OverviewTopPackageElement
AdverseEventReporting UML Documentation
Summary:Enumeration LiteralsProperties
AdverseEventReporting
Enumeration AESeriousness

"The seriousness criteria of the reaction/event should be based on the definitions provided in the ICH E2A and E2D guidelines. More than one seriousness criteria can be chosen. If the event is not serious, all of these data elements should be left blank. It is assumed that the event seriousness is provided by the reporter; otherwise, it is assessed by the sender. In cases of foetal demise such as miscarriage, (where the ICSR should be prepared only for the parent), the seriousness criterion is Other medically important condition. Furthermore, depending if the parent experienced complications, the seriousness criterion could also include Life-threatening and/or Hospitalisation." - ICH E2B(R3), E.i.3.2.

Enumeration Literals
causedOrProlongedHospitalization causedOrProlongedHospitalization

Was hospitalization required (either initial, or if already hospitalized, a prolonged stay) as an outcome attributed to the Adverse Event? - ICH E2B(R3), E.i.3.2c.
MedWatch 3500 form question B.2, box 3.
MedWatch 3500A form question B.2, box 3.
MedWatch 3500B form question A.2, box 1.
VAERS-1 form question 8, box 4.
congenitalAnomalyOrBirthDefect congenitalAnomalyOrBirthDefect

Did some kind of congenital anomaly or birth defect occur as an outcome attributed to the Adverse Event? - ICH E2B(R3), E.i.3.2e.
MedWatch 3500 form question B.2, box 6.
MedWatch 3500A form question B.2, box 6.
MedWatch 3500B form question A.2, box 4.
(note that the VAERS-1 form does not have this element).
disablingOrIncapacitating disablingOrIncapacitating

Did some kind of disability or permanent damage occur as an outcome attributed to the Adverse Event? - ICH E2B(R3), E.i.3.2d.
MedWatch 3500 form question B.2, box 5.
MedWatch 3500A form question B.2, box 5.
MedWatch 3500B form question A.2, box 3.
VAERS-1 form question 8, box 6.
lifeThreatening lifeThreatening

Did a life-threatening condition occur as an outcome attributed to the Adverse Event? - ICH E2B(R3), E.i.3.2b.
MedWatch 3500 form question B.2, box 2.
MedWatch 3500A form question B.2, box 2.
MedWatch 3500B form question A.2, box 5.
VAERS-1 form question 8, box 2.
otherImportantCondition otherImportantCondition

Did some other kind of serious outcomes occur that are attributable to the Adverse Event? - ICH E2B(R3), E.i.3.2f.
MedWatch 3500 form question B.2, box 7.
MedWatch 3500A form question B.2, box 7.
MedWatch 3500B form question A.2, box 7.
(note that the VAERS-1 form does not have this element).
requiredIntervention requiredIntervention

Was some kind of intervention required in order to prevent permanent imparement or damage as an outcome attributed to the Adverse Event (used only when the product is a medical device)? Note that this property is not in ICH, nor is it used in VAERS, because neither ICH nor VAERS are concerned with devices.
MedWatch 3500 form question B.2, box 4.
MedWatch 3500A form question B.2, box 4.
MedWatch 3500B form question A.2, box 2.
resultedInDeath resultedInDeath

Indicates that the report subject died as a result of the Adverse Reaction or Event. - ICH E2B(R3), E.i.3.2a.
MedWatch 3500 form question B.2, box 1.
MedWatch 3500A form question B.2, box 1.
MedWatch 3500B form question A.2, box 6.
VAERS-1 form question 8, box 1.

Properties:
Alias
Is Abstractfalse
Is Leaffalse
Keywords
NameAESeriousness
Name Expression
NamespaceAdverseEventReporting
Owned Template Signature
OwnerAdverseEventReporting
Owning Template Parameter
PackageAdverseEventReporting
Qualified NameFHIM::AdverseEventReporting::AESeriousness
Representation
Stereotype
Template Parameter
VisibilityPublic

OverviewTopPackageElement
AdverseEventReporting UML Documentation
Summary:Enumeration LiteralsProperties