Adverse Event Clinical Research
1.0.1 - STU1
Adverse Event Clinical Research
1.0.1 - STU1
Adverse Event Clinical Research, 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-ig/ and changes regularly. See the Directory of published versions
| Page standards status: Informative |
{
"resourceType" : "AdverseEvent",
"id" : "SeriousAdverseEventResearchStudy",
"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=\"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>Adverse Event 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><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><p><b>Adverse event caused subject to discontinue the study</b>: true</p><p><b>status</b>: completed</p><p><b>actuality</b>: actual</p><p><b>code</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>occurrence</b>: 2021-12-02 --> 2021-12-09</p><p><b>resultingEffect</b>: <a href=\"Condition-GIBleed.html\">Condition/GIBleed</a></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>: 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><p><b>expectedInResearchStudy</b>: false</p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"MedicationAdministration-study-medication-administration-ABC.html\">MedicationAdministration/study-medication-administration-ABC</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>Possibly Related <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>#C53258)</span></td></tr></table></blockquote><blockquote><p><b>mitigatingAction</b></p><p><b>item</b>: <a href=\"Procedure-procedure-upper-endoscopy.html\">Procedure/procedure-upper-endoscopy</a></p></blockquote><blockquote><p><b>mitigatingAction</b></p><p><b>item</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>mitigatingAction</b></p><p><b>item</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><h3>SupportingInfos</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Item[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><span>: Supporting info would have context such as an Observation on the drop in hemoglobin</span></td></tr></table><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></div>"
},
"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" : "severe",
"display" : "Severe"
}
]
}
},
{
"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-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" : 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" : "C48275",
"display" : "Death Related to Adverse Event"
}
]
}
},
{
"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" : "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"
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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" : "C201939",
"display" : "Required Intervention to Prevent Permanent Impairment/damage"
}
]
}
},
{
"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/caused-subject-to-discontinue-study",
"valueBoolean" : true
}
],
"status" : "completed",
"actuality" : "actual",
"code" : {
"coding" : [
{
"system" : "https://www.meddra.org",
"code" : "10017955",
"display" : "Gastrointestinal haemorrhage"
}
]
},
"subject" : {
🔗 "reference" : "Patient/SCHJO"
},
"occurrencePeriod" : {
"start" : "2021-12-02",
"end" : "2021-12-09"
},
"resultingEffect" : [
{
🔗 "reference" : "Condition/GIBleed"
}
],
"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" : "C49498",
"display" : "Recovered/Resolved"
}
]
}
],
"study" : [
{
🔗 "reference" : "ResearchStudy/research-study-XYZ"
}
],
"expectedInResearchStudy" : false,
"suspectEntity" : [
{
"instanceReference" : {
🔗 "reference" : "MedicationAdministration/study-medication-administration-ABC"
},
"causality" : {
"entityRelatedness" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C53258",
"display" : "Possibly Related"
}
]
}
}
}
],
"mitigatingAction" : [
{
"itemReference" : {
🔗 "reference" : "Procedure/procedure-upper-endoscopy"
}
},
{
"itemCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C49502",
"display" : "DRUG WITHDRAWN"
}
],
"text" : "study drug withdrawn"
}
},
{
"itemReference" : {
🔗 "reference" : "MedicationRequest/medicationrequest-for-study-medication-administration-ABC",
"display" : "Medication Request where study drug prescription was discontinued"
}
}
],
"supportingInfo" : [
{
"itemReference" : {
"display" : "Supporting info would have context such as an Observation on the drop in hemoglobin"
}
}
],
"note" : [
{
"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."
}
]
}
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.ae-research-ig#1.0.1 based on FHIR 5.0.0. Generated 2024-04-30
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