy, surgical procedures, psychological trauma, risk factors, etc.).

String releventMedicalHistoryText releventMedicalHistoryText

"Information about any other medical history that could not be coded in [the structured relevant medical history / concurrent conditions]." - ICH E2B(R3), D.7.2 and D.10.7.2.

«CS» Code sex sex

The sex of the person in question. Note that this property can be derived from the person's demographics information.

If the person in question is the patient, see ICH E2B(R3), D.2.1
If the person in question is a parent (typically the mother) of the patient, see ICH E2B(R3), D.10.6.
It is noted that ICH does not support sibling information.

Medwatch 3500 form question A.3; Medwatch 3500A form question A.3; Medwatch 3500B form question D.2; VAERS-1 form question 5.

WeightObservation weightObservation weightObservation

Pointer to the reported body weight of the person in question at the time that the adverse event or reaction first occured.

If the person in question is the patient, this is their reported body weight when the event or reaction first occurred to them. See ICH E2B(R3), D.3.
If the person in question is a parent (typically the mother) of the patient, this is the reported body weight of the parent at the time that the event or reaction first occurred to the child or fetus. See ICH E2B(R3), D.10.4.
If the person in question is a sibling of the patient, this propery will likely not be used.


Properties:

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

Attribute Details

 ageAtOnset
Public «PQ» TimeQuantity ageAtOnset

This property contains age of the person in question at the time that the event occured. Note that if the person's date of birth is known, this property can be derived from the patient's Person demographics information. However, in general, this property is used only when the date of birth is not known, thereby conveying the approximate age of the person at the time of the first reaction or event.

If the person in question is the patient, this is their age when the event or reaction first occurred to them. See ICH E2B(R3), D.2.2.a and D.2.2b.
If the person in question is a parent (typically the mother) of the patient, this is their age at the time that the event or reaction first occurred to the child or fetus. ICH E2B(R3), D.10.2.2a and D.10.2.2b.
If the person in question is a sibling of the patient, this is their age when the date/time the event or reaction first occurred to the sibling. Note that ICH does not include siblings.

Medwatch 3500 form question A.2.a; Medwatch 3500A form question A.2.a; Medwatch 3500B form question D.3.a; VAERS-1 form question 4.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassAbstractReportSubjectObservation
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
NameageAtOnset
Name Expression
NamespaceAbstractReportSubjectObservation
Opposite
OwnerAbstractReportSubjectObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::AbstractReportSubjectObservation::ageAtOnset
Stereotype
Template Parameter
Type«PQ» TimeQuantity
Upper1
Upper Value(1)
VisibilityPublic


 dateOfBirth
Public «TS» PointInTime dateOfBirth

The date of birth of the person in question, which would be used to calculate their age at time that the adverse event or reaction occurred. Note that this property can be derived from the person's demographics information.

If the person in question is the patient, see ICH E2B(R3), D.2.1
If the person in question is a parent (typically the mother) of the patient, see ICH E2B(R3), D.10.2.1
It is noted that ICH does not support sibling information.

Medwatch 3500 form question A.2.b; Medwatch 3500A form question A.2.b; Medwatch 3500B form question D.3.b; VAERS-1 form question 3.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassAbstractReportSubjectObservation
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
NamedateOfBirth
Name Expression
NamespaceAbstractReportSubjectObservation
Opposite
OwnerAbstractReportSubjectObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::AbstractReportSubjectObservation::dateOfBirth
Stereotype
Template Parameter
Type«TS» PointInTime
Upper1
Upper Value(1)
VisibilityPublic


 heightObservation
Public HeightObservation heightObservation

Pointer to the reported height in centimeters of the person in question at the time that the adverse event or reaction first occured.

If the person in question is the patient, this is their reported height when the event or reaction first occurred to them. See ICH E2B(R3), D.4.
If the person in question is a parent (typically the mother) of the patient, this is the reported height of the parent at the time that the event or reaction first occurred to the child or fetus. See ICH E2B(R3), D.10.5.
If the person in question is a sibling of the patient, this property will likely not be used.

Constraints:
Properties:

AggregationNone
Alias
AssociationindvidualCaseSafetyReport_heightObservation
Association End
ClassAbstractReportSubjectObservation
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
NameheightObservation
Name Expression
NamespaceAbstractReportSubjectObservation
Opposite
OwnerAbstractReportSubjectObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::AbstractReportSubjectObservation::heightObservation
Stereotype
Template Parameter
TypeHeightObservation
Upper1
Upper Value(1)
VisibilityPublic


 initials
Public String initials

The first letter of each part of a proper name. This property stores the initials of a person's name, which is used in research studies to identify the patient without divulging the person's entire name. Note that this property can be derived from the patient's Person demographics information.
Medwatch 3500B form question D.1.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassAbstractReportSubjectObservation
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
Nameinitials
Name Expression
NamespaceAbstractReportSubjectObservation
Opposite
OwnerAbstractReportSubjectObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::AbstractReportSubjectObservation::initials
Stereotype
Template Parameter
TypeString
Upper1
Upper Value(1)
VisibilityPublic


 lastMenstrualPeriodObservation
Public LastMenstrualPeriodStartDate lastMenstrualPeriodObservation

Pointer to a Clinical Observation of when the patient's last menstrual period began, if applicable.

Constraints:
Properties:

AggregationNone
Alias
Association(lastMenstrualPeriodObservation:LastMenstrualPeriodStartDate)
Association End
ClassAbstractReportSubjectObservation
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
NamelastMenstrualPeriodObservation
Name Expression
NamespaceAbstractReportSubjectObservation
Opposite
OwnerAbstractReportSubjectObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::AbstractReportSubjectObservation::lastMenstrualPeriodObservation
Stereotype
Template Parameter
TypeLastMenstrualPeriodStartDate
Upper1
Upper Value(1)
VisibilityPublic


 race
Public «CS» Code race

The patient's race. Note that this property can be derived from the patient's Person demographics information.
Medwatch 3500B form question D.5.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassAbstractReportSubjectObservation
Terminologies[
FHIM_Defined_Content Race Category Excluding Nulls 2.16.840.1.113883.3.2074.1.1.3
]
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
Namerace
Name Expression
NamespaceAbstractReportSubjectObservation
Opposite
OwnerAbstractReportSubjectObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::AbstractReportSubjectObservation::race
StereotypeValueSetConstraints
Template Parameter
Type«CS» Code
Upper1
Upper Value(1)
VisibilityPublic


 relevantLabTest
Public RelevantLabResult relevantLabTest

Pointer to laboratory test information pertinent to understanding the case.

Constraints:
Properties:

AggregationNone
Alias
Association(relevantLabTest:RelevantLabResult)
Association End
ClassAbstractReportSubjectObservation
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*
NamerelevantLabTest
Name Expression
NamespaceAbstractReportSubjectObservation
Opposite
OwnerAbstractReportSubjectObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::AbstractReportSubjectObservation::relevantLabTest
Stereotype
Template Parameter
TypeRelevantLabResult
Upper*
Upper Value(*)
VisibilityPublic


 relevantPastDrugHistory
Public RelevantPastDrugHistory relevantPastDrugHistory

Pointer to relevant drugs previously administered and which have been stopped before the Adverse Event onset.

Constraints:
Properties:

AggregationNone
Alias
Association(relevantPastDrugHistory:RelevantPastDrugHistory)
Association End
ClassAbstractReportSubjectObservation
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*
NamerelevantPastDrugHistory
Name Expression
NamespaceAbstractReportSubjectObservation
Opposite
OwnerAbstractReportSubjectObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::AbstractReportSubjectObservation::relevantPastDrugHistory
Stereotype
Template Parameter
TypeRelevantPastDrugHistory
Upper*
Upper Value(*)
VisibilityPublic


 releventMedicalHistory
Public ReleventMedicalHistory releventMedicalHistory

Pointer to information pertinent to understanding the case (such as diseases, conditions such as pregnancy, surgical procedures, psychological trauma, risk factors, etc.).

Constraints:
Properties:

AggregationNone
Alias
Association(releventMedicalHistory:ReleventMedicalHistory)
Association End
ClassAbstractReportSubjectObservation
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*
NamereleventMedicalHistory
Name Expression
NamespaceAbstractReportSubjectObservation
Opposite
OwnerAbstractReportSubjectObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::AbstractReportSubjectObservation::releventMedicalHistory
Stereotype
Template Parameter
TypeReleventMedicalHistory
Upper*
Upper Value(*)
VisibilityPublic


 releventMedicalHistoryText
Public String releventMedicalHistoryText

"Information about any other medical history that could not be coded in [the structured relevant medical history / concurrent conditions]." - ICH E2B(R3), D.7.2 and D.10.7.2.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassAbstractReportSubjectObservation
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
NamereleventMedicalHistoryText
Name Expression
NamespaceAbstractReportSubjectObservation
Opposite
OwnerAbstractReportSubjectObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::AbstractReportSubjectObservation::releventMedicalHistoryText
Stereotype
Template Parameter
TypeString
Upper1
Upper Value(1)
VisibilityPublic


 sex
Public «CS» Code sex

The sex of the person in question. Note that this property can be derived from the person's demographics information.

If the person in question is the patient, see ICH E2B(R3), D.2.1
If the person in question is a parent (typically the mother) of the patient, see ICH E2B(R3), D.10.6.
It is noted that ICH does not support sibling information.

Medwatch 3500 form question A.3; Medwatch 3500A form question A.3; Medwatch 3500B form question D.2; VAERS-1 form question 5.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassAbstractReportSubjectObservation
Terminologies[
FHIM_Defined_Content Administrative Gender Excluding Nulls 2.16.840.1.113883.3.2074.1.1.5
]
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
Namesex
Name Expression
NamespaceAbstractReportSubjectObservation
Opposite
OwnerAbstractReportSubjectObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::AbstractReportSubjectObservation::sex
StereotypeValueSetConstraints
Template Parameter
Type«CS» Code
Upper1
Upper Value(1)
VisibilityPublic


 weightObservation
Public WeightObservation weightObservation

Pointer to the reported body weight of the person in question at the time that the adverse event or reaction first occured.

If the person in question is the patient, this is their reported body weight when the event or reaction first occurred to them. See ICH E2B(R3), D.3.
If the person in question is a parent (typically the mother) of the patient, this is the reported body weight of the parent at the time that the event or reaction first occurred to the child or fetus. See ICH E2B(R3), D.10.4.
If the person in question is a sibling of the patient, this propery will likely not be used.

Constraints:
Properties:

AggregationNone
Alias
AssociationindvidualCaseSafetyReport_weightObservation
Association End
ClassAbstractReportSubjectObservation
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
NameweightObservation
Name Expression
NamespaceAbstractReportSubjectObservation
Opposite
OwnerAbstractReportSubjectObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::AbstractReportSubjectObservation::weightObservation
Stereotype
Template Parameter
TypeWeightObservation
Upper1
Upper Value(1)
VisibilityPublic