<?xml version="1.0" encoding="UTF-8"?><ValueSet xmlns="http://hl7.org/fhir"><id value="adverse-event-clinical-research-outcomes"/><meta><profile value="http://hl7.org/fhir/StructureDefinition/shareablevalueset"/></meta><text><status value="generated"/><div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet adverse-event-clinical-research-outcomes</b></p><a name="adverse-event-clinical-research-outcomes"> </a><a name="hcadverse-event-clinical-research-outcomes"> </a><a name="adverse-event-clinical-research-outcomes-en-US"> </a><ul><li>Include these codes as defined in <a href="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>C48275</td><td>Fatal</td></tr><tr><td>C49494</td><td>Not recovering/not resolved</td></tr><tr><td>C49495</td><td>Recovered/Resolved with sequelae</td></tr><tr><td>C49498</td><td>Recovered/Resolved</td></tr><tr><td>C49496</td><td>Recovering/Resolving</td></tr></table></li></ul></div></text><extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"><valueCode value="brr"/></extension><extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"><valueInteger value="1"/></extension><url value="http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes"/><identifier><system value="urn:ietf:rfc:3986"/><value value="urn:oid:2.16.840.1.113883.11.21025"/></identifier><version value="1.0.0"/><name value="AdverseEventClinicalResearchOutcomes"/><title value="Adverse Event Clinical Research Outcomes"/><status value="active"/><experimental value="false"/><date value="2023-07-28T19:27:19+00:00"/><publisher value="Health Level Seven International"/><contact><telecom><system value="url"/><value value="http://hl7.org"/></telecom><telecom><system value="email"/><value value="hq@HL7.org"/></telecom></contact><description value="This value set includes codes that describe the type of outcome from the adverse event as typically used in reporting for Clinical Research, post-market surveillance (e.g. Medwatch forms). NCI codes used here This list originates from the ICH E2B R3 (https://database.ich.org/sites/default/files/E2D_Guideline.pdf), specifically CDISC CL.C66768.OUT. For information on ICH see https://admin.ich.org/sites/default/files/inline-files/OID_Information_Paper_1.pdf from the INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE (ICH) document ICH E2B(R3), the Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide Data Elements and Message Specification, and ICH M8, the Electronic Common Technical Document."/><copyright value="This material derives from the HL7 Terminology THO. THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license.html"/><compose><include><system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/><concept><code value="C48275"/><display value="Fatal"/></concept><concept><code value="C49494"/><display value="Not recovering/not resolved"/></concept><concept><code value="C49495"/><display value="Recovered/Resolved with sequelae"/></concept><concept><code value="C49498"/><display value="Recovered/Resolved"/></concept><concept><code value="C49496"/><display value="Recovering/Resolving"/></concept></include></compose></ValueSet>