HL7 FHIR Implementation Guide: Common Terminology Criteria (CTC) Adverse Events Release 1 - DRAFT
0.0.1 - DRAFT
HL7 FHIR Implementation Guide: Common Terminology Criteria (CTC) Adverse Events Release 1 - DRAFT, published by HL7 International Clinical Interoperability Council. This guide is not an authorized publication; it is the continuous build for version 0.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/standardhealth/fsh-ae/ and changes regularly. See the Directory of published versions
{
"resourceType" : "AdverseEvent",
"id" : "ctc-adverse-event-compass-ex1a",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/ctcae/StructureDefinition/ctc-adverse-event"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: AdverseEvent</b><a name=\"ctc-adverse-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 "ctc-adverse-event-compass-ex1a" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ctc-adverse-event.html\">CTC Adverse Event</a></p></div><p><b>CTC Adverse Event Grade</b>: Severe Adverse Event <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-ctcae-grade-code-system.html\">CTCAE Grade Code System</a>#3)</span></p><blockquote><p><b>Adverse Event 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/5.3.0/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-us-core-practitioner-owen-oncologist.html\">Practitioner/us-core-practitioner-owen-oncologist</a> " ONCOLOGIST"</p></blockquote><p><b>Adverse Event Expectation</b>: Expected Adverse Event <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C41333)</span></p><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\"> (MedDRA Am Engl[20.3]#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 Adverse Event <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C41336)</span></p><p><b>outcome</b>: Ongoing <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R4/codesystem-adverse-event-outcome.html\">AdverseEventOutcome</a>#ongoing)</span></p><p><b>recorder</b>: <a href=\"Practitioner-us-core-practitioner-nancy-oncology-nurse.html\">Practitioner/us-core-practitioner-nancy-oncology-nurse</a> " NURSE"</p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"MedicationAdministration-medication-administration-kadcyla.html\">MedicationAdministration/medication-administration-kadcyla</a></p><h3>Causalities</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Assessment</b></td></tr><tr><td style=\"display: none\">*</td><td>Adverse Event Probably Related to Intervention <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C53259)</span></td></tr></table></blockquote><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"MedicationAdministration-medication-administration-tucatinib.html\">MedicationAdministration/medication-administration-tucatinib</a></p><h3>Causalities</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Assessment</b></td></tr><tr><td style=\"display: none\">*</td><td>Adverse Event Probably Related to Intervention <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C53259)</span></td></tr></table></blockquote><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/us/ctcae/StructureDefinition/ctcae-grade",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/ctcae/CodeSystem/ctcae-grade-code-system",
"code" : "3"
}
]
}
},
{
"extension" : [
{
"url" : "function",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-ParticipationType",
"code" : "AUTHEN"
}
]
}
},
{
"url" : "actor",
"valueReference" : {
🔗 "reference" : "Practitioner/us-core-practitioner-owen-oncologist"
}
}
],
"url" : "http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-participant"
},
{
"url" : "http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-expectation",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C41333",
"display" : "Expected Adverse Event"
}
]
}
}
],
"actuality" : "actual",
"event" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/MDRAE",
"version" : "20.3",
"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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C41336",
"display" : "Non-serious Adverse Event"
}
]
},
"outcome" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/adverse-event-outcome",
"code" : "ongoing"
}
]
},
"recorder" : {
🔗 "reference" : "Practitioner/us-core-practitioner-nancy-oncology-nurse"
},
"suspectEntity" : [
{
"instance" : {
🔗 "reference" : "MedicationAdministration/medication-administration-kadcyla"
},
"causality" : [
{
"assessment" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C53259"
}
],
"text" : "Adverse Event Probably Related to Intervention"
}
}
]
},
{
"instance" : {
🔗 "reference" : "MedicationAdministration/medication-administration-tucatinib"
},
"causality" : [
{
"assessment" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C53259"
}
],
"text" : "Adverse Event Probably Related to Intervention"
}
}
]
}
],
"study" : [
{
🔗 "reference" : "ResearchStudy/clinical-trial-example-compass"
}
]
}