<?xml version="1.0" encoding="UTF-8"?>

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="icr-serious-criteria-cs"/>
  <text>
    <status value="generated"/><div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem icr-serious-criteria-cs</b></p><a name="icr-serious-criteria-cs"> </a><a name="hcicr-serious-criteria-cs"> </a><p>This case-sensitive code system <code>https://icr.healthcampaigns.org/CodeSystem/icr-serious-criteria-cs</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style="white-space:nowrap">death<a name="icr-serious-criteria-cs-death"> </a></td><td>Results in death</td><td>The event resulted in death.</td></tr><tr><td style="white-space:nowrap">life-threatening<a name="icr-serious-criteria-cs-life-threatening"> </a></td><td>Life-threatening</td><td>The event was life-threatening.</td></tr><tr><td style="white-space:nowrap">hospitalization<a name="icr-serious-criteria-cs-hospitalization"> </a></td><td>Requires/prolongs hospitalization</td><td>Required inpatient hospitalization or prolonged an existing stay.</td></tr><tr><td style="white-space:nowrap">disability<a name="icr-serious-criteria-cs-disability"> </a></td><td>Persistent / significant disability</td><td>Resulted in persistent or significant disability/incapacity.</td></tr><tr><td style="white-space:nowrap">congenital-anomaly<a name="icr-serious-criteria-cs-congenital-anomaly"> </a></td><td>Congenital anomaly / birth defect</td><td>Resulted in a congenital anomaly/birth defect.</td></tr><tr><td style="white-space:nowrap">medically-important<a name="icr-serious-criteria-cs-medically-important"> </a></td><td>Other medically important event</td><td>A medically important condition not otherwise listed (clinical judgement).</td></tr></table></div>
  </text>
  <url value="https://icr.healthcampaigns.org/CodeSystem/icr-serious-criteria-cs"/>
  <version value="0.1.0"/>
  <name value="ICRSeriousCriteriaCS"/>
  <title value="ICR Serious-Event Criteria"/>
  <status value="draft"/>
  <experimental value="false"/>
  <date value="2026-08-07T08:41:18-04:00"/>
  <publisher value="UNICEF"/>
  <contact>
    <name value="UNICEF"/>
    <telecom>
      <system value="url"/>
      <value value="https://www.unicef.org"/>
    </telecom>
  </contact>
  <description value="WHO/CIOMS criteria that make an adverse event SERIOUS — the reason behind AdverseEvent.seriousness = serious. Intervention-neutral (AEFI and MDA pharmacovigilance) (espen-v4 / §17.2 C1)."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <caseSensitive value="true"/>
  <content value="complete"/>
  <count value="6"/>
  <concept>
    <code value="death"/>
    <display value="Results in death"/>
    <definition value="The event resulted in death."/>
  </concept>
  <concept>
    <code value="life-threatening"/>
    <display value="Life-threatening"/>
    <definition value="The event was life-threatening."/>
  </concept>
  <concept>
    <code value="hospitalization"/>
    <display value="Requires/prolongs hospitalization"/>
    <definition value="Required inpatient hospitalization or prolonged an existing stay."/>
  </concept>
  <concept>
    <code value="disability"/>
    <display value="Persistent / significant disability"/>
    <definition value="Resulted in persistent or significant disability/incapacity."/>
  </concept>
  <concept>
    <code value="congenital-anomaly"/>
    <display value="Congenital anomaly / birth defect"/>
    <definition value="Resulted in a congenital anomaly/birth defect."/>
  </concept>
  <concept>
    <code value="medically-important"/>
    <display value="Other medically important event"/>
    <definition value="A medically important condition not otherwise listed (clinical judgement)."/>
  </concept>
</CodeSystem>