R4 Ballot #1 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.3.0: R4 Ballot 2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R4B R4 R3

Codesystem-adverse-event-causality-assess.xml

Patient Care Work GroupMaturity Level: N/ABallot Status: Informative

Raw XML (canonical form)

Definition for Code System AdverseEventCausalityAssessment

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="adverse-event-causality-assess"/> 
  <meta> 
    <lastUpdated value="2018-04-03T12:05:46.262+10:00"/> 
  </meta> 
  <text> 
    <status value="generated"/> 
    <div xmlns="http://www.w3.org/1999/xhtml">
      <h2> AdverseEventCausalityAssessment</h2> 
      <div> 
        <p> TODO</p> 

      </div> 
      <p> This code system http://hl7.org/fhir/adverse-event-causality-assess 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">Certain
            <a name="adverse-event-causality-assess-Certain"> </a> 
          </td> 
          <td> Certain</td> 
          <td> i) Event or laboratory test abnormality, with plausible time relationship to drug intake
             ii) Cannot be explained by disease or other drugs iii) Response to withdrawal plausible
             (pharmacologically, pathologically) iv) Event definitive pharmacologically or phenomenologically
             (i.e. an objective and specific medical disorder or a recognized pharmacological phenomenon)
             v) Re-challenge satisfactory, if necessary</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">Probably-Likely
            <a name="adverse-event-causality-assess-Probably-Likely"> </a> 
          </td> 
          <td> Probably/Likely</td> 
          <td> i) Event or laboratory test abnormality, with reasonable time relationship to drug intake
             ii) Unlikely to be attributed to disease or other drugs iii) Response to withdrawal clinically
             reasonable iv) Re-challenge not required</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">Possible
            <a name="adverse-event-causality-assess-Possible"> </a> 
          </td> 
          <td> Possible</td> 
          <td> i) Event or laboratory test abnormality, with reasonable time relationship to drug intake
             ii) Could also be explained by disease or other drugs iii) Information on drug withdrawal
             may be lacking or unclear</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">Unlikely
            <a name="adverse-event-causality-assess-Unlikely"> </a> 
          </td> 
          <td> Unlikely</td> 
          <td> i) Event or laboratory test abnormality, with a time to drug intake that makes a relationship
             improbable (but not impossible) ii) Disease or other drugs provide plausible explanations</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">Conditional-Classified
            <a name="adverse-event-causality-assess-Conditional-Classified"> </a> 
          </td> 
          <td> Conditional/Classified</td> 
          <td> i) Event or laboratory test abnormality ii) More data for proper assessment needed, or
             iii) Additional data under examination</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">Unassessable-Unclassifiable
            <a name="adverse-event-causality-assess-Unassessable-Unclassifiable"> </a> 
          </td> 
          <td> Unassessable/Unclassifiable</td> 
          <td> i) Report suggesting an adverse reaction ii) Cannot be judged because information is insufficient
             or contradictory iii) Data cannot be supplemented or verified</td> 
        </tr> 
      </table> 
    </div> 
  </text> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="pc"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-ballot-status">
    <valueString value="Draft"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/> 
  </extension> 
  <url value="http://hl7.org/fhir/adverse-event-causality-assess"/> 
  <identifier> 
    <system value="urn:ietf:rfc:3986"/> 
    <value value="urn:oid:2.16.840.1.113883.4.642.1.841"/> 
  </identifier> 
  <version value="3.3.0"/> 
  <name value="AdverseEventCausalityAssessment"/> 
  <status value="draft"/> 
  <experimental value="false"/> 
  <date value="2018-04-03T12:05:46+10:00"/> 
  <publisher value="HL7 (FHIR Project)"/> 
  <contact> 
    <telecom> 
      <system value="url"/> 
      <value value="http://hl7.org/fhir"/> 
    </telecom> 
    <telecom> 
      <system value="email"/> 
      <value value="fhir@lists.hl7.org"/> 
    </telecom> 
  </contact> 
  <description value="TODO"/> 
  <caseSensitive value="true"/> 
  <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-causality-assess"/> 
  <content value="complete"/> 
  <concept> 
    <code value="Certain"/> 
    <display value="Certain"/> 
    <definition value="i) Event or laboratory test abnormality, with plausible time relationship to drug intake
     ii) Cannot be explained by disease or other drugs iii) Response to withdrawal plausible
     (pharmacologically, pathologically) iv) Event definitive pharmacologically or phenomenologically
     (i.e. an objective and specific medical disorder or a recognized pharmacological phenomenon)
     v) Re-challenge satisfactory, if necessary"/> 
  </concept> 
  <concept> 
    <code value="Probably-Likely"/> 
    <display value="Probably/Likely"/> 
    <definition value="i) Event or laboratory test abnormality, with reasonable time relationship to drug intake
     ii) Unlikely to be attributed to disease or other drugs iii) Response to withdrawal clinically
     reasonable iv) Re-challenge not required"/> 
  </concept> 
  <concept> 
    <code value="Possible"/> 
    <display value="Possible"/> 
    <definition value="i) Event or laboratory test abnormality, with reasonable time relationship to drug intake
     ii) Could also be explained by disease or other drugs iii) Information on drug withdrawal
     may be lacking or unclear"/> 
  </concept> 
  <concept> 
    <code value="Unlikely"/> 
    <display value="Unlikely"/> 
    <definition value="i) Event or laboratory test abnormality, with a time to drug intake that makes a relationship
     improbable (but not impossible) ii) Disease or other drugs provide plausible explanations"/> 
  </concept> 
  <concept> 
    <code value="Conditional-Classified"/> 
    <display value="Conditional/Classified"/> 
    <definition value="i) Event or laboratory test abnormality ii) More data for proper assessment needed, or
     iii) Additional data under examination"/> 
  </concept> 
  <concept> 
    <code value="Unassessable-Unclassifiable"/> 
    <display value="Unassessable/Unclassifiable"/> 
    <definition value="i) Report suggesting an adverse reaction ii) Cannot be judged because information is insufficient
     or contradictory iii) Data cannot be supplemented or verified"/> 
  </concept> 
</CodeSystem> 

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.