Adverse Event Clinical Research R4 Backport
1.0.1 - STU1 International flag

Adverse Event Clinical Research R4 Backport, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-ae-research-backport-ig/ and changes regularly. See the Directory of published versions

Example AdverseEvent: adverse-event-compass-ex1b

Generated Narrative: AdverseEvent

Resource AdverseEvent "adverse-event-compass-ex1b"

Profile: Adverse Event Clinical Research

Resulting Effect: : Reference to Observation of Alanine aminotransferase (ALT) decreased to 60

Supporting information relevant to the event

url

item

value: : Supporting info would have context such as an Reference to Observation of Alanine aminotransferase (ALT) decreased to 60

Adverse Event Grade: Grade 1 Mild Adverse Event (NCI Thesaurus#C41338)

Participant

url

function

value: authenticator (ParticipationType#AUTHEN)

url

actor

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

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

Adverse Event resolution date: 2020-06-10

Note: treatment given with reduced dose per protocol guidelines

Mitigating Action

url

item

value: MedicationAdministration/medication-administration-kadcyla-reduced

Mitigating Action

url

item

value: MedicationAdministration/medication-administration-tucatinib-reduced

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

actuality: actual

event: Alanine aminotransferase (ALT) decreased to 60 (Medical Dictionary for Regulatory Activities#10001551 "Alanine aminotransferase increased")

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

date: 2020-05-20

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

outcome: Recovered/Resolved (NCI Thesaurus#C49498)

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

study: ResearchStudy/clinical-trial-example-compass