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: AdverseEventFromProcedureNotStudyDrug

Page standards status: Informative

Generated Narrative: AdverseEvent

Resource AdverseEvent "AdverseEventFromProcedureNotStudyDrug"

Profile: Adverse Event Clinical Research

Adverse Event Severity: Moderate (AdverseEventSeverity#moderate)

Adverse event caused subject to discontinue the study: false

status: completed

actuality: actual

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

subject: Patient/patient-slp " EXAMPLE"

occurrence: 2021-01-15 --> 2021-01-15

resultingEffect: Condition/AEModeratehives: Moderate hives

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

outcome: Recovered/Resolved (NCI Thesaurus#C49498)

study: ResearchStudy/research-study-acme

expectedInResearchStudy: false

suspectEntity

instance: MedicationAdministration/study-medication-administration-WBY

Causalities

-EntityRelatedness
*Unlikely Related (NCI Thesaurus#C53257)

suspectEntity

instance: MedicationAdministration/medication-administration-contrast-dye

Causalities

-EntityRelatedness
*Related (NCI Thesaurus#C53260)

ContributingFactors

-Item[x]
*Procedure/clinical-trial-acme-procedure

MitigatingActions

-Item[x]
*MedicationAdministration/medication-administration-forhives

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