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. For a full list of available versions, see the Directory of published versions

Example AdverseEvent: adverse-event-compass-ex1a

Page standards status: Informative

Generated Narrative: AdverseEvent

Resource AdverseEvent "adverse-event-compass-ex1a"

Profile: Adverse Event Clinical Research

Adverse Event Grade: Grade 3 Severe Adverse Event (NCI Thesaurus#C41340)

status: in-progress

actuality: actual

code: Alanine aminotransferase (ALT) increased to 200 (Medical Dictionary for Regulatory Activities#10001551 "Alanine aminotransferase increased")

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

occurrence: 2020-05-13 --> (ongoing)

resultingEffect: : Reference to Observation of Alanine aminotransferase (ALT) increased at 200

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

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

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

Participants

-FunctionActor
*authenticator (ParticipationType#AUTHEN)Practitioner/practitioner-owen-oncologist " ONCOLOGIST"

study: ResearchStudy/clinical-trial-example-compass

expectedInResearchStudy: true

suspectEntity

instance: MedicationAdministration/medication-administration-kadcyla

Causalities

-EntityRelatedness
*Possibly Related (NCI Thesaurus#C53258)

suspectEntity

instance: MedicationAdministration/medication-administration-tucatinib

Causalities

-EntityRelatedness
*Possibly Related (NCI Thesaurus#C53258)

SupportingInfos

-Item[x]
*: Supporting info would have context such as an Reference to Observation of Alanine aminotransferase (ALT) increased at 200

note: treatment held today per protocol guidelines and the patient was scheduled to return in one week for repeat lab work