| Name | Flags | Card. | Type |
Description & Constraints
|
|---|---|---|---|---|
AdverseEvent
|
C | AdverseEvent | aeClinRes-seriousness-1: If seriousness is serious then must have at least one seriousness criterion. | |
Slices for extension
|
Slice: Unordered, Open by value:url | |||
research-subject-ref
|
0..1 | Reference ( ResearchSubject ) |
Research Subject record of subject URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/research-subject-ref |
|
|
caused-subject-to-discontinue-study
|
0..1 | boolean |
Adverse event caused subject to discontinue the study
URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study |
|
|
seriousness-criteria
|
0..* | (Complex) |
Criteria reviewed in determining serious adverse event
URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria |
|
|
severity-or-grade
|
0..1 | CodeableConcept |
The degree of something undesirable URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/severity-or-grade Binding: AdverseEvent Severity or Grade Value Set ( preferred ) |
|
|
expected-in-research-study
|
0..1 | boolean |
Considered likely or probable or anticipated in the research study URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study |
|
|
note
|
0..* | Annotation |
Comment on adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note |
|
|
resolve-date
|
0..1 | dateTime |
Adverse Event resolution date URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date |
|
|
suspect-entity
|
Σ | 0..* | (Complex) |
A suspected agent causing the adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity |
|
contributing-factor
|
Σ | 0..* | (Complex) |
Contributing factors suspected to have increased the probability or severity of the adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor |
|
mitigating-action
|
Σ | 0..* | (Complex) |
Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action |
|
supporting-info
|
Σ | 0..* | (Complex) |
Subject medical history or document relevant to this adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info |
|
participant
|
0..* | (Complex) |
Who was involved in the adverse event or the potential adverse event and what they did URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant |
|
|
resultingEffect
|
0..* | Reference ( Condition | Observation ) |
Effect on the subject due to this event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect |
|
Slices for modifierExtension
|
1.. | Slice: Unordered, Open by value:url | ||
|
modifierExtension:status
|
Σ | 1..1 | Extension |
in-progress | completed | entered-in-error | unknown Binding: todo ( required ): Codes identifying the lifecycle stage of an event. |
actuality
|
actual Required Pattern: actual |
|||
|
event
|
Event or incident that occurred or was averted Binding: AdverseEvent Type ( example ): Detailed type of event. |
|||
|
resultingCondition
|
.. 0 | |||
|
seriousness
|
S | 1.. |
Investigator defined severity of the adverse event, in relation to the subject not the resulting condition Binding: AdverseEvent Seriousness Non-serious Codes Only ( required ) |
|
|
severity
|
.. 0 | |||
|
outcome
|
S | 1.. | Binding: Adverse Event Clinical Research Outcomes ( required ) | |
|
suspectEntity
|
.. 0 | |||
|
subjectMedicalHistory
|
.. 0 | |||
|
referenceDocument
|
.. 0 | |||
study
|
S | 1..1 | ||
|
Documentation for this format
|
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