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: ClinicalResearchAdverseEventUseCase17

Page standards status: Informative

Generated Narrative: AdverseEvent

Resource AdverseEvent "ClinicalResearchAdverseEventUseCase17"

Profile: Adverse Event Clinical Research

Severity Or Grade: Moderate (AdverseEvent Severity or Grade Codes#2)

Adverse event caused subject to discontinue the study: false

status: completed

actuality: actual

code: Moderate hives (NCI Thesaurus#C57954 "Grade 2 - Urticaria")

subject: Patient/patient-slp " EXAMPLE"

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

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