{
  "resourceType" : "AdverseEvent",
  "id" : "NonSeriousAdverseEventResearchStudyMed",
  "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=\"NonSeriousAdverseEventResearchStudyMed\"> </a><a name=\"hcNonSeriousAdverseEventResearchStudyMed\"> </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;NonSeriousAdverseEventResearchStudyMed&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-AEHeadache.html\">Condition/AEHeadache: Mild Headache</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-study-medication-administration-MMD.html\">MedicationAdministration/study-medication-administration-MMD</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><blockquote><p><b>Mitigating Action</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href=\"MedicationAdministration-medication-administration-tylenol.html\">MedicationAdministration/medication-administration-tylenol</a></p></blockquote><p><b>Adverse event caused subject to discontinue the study</b>: false</p><p><b>Expected In Research Study</b>: true</p><p><b>Note</b>: Headaches are mild, occur once a week and resolved with Tylenol, but still ongoing. Action taken with the study is dose not chnaged.</p><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>: Headache <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)</span></p><p><b>subject</b>: <a href=\"Patient-patient-moumic.html\">Patient/patient-moumic</a> &quot; EXAMPLE&quot;</p><p><b>date</b>: 2022-02-01</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>severity</b>: Mild <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>#mild)</span></p><p><b>outcome</b>: Not recovering/not 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>#C49494)</span></p><p><b>study</b>: <a href=\"ResearchStudy-research-study-DISNEY.html\">ResearchStudy/research-study-DISNEY</a></p></div>"
  },
  "extension" : [{
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect",
    "valueReference" : {
      "reference" : "Condition/AEHeadache",
      "display" : "Mild Headache"
    }
  },
  {
    "extension" : [{
      "url" : "instance",
      "valueReference" : {
        "reference" : "MedicationAdministration/study-medication-administration-MMD"
      }
    },
    {
      "extension" : [{
        "url" : "entityRelatedness",
        "valueCodeableConcept" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C53257",
            "display" : "Unlikely Related"
          }]
        }
      }],
      "url" : "causality"
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity"
  },
  {
    "extension" : [{
      "url" : "item",
      "valueReference" : {
        "reference" : "MedicationAdministration/medication-administration-tylenol"
      }
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action"
  },
  {
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study",
    "valueBoolean" : false
  },
  {
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study",
    "valueBoolean" : true
  },
  {
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note",
    "valueAnnotation" : {
      "text" : "Headaches are mild, occur once a week and resolved with Tylenol, but still ongoing. Action taken with the study is dose not chnaged."
    }
  }],
  "modifierExtension" : [{
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status",
    "valueCode" : "completed"
  }],
  "actuality" : "actual",
  "event" : {
    "coding" : [{
      "system" : "https://www.meddra.org",
      "code" : "10019211",
      "display" : "Headache"
    }]
  },
  "subject" : {
    "reference" : "Patient/patient-moumic"
  },
  "date" : "2022-02-01",
  "seriousness" : {
    "coding" : [{
      "system" : "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
      "code" : "non-serious",
      "display" : "Non-serious"
    }]
  },
  "severity" : {
    "coding" : [{
      "system" : "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
      "code" : "mild",
      "display" : "Mild"
    }]
  },
  "outcome" : {
    "coding" : [{
      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
      "code" : "C49494",
      "display" : "Not recovering/not resolved"
    }]
  },
  "study" : [{
    "reference" : "ResearchStudy/research-study-DISNEY"
  }]
}