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FHIR IG analytics

Packagehl7.fhir.uv.ae-research-ig
Resource TypeAdverseEvent
IdAdverseEvent-NonSeriousAdverseEventResearchStudyMed.json
FHIR VersionR5

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 "NonSeriousAdverseEventResearchStudyMed"

Profile: Adverse Event Clinical Research

Adverse Event Severity: Mild (AdverseEventSeverity#mild)

Adverse event caused subject to discontinue the study: false

status: completed

actuality: actual

code: Headache (Medical Dictionary for Regulatory Activities#10019211)

subject: Patient/patient-moumic " EXAMPLE"

occurrence: 2022-02-01 --> (ongoing)

resultingEffect: Condition/AEHeadache: Mild Headache

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

outcome: Not recovering/not resolved (NCI Thesaurus#C49494)

study: ResearchStudy/research-study-DISNEY

expectedInResearchStudy: true

suspectEntity

instance: MedicationAdministration/study-medication-administration-MMD

Causalities

-EntityRelatedness
*Unlikely Related (NCI Thesaurus#C53257)

MitigatingActions

-Item[x]
*MedicationAdministration/medication-administration-tylenol

note: Headaches are mild, occur once a week and resolved with Tylenol, but still ongoing. Action taken with the study is dose not changed.


Source1

{
  "resourceType": "AdverseEvent",
  "id": "NonSeriousAdverseEventResearchStudyMed",
  "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": "mild",
            "display": "Mild"
          }
        ]
      }
    },
    {
      "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": "Headache"
      }
    ]
  },
  "subject": {
    "reference": "Patient/patient-moumic"
  },
  "occurrencePeriod": {
    "start": "2022-02-01"
  },
  "resultingEffect": [
    {
      "reference": "Condition/AEHeadache",
      "display": "Mild Headache"
    }
  ],
  "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": "C49494",
          "display": "Not recovering/not resolved"
        }
      ]
    }
  ],
  "study": [
    {
      "reference": "ResearchStudy/research-study-DISNEY"
    }
  ],
  "expectedInResearchStudy": true,
  "suspectEntity": [
    {
      "instanceReference": {
        "reference": "MedicationAdministration/study-medication-administration-MMD"
      },
      "causality": {
        "entityRelatedness": {
          "coding": [
            {
              "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code": "C53257",
              "display": "Unlikely Related"
            }
          ]
        }
      }
    }
  ],
  "mitigatingAction": [
    {
      "itemReference": {
        "reference": "MedicationAdministration/medication-administration-tylenol"
      }
    }
  ],
  "note": [
    {
      "text": "Headaches are mild, occur once a week and resolved with Tylenol, but still ongoing. Action taken with the study is dose not changed."
    }
  ]
}