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Narrative

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Source1

{
  "resourceType": "AdverseEvent",
  "id": "adverse-event-compass-ex1b",
  "meta": {
    "profile": [
      "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research"
    ]
  },
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade",
      "valueCodeableConcept": {
        "coding": [
          {
            "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code": "C41338"
          }
        ],
        "text": "Grade 1 Mild Adverse Event"
      }
    }
  ],
  "status": "completed",
  "actuality": "actual",
  "code": {
    "coding": [
      {
        "system": "https://www.meddra.org",
        "code": "10001551",
        "display": "Alanine aminotransferase increased"
      }
    ],
    "text": "Alanine aminotransferase (ALT) decreased to 60"
  },
  "subject": {
    "reference": "Patient/patient-example-kaitlyn-b"
  },
  "occurrencePeriod": {
    "start": "2020-05-20",
    "end": "2020-06-10"
  },
  "resultingEffect": [
    {
      "display": "Reference to Observation of Alanine aminotransferase (ALT) decreased to 60"
    }
  ],
  "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"
        }
      ]
    }
  ],
  "recorder": {
    "reference": "Practitioner/practitioner-oncology-nurse-jane"
  },
  "participant": [
    {
      "function": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/v3-ParticipationType",
            "code": "AUTHEN"
          }
        ]
      },
      "actor": {
        "reference": "Practitioner/practitioner-owen-oncologist"
      }
    }
  ],
  "study": [
    {
      "reference": "ResearchStudy/clinical-trial-example-compass"
    }
  ],
  "expectedInResearchStudy": true,
  "suspectEntity": [
    {
      "instanceReference": {
        "reference": "MedicationAdministration/medication-administration-kadcyla"
      },
      "causality": {
        "entityRelatedness": {
          "coding": [
            {
              "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code": "C53258",
              "display": "Possibly Related"
            }
          ]
        }
      }
    },
    {
      "instanceReference": {
        "reference": "MedicationAdministration/medication-administration-tucatinib"
      },
      "causality": {
        "entityRelatedness": {
          "coding": [
            {
              "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code": "C53258",
              "display": "Possibly Related"
            }
          ]
        }
      }
    }
  ],
  "mitigatingAction": [
    {
      "itemReference": {
        "reference": "MedicationAdministration/medication-administration-kadcyla-reduced"
      }
    },
    {
      "itemReference": {
        "reference": "MedicationAdministration/medication-administration-tucatinib-reduced"
      }
    }
  ],
  "supportingInfo": [
    {
      "itemReference": {
        "display": "Supporting info would have context such as an Reference to Observation of Alanine aminotransferase (ALT) decreased to 60"
      }
    }
  ],
  "note": [
    {
      "text": "treatment given with reduced dose per protocol guidelines"
    }
  ]
}