Adverse Event Clinical Research
1.0.0-ballot - ballot International flag

This page is part of the Adverse Event Clinical Research (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR v5.0.0. . For a full list of available versions, see the Directory of published versions

Example AdverseEvent: ClinicalResearchAdverseEventUseCase7

Page standards status: Informative

Generated Narrative: AdverseEvent

Resource AdverseEvent "ClinicalResearchAdverseEventUseCase7"

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: Results In Death (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 or Damage (Devices) (FDA Additional Seriousness Criteria CodeSystem#requiresPreventImpairment)

url

criterionPresent

value: true

Severity Or Grade: Life Threatening or Disabling (AdverseEvent Severity or Grade Codes#4)

status: completed

actuality: actual

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

subject: Patient/ClinicalTrialSubject5 " CLINICAL TRAIL"

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 Use Case 7

Causalities

-EntityRelatedness
*Certain (AdverseEventCausalityAssessment#certain)

MitigatingActions

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