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Patient Care Work Group | Maturity Level: N/A | Standards Status: Informative |
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Definition for Code SystemAdverseEventCausalityAssessment
{ "resourceType" : "CodeSystem", "id" : "adverse-event-causality-assess", "meta" : { "lastUpdated" : "2022-09-10T04:52:37.223+10:00", "profile" : ["http://hl7.org/fhir/StructureDefinition/shareablecodesystem"] }, "text" : { "status" : "generated", "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This code system <code>http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess</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\">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>" }, "extension" : [{ "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode" : "pc" }, { "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode" : "draft" }, { "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm", "valueInteger" : 1 }], "url" : "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess", "identifier" : [{ "system" : "urn:ietf:rfc:3986", "value" : "urn:oid:2.16.840.1.113883.4.642.4.1254" }], "version" : "5.0.0-ballot", "name" : "AdverseEventCausalityAssessment", "title" : "AdverseEventCausalityAssessment", "status" : "draft", "experimental" : false, "date" : "2020-12-28T16:55:11+11:00", "publisher" : "HL7 (FHIR Project)", "contact" : [{ "telecom" : [{ "system" : "url", "value" : "http://hl7.org/fhir" }, { "system" : "email", "value" : "fhir@lists.hl7.org" }] }], "description" : "Codes for the assessment of whether the entity caused the event.", "caseSensitive" : true, "valueSet" : "http://hl7.org/fhir/ValueSet/adverse-event-causality-assess", "content" : "complete", "concept" : [{ "code" : "certain", "display" : "Certain", "definition" : "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." }, { "code" : "probably-likely", "display" : "Probably/Likely", "definition" : "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." }, { "code" : "possible", "display" : "Possible", "definition" : "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." }, { "code" : "unlikely", "display" : "Unlikely", "definition" : "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." }, { "code" : "conditional-classified", "display" : "Conditional/Classified", "definition" : "i) Event or laboratory test abnormality; ii) More data for proper assessment needed; or iii) Additional data under examination." }, { "code" : "unassessable-unclassifiable", "display" : "Unassessable/Unclassifiable", "definition" : "i) Report suggesting an adverse reaction; ii) Cannot be judged because information is insufficient or contradictory; or iii) Data cannot be supplemented or verified." }] }
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.
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