FHIR IG analytics| Package | hl7.fhir.uv.ae-research-ig |
| Resource Type | AdverseEvent |
| Id | AdverseEvent-NonSeriousAdverseEventResearchStudyMed.json |
| FHIR Version | R5 |
No resources found
No resources found
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)
| 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.
{
"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."
}
]
}