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

EvidenceVariable: Incidence of adverse events (NCT05327010)

Official URL: https://fevir.net/resources/EvidenceVariable/583775 Version: 1.0.0-ballot3
Standards status: Informative Computable Name: Incidence_of_adverse_events_NCT05327010
Other Identifiers: FEvIR Object Identifier: FEvIR Object Identifier#583775, FEvIR Linking Identifier: NCT05327010-secondaryOutcome-4, OID:2.16.840.1.113883.4.642.40.44.24.154

Copyright/Legal: 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).

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.

version: 2; Last updated: 2026-07-27 13:49:52+0000

Profile: VariableDefinition

ArtifactPublicationStatus: Active

url: EvidenceVariable Incidence of adverse events (NCT05327010)

identifier: FEvIR Object Identifier/583775, FEvIR Linking Identifier/NCT05327010-secondaryOutcome-4, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.24.154

version: 1.0.0-ballot3

name: Incidence_of_adverse_events_NCT05327010

title: Incidence of adverse events (NCT05327010)

citeAs:

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.

status: Active

date: 2026-11-05 14:34:28+0000

author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter:

publisher: HL7 International / Clinical Decision Support

contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss

description:

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.

copyright:

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).

Definitions

-Concept
*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.

handling: Evidence variable handling not specified

Timings

-Text
*Up to 2 years