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

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: AdverseEventFromProcedureNotStudyDrug - JSON Representation

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{
  "resourceType" : "AdverseEvent",
  "id" : "AdverseEventFromProcedureNotStudyDrug",
  "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=\"AdverseEventFromProcedureNotStudyDrug\"> </a><a name=\"hcAdverseEventFromProcedureNotStudyDrug\"> </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;AdverseEventFromProcedureNotStudyDrug&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-AdverseEvent-clinical-research.html\">Adverse Event Clinical Research</a></p></div><p><b>Adverse Event Severity</b>: Moderate <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>#moderate)</span></p><p><b>Adverse event caused subject to discontinue the study</b>: false</p><p><b>status</b>: completed</p><p><b>actuality</b>: actual</p><p><b>code</b>: Moderate hives <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-mdr.html\">Medical Dictionary for Regulatory Activities</a>#10019211 &quot;Hypersensitivity reaction&quot;)</span></p><p><b>subject</b>: <a href=\"Patient-patient-slp.html\">Patient/patient-slp</a> &quot; EXAMPLE&quot;</p><p><b>occurrence</b>: 2021-01-15 --&gt; 2021-01-15</p><p><b>resultingEffect</b>: <a href=\"Condition-AEModeratehives.html\">Condition/AEModeratehives: Moderate hives</a></p><p><b>seriousness</b>: Non-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>#non-serious)</span></p><p><b>outcome</b>: Recovered/Resolved <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>#C49498)</span></p><p><b>study</b>: <a href=\"ResearchStudy-research-study-acme.html\">ResearchStudy/research-study-acme</a></p><p><b>expectedInResearchStudy</b>: false</p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"MedicationAdministration-study-medication-administration-WBY.html\">MedicationAdministration/study-medication-administration-WBY</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>Unlikely 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>#C53257)</span></td></tr></table></blockquote><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"MedicationAdministration-medication-administration-contrast-dye.html\">MedicationAdministration/medication-administration-contrast-dye</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>ContributingFactors</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=\"Procedure-clinical-trial-acme-procedure.html\">Procedure/clinical-trial-acme-procedure</a></td></tr></table><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=\"MedicationAdministration-medication-administration-forhives.html\">MedicationAdministration/medication-administration-forhives</a></td></tr></table><p><b>note</b>: The action taken with the study treatment was the study drug dose not changed</p></div>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity",
      "valueCodeableConcept" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
            "code" : "moderate",
            "display" : "Moderate"
          }
        ]
      }
    },
    {
      "url" : "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/caused-subject-to-discontinue-study",
      "valueBoolean" : false
    }
  ],
  "status" : "completed",
  "actuality" : "actual",
  "code" : {
    "coding" : [
      {
        "system" : "https://www.meddra.org",
        "code" : "10019211",
        "display" : "Hypersensitivity reaction"
      }
    ],
    "text" : "Moderate hives"
  },
  "subject" : {
    🔗 "reference" : "Patient/patient-slp"
  },
  "occurrencePeriod" : {
    "start" : "2021-01-15",
    "end" : "2021-01-15"
  },
  "resultingEffect" : [
    {
      🔗 "reference" : "Condition/AEModeratehives",
      "display" : "Moderate hives"
    }
  ],
  "seriousness" : {
    "coding" : [
      {
        "system" : "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
        "code" : "non-serious",
        "display" : "Non-serious"
      }
    ]
  },
  "outcome" : [
    {
      "coding" : [
        {
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C49498",
          "display" : "Recovered/Resolved"
        }
      ]
    }
  ],
  "study" : [
    {
      🔗 "reference" : "ResearchStudy/research-study-acme"
    }
  ],
  "expectedInResearchStudy" : false,
  "suspectEntity" : [
    {
      "instanceReference" : {
        🔗 "reference" : "MedicationAdministration/study-medication-administration-WBY"
      },
      "causality" : {
        "entityRelatedness" : {
          "coding" : [
            {
              "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code" : "C53257",
              "display" : "Unlikely Related"
            }
          ]
        }
      }
    },
    {
      "instanceReference" : {
        🔗 "reference" : "MedicationAdministration/medication-administration-contrast-dye"
      },
      "causality" : {
        "entityRelatedness" : {
          "coding" : [
            {
              "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code" : "C53260",
              "display" : "Related"
            }
          ]
        }
      }
    }
  ],
  "contributingFactor" : [
    {
      "itemReference" : {
        🔗 "reference" : "Procedure/clinical-trial-acme-procedure"
      }
    }
  ],
  "mitigatingAction" : [
    {
      "itemReference" : {
        🔗 "reference" : "MedicationAdministration/medication-administration-forhives"
      }
    }
  ],
  "note" : [
    {
      "text" : "The action taken with the study treatment was the study drug dose not changed"
    }
  ]
}