Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3 World

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

: Incidence of adverse events (NCT05327010)

Page standards status: Informative

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<EvidenceVariable xmlns="http://hl7.org/fhir">
  <id value="583775"/>
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    <lastUpdated value="2026-07-27T13:49:52.712Z"/>
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  <language value="en"/>
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    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: EvidenceVariable 583775</b></p><a name="583775"> </a><a name="hc583775"> </a><div style="display: inline-block; background-color: #fbffeb; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 2; Last updated: 2026-07-27 13:49:52+0000</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>ArtifactPublicationStatus</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-status-type active}">Active</span></p><p><b>url</b>: <a href="EvidenceVariable-583775.html">EvidenceVariable Incidence of adverse events (NCT05327010)</a></p><p><b>identifier</b>: FEvIR Object Identifier/583775, FEvIR Linking Identifier/NCT05327010-secondaryOutcome-4, <a href="http://terminology.hl7.org/7.5.0/NamingSystem-uri.html" title="As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt 

This oid is used as an identifier II.root to indicate the the extension is an absolute URI (technically, an IRI). Typically, this is used for OIDs and GUIDs. Note that when this OID is used with OIDs and GUIDs, the II.extension should start with urn:oid or urn:uuid: 

Note that this OID is created to aid with interconversion between CDA and FHIR - FHIR uses urn:ietf:rfc:3986 as equivalent to this OID. URIs as identifiers appear more commonly in FHIR.

This OID may also be used in CD.codeSystem.">Uniform Resource Identifier (URI)</a>/urn:oid:2.16.840.1.113883.4.642.40.44.24.154</p><p><b>version</b>: 1.0.0-ballot3</p><p><b>name</b>: Incidence_of_adverse_events_NCT05327010</p><p><b>title</b>: Incidence of adverse events (NCT05327010)</p><p><b>citeAs</b>: </p><div><p>Incidence of adverse events (NCT05327010) [Database Entry: FHIR EvidenceVariable Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 583775. Revised 2026-07-27. Available at: https://fevir.net/resources/EvidenceVariable/583775. Computable resource at: https://fevir.net/resources/EvidenceVariable/583775#json.</p>
</div><p><b>status</b>: Active</p><p><b>date</b>: 2026-11-05 14:34:28+0000</p><p><b>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><p><b>publisher</b>: HL7 International / Clinical Decision Support</p><p><b>contact</b>: HL7 International / Clinical Decision Support: <a href="http://www.hl7.org/Special/committees/dss">http://www.hl7.org/Special/committees/dss</a></p><p><b>description</b>: </p><div><p>Incidence and severity of adverse events and serious adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Includes significant changes in laboratory parameters, electrocardiograms, and vital signs. Summarized by grade and type.</p>
</div><p><b>copyright</b>: </p><div><p>Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse).</p>
</div><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Incidence of adverse events Incidence and severity of adverse events and serious adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Includes significant changes in laboratory parameters, electrocardiograms, and vital signs. Summarized by grade and type.</span></td></tr></table><p><b>handling</b>: <span title="Codes:{https://fevir.net/resources/CodeSystem/179423 evidence-variable-handling-not-specified}">Evidence variable handling not specified</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>Up to 2 years</td></tr></table></div>
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  <url value="https://fevir.net/resources/EvidenceVariable/583775"/>
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    <system value="https://fevir.net/FLI"/>
    <value value="NCT05327010-secondaryOutcome-4"/>
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  <version value="1.0.0-ballot3"/>
  <name value="Incidence_of_adverse_events_NCT05327010"/>
  <title value="Incidence of adverse events (NCT05327010)"/>
  <citeAs
          value="Incidence of adverse events (NCT05327010) [Database Entry: FHIR EvidenceVariable Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 583775. Revised 2026-07-27. Available at: https://fevir.net/resources/EvidenceVariable/583775. Computable resource at: https://fevir.net/resources/EvidenceVariable/583775#json."/>
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               value="Incidence and severity of adverse events and serious adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Includes significant changes in laboratory parameters, electrocardiograms, and vital signs. Summarized by grade and type."/>
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             value="Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse)."/>
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            value="Incidence of adverse events Incidence and severity of adverse events and serious adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Includes significant changes in laboratory parameters, electrocardiograms, and vital signs. Summarized by grade and type."/>
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