{ "resourceType": "CodeSystem", "id": "adverse-event-causality-assess", "meta": { "lastUpdated": "2019-11-01T09:29:23.356+11:00" }, "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": "4.0.1", "name": "AdverseEventCausalityAssessment", "title": "AdverseEventCausalityAssessment", "status": "draft", "experimental": false, "date": "2019-11-01T09:29:23+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." } ] }