Extensions for Using Data Elements from FHIR R4B in FHIR R5 - Downloaded Version null See the Directory of published versions
| Page standards status: Draft | Maturity Level: 1 |
<CodeSystem xmlns="http://hl7.org/fhir">
<id value="adverse-event-causality-assess"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<h2>AdverseEventCausalityAssessment</h2>
<div>
<p>Codes for the assessment of whether the entity caused the event.</p>
</div>
<p>This code system http://terminology.hl7.org/CodeSystem/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); or 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; or 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; or 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); or 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; or iii) Data cannot be supplemented or verified.</td>
</tr>
</table>
</div>
</text>
<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>
<extension url="http://hl7.org/fhir/StructureDefinition/package-source">
<extension url="packageId">
<valueId value="hl7.fhir.uv.xver-r4b.r5"/>
</extension>
<extension url="version">
<valueString value="0.1.0"/>
</extension>
<extension url="uri">
<valueUri
value="http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r4b.r5"/>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="pc"/>
</extension>
<url
value="http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess"/>
<version value="4.3.0"/>
<name value="AdverseEventCausalityAssessment"/>
<title value="AdverseEventCausalityAssessment"/>
<status value="draft"/>
<experimental value="false"/>
<date value="2021-01-16T14:06:13-06:00"/>
<publisher value="Patient Care"/>
<contact>
<name value="Patient Care"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/patientcare"/>
</telecom>
</contact>
<description
value="Codes for the assessment of whether the entity caused the event."/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<caseSensitive value="true"/>
<valueSet
value="http://hl7.org/fhir/ValueSet/adverse-event-causality-assess|5.0.0"/>
<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>