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{ "resourceType" : "CodeSystem", "id" : "adverse-event-causality-assess", "meta" : { "lastUpdated" : "2020-04-09T21:10:28.568+00:00" }, "text" : { "status" : "generated", "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n \n <h2>AdverseEventCausalityAssessment</h2>\n \n <div>\n \n <p>Codes for the assessment of whether the entity caused the event.</p>\n\n \n </div>\n \n <p>This code system http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess defines the following codes:</p>\n \n <table class=\"codes\">\n \n <tr>\n \n <td style=\"white-space:nowrap\">\n \n <b>Code</b>\n \n </td>\n \n <td>\n \n <b>Display</b>\n \n </td>\n \n <td>\n \n <b>Definition</b>\n \n </td>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">certain\n \n <a name=\"adverse-event-causality-assess-certain\"> </a>\n \n </td>\n \n <td>Certain</td>\n \n <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>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">probably-likely\n \n <a name=\"adverse-event-causality-assess-probably-likely\"> </a>\n \n </td>\n \n <td>Probably/Likely</td>\n \n <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>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">possible\n \n <a name=\"adverse-event-causality-assess-possible\"> </a>\n \n </td>\n \n <td>Possible</td>\n \n <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>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">unlikely\n \n <a name=\"adverse-event-causality-assess-unlikely\"> </a>\n \n </td>\n \n <td>Unlikely</td>\n \n <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>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">conditional-classified\n \n <a name=\"adverse-event-causality-assess-conditional-classified\"> </a>\n \n </td>\n \n <td>Conditional/Classified</td>\n \n <td>i) Event or laboratory test abnormality; ii) More data for proper assessment needed; or iii) Additional data under examination.</td>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">unassessable-unclassifiable\n \n <a name=\"adverse-event-causality-assess-unassessable-unclassifiable\"> </a>\n \n </td>\n \n <td>Unassessable/Unclassifiable</td>\n \n <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>\n \n </tr>\n \n </table>\n \n </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:2.16.840.1.113883.4.642.1.1254" } ], "version" : "4.2.0", "name" : "AdverseEventCausalityAssessment", "title" : "AdverseEventCausalityAssessment", "status" : "draft", "experimental" : false, "date" : "2020-04-09T21:10:28+00:00", "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://terminology.hl7.org/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." } ] }