Adverse Event Clinical Research
1.0.1 - STU1 International flag

Adverse Event Clinical Research, 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-ig/ and changes regularly. See the Directory of published versions

Example AdverseEvent: adverse-event-compass-ex1b

Page standards status: Informative

Generated Narrative: AdverseEvent

Resource AdverseEvent "adverse-event-compass-ex1b"

Profile: Adverse Event Clinical Research

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

status: completed

actuality: actual

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

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

occurrence: 2020-05-20 --> 2020-06-10

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

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

outcome: Recovered/Resolved (NCI Thesaurus#C49498)

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)

mitigatingAction

item: MedicationAdministration/medication-administration-kadcyla-reduced

mitigatingAction

item: MedicationAdministration/medication-administration-tucatinib-reduced

SupportingInfos

-Item[x]
*: Supporting info would have context such as an Reference to Observation of Alanine aminotransferase (ALT) decreased to 60

note: treatment given with reduced dose per protocol guidelines