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" : "adverse-event-device-death",
"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=\"adverse-event-device-death\"> </a><a name=\"hcadverse-event-device-death\"> </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 "adverse-event-device-death" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-AdverseEvent-clinical-research.html\">Adverse Event Clinical Research</a></p></div><p><b>Adverse Event Grade</b>: Grade 5 Death related to adverse event <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>#C48275)</span></p><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Results In Persistent Or Significant Disability <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>#C11338)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Requires Inpatient Hospitalization <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>#C83052)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Death Related to Adverse Event <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>#C48275)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: true</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Is Life Threatening <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>#C84266)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Congenital Anomaly or Birth Defect <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>#C83117)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Other Medically Important Condition <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>#C82521)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Required Intervention to Prevent Permanent Impairment/damage <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>#C201939)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><p><b>Resulting Effect</b>: <span>: Condition with Deep puncture wound (disorder) - SNOMED CT code. Note this different than the AdverseEvent.code in this instance.</span></p><blockquote><p><b>Participant</b></p><blockquote><p><b>url</b></p><code>function</code></blockquote><p><b>value</b>: authenticator <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-ParticipationType.html\">ParticipationType</a>#AUTHEN)</span></p><blockquote><p><b>url</b></p><code>actor</code></blockquote><p><b>value</b>: <a href=\"Practitioner-practitioner-owen-oncologist.html\">Practitioner/practitioner-owen-oncologist</a> " ONCOLOGIST"</p></blockquote><blockquote><p><b>Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href=\"Device-device-infuser.html\">Device/device-infuser</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-kadcyla1.html\">MedicationAdministration/medication-administration-kadcyla1</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>: During infusion of kadcyla an infuser exploded, shrapnel from the explosion caused a fatal puncture wound.</p><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>category</b>: Device <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-adverse-event-category.html\">AdverseEventCategory</a>#device)</span></p><p><b>event</b>: Patient death due to device explosion <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOMED CT</a>#370903006 "Patient death or serious disability associated with the use or function of a device in patient care, in which the device is used or functions other than as intended (event)")</span></p><p><b>subject</b>: <a href=\"Patient-patient-example-kaitlyn-b1.html\">Patient/patient-example-kaitlyn-b1</a> " HAMMER"</p><p><b>date</b>: 2020-05-20</p><p><b>seriousness</b>: 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>#serious)</span></p><p><b>outcome</b>: Fatal <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>#C48275)</span></p><p><b>recorder</b>: <a href=\"Practitioner-practitioner-oncology-nurse-jane.html\">Practitioner/practitioner-oncology-nurse-jane</a> " NURSE"</p><p><b>study</b>: <a href=\"ResearchStudy-clinical-trial-example-compass.html\">ResearchStudy/clinical-trial-example-compass</a></p></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/ae-grade",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48275"
}
],
"text" : "Grade 5 Death related to adverse event"
}
},
{
"extension" : [
{
"url" : "criterionCode",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C11338",
"display" : "Results In Persistent Or Significant Disability"
}
]
}
},
{
"url" : "criterionPresent",
"valueBoolean" : false
}
],
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
},
{
"extension" : [
{
"url" : "criterionCode",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C83052",
"display" : "Requires Inpatient Hospitalization"
}
]
}
},
{
"url" : "criterionPresent",
"valueBoolean" : false
}
],
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
},
{
"extension" : [
{
"url" : "criterionCode",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48275",
"display" : "Death Related to Adverse Event"
}
]
}
},
{
"url" : "criterionPresent",
"valueBoolean" : true
}
],
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
},
{
"extension" : [
{
"url" : "criterionCode",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C84266",
"display" : "Is Life Threatening"
}
]
}
},
{
"url" : "criterionPresent",
"valueBoolean" : false
}
],
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
},
{
"extension" : [
{
"url" : "criterionCode",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C83117",
"display" : "Congenital Anomaly or Birth Defect"
}
]
}
},
{
"url" : "criterionPresent",
"valueBoolean" : false
}
],
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
},
{
"extension" : [
{
"url" : "criterionCode",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C82521",
"display" : "Other Medically Important Condition"
}
]
}
},
{
"url" : "criterionPresent",
"valueBoolean" : false
}
],
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
},
{
"extension" : [
{
"url" : "criterionCode",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C201939",
"display" : "Required Intervention to Prevent Permanent Impairment/damage"
}
]
}
},
{
"url" : "criterionPresent",
"valueBoolean" : false
}
],
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
},
{
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect",
"valueReference" : {
"display" : "Condition with Deep puncture wound (disorder) - SNOMED CT code. Note this different than the AdverseEvent.code in this instance."
}
},
{
"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" : "Device/device-infuser"
}
},
{
"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"
},
{
"extension" : [
{
"url" : "instance",
"valueReference" : {
🔗 "reference" : "MedicationAdministration/medication-administration-kadcyla1"
}
},
{
"extension" : [
{
"url" : "entityRelatedness",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C53256",
"display" : "Not 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" : "During infusion of kadcyla an infuser exploded, shrapnel from the explosion caused a fatal puncture wound."
}
}
],
"modifierExtension" : [
{
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status",
"valueCode" : "completed"
}
],
"actuality" : "actual",
"category" : [
{
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/adverse-event-category",
"code" : "device",
"display" : "Device"
}
]
}
],
"event" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "370903006",
"display" : "Patient death or serious disability associated with the use or function of a device in patient care, in which the device is used or functions other than as intended (event)"
}
],
"text" : "Patient death due to device explosion"
},
"subject" : {
🔗 "reference" : "Patient/patient-example-kaitlyn-b1"
},
"date" : "2020-05-20",
"seriousness" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
"code" : "serious",
"display" : "Serious"
}
]
},
"outcome" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48275"
}
],
"text" : "Fatal"
},
"recorder" : {
🔗 "reference" : "Practitioner/practitioner-oncology-nurse-jane"
},
"study" : [
{
🔗 "reference" : "ResearchStudy/clinical-trial-example-compass"
}
]
}
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
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change