Adverse Event Clinical Research
1.0.1 - STU1 International flag

This page is part of the Adverse Event Clinical Research (v1.0.1: STU 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Example AdverseEvent: ClinicalTrialSignificantAdverseEvent

Page standards status: Informative

Generated Narrative: AdverseEvent

Resource AdverseEvent "ClinicalTrialSignificantAdverseEvent"

Profile: Adverse Event Clinical Research

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Results In Persistent Or Significant Disability (NCI Thesaurus#C11338)

url

criterionPresent

value: false

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Requires Inpatient Hospitalization (NCI Thesaurus#C83052)

url

criterionPresent

value: true

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Death Related to Adverse Event (NCI Thesaurus#C48275)

url

criterionPresent

value: false

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Is Life Threatening (NCI Thesaurus#C84266)

url

criterionPresent

value: true

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Congenital Anomaly or Birth Defect (NCI Thesaurus#C83117)

url

criterionPresent

value: false

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Other Medically Important Condition (NCI Thesaurus#C82521)

url

criterionPresent

value: false

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Required Intervention to Prevent Permanent Impairment/damage (NCI Thesaurus#C201939)

url

criterionPresent

value: true

Adverse Event Severity: Severe (AdverseEventSeverity#severe)

status: completed

actuality: actual

code: Serious reportable event associated with product or device (SNOMED CT#370901008)

subject: Patient/ClinicalTrialSubject5 " CLINICAL TRIAL"

detected: 1905-08-23

recordedDate: 1905-08-24

resultingEffect:

seriousness: Serious (AdverseEventSeriousness#serious)

outcome: Recovering/Resolving (NCI Thesaurus#C49496)

recorder: : Clinical Research Associate

study: : NCT1010101

suspectEntity

instance: MedicationAdministration/medadmin0301: Study Medication

Causalities

-EntityRelatedness
*Related (NCI Thesaurus#C53260)

MitigatingActions

-Item[x]
*MedicationRequest/medicationrequest0301-discontinue: Medication Request where study drug prescription was discontinued