Publication Build: This will be filled in by the publication tooling

• Narrative Content
• XML
• JSON

: ClinicalTrialSignificantAdverseEvent - JSON Representation

Raw json | Download

{
  "resourceType" : "AdverseEvent",
  "id" : "ClinicalTrialSignificantAdverseEvent",
  "meta" : {
    "profile" : [
      🔗 "http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-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-fujitsu-adverseEvent-clinical-research.html\">Fujitsu Adverse Event Clinical Research</a></p></div><p><b>Fujitsu Resulting Effect</b>: <a href=\"Condition-AEHepaticFailurecomplication.html\">Condition/AEHepaticFailurecomplication</a></p><blockquote><p><b>Fujitsu 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>Fujitsu 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>Fujitsu 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://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-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 TRAIL&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://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resulting-effect",
      "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://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-suspect-entity"
    },
    {
      "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://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-seriousness-criteria"
    },
    {
      "extension" : [
        {
          "url" : "item",
          "valueReference" : {
            🔗 "reference" : "MedicationRequest/medicationrequest0301-discontinue",
            "display" : "Medication Request where study drug prescription was discontinued"
          }
        }
      ],
      "url" : "http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-mitigating-action"
    }
  ],
  "modifierExtension" : [
    {
      "url" : "http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-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"
    }
  ]
}