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FHIR IG analytics

Packagehl7.fhir.uv.ae-research-backport-ig
Resource TypeAdverseEvent
IdAdverseEvent-NonSeriousAdverseEventResearchStudyMed.json
FHIR VersionR4

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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

Resulting Effect: Condition/AEHeadache: Mild Headache

Suspect Entity

url

instance

value: MedicationAdministration/study-medication-administration-MMD

url

causality

Mitigating Action

url

item

value: MedicationAdministration/medication-administration-tylenol

Adverse event caused subject to discontinue the study: false

Expected In Research Study: true

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

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

actuality: actual

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

subject: Patient/patient-moumic " EXAMPLE"

date: 2022-02-01

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

severity: Mild (AdverseEventSeverity#mild)

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

study: ResearchStudy/research-study-DISNEY


Source1

{
  "resourceType": "AdverseEvent",
  "id": "NonSeriousAdverseEventResearchStudyMed",
  "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/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"
    }
  ]
}