FHIR IG analytics| Package | hl7.fhir.uv.ae-research-backport-ig.r4b |
| Resource Type | AdverseEvent |
| Id | AdverseEvent-ClinicalResearchAdverseEventUseCase16.json |
| FHIR Version | R4B |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: AdverseEvent
Resource AdverseEvent "ClinicalResearchAdverseEventUseCase16"
Profile: Adverse Event Clinical Research
Severity Or Grade: Mild (AdverseEvent Severity or Grade Codes#1)
Suspect Entity
url
instancevalue: MedicationAdministration/study-medication-administration-MMD
url
causality
Mitigating Action
url
itemvalue: 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 (www.meddra.org#10019211)
subject: Patient/patient-moumic " EXAMPLE"
date: 2022-02-01
seriousness: Non-serious (AdverseEventSeriousness#non-serious)
outcome: Not recovering/not resolved (NCI Thesaurus#C49494)
{
"resourceType": "AdverseEvent",
"id": "ClinicalResearchAdverseEventUseCase16",
"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": "1",
"display": "Mild"
}
]
}
},
{
"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"
}
]
},
"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"
}
]
}