FHIR IG analytics

Resources that use this resource

No resources found

Resources that this resource uses

No resources found

Narrative

Note: links and images are rebased to the (stated) source

Source1

{
  "resourceType": "AdverseEvent",
  "id": "AdverseEventFromProcedureNotStudyDrug",
  "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-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"
    }
  ]
}