{
  "resourceType" : "AdverseEvent",
  "id" : "ClinicalTrialSignificantAdverseEvent",
  "meta" : {
    "profile" : ["http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research"]
  },
  "text" : {
    "status" : "extensions",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: AdverseEvent</b><a name=\"ClinicalTrialSignificantAdverseEvent\"> </a><a name=\"hcClinicalTrialSignificantAdverseEvent\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource AdverseEvent &quot;ClinicalTrialSignificantAdverseEvent&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-AdverseEvent-clinical-research.html\">Adverse Event Clinical Research</a></p></div><p><b>Resulting Effect</b>: <a href=\"Condition-AEHepaticFailure.html\">Condition/AEHepaticFailure</a></p><p><b>Resulting Effect</b>: <a href=\"Condition-AEHepaticFailurecomplication.html\">Condition/AEHepaticFailurecomplication</a></p><blockquote><p><b>Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href=\"MedicationAdministration-medadmin0301.html\">MedicationAdministration/medadmin0301: Study Medication Use Case 7</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Results In Persistent Or Significant Disability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C11338)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Requires Inpatient Hospitalization <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C83052)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: true</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Death Related to Adverse Event <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C48275)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Is Life Threatening <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C84266)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: true</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Congenital Anomaly or Birth Defect <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C83117)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Other Medically Important Condition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C82521)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Required Intervention to Prevent Permanent Impairment/damage <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C201939)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: true</p></blockquote><blockquote><p><b>Mitigating Action</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href=\"MedicationRequest-medicationrequest0301-discontinue.html\">MedicationRequest/medicationrequest0301-discontinue: Medication Request where study drug prescription was discontinued</a></p></blockquote><blockquote><p><b>modifierExtension[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]</b></p></blockquote><p><b>actuality</b>: actual</p><p><b>event</b>: Serious reportable event associated with product or device <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOMED CT</a>#370901008)</span></p><p><b>subject</b>: <a href=\"Patient-ClinicalTrialSubject5.html\">Patient/ClinicalTrialSubject5</a> &quot; CLINICAL TRIAL&quot;</p><p><b>detected</b>: 1905-08-23</p><p><b>recordedDate</b>: 1905-08-24</p><p><b>seriousness</b>: Serious <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-adverse-event-seriousness.html\">AdverseEventSeriousness</a>#serious)</span></p><p><b>severity</b>: Severe <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-adverse-event-severity.html\">AdverseEventSeverity</a>#severe)</span></p><p><b>outcome</b>: Recovering/Resolving <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C49496)</span></p><p><b>recorder</b>: <span>: Clinical Research Associate</span></p><p><b>study</b>: <span>: NCT1010101</span></p></div>"
  },
  "extension" : [{
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect",
    "valueReference" : {
      "reference" : "Condition/AEHepaticFailure"
    }
  },
  {
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect",
    "valueReference" : {
      "reference" : "Condition/AEHepaticFailurecomplication"
    }
  },
  {
    "extension" : [{
      "url" : "instance",
      "valueReference" : {
        "reference" : "MedicationAdministration/medadmin0301",
        "display" : "Study Medication Use Case 7"
      }
    },
    {
      "extension" : [{
        "url" : "entityRelatedness",
        "valueCodeableConcept" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C53260",
            "display" : "Related"
          }]
        }
      }],
      "url" : "causality"
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity"
  },
  {
    "extension" : [{
      "url" : "criterionCode",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C11338",
          "display" : "Results In Persistent Or Significant Disability"
        }]
      }
    },
    {
      "url" : "criterionPresent",
      "valueBoolean" : false
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
  },
  {
    "extension" : [{
      "url" : "criterionCode",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C83052",
          "display" : "Requires Inpatient Hospitalization"
        }]
      }
    },
    {
      "url" : "criterionPresent",
      "valueBoolean" : true
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
  },
  {
    "extension" : [{
      "url" : "criterionCode",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C48275",
          "display" : "Death Related to Adverse Event"
        }]
      }
    },
    {
      "url" : "criterionPresent",
      "valueBoolean" : false
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
  },
  {
    "extension" : [{
      "url" : "criterionCode",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C84266",
          "display" : "Is Life Threatening"
        }]
      }
    },
    {
      "url" : "criterionPresent",
      "valueBoolean" : true
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
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  {
    "extension" : [{
      "url" : "criterionCode",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C83117",
          "display" : "Congenital Anomaly or Birth Defect"
        }]
      }
    },
    {
      "url" : "criterionPresent",
      "valueBoolean" : false
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
  },
  {
    "extension" : [{
      "url" : "criterionCode",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C82521",
          "display" : "Other Medically Important Condition"
        }]
      }
    },
    {
      "url" : "criterionPresent",
      "valueBoolean" : false
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
  },
  {
    "extension" : [{
      "url" : "criterionCode",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C201939",
          "display" : "Required Intervention to Prevent Permanent Impairment/damage"
        }]
      }
    },
    {
      "url" : "criterionPresent",
      "valueBoolean" : true
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
  },
  {
    "extension" : [{
      "url" : "item",
      "valueReference" : {
        "reference" : "MedicationRequest/medicationrequest0301-discontinue",
        "display" : "Medication Request where study drug prescription was discontinued"
      }
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action"
  }],
  "modifierExtension" : [{
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status",
    "valueCode" : "completed"
  }],
  "actuality" : "actual",
  "event" : {
    "coding" : [{
      "system" : "http://snomed.info/sct",
      "code" : "370901008",
      "display" : "Serious reportable event associated with product or device"
    }]
  },
  "subject" : {
    "reference" : "Patient/ClinicalTrialSubject5"
  },
  "detected" : "1905-08-23",
  "recordedDate" : "1905-08-24",
  "seriousness" : {
    "coding" : [{
      "system" : "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
      "code" : "serious"
    }]
  },
  "severity" : {
    "coding" : [{
      "system" : "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
      "code" : "severe",
      "display" : "Severe"
    }]
  },
  "outcome" : {
    "coding" : [{
      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
      "code" : "C49496",
      "display" : "Recovering/Resolving"
    }]
  },
  "recorder" : {
    "display" : "Clinical Research Associate"
  },
  "study" : [{
    "display" : "NCT1010101"
  }]
}