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FHIR IG analytics

Packagehl7.fhir.uv.ae-research-backport-ig.r4b
Resource TypeAdverseEvent
IdAdverseEvent-ClinicalResearchAdverseEventUseCase17.json
FHIR VersionR4B

Resources that use this resource

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Resources that this resource uses

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Narrative

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

Generated Narrative: AdverseEvent

Resource AdverseEvent "ClinicalResearchAdverseEventUseCase17"

Profile: Adverse Event Clinical Research

Severity Or Grade: Moderate (AdverseEvent Severity or Grade Codes#2)

Adverse Event resolution date: 2021-01-15

Suspect Entity

url

instance

value: MedicationAdministration/study-medication-administration-WBY

url

causality

Suspect Entity

url

instance

value: MedicationAdministration/medication-administration-contrast-dye

url

causality

Expected In Research Study: false

Note: The action taken with the study treatment was the study drug dose not changed

Adverse event caused subject to discontinue the study: false

Mitigating Action

url

item

value: MedicationAdministration/medication-administration-forhives

Contributing Factor

url

item

value: Procedure/clinical-trial-acme-procedure

modifierExtension[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]

actuality: actual

event: Moderate hives (NCI Thesaurus#C57954 "Grade 2 - Urticaria")

subject: Patient/patient-slp " EXAMPLE"

date: 2021-01-15

seriousness: Non-serious (AdverseEventSeriousness#non-serious)

outcome: C49498"Recovered/Resolved" (NCI Thesaurus#C49498"Recovered/Resolved")

study: ResearchStudy/research-study-acme


Source1

{
  "resourceType": "AdverseEvent",
  "id": "ClinicalResearchAdverseEventUseCase17",
  "meta": {
    "profile": [
      "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research"
    ]
  },
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/severity-or-grade",
      "valueCodeableConcept": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/uv/ae-research-backport-ig/CodeSystem/adverse-event-severity-or-grade-cs",
            "code": "2",
            "display": "Moderate"
          }
        ]
      }
    },
    {
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date",
      "valueDateTime": "2021-01-15"
    },
    {
      "extension": [
        {
          "url": "instance",
          "valueReference": {
            "reference": "MedicationAdministration/study-medication-administration-WBY"
          }
        },
        {
          "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": "instance",
          "valueReference": {
            "reference": "MedicationAdministration/medication-administration-contrast-dye"
          }
        },
        {
          "extension": [
            {
              "url": "entityRelatedness",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                    "code": "C53260",
                    "display": "Related"
                  }
                ]
              }
            }
          ],
          "url": "causality"
        }
      ],
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity"
    },
    {
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study",
      "valueBoolean": false
    },
    {
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note",
      "valueAnnotation": {
        "text": "The action taken with the study treatment was the study drug dose not changed"
      }
    },
    {
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study",
      "valueBoolean": false
    },
    {
      "extension": [
        {
          "url": "item",
          "valueReference": {
            "reference": "MedicationAdministration/medication-administration-forhives"
          }
        }
      ],
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action"
    },
    {
      "extension": [
        {
          "url": "item",
          "valueReference": {
            "reference": "Procedure/clinical-trial-acme-procedure"
          }
        }
      ],
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor"
    }
  ],
  "modifierExtension": [
    {
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status",
      "valueCode": "completed"
    }
  ],
  "actuality": "actual",
  "event": {
    "coding": [
      {
        "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
        "code": "C57954",
        "display": "Grade 2 - Urticaria"
      }
    ],
    "text": "Moderate hives"
  },
  "subject": {
    "reference": "Patient/patient-slp"
  },
  "date": "2021-01-15",
  "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\"Recovered/Resolved\""
      }
    ]
  },
  "study": [
    {
      "reference": "ResearchStudy/research-study-acme"
    }
  ]
}