Adverse Event Clinical Research
1.0.0-ballot - ballot
Adverse Event Clinical Research
1.0.0-ballot - ballot
This page is part of the Adverse Event Clinical Research (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR v5.0.0. . For a full list of available versions, see the Directory of published versions 
| Page standards status: Informative |
{
"resourceType" : "AdverseEvent",
"id" : "ClinicalResearchAdverseEventUseCase7",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/ae-research-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=\"ClinicalResearchAdverseEventUseCase7\"> </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 "ClinicalResearchAdverseEventUseCase7" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-AdverseEvent-clinical-research.html\">Adverse Event Clinical Research</a></p></div><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/5.0.0/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/5.0.0/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>: Results In Death <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/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/5.0.0/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/5.0.0/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/5.0.0/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 or Damage (Devices) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-fda-add-seriousness-criteria-cs.html\">FDA Additional Seriousness Criteria CodeSystem</a>#requiresPreventImpairment)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: true</p></blockquote><p><b>Severity Or Grade</b>: Life Threatening or Disabling <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-adverse-event-severity-or-grade-cs.html\">AdverseEvent Severity or Grade Codes</a>#4)</span></p><p><b>status</b>: completed</p><p><b>actuality</b>: actual</p><p><b>code</b>: Serious reportable event associated with product or device <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOMED CT</a>#370901008)</span></p><p><b>subject</b>: <a href=\"Patient-ClinicalTrialSubject5.html\">Patient/ClinicalTrialSubject5</a> " CLINICAL TRAIL"</p><p><b>detected</b>: 1905-08-23</p><p><b>recordedDate</b>: 1905-08-24</p><p><b>resultingEffect</b>: </p><ul><li><a href=\"Condition-AEHepaticFailureUseCase7.html\">Condition/AEHepaticFailureUseCase7</a></li><li><a href=\"Condition-AEHepaticFailureUseCase7complication.html\">Condition/AEHepaticFailureUseCase7complication</a></li></ul><p><b>seriousness</b>: Serious <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-adverse-event-seriousness.html\">AdverseEventSeriousness</a>#serious)</span></p><p><b>outcome</b>: Recovering/Resolving <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C49496)</span></p><p><b>recorder</b>: <span>: Clinical Research Associate</span></p><p><b>study</b>: <span>: NCT1010101</span></p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"MedicationAdministration-medadmin0301.html\">MedicationAdministration/medadmin0301: Study Medication Use Case 7</a></p><h3>Causalities</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>EntityRelatedness</b></td></tr><tr><td style=\"display: none\">*</td><td>Certain <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-adverse-event-causality-assess.html\">AdverseEventCausalityAssessment</a>#certain)</span></td></tr></table></blockquote><h3>MitigatingActions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Item[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"MedicationRequest-medicationrequest0301-discontinue.html\">MedicationRequest/medicationrequest0301-discontinue: Medication Request where study drug prescription was discontinued</a></td></tr></table></div>"
},
"extension" : [
{
"extension" : [
{
"url" : "criterionCode",
"valueCodeableConcept" : {
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{
"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-ig/StructureDefinition/seriousness-criteria"
},
{
"extension" : [
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"url" : "criterionCode",
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"coding" : [
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"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
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"display" : "Requires Inpatient Hospitalization"
}
]
}
},
{
"url" : "criterionPresent",
"valueBoolean" : true
}
],
"url" : "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"
},
{
"extension" : [
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"coding" : [
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"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48275",
"display" : "Results In Death"
}
]
}
},
{
"url" : "criterionPresent",
"valueBoolean" : false
}
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"url" : "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"
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{
"extension" : [
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"url" : "criterionCode",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C84266",
"display" : "Is Life Threatening"
}
]
}
},
{
"url" : "criterionPresent",
"valueBoolean" : true
}
],
"url" : "http://hl7.org/fhir/uv/ae-research-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-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
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],
"url" : "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"
},
{
"extension" : [
{
"url" : "criterionCode",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/ae-research-ig/CodeSystem/fda-add-seriousness-criteria-cs",
"code" : "requiresPreventImpairment",
"display" : "Required Intervention to Prevent Permanent Impairment or Damage (Devices)"
}
]
}
},
{
"url" : "criterionPresent",
"valueBoolean" : true
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"url" : "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"
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{
"url" : "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/severity-or-grade",
"valueCodeableConcept" : {
"coding" : [
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"code" : "4",
"display" : "Life Threatening or Disabling"
}
]
}
}
],
"status" : "completed",
"actuality" : "actual",
"code" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "370901008",
"display" : "Serious reportable event associated with product or device"
}
]
},
"subject" : {
"reference" : "Patient/ClinicalTrialSubject5"
},
"detected" : "1905-08-23",
"recordedDate" : "1905-08-24",
"resultingEffect" : [
{
"reference" : "Condition/AEHepaticFailureUseCase7"
},
{
"reference" : "Condition/AEHepaticFailureUseCase7complication"
}
],
"seriousness" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
"code" : "serious"
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},
"outcome" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C49496",
"display" : "Recovering/Resolving"
}
]
}
],
"recorder" : {
"display" : "Clinical Research Associate"
},
"study" : [
{
"display" : "NCT1010101"
}
],
"suspectEntity" : [
{
"instanceReference" : {
"reference" : "MedicationAdministration/medadmin0301",
"display" : "Study Medication Use Case 7"
},
"causality" : {
"entityRelatedness" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
"code" : "certain",
"display" : "Certain"
}
]
}
}
}
],
"mitigatingAction" : [
{
"itemReference" : {
"reference" : "MedicationRequest/medicationrequest0301-discontinue",
"display" : "Medication Request where study drug prescription was discontinued"
}
}
]
}
IG © 2020+ HL7 International - Biomedical Research and Regulation, Vulcan AdverseEvent groups. Package hl7.fhir.uv.ae-research-ig#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-07-28
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