Adverse Event Clinical Research R4 Backport
1.0.1 - STU1

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-ex1

Generated Narrative: AdverseEvent

Resource AdverseEvent "adverse-event-compass-ex1"

Profile: Adverse Event Clinical Research

Resulting Effect: : Reference to Observation of Alanine aminotransferase (ALT) increased at 50

> Supporting information relevant to the event

> > url

> > `item`

> value: : Supporting info would have context such as an Reference to Observation of Alanine aminotransferase (ALT) increased at 50

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"

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 (Medical Dictionary for Regulatory Activities#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