This page is part of the HL7 Terminology (v1.0.0: Release) based on FHIR (HL7® FHIR® Standard) R4. The current version which supersedes this version is 7.0.0. For a full list of available versions, see the Directory of published versions
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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."
}
]
}