Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot
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
| Page standards status: Informative |
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Primary objective label: Treatment success</p><p>Primary objective description:To demonstrate that 3 mg LY900018 is non-inferior to 1 mg IMG for the proportion of patients achieving treatment success from insulin-induced hypoglycemia using a non-inferiority margin of 10%</p><table><tbody><tr><th>Type</th><th>Primary</th></tr><tr><td>Population</td><td>Study Population.</td></tr><tr><td>Treatment</td><td>Glucagon Nasal Powder (Experimental)</td></tr><tr><td>Treatment</td><td>Glucagon Hydrochloride Solution (Active Comparator)</td></tr><tr><td>Endpoint</td><td><p>Proportion achieving treatment success</p><p>Endpoint title: Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia (NCT03421379)</p><p>Outcome description: The proportion of patients achieving treatment success defined as either an increase in PG to >70 mg/dL or an increase of >20 mg/dL from nadir within 30 minutes after administration of glucagon. The nadir is defined as the minimum PG value at the time of or within 10 minutes following glucagon administration.</p></td></tr><tr><td>Population-level Summary</td><td>risk difference</td></tr></tbody></table></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Secondary objective label: To characterize the PK profile of 3 mg LY900018 compared to 1 mg IMG</p><p>Secondary objective description: PK parameters include AUC, Cmax, Tmax PD parameters include BGmax and Tmax</p><table><tbody><tr><th>Estimand Characteristic</th><th>Description</th></tr><tr><td>Endpoint</td><td><p>Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)</p></td></tr></tbody></table></div>"
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"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Secondary objective label: To characterize the PK profile of 3 mg LY900018 compared to 1 mg IMG</p><p>Secondary objective description: PK parameters include AUC, Cmax, Tmax PD parameters include BGmax and Tmax</p><table><tbody><tr><th>Estimand Characteristic</th><th>Description</th></tr><tr><td>Endpoint</td><td><p>PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)</p></td></tr></tbody></table></div>"
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"title" : "3.3 Exploratory Objective(s)",
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"focus" : {
"display" : "Presence of anti-glucagon antibodies"
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"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><div><p> \u00a0 </p>\n</div>\n<div><strong>Exploratory Objectives</strong>\n <p><strong>Description </strong>Explore the formation of anti-glucagon antibodies to glucagon</p>\n <p><strong>Outcome Measures:</strong></p>\n <p><strong>Unnamed outcome measure</strong></p>\n <table>\n <tbody>\n <tr>\n <td><strong>Endpoint</strong></td>\n <td>Presence of anti-glucagon antibodies</td>\n </tr>\n </tbody>\n </table><p> \u00a0 \u00a0 </p>\n <p><strong>Name: </strong>To evaluate the recovery from clinical symptoms of hypoglycemia</p>\n <p><strong>Description </strong>Hypoglycemia symptoms questionnaire</p></div></div>"
},
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}
IG © 2024+ HL7 International / Clinical Decision Support.
Package hl7.fhir.uv.ebm#1.0.0-ballot3 based on FHIR 6.0.0-ballot3.
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2026-06-24
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