HL7 Terminology (THO)
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: Adverse Event Clinical Research Outcomes - XML Representation

Active as of 2023-07-28 Maturity Level: 1

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<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"><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"/>
  <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>