FHIR IG analytics| Package | hl7.fhir.uv.ae-research-backport-ig.r4b |
| Resource Type | AdverseEvent |
| Id | AdverseEvent-ClinicalResearchAdverseEventUseCase17.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 "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
instancevalue: MedicationAdministration/study-medication-administration-WBY
url
causality
Suspect Entity
url
instancevalue: 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
itemvalue: MedicationAdministration/medication-administration-forhives
Contributing Factor
url
item
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")
{
"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"
}
]
}