Adverse Event Clinical Research R4 Backport
1.0.1 - STU1 International flag

This page is part of the Adverse Event Clinical Research R4 Backport (v1.0.1: STU 1) based on FHIR (HL7® FHIR® Standard) R4. 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: AdverseEventFromProcedureNotStudyDrug

Generated Narrative: AdverseEvent

Resource AdverseEvent "AdverseEventFromProcedureNotStudyDrug"

Profile: Adverse Event Clinical Research

Resulting Effect: Condition/AEModeratehives: Moderate hives

Adverse Event resolution date: 2021-01-15

Suspect Entity

url

instance

value: MedicationAdministration/study-medication-administration-WBY

url

causality

Suspect Entity

url

instance

value: MedicationAdministration/medication-administration-contrast-dye

url

causality

Expected In Research Study: false

Note: The action taken with the study treatment was the study drug dose not changed

Adverse event caused subject to discontinue the study: false

Mitigating Action

url

item

value: MedicationAdministration/medication-administration-forhives

Contributing Factor

url

item

value: Procedure/clinical-trial-acme-procedure

modifierExtension[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]

actuality: actual

event: Moderate hives (Medical Dictionary for Regulatory Activities#10019211 "Hypersensitivity reaction")

subject: Patient/patient-slp " EXAMPLE"

date: 2021-01-15

seriousness: Non-serious (AdverseEventSeriousness#non-serious)

severity: Moderate (AdverseEventSeverity#moderate)

outcome: Recovered/Resolved (NCI Thesaurus#C49498)

study: ResearchStudy/research-study-acme