Adverse Event Clinical Research
1.0.1 - STU1

Adverse Event Clinical Research, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-ae-research-ig/ and changes regularly. See the Directory of published versions

## : ClinicalTrialSignificantAdverseEvent - JSON Representation

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    {
      "resourceType" : "AdverseEvent",
      "id" : "ClinicalTrialSignificantAdverseEvent",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ae-research-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><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><p><b>Adverse Event 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>status</b>: completed</p><p><b>actuality</b>: actual</p><p><b>code</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>resultingEffect</b>: </p><ul><li><a href=\"Condition-AEHepaticFailure.html\">Condition/AEHepaticFailure</a></li><li><a href=\"Condition-AEHepaticFailurecomplication.html\">Condition/AEHepaticFailurecomplication</a></li></ul><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>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><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"MedicationAdministration-medadmin0301.html\">MedicationAdministration/medadmin0301: Study Medication</a></p><h3>Causalities</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>EntityRelatedness</b></td></tr><tr><td style=\"display: none\">*</td><td>Related <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>#C53260)</span></td></tr></table></blockquote><h3>MitigatingActions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Item[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"MedicationRequest-medicationrequest0301-discontinue.html\">MedicationRequest/medicationrequest0301-discontinue: Medication Request where study drug prescription was discontinued</a></td></tr></table></div>"
      },
      "extension" : [
        {
          "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-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-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-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-ig/StructureDefinition/seriousness-criteria"
        },
        {
          "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-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-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-ig/StructureDefinition/seriousness-criteria"
        },
        {
          "url" : "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity",
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
                "code" : "severe",
                "display" : "Severe"
              }
            ]
          }
        }
      ],
      "status" : "completed",
      "actuality" : "actual",
      "code" : {
        "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",
      "resultingEffect" : [
        {
          🔗 "reference" : "Condition/AEHepaticFailure"
        },
        {
          🔗 "reference" : "Condition/AEHepaticFailurecomplication"
        }
      ],
      "seriousness" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
            "code" : "serious"
          }
        ]
      },
      "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"
        }
      ],
      "suspectEntity" : [
        {
          "instanceReference" : {
            🔗 "reference" : "MedicationAdministration/medadmin0301",
            "display" : "Study Medication"
          },
          "causality" : {
            "entityRelatedness" : {
              "coding" : [
                {
                  "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                  "code" : "C53260",
                  "display" : "Related"
                }
              ]
            }
          }
        }
      ],
      "mitigatingAction" : [
        {
          "itemReference" : {
            🔗 "reference" : "MedicationRequest/medicationrequest0301-discontinue",
            "display" : "Medication Request where study drug prescription was discontinued"
          }
        }
      ]
    }