| 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 | |||
caused-subject-to-discontinue-study
|
0..1 | boolean |
Adverse event caused subject to discontinue the study
URL: http://hl7.org/fhir/uv/ae-research-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-ig/StructureDefinition/seriousness-criteria |
|
|
severity-or-grade
|
0..1 | CodeableConcept |
The degree of something undesirable URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/severity-or-grade Binding: AdverseEvent Severity or Grade Value Set ( preferred ) |
|
actuality
|
actual Required Pattern: actual |
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occurrence[x]
|
S | Period | ||
|
resultingEffect
|
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|
seriousness
|
S | 1.. |
Investigator defined severity of the adverse event, in relation to the subject not the resulting condition Binding: Adverse Event Seriousness ( required ) |
|
|
outcome
|
S | 1..1 | Binding: Adverse Event Clinical Research Outcomes ( required ) | |
|
study
|
S | 1..1 | ||
|
suspectEntity
|
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causality
|
S | 1.. | ||
assessmentMethod
|
Method of evaluating the relatedness of the suspected entity to the event. Binding: Adverse Event Causality Method ( preferred ): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist. |
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|
entityRelatedness
|
Binding: Causality Relatedness values ( preferred ) | |||
|
preventiveAction
|
.. 0 | |||
|
supportingInfo
|
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|
item[x]
|
Binding:
AdverseEvent Supporting Information
( example
): Codes describing the supporting information relevant to the event. |
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|
Documentation for this format
|
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