{
  "resourceType" : "CodeSystem",
  "id" : "adverse-event-causality-assess",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n      \n      \n            <h2>AdverseEventCausalityAssessment</h2>\n      \n      \n            <div>\n        \n        \n              <p>Codes for the assessment of whether the entity caused the event.</p>\n\n      \n      \n            </div>\n      \n      \n            <p>This code system http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess defines the following codes:</p>\n      \n      \n            <table class=\"codes\">\n        \n        \n              <tr>\n          \n          \n                <td style=\"white-space:nowrap\">\n            \n            \n                  <b>Code</b>\n          \n          \n                </td>\n          \n          \n                <td>\n            \n            \n                  <b>Display</b>\n          \n          \n                </td>\n          \n          \n                <td>\n            \n            \n                  <b>Definition</b>\n          \n          \n                </td>\n        \n        \n              </tr>\n        \n        \n              <tr>\n          \n          \n                <td style=\"white-space:nowrap\">Certain\n            \n            \n                  <a name=\"adverse-event-causality-assess-Certain\"> </a>\n          \n          \n                </td>\n          \n          \n                <td>Certain</td>\n          \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        \n              </tr>\n        \n        \n              <tr>\n          \n          \n                <td style=\"white-space:nowrap\">Probably-Likely\n            \n            \n                  <a name=\"adverse-event-causality-assess-Probably-Likely\"> </a>\n          \n          \n                </td>\n          \n          \n                <td>Probably/Likely</td>\n          \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        \n              </tr>\n        \n        \n              <tr>\n          \n          \n                <td style=\"white-space:nowrap\">Possible\n            \n            \n                  <a name=\"adverse-event-causality-assess-Possible\"> </a>\n          \n          \n                </td>\n          \n          \n                <td>Possible</td>\n          \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        \n              </tr>\n        \n        \n              <tr>\n          \n          \n                <td style=\"white-space:nowrap\">Unlikely\n            \n            \n                  <a name=\"adverse-event-causality-assess-Unlikely\"> </a>\n          \n          \n                </td>\n          \n          \n                <td>Unlikely</td>\n          \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        \n              </tr>\n        \n        \n              <tr>\n          \n          \n                <td style=\"white-space:nowrap\">Conditional-Classified\n            \n            \n                  <a name=\"adverse-event-causality-assess-Conditional-Classified\"> </a>\n          \n          \n                </td>\n          \n          \n                <td>Conditional/Classified</td>\n          \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        \n              </tr>\n        \n        \n              <tr>\n          \n          \n                <td style=\"white-space:nowrap\">Unassessable-Unclassifiable\n            \n            \n                  <a name=\"adverse-event-causality-assess-Unassessable-Unclassifiable\"> </a>\n          \n          \n                </td>\n          \n          \n                <td>Unassessable/Unclassifiable</td>\n          \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        \n              </tr>\n      \n      \n            </table>\n    \n    \n          </div>"
  },
  "extension" : [{
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
    "valueCode" : "draft"
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
    "valueInteger" : 1
  },
  {
    "extension" : [{
      "url" : "packageId",
      "valueId" : "hl7.fhir.uv.xver-r4b.r5"
    },
    {
      "url" : "version",
      "valueString" : "0.1.0"
    },
    {
      "url" : "uri",
      "valueUri" : "http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r4b.r5"
    }],
    "url" : "http://hl7.org/fhir/StructureDefinition/package-source"
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
    "valueCode" : "pc"
  }],
  "url" : "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
  "version" : "4.3.0",
  "name" : "AdverseEventCausalityAssessment",
  "title" : "AdverseEventCausalityAssessment",
  "status" : "draft",
  "experimental" : false,
  "date" : "2021-01-16T14:06:13-06:00",
  "publisher" : "Patient Care",
  "contact" : [{
    "name" : "Patient Care",
    "telecom" : [{
      "system" : "url",
      "value" : "http://www.hl7.org/Special/committees/patientcare"
    }]
  }],
  "description" : "Codes for the assessment of whether the entity caused the event.",
  "jurisdiction" : [{
    "coding" : [{
      "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
      "code" : "001",
      "display" : "World"
    }]
  }],
  "caseSensitive" : true,
  "valueSet" : "http://hl7.org/fhir/ValueSet/adverse-event-causality-assess|5.0.0",
  "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."
  }]
}