Fujitsu Healthy Living Implementation Guide
1.1.28 - release

Publication Build: This will be filled in by the publication tooling

Example AdverseEvent: adverse-event-compass-ex1b

Generated Narrative: AdverseEvent

Resource AdverseEvent "adverse-event-compass-ex1b"

Profile: Fujitsu Adverse Event Clinical Research

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

Fujitsu 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

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

Fujitsu Participant

url

actor

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

url

function

value: authenticator (ParticipationType#AUTHEN)

Fujitsu Suspect Entity

url

instance

value: MedicationAdministration/medication-administration-tucatinib

url

causality

Fujitsu Expected In Research Study: true

Fujitsu Adverse Event resolution date: 2020-06-10

Fujitsu Note: treatment given with reduced dose per protocol guidelines

Fujitsu Mitigating Action

url

item

value: MedicationAdministration/medication-administration-tucatinib-reduced

modifierExtension[http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-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