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-compass-ex1a",
"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-compass-ex1a\"> </a><a name=\"hcadverse-event-compass-ex1a\"> </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-compass-ex1a" </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>: <span>: Reference to Observation of Alanine aminotransferase (ALT) increased at 200</span></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 Reference to Observation of Alanine aminotransferase (ALT) increased at 200</span></p></blockquote><p><b>Adverse Event Grade</b>: Grade 3 Severe 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>#C41340)</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=\"MedicationAdministration-medication-administration-kadcyla.html\">MedicationAdministration/medication-administration-kadcyla</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-tucatinib.html\">MedicationAdministration/medication-administration-tucatinib</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><p><b>Expected In Research Study</b>: true</p><p><b>Note</b>: treatment held today per protocol guidelines and the patient was scheduled to return in one week for repeat lab work</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>: Alanine aminotransferase (ALT) increased to 200 <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>#10001551 "Alanine aminotransferase increased")</span></p><p><b>subject</b>: <a href=\"Patient-patient-example-kaitlyn-b.html\">Patient/patient-example-kaitlyn-b</a> " BOUNCE"</p><p><b>date</b>: 2020-05-13</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>outcome</b>: Not recovering/not 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>#C49494)</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/resultingEffect",
"valueReference" : {
"display" : "Reference to Observation of Alanine aminotransferase (ALT) increased at 200"
}
},
{
"extension" : [
{
"url" : "item",
"valueReference" : {
"display" : "Supporting info would have context such as an Reference to Observation of Alanine aminotransferase (ALT) increased at 200"
}
}
],
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info"
},
{
"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" : "C41340"
}
],
"text" : "Grade 3 Severe Adverse Event"
}
},
{
"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" : "MedicationAdministration/medication-administration-kadcyla"
}
},
{
"extension" : [
{
"url" : "entityRelatedness",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C53258",
"display" : "Possibly Related"
}
]
}
}
],
"url" : "causality"
}
],
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity"
},
{
"extension" : [
{
"url" : "instance",
"valueReference" : {
🔗 "reference" : "MedicationAdministration/medication-administration-tucatinib"
}
},
{
"extension" : [
{
"url" : "entityRelatedness",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C53258",
"display" : "Possibly 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" : true
},
{
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note",
"valueAnnotation" : {
"text" : "treatment held today per protocol guidelines and the patient was scheduled to return in one week for repeat lab work"
}
}
],
"modifierExtension" : [
{
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status",
"valueCode" : "in-progress"
}
],
"actuality" : "actual",
"event" : {
"coding" : [
{
"system" : "https://www.meddra.org",
"code" : "10001551",
"display" : "Alanine aminotransferase increased"
}
],
"text" : "Alanine aminotransferase (ALT) increased to 200"
},
"subject" : {
🔗 "reference" : "Patient/patient-example-kaitlyn-b"
},
"date" : "2020-05-13",
"seriousness" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
"code" : "non-serious",
"display" : "Non-serious"
}
]
},
"outcome" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C49494",
"display" : "Not recovering/not resolved"
}
]
},
"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
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