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\"><table><tbody><tr><td>Sponsor Confidentiality Statement:</td><td>This study does not have a confidentiality statement, but this is an example of how the data would appear if there was such a statement.</td></tr><tr><td>Full Title:</td><td>A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients with Diabetes Mellitus<p> \u00a0 </p></td></tr><tr><td>Sponsor Protocol Identifier:</td><td>I8R-JE-IGBJ</td></tr><tr><td>Original Protocol:</td><td>No</td></tr><tr><td>Version Number:</td><td>(a)</td></tr><tr><td>Version Date:</td><td>05-Dec-2017</td></tr><tr><td>Sponsor’s Investigational Product Code(s):</td><td>LY900018</td></tr><tr><td>Investigational Product Name(s):</td><td>Glucagon</td></tr><tr><td>Trial Phase:</td><td>Phase 3</td></tr><tr><td>Short Title:</td><td>A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example<p> \u00a0 </p></td></tr><tr><td>Sponsor Name and Address:</td><td><p>Eli Lilly Japan K.K</p><p>Japan</p></td></tr><tr><td>Regulatory or Clinical Trial Identifier(s):</td><td><p>ClinicalTrials.gov NCT03421379</p><p>identifier 16962 assigned by Eli Lilly and Company</p><p>Amendment Identifier I8R-JE-IGBJ(a)</p></td></tr><tr><td>Sponsor Approval:</td><td>26-Oct-2017</td></tr></tbody></table><p>Sponsor Signatory: Signature block and date on file at Eli Lilly and Company</p><p>Medical Expert Contact: Medical Expert details on file at Eli Lilly and Company</p><p>Amendment Details: This is the first protocol amendment.</p><p><strong>Overall Rationale for the Amendment:</strong></p><p><em>Updates to address safety concern & align with product guidelines.</em></p><p>The table below describes the current amendment.</p><table><tbody><tr><td><strong>Approximate % Enrolled at time of Sponsor Approval:</strong></td><td>Approximate ??% enrolled Globally. (not known for creating sample protocol)</td></tr><tr><td><strong>Reason(s) for Amendment:</strong></td><td>Primary: Safety, Secondary: NA</td></tr><tr><td><strong>Amendment Summary:</strong></td><td>Protocol I8R-JE-IGBJ A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients with Diabetes Mellitus has been amended. The new protocol is indicated by Amendment (a) and will be used to conduct the study in place of any preceding version of the protocol. The overall changes and rationale for the changes made to this protocol are as follows: \n<ul><li>An exclusion criterion for patients with retinopathy or maculopathy was added due to the potential risk of fundal hemorrhage induced by hypoglycemia.</li>\n<li>The GlucaGen reconstitution volume was changed from 1.0 mL to 1.1 mL in accordance with instructions in the Summary of Product Characteristics (2015).</li></ul> </td></tr><tr><td>Is this amendment likely to have a substantial impact on the safety or rights of the participants?</td><td>Yes, Specifically implemented to decrease safety risks.</td></tr><tr><td>Is this amendment likely to have a substantial impact on the reliability and robustness of the data generated in the clinical trial?</td><td>No</td></tr></tbody></table><p> \u00a0 </p><p><strong>Overview of Changes in the Current Amendment:</strong></p><table><thead><tr><th>Description of Change</th><th>Brief Rationale for Change</th><th>Section # and Name</th></tr></thead><tbody><tr><td>An exclusion criterion for patients with retinopathy or maculopathy was added due to the potential risk of fundal hemorrhage induced by hypoglycemia.</td><td>Mitigate risk of fundal hemorrhage induced by hypoglycemia.</td><td>Section 6.2 Exclusions Criteria</td></tr><tr><td>The GlucaGen reconstitution volume was changed from 1.0 mL to 1.1 mL in accordance with instructions in the Summary of Product Characteristics (2015).</td><td>Ensure alignment with Summary of Product Characteristics (2015)</td><td>9.2.2 Intramuscular Glucagon Administration</td></tr></tbody></table></div>"
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Package hl7.fhir.uv.ebm#1.0.0-ballot3 based on FHIR 6.0.0-ballot3.
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2026-06-02
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