HL7 FHIR Implementation Guide: Common Terminology Criteria (CTC) Adverse Events Release 1 - DRAFT, published by HL7 International Clinical Interoperability Council. This guide is not an authorized publication; it is the continuous build for version 0.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/standardhealth/fsh-ae/ and changes regularly. See the Directory of published versions
: Adverse Event Expectation Value Set - TTL Representation
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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:ValueSet ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "adverse-event-expectation-value-set"] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><ul><li>Include these codes as defined in <a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>C41333</td><td>Expected Adverse Event</td></tr><tr><td>C41334</td><td>Unexpected Adverse Event</td></tr></table></li></ul></div>"
] ; #
fhir:url [ fhir:v "http://hl7.org/fhir/us/ctcae/ValueSet/adverse-event-expectation-value-set"^^xsd:anyURI] ; #
fhir:version [ fhir:v "0.0.1"] ; #
fhir:name [ fhir:v "AdverseEventExpectationVS"] ; #
fhir:title [ fhir:v "Adverse Event Expectation Value Set"] ; #
fhir:status [ fhir:v "draft"] ; #
fhir:date [ fhir:v "2024-02-28T19:15:22+00:00"^^xsd:dateTime] ; #
fhir:publisher [ fhir:v "HL7 International Clinical Interoperability Council"] ; #
fhir:contact ( [
fhir:name [ fhir:v "HL7 International Clinical Interoperability Council" ] ;
( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.mcodeinitiative.org" ] ] )
] ) ; #
fhir:description [ fhir:v "An expected adverse event is one whose nature and severity have been previously observed, identified in nature, severity, or frequency, and documented in the investigator brochure, investigational plan, protocol, current consent form, scientific publication, or in other relevant and reliable document. An unexpected adverse event is one that has not been previously observed, whether or not the event was anticipated because of the pharmacologic properties of the study agent or the nature of the medical procedure. This includes events that are more serious than expected or occur more frequently than expected, particularly, any adverse experience, the nature, severity or frequency of which is not consistent with the product label, or with the current investigator brochure for investigational agent; or with the risk information described in the investigational plan or protocol or consent form (NCI Thesaurus)."] ; #
fhir:jurisdiction ( [
( fhir:coding [
fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
fhir:code [ fhir:v "US" ] ;
fhir:display [ fhir:v "United States of America" ] ] )
] ) ; #
fhir:compose [
( fhir:include [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
( fhir:concept [
fhir:code [ fhir:v "C41333" ] ;
fhir:display [ fhir:v "Expected Adverse Event" ] ] [
fhir:code [ fhir:v "C41334" ] ;
fhir:display [ fhir:v "Unexpected Adverse Event" ] ] ) ] )
] . #