Fujitsu Healthy Living Implementation Guide
1.1.28 - release

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

Example AdverseEvent: ClinicalTrialSignificantAdverseEvent

Generated Narrative: AdverseEvent

Resource AdverseEvent "ClinicalTrialSignificantAdverseEvent"

Profile: Fujitsu Adverse Event Clinical Research

Fujitsu Resulting Effect: Condition/AEHepaticFailurecomplication

Fujitsu Suspect Entity

url

instance

value: MedicationAdministration/medadmin0301: Study Medication Use Case 7

url

causality

Fujitsu Criteria reviewed in determining serious adverse event

url

criterionCode

value: Required Intervention to Prevent Permanent Impairment/damage (NCI Thesaurus#C201939)

url

criterionPresent

value: true

Fujitsu Mitigating Action

url

item

value: MedicationRequest/medicationrequest0301-discontinue: Medication Request where study drug prescription was discontinued

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

actuality: actual

event: Serious reportable event associated with product or device (SNOMED CT#370901008)

subject: Patient/ClinicalTrialSubject5 " CLINICAL TRAIL"

detected: 1905-08-23

recordedDate: 1905-08-24

seriousness: Serious (AdverseEventSeriousness#serious)

severity: Severe (AdverseEventSeverity#severe)

outcome: Recovering/Resolving (NCI Thesaurus#C49496)

recorder: : Clinical Research Associate

study: : NCT1010101