Adverse Event Clinical Research R4 Backport
1.0.0-ballot - ballot International flag

This page is part of the Adverse Event Clinical Research R4 Backport (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

Example AdverseEvent: adverse-event-compass-ex1

Generated Narrative: AdverseEvent

Resource AdverseEvent "adverse-event-compass-ex1"

Profile: Adverse Event Clinical Research

Severity Or Grade: Mild (AdverseEvent Severity or Grade Codes#1)

Participant

url

function

value: authenticator (ParticipationType#AUTHEN)

url

actor

value: Practitioner/practitioner-owen-oncologist " ONCOLOGIST"

Research Subject record of subject: ResearchSubject/clinical-trial-example-subject

Suspect Entity

url

instance

value: MedicationAdministration/medication-administration-kadcyla

url

causality

Suspect Entity

url

instance

value: MedicationAdministration/medication-administration-tucatinib

url

causality

Expected In Research Study: true

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

actuality: actual

event: Alanine aminotransferase (ALT) increased at 50 (www.meddra.org#10001551 "Alanine aminotransferase increased")

subject: Patient/patient-example-kaitlyn-b " BOUNCE"

date: 2020-04-22

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

outcome: Not recovering/not resolved (NCI Thesaurus#C49494)

recorder: Practitioner/practitioner-oncology-nurse-jane " NURSE"

study: ResearchStudy/clinical-trial-example-compass