FHIR IG analytics| Package | hl7.fhir.uv.ae-research-backport-ig.r4b |
| Resource Type | AdverseEvent |
| Id | AdverseEvent-adverse-event-compass-ex1b.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 "adverse-event-compass-ex1b"
Profile: Adverse Event Clinical Research
Severity Or Grade: Mild (AdverseEvent Severity or Grade Codes#1)
Participant
url
functionvalue: authenticator (ParticipationType#AUTHEN)
url
actorvalue: Practitioner/practitioner-owen-oncologist " ONCOLOGIST"
Suspect Entity
url
instancevalue: MedicationAdministration/medication-administration-kadcyla
url
causality
Suspect Entity
url
instancevalue: MedicationAdministration/medication-administration-tucatinib
url
causality
Expected In Research Study: true
Adverse Event resolution date: 2020-06-10
Note: treatment given with reduced dose per protocol guidelines
Mitigating Action
url
itemvalue: MedicationAdministration/medication-administration-kadcyla-reduced
Mitigating Action
url
itemvalue: MedicationAdministration/medication-administration-tucatinib-reduced
modifierExtension[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]
actuality: actual
event: Alanine aminotransferase (ALT) decreased to 60 (www.meddra.org#10001551 "Alanine aminotransferase increased")
subject: Patient/patient-example-kaitlyn-b " BOUNCE"
date: 2020-05-20
seriousness: Non-serious (AdverseEventSeriousness#non-serious)
outcome: C49498"Recovered/Resolved" (NCI Thesaurus#C49498"Recovered/Resolved")
recorder: Practitioner/practitioner-oncology-nurse-jane " NURSE"
{
"resourceType": "AdverseEvent",
"id": "adverse-event-compass-ex1b",
"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": "function",
"valueCodeableConcept": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ParticipationType",
"code": "AUTHEN"
}
]
}
},
{
"url": "actor",
"valueReference": {
"reference": "Practitioner/practitioner-owen-oncologist"
}
}
],
"url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant"
},
{
"extension": [
{
"url": "instance",
"valueReference": {
"reference": "MedicationAdministration/medication-administration-kadcyla"
}
},
{
"extension": [
{
"url": "entityRelatedness",
"valueCodeableConcept": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C53258",
"display": "Possibly Related"
}
]
}
}
],
"url": "causality"
}
],
"url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity"
},
{
"extension": [
{
"url": "instance",
"valueReference": {
"reference": "MedicationAdministration/medication-administration-tucatinib"
}
},
{
"extension": [
{
"url": "entityRelatedness",
"valueCodeableConcept": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C53258",
"display": "Possibly 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": true
},
{
"url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date",
"valueDateTime": "2020-06-10"
},
{
"url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note",
"valueAnnotation": {
"text": "treatment given with reduced dose per protocol guidelines"
}
},
{
"extension": [
{
"url": "item",
"valueReference": {
"reference": "MedicationAdministration/medication-administration-kadcyla-reduced"
}
}
],
"url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action"
},
{
"extension": [
{
"url": "item",
"valueReference": {
"reference": "MedicationAdministration/medication-administration-tucatinib-reduced"
}
}
],
"url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action"
}
],
"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": "10001551",
"display": "Alanine aminotransferase increased"
}
],
"text": "Alanine aminotransferase (ALT) decreased to 60"
},
"subject": {
"reference": "Patient/patient-example-kaitlyn-b"
},
"date": "2020-05-20",
"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\""
}
]
},
"recorder": {
"reference": "Practitioner/practitioner-oncology-nurse-jane"
},
"study": [
{
"reference": "ResearchStudy/clinical-trial-example-compass"
}
]
}