Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
TU | DomainResource | An event that may be related to unintended effects on a patient or research participant Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension | ||
Σ | 0..* | Identifier | Business identifier for the event | |
?!Σ | 1..1 | code | in-progress | completed | entered-in-error | unknown Binding: Adverse Event Status (Required) | |
?!Σ | 1..1 | code | actual | potential Binding: Adverse Event Actuality (Required) | |
Σ | 0..* | CodeableConcept | wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site Binding: Adverse Event Category (Example) | |
Σ | 0..1 | CodeableConcept | Event or incident that occurred or was averted Binding: AdverseEvent Type (Example) | |
Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) | Subject impacted by event | |
Σ | 0..1 | Reference(Encounter) | The Encounter associated with the start of the AdverseEvent | |
Σ | 0..1 | When the event occurred | ||
dateTime | ||||
Period | ||||
Timing | ||||
Σ | 0..1 | dateTime | When the event was detected | |
Σ | 0..1 | dateTime | When the event was recorded | |
Σ | 0..* | Reference(Condition | Observation) | Effect on the subject due to this event | |
Σ | 0..1 | Reference(Location) | Location where adverse event occurred | |
Σ | 0..1 | CodeableConcept | Seriousness or gravity of the event Binding: Adverse Event Seriousness (Example) | |
Σ | 0..* | CodeableConcept | Type of outcome from the adverse event Binding: AdverseEvent Outcome (Example) | |
Σ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Who recorded the adverse event | |
Σ | 0..* | BackboneElement | Who was involved in the adverse event or the potential adverse event and what they did | |
Σ | 0..1 | CodeableConcept | Type of involvement Binding: AdverseEvent Participant Function (Example) | |
Σ | 1..1 | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject) | Who was involved in the adverse event or the potential adverse event | |
Σ | 0..* | Reference(ResearchStudy) | Research study that the subject is enrolled in | |
0..1 | boolean | Considered likely or probable or anticipated in the research study | ||
Σ | 0..* | BackboneElement | The suspected agent causing the adverse event | |
Σ | 1..1 | Refers to the specific entity that caused the adverse event | ||
CodeableConcept | ||||
Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | ||||
Σ | 0..1 | BackboneElement | Information on the possible cause of the event | |
Σ | 0..1 | CodeableConcept | Method of evaluating the relatedness of the suspected entity to the event Binding: Adverse Event Causality Method (Example) | |
Σ | 0..1 | CodeableConcept | Result of the assessment regarding the relatedness of the suspected entity to the event Binding: Adverse Event Causality Assessment (Example) | |
Σ | 0..1 | Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject) | Author of the information on the possible cause of the event | |
Σ | 0..* | BackboneElement | Contributing factors suspected to have increased the probability or severity of the adverse event | |
Σ | 1..1 | Item suspected to have increased the probability or severity of the adverse event Binding: AdverseEvent Contributing Factor (Example) | ||
Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement) | ||||
CodeableConcept | ||||
Σ | 0..* | BackboneElement | Preventive actions that contributed to avoiding the adverse event | |
Σ | 1..1 | Action that contributed to avoiding the adverse event Binding: AdverseEvent Preventive Action (Example) | ||
Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | ||||
CodeableConcept | ||||
Σ | 0..* | BackboneElement | Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm | |
Σ | 1..1 | Ameliorating action taken after the adverse event occured in order to reduce the extent of harm Binding: AdverseEvent Mitigating Action (Example) | ||
Reference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | ||||
CodeableConcept | ||||
Σ | 0..* | BackboneElement | Supporting information relevant to the event | |
Σ | 1..1 | Subject medical history or document relevant to this adverse event Binding: AdverseEvent Supporting Information (Example) | ||
Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse) | ||||
CodeableConcept | ||||
Σ | 0..* | Annotation | Comment on adverse event | |