AdverseEvent

Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.

= Must Support, = Is Modifier, = QiCore defined extension

FieldCard.TypeDescription
category0..1StringThe type of event which is important to characterize what occurred and caused harm to the subject, or had the potential to cause harm to the subject.
Binding: Overall categorization of the event, e.g. real or potential (required)
type1..1ConceptThis element defines the specific type of event that occurred or that was prevented from occurring.
Binding: The type of adverse event: an incident, near-miss, or unsafe condition (example)
subject1..1Patient | ResearchSubject | Medication | DeviceThis subject or group impacted by the event. With a prospective adverse event, there will be no subject as the adverse event was prevented.
date0..1DateTimeThe date (and perhaps time) when the adverse event occurred.
reaction0..*List<Condition>Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).
location0..1LocationThe information about where the adverse event occurred.
seriousness0..1ConceptDescribes the seriousness or severity of the adverse event.
Binding: A subjective assessment of the severity of the adverse event as evaluated by the clinician. (example)
recorder0..1Patient | RelatedPerson | PractitionerInformation on who recorded the adverse event. May be the patient or a practitioner.
suspectEntity0..*List<suspectEntity>Describes the entity that is suspected to have caused the adverse event.
study0..*List<ResearchStudy>TODO.