Adverse Event Clinical Research R4 Backport
1.0.1 - STU1
Adverse Event Clinical Research R4 Backport
1.0.1 - STU1
Adverse Event Clinical Research R4 Backport, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-ae-research-backport-ig/ and changes regularly. See the Directory of published versions
{
"resourceType" : "AdverseEvent",
"id" : "AdverseEventFromProcedureNotStudyDrug",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: AdverseEvent</b><a name=\"AdverseEventFromProcedureNotStudyDrug\"> </a><a name=\"hcAdverseEventFromProcedureNotStudyDrug\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource AdverseEvent "AdverseEventFromProcedureNotStudyDrug" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-AdverseEvent-clinical-research.html\">Adverse Event Clinical Research</a></p></div><p><b>Resulting Effect</b>: <a href=\"Condition-AEModeratehives.html\">Condition/AEModeratehives: Moderate hives</a></p><p><b>Adverse Event resolution date</b>: 2021-01-15</p><blockquote><p><b>Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href=\"MedicationAdministration-study-medication-administration-WBY.html\">MedicationAdministration/study-medication-administration-WBY</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><blockquote><p><b>Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href=\"MedicationAdministration-medication-administration-contrast-dye.html\">MedicationAdministration/medication-administration-contrast-dye</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><p><b>Expected In Research Study</b>: false</p><p><b>Note</b>: The action taken with the study treatment was the study drug dose not changed</p><p><b>Adverse event caused subject to discontinue the study</b>: false</p><blockquote><p><b>Mitigating Action</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href=\"MedicationAdministration-medication-administration-forhives.html\">MedicationAdministration/medication-administration-forhives</a></p></blockquote><blockquote><p><b>Contributing Factor</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href=\"Procedure-clinical-trial-acme-procedure.html\">Procedure/clinical-trial-acme-procedure</a></p></blockquote><blockquote><p><b>modifierExtension[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]</b></p></blockquote><p><b>actuality</b>: actual</p><p><b>event</b>: Moderate hives <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-mdr.html\">Medical Dictionary for Regulatory Activities</a>#10019211 "Hypersensitivity reaction")</span></p><p><b>subject</b>: <a href=\"Patient-patient-slp.html\">Patient/patient-slp</a> " EXAMPLE"</p><p><b>date</b>: 2021-01-15</p><p><b>seriousness</b>: Non-serious <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-adverse-event-seriousness.html\">AdverseEventSeriousness</a>#non-serious)</span></p><p><b>severity</b>: Moderate <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-adverse-event-severity.html\">AdverseEventSeverity</a>#moderate)</span></p><p><b>outcome</b>: Recovered/Resolved <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C49498)</span></p><p><b>study</b>: <a href=\"ResearchStudy-research-study-acme.html\">ResearchStudy/research-study-acme</a></p></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect",
"valueReference" : {
🔗 "reference" : "Condition/AEModeratehives",
"display" : "Moderate hives"
}
},
{
"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" : "https://www.meddra.org",
"code" : "10019211",
"display" : "Hypersensitivity reaction"
}
],
"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"
}
]
},
"severity" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
"code" : "moderate",
"display" : "Moderate"
}
]
},
"outcome" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C49498",
"display" : "Recovered/Resolved"
}
]
},
"study" : [
{
🔗 "reference" : "ResearchStudy/research-study-acme"
}
]
}
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.ae-research-backport-ig#1.0.1 based on FHIR 4.0.1. Generated 2024-04-30
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