Adverse Event Clinical Research R4 Backport
1.0.1 - STU1
Adverse Event Clinical Research R4 Backport
1.0.1 - STU1
This page is part of the Adverse Event Clinical Research R4 Backport (v1.0.1: STU 1) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions
{
"resourceType" : "AdverseEvent",
"id" : "SeriousAdverseEventResearchStudy",
"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=\"SeriousAdverseEventResearchStudy\"> </a><a name=\"hcSeriousAdverseEventResearchStudy\"> </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 "SeriousAdverseEventResearchStudy" </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-GIBleed.html\">Condition/GIBleed</a></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-ABC.html\">MedicationAdministration/study-medication-administration-ABC</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><p><b>Adverse Event resolution date</b>: 2021-12-09</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>: 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>: 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>: 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>: 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>: 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>: 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>: true</p></blockquote><blockquote><p><b>Mitigating Action</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href=\"Procedure-procedure-upper-endoscopy.html\">Procedure/procedure-upper-endoscopy</a></p></blockquote><blockquote><p><b>Mitigating Action</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: study drug withdrawn <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>#C49502 "DRUG WITHDRAWN")</span></p></blockquote><blockquote><p><b>Mitigating Action</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href=\"MedicationRequest-medicationrequest-for-study-medication-administration-ABC.html\">MedicationRequest/medicationrequest-for-study-medication-administration-ABC: Medication Request where study drug prescription was discontinued</a></p></blockquote><p><b>Adverse event caused subject to discontinue the study</b>: true</p><p><b>Expected In Research Study</b>: false</p><blockquote><p><b>Supporting information relevant to the event</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <span>: Supporting info would have context such as an Observation on the drop in hemoglobin</span></p></blockquote><p><b>Note</b>: The patient’s hemoglobin dropped to 6.5 g/dL and received 2 units of PRBCs. The patient had an upper endoscopy that showed a moderate amount of bleeding from the esophagus. The site was cauterized, and the patient had no further bleeding after the procedure. The GI bleed resolved within one week after discontinuation of study drug and the patient was discharged on 9-Dec-2021 in good condition.</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>event</b>: Gastrointestinal haemorrhage <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>#10017955)</span></p><p><b>subject</b>: <a href=\"Patient-SCHJO.html\">Patient/SCHJO</a> ""</p><p><b>date</b>: 2021-12-02</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>severity</b>: Severe <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>#severe)</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-XYZ.html\">ResearchStudy/research-study-XYZ</a></p></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect",
"valueReference" : {
🔗 "reference" : "Condition/GIBleed"
}
},
{
"extension" : [
{
"url" : "instance",
"valueReference" : {
🔗 "reference" : "MedicationAdministration/study-medication-administration-ABC"
}
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"extension" : [
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"url" : "entityRelatedness",
"valueCodeableConcept" : {
"coding" : [
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"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C53258",
"display" : "Possibly Related"
}
]
}
}
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"url" : "causality"
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"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity"
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{
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date",
"valueDateTime" : "2021-12-09"
},
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"extension" : [
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"url" : "criterionCode",
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"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C11338",
"display" : "Results In Persistent Or Significant Disability"
}
]
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{
"url" : "criterionPresent",
"valueBoolean" : false
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"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
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}
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"valueBoolean" : true
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"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
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"display" : "Death Related to Adverse Event"
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"valueBoolean" : false
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"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
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"display" : "Congenital Anomaly or Birth Defect"
}
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"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
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{
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"valueCodeableConcept" : {
"coding" : [
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"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C201939",
"display" : "Required Intervention to Prevent Permanent Impairment/damage"
}
]
}
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{
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"valueBoolean" : true
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"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
},
{
"extension" : [
{
"url" : "item",
"valueReference" : {
🔗 "reference" : "Procedure/procedure-upper-endoscopy"
}
}
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"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action"
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{
"extension" : [
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"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C49502",
"display" : "DRUG WITHDRAWN"
}
],
"text" : "study drug withdrawn"
}
}
],
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action"
},
{
"extension" : [
{
"url" : "item",
"valueReference" : {
🔗 "reference" : "MedicationRequest/medicationrequest-for-study-medication-administration-ABC",
"display" : "Medication Request where study drug prescription was discontinued"
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}
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{
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study",
"valueBoolean" : true
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{
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study",
"valueBoolean" : false
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{
"extension" : [
{
"url" : "item",
"valueReference" : {
"display" : "Supporting info would have context such as an Observation on the drop in hemoglobin"
}
}
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"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info"
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{
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note",
"valueAnnotation" : {
"text" : "The patient’s hemoglobin dropped to 6.5 g/dL and received 2 units of PRBCs. The patient had an upper endoscopy that showed a moderate amount of bleeding from the esophagus. The site was cauterized, and the patient had no further bleeding after the procedure. The GI bleed resolved within one week after discontinuation of study drug and the patient was discharged on 9-Dec-2021 in good condition."
}
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"valueCode" : "completed"
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"actuality" : "actual",
"event" : {
"coding" : [
{
"system" : "https://www.meddra.org",
"code" : "10017955",
"display" : "Gastrointestinal haemorrhage"
}
]
},
"subject" : {
🔗 "reference" : "Patient/SCHJO"
},
"date" : "2021-12-02",
"seriousness" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
"code" : "serious",
"display" : "Serious"
}
]
},
"severity" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
"code" : "severe",
"display" : "Severe"
}
]
},
"outcome" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C49498",
"display" : "Recovered/Resolved"
}
]
},
"study" : [
{
🔗 "reference" : "ResearchStudy/research-study-XYZ"
}
]
}
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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