<?xml version="1.0" encoding="UTF-8"?>
<CodeSystem xmlns="http://hl7.org/fhir">
<id value="adverse-event-causality-assess"/>
<meta>
<lastUpdated value="2019-11-01T09:29:23.356+11:00"/>
</meta>
<extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="pc"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="draft"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
<valueInteger value="1"/>
</extension>
<url value="http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.4.1254"/>
</identifier>
<version value="4.0.1"/>
<name value="AdverseEventCausalityAssessment"/>
<title value="AdverseEventCausalityAssessment"/>
<status value="draft"/>
<experimental value="false"/>
<date value="2019-11-01T09:29:23+11:00"/>
<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="Codes for the assessment of whether the entity caused the event."/>
<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); or 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; or 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; or 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); or 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; or iii) Data cannot be supplemented or verified."/>
</concept>
</CodeSystem>