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: Percentage of Participants With Serious Adverse Events (SAEs) (NCT03640312)

Official URL: https://fevir.net/resources/EvidenceVariable/367896 Version: 1.0.0-ballot3
Standards status: Informative Computable Name: Percentage_of_Participants_With_Serious_Adverse_Events_SAEs_NCT03640312
Other Identifiers: FEvIR Object Identifier: FEvIR Object Identifier#367896, FEvIR Linking Identifier: NCT03640312-otherOutcome-0, OID:2.16.840.1.113883.4.642.40.44.24.171

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).

Percentage of participants with any Serious Adverse Events (SAE) according to Good Clinical Practice definition: adverse events that result in death, are life threatening, require hospitalization or prolong existing hospitalization, result in persistent disability, result in congenital anomaly or birth defect, or unimportant medical event that requires intervention to prevent any of the above.

version: 31; Last updated: 2026-09-08 12:21:25+0000

Profile: VariableDefinition

ArtifactPublicationStatus: Active

url: EvidenceVariable Percentage of Participants With Serious Adverse Events (SAEs) (NCT03640312)

identifier: FEvIR Object Identifier/367896, FEvIR Linking Identifier/NCT03640312-otherOutcome-0, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.24.171

version: 1.0.0-ballot3

name: Percentage_of_Participants_With_Serious_Adverse_Events_SAEs_NCT03640312

title: Percentage of Participants With Serious Adverse Events (SAEs) (NCT03640312)

citeAs:

Percentage of Participants With Serious Adverse Events (SAEs) (NCT03640312) [Database Entry: FHIR EvidenceVariable Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 367896. Revised 2026-09-08. Available at: https://fevir.net/resources/EvidenceVariable/367896. Computable resource at: https://fevir.net/resources/EvidenceVariable/367896#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:

Percentage of participants with any Serious Adverse Events (SAE) according to Good Clinical Practice definition: adverse events that result in death, are life threatening, require hospitalization or prolong existing hospitalization, result in persistent disability, result in congenital anomaly or birth defect, or unimportant medical event that requires intervention to prevent any of the above.

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
*Percentage of Participants With Serious Adverse Events (SAEs) Percentage of participants with any Serious Adverse Events (SAE) according to Good Clinical Practice definition: adverse events that result in death, are life threatening, require hospitalization or prolong existing hospitalization, result in persistent disability, result in congenital anomaly or birth defect, or unimportant medical event that requires intervention to prevent any of the above.

handling: Evidence variable handling not specified

Timings

-Text
*12 weeks