| AdverseEventReporting UML Documentation |
Summary:AttributesProperties | Detail:Attributes |
Attributes | ||
«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. |
«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. |
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. |
«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. |
«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. |
«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. |
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. |
Properties:
Alias | |
Classifier Behavior | |
Is Abstract | false |
Is Active | false |
Is Leaf | false |
Keywords | |
Name | ReportSubjectObservation |
Name Expression | |
Namespace | AdverseEventReporting |
Owned Template Signature | |
Owner | AdverseEventReporting |
Owning Template Parameter | |
Package | AdverseEventReporting |
Qualified Name | FHIM::AdverseEventReporting::ReportSubjectObservation |
Representation | |
Stereotype | |
Template Parameter | |
Visibility | Public |
Attribute Details |
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.
Aggregation | None |
Alias | |
Association | |
Association End | |
Class | ReportSubjectObservation |
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 | ageGroup |
Name Expression | |
Namespace | ReportSubjectObservation |
Opposite | |
Owner | ReportSubjectObservation |
Owning Association | |
Owning Template Parameter | |
Qualified Name | FHIM::AdverseEventReporting::ReportSubjectObservation::ageGroup |
Stereotype | |
Template Parameter | |
Type | «CS» Code |
Upper | 1 |
Upper Value | (1) |
Visibility | Public |
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.
Aggregation | None |
Alias | |
Association | |
Association End | |
Class | ReportSubjectObservation |
Datatype | |
Default | |
Default Value | |
Is Composite | false |
Is Derived | true |
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 | autopsyDeterminedCauseOfDeath |
Name Expression | |
Namespace | ReportSubjectObservation |
Opposite | |
Owner | ReportSubjectObservation |
Owning Association | |
Owning Template Parameter | |
Qualified Name | FHIM::AdverseEventReporting::ReportSubjectObservation::autopsyDeterminedCauseOfDeath |
Stereotype | |
Template Parameter | |
Type | «CS» Code |
Upper | * |
Upper Value | (*) |
Visibility | Public |
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.
Aggregation | None |
Alias | |
Association | |
Association End | |
Class | ReportSubjectObservation |
Datatype | |
Default | |
Default Value | |
Is Composite | false |
Is Derived | true |
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 | autopsyDeterminedCauseOfDeathText |
Name Expression | |
Namespace | ReportSubjectObservation |
Opposite | |
Owner | ReportSubjectObservation |
Owning Association | |
Owning Template Parameter | |
Qualified Name | FHIM::AdverseEventReporting::ReportSubjectObservation::autopsyDeterminedCauseOfDeathText |
Stereotype | |
Template Parameter | |
Type | String |
Upper | * |
Upper Value | (*) |
Visibility | Public |
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.
Aggregation | None |
Alias | |
Association | |
Association End | |
Class | ReportSubjectObservation |
Datatype | |
Default | |
Default Value | |
Is Composite | false |
Is Derived | true |
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 | dateOfDeath |
Name Expression | |
Namespace | ReportSubjectObservation |
Opposite | |
Owner | ReportSubjectObservation |
Owning Association | |
Owning Template Parameter | |
Qualified Name | FHIM::AdverseEventReporting::ReportSubjectObservation::dateOfDeath |
Stereotype | |
Template Parameter | |
Type | «TS» PointInTime |
Upper | 1 |
Upper Value | (1) |
Visibility | Public |
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.
Aggregation | None |
Alias | |
Association | |
Association End | |
Class | ReportSubjectObservation |
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 | gestationalAgeAtOnset |
Name Expression | |
Namespace | ReportSubjectObservation |
Opposite | |
Owner | ReportSubjectObservation |
Owning Association | |
Owning Template Parameter | |
Qualified Name | FHIM::AdverseEventReporting::ReportSubjectObservation::gestationalAgeAtOnset |
Stereotype | |
Template Parameter | |
Type | «PQ» TimeQuantity |
Upper | 1 |
Upper Value | (1) |
Visibility | Public |
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.
Aggregation | None |
Alias | |
Association | |
Association End | |
Class | ReportSubjectObservation |
Datatype | |
Default | |
Default Value | |
Is Composite | false |
Is Derived | true |
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 | reportedCauseOfDeath |
Name Expression | |
Namespace | ReportSubjectObservation |
Opposite | |
Owner | ReportSubjectObservation |
Owning Association | |
Owning Template Parameter | |
Qualified Name | FHIM::AdverseEventReporting::ReportSubjectObservation::reportedCauseOfDeath |
Stereotype | |
Template Parameter | |
Type | «CS» Code |
Upper | * |
Upper Value | (*) |
Visibility | Public |
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.
Aggregation | None |
Alias | |
Association | |
Association End | |
Class | ReportSubjectObservation |
Datatype | |
Default | |
Default Value | |
Is Composite | false |
Is Derived | true |
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 | reportedCauseOfDeathText |
Name Expression | |
Namespace | ReportSubjectObservation |
Opposite | |
Owner | ReportSubjectObservation |
Owning Association | |
Owning Template Parameter | |
Qualified Name | FHIM::AdverseEventReporting::ReportSubjectObservation::reportedCauseOfDeathText |
Stereotype | |
Template Parameter | |
Type | String |
Upper | * |
Upper Value | (*) |
Visibility | Public |
| AdverseEventReporting UML Documentation |
Summary:AttributesProperties | Detail:Attributes |