HL7 FHIR Implementation Guide: Common Terminology Criteria (CTC) Adverse Events Release 1 - DRAFT
0.0.1 - DRAFT
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
Draft as of 2024-02-28 |
<ValueSet xmlns="http://hl7.org/fhir">
<id value="adverse-event-expectation-value-set"/>
<text>
<status value="generated"/>
<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>
</text>
<url
value="http://hl7.org/fhir/us/ctcae/ValueSet/adverse-event-expectation-value-set"/>
<version value="0.0.1"/>
<name value="AdverseEventExpectationVS"/>
<title value="Adverse Event Expectation Value Set"/>
<status value="draft"/>
<date value="2024-02-28T19:15:22+00:00"/>
<publisher value="HL7 International Clinical Interoperability Council"/>
<contact>
<name value="HL7 International Clinical Interoperability Council"/>
<telecom>
<system value="url"/>
<value value="http://www.mcodeinitiative.org"/>
</telecom>
</contact>
<description
value="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)."/>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="US"/>
<display value="United States of America"/>
</coding>
</jurisdiction>
<compose>
<include>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<concept>
<code value="C41333"/>
<display value="Expected Adverse Event"/>
</concept>
<concept>
<code value="C41334"/>
<display value="Unexpected Adverse Event"/>
</concept>
</include>
</compose>
</ValueSet>