Evidence Based Medicine on FHIR Implementation Guide
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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

Evidence: Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration Statistical Analysis for Glucagon Nasal Powder vs Glucagon Hydrochloride Solution in NCT03421379

Computable Name:

version: 9; Last updated: 2025-12-11 20:35:21+0000; Language: en

Profile: ComparativeEvidence

url: https://fevir.net/resources/Evidence/267244

identifier: FEvIR Object Identifier/267244, FEvIR Linking Identifier/NCT03421379-primaryOutcomeMeasure-0-OutcomeAnalysis-0-BetweenGroupAnalysis-OG000-OG001

name: NCT03421379_primaryOutcomeMeasure_0_OutcomeAnalysis_0_BetweenGroupAnalysis_OG000_OG001

title: Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration Statistical Analysis for Glucagon Nasal Powder vs Glucagon Hydrochloride Solution in NCT03421379

citeAs:

Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration Statistical Analysis for Glucagon Nasal Powder vs Glucagon Hydrochloride Solution in NCT03421379 [Database Entry: FHIR Evidence Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 267244. Revised 2025-12-11. Available at: https://fevir.net/resources/Evidence/267244. Computable resource at: https://fevir.net/resources/Evidence/267244#json.

status: Active

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

publisher: Computable Publishing LLC

contact: support@computablepublishing.com

copyright:

https://creativecommons.org/licenses/by-nc-sa/4.0/

description:

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

variableDefinition

note:

All randomized participant who completed both treatment visits and had evaluable treatment success data.

variableRole: Population

intended: Group NCT03421379 Eligibility Criteria

variableDefinition

description:

Group Assignment: Glucagon Nasal Powder vs. Glucagon Hydrochloride Solution

variableRole: Exposure

comparatorCategory: Glucagon Hydrochloride Solution

observed: Group Assignment: A single dose of 3 mg glucagon nasal powder was administered intranasally vs. A single dose of 1 mg glucagon hydrochloride solution was administered IM

variableDefinition

variableRole: Outcome

observed: Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration (NCT03421379)

statistic

note: ,

Outcome Analysis NonInferiority Type: Non-Inferiority

Outcome Analysis NonInferiority Comment: The pre-defined non-inferiority margin is (10%)

statisticType: Treatment Difference Wald's Method

quantity: 0 percentage of participants

AttributeEstimates

-NoteTypeLevelRange
*

CI Number of Sides: 2-Sided

Confidence interval0.95-1.47-1.47 percentage of participants