Adverse Events Report for NCT03421379 - XML Representation - Evidence Based Medicine on FHIR Implementation Guide v1.0.0-ballot3

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
: Adverse Events Report for NCT03421379

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    <div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><p class="res-header-id"><b>Generated Narrative: Composition 399874</b></p><a name="399874"> </a><a name="hc399874"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 5; Last updated: 2025-12-11 20:35:21+0000; Language: en</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-outcome-measure-report.html">OutcomeMeasureReport</a></p></div><p><b>url</b>: <a href="https://fevir.net/resources/Composition/399874">https://fevir.net/resources/Composition/399874</a></p><p><b>identifier</b>: FEvIR Object Identifier/399874, FEvIR Linking Identifier/NCT03421379-adverse-events-report</p><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{https://fevir.net/resources/CodeSystem/179423 OutcomeMeasureReport}">Outcome Measure Report</span></p><p><b>date</b>: 2025-12-11 20:35:21+0000</p><p><b>author</b>: [No author listed.]</p><p><b>title</b>: Adverse Events Report for NCT03421379</p><p><b>custodian</b>: <a href="Organization-118079.html">Computable Publishing LLC</a></p><h3>RelatesTos</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Target[x]</b></td></tr><tr><td style="display: none">*</td><td>Cite As</td><td><div><p>Adverse Events Report for NCT03421379 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 399874. Revised 2025-12-11. Available at: https://fevir.net/resources/Composition/399874. Computable resource at: https://fevir.net/resources/Composition/399874#json.</p>
</div></td></tr></table><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-AllCauseMortality</b></p><a name="399874/NCT03421379-AllCauseMortality"> </a><a name="hc399874/NCT03421379-AllCauseMortality"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: All-cause mortality (timeframe for NCT03421379)</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">All-cause mortality</span></td></tr></table><p><b>handling</b>: boolean variable</p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-SeriousAdverseEvents</b></p><a name="399874/NCT03421379-SeriousAdverseEvents"> </a><a name="hc399874/NCT03421379-SeriousAdverseEvents"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Serious Adverse Events (timeframe for NCT03421379)</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Serious Adverse Events</span></td></tr></table><p><b>handling</b>: boolean variable</p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvents</b></p><a name="399874/NCT03421379-OtherAdverseEvents"> </a><a name="hc399874/NCT03421379-OtherAdverseEvents"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Other Adverse Events (timeframe for NCT03421379)</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Other Adverse Events</span></td></tr></table><p><b>handling</b>: boolean variable</p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-AllCauseMortality-EG000</b></p><a name="399874/NCT03421379-AllCauseMortality-EG000"> </a><a name="hc399874/NCT03421379-AllCauseMortality-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_AllCauseMortality_EG000</p><p><b>title</b>: All-cause mortality for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-AllCauseMortality">EvidenceVariable All-cause mortality (timeframe for NCT03421379)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-SeriousAdverseEvents-EG000</b></p><a name="399874/NCT03421379-SeriousAdverseEvents-EG000"> </a><a name="hc399874/NCT03421379-SeriousAdverseEvents-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_SeriousAdverseEvents_EG000</p><p><b>title</b>: Serious Adverse Events for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-SeriousAdverseEvents">EvidenceVariable Serious Adverse Events (timeframe for NCT03421379)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvents-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvents-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvents-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvents_EG000</p><p><b>title</b>: Other Adverse Events for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvents">EvidenceVariable Other Adverse Events (timeframe for NCT03421379)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.2113</p><p><b>numberAffected</b>: 15</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-AllCauseMortality-EG001</b></p><a name="399874/NCT03421379-AllCauseMortality-EG001"> </a><a name="hc399874/NCT03421379-AllCauseMortality-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_AllCauseMortality_EG001</p><p><b>title</b>: All-cause mortality for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-AllCauseMortality">EvidenceVariable All-cause mortality (timeframe for NCT03421379)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-SeriousAdverseEvents-EG001</b></p><a name="399874/NCT03421379-SeriousAdverseEvents-EG001"> </a><a name="hc399874/NCT03421379-SeriousAdverseEvents-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_SeriousAdverseEvents_EG001</p><p><b>title</b>: Serious Adverse Events for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-SeriousAdverseEvents">EvidenceVariable Serious Adverse Events (timeframe for NCT03421379)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0143</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvents-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvents-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvents-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvents_EG001</p><p><b>title</b>: Other Adverse Events for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvents">EvidenceVariable Other Adverse Events (timeframe for NCT03421379)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.1857</p><p><b>numberAffected</b>: 13</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-SeriousAdverseEvent-0-EG000</b></p><a name="399874/NCT03421379-SeriousAdverseEvent-0-EG000"> </a><a name="hc399874/NCT03421379-SeriousAdverseEvent-0-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_SeriousAdverseEvent_0_EG000</p><p><b>title</b>: Vertigo positional as serious adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-SeriousAdverseEvent-0">EvidenceVariable Vertigo positional as serious adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-SeriousAdverseEvent-0-EG001</b></p><a name="399874/NCT03421379-SeriousAdverseEvent-0-EG001"> </a><a name="hc399874/NCT03421379-SeriousAdverseEvent-0-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_SeriousAdverseEvent_0_EG001</p><p><b>title</b>: Vertigo positional as serious adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-SeriousAdverseEvent-0">EvidenceVariable Vertigo positional as serious adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0143</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-SeriousAdverseEvent-0</b></p><a name="399874/NCT03421379-SeriousAdverseEvent-0"> </a><a name="hc399874/NCT03421379-SeriousAdverseEvent-0"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Vertigo positional as serious adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Vertigo positional as serious adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Serious Adverse Event</span>, <span title="Codes:">Ear and labyrinth disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-0-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-0-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-0-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_0_EG000</p><p><b>title</b>: Ear pain as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-0">EvidenceVariable Ear pain as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0282</p><p><b>numberOfEvents</b>: 2</p><p><b>numberAffected</b>: 2</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-0-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-0-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-0-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_0_EG001</p><p><b>title</b>: Ear pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-0">EvidenceVariable Ear pain as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-0</b></p><a name="399874/NCT03421379-OtherAdverseEvent-0"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-0"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Ear pain as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Ear pain as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Ear and labyrinth disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-1-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-1-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-1-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_1_EG000</p><p><b>title</b>: Eye pain as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-1">EvidenceVariable Eye pain as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0141</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-1-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-1-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-1-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_1_EG001</p><p><b>title</b>: Eye pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-1">EvidenceVariable Eye pain as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-1</b></p><a name="399874/NCT03421379-OtherAdverseEvent-1"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-1"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Eye pain as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Eye pain as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Eye disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-2-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-2-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-2-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_2_EG000</p><p><b>title</b>: Eye pruritus as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-2">EvidenceVariable Eye pruritus as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0141</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-2-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-2-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-2-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_2_EG001</p><p><b>title</b>: Eye pruritus as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-2">EvidenceVariable Eye pruritus as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-2</b></p><a name="399874/NCT03421379-OtherAdverseEvent-2"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-2"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Eye pruritus as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Eye pruritus as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Eye disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-3-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-3-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-3-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_3_EG000</p><p><b>title</b>: Lacrimation increased as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-3">EvidenceVariable Lacrimation increased as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0141</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-3-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-3-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-3-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_3_EG001</p><p><b>title</b>: Lacrimation increased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-3">EvidenceVariable Lacrimation increased as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-3</b></p><a name="399874/NCT03421379-OtherAdverseEvent-3"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-3"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Lacrimation increased as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Lacrimation increased as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Eye disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-4-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-4-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-4-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_4_EG000</p><p><b>title</b>: Diarrhoea as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-4">EvidenceVariable Diarrhoea as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0141</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-4-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-4-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-4-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_4_EG001</p><p><b>title</b>: Diarrhoea as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-4">EvidenceVariable Diarrhoea as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-4</b></p><a name="399874/NCT03421379-OtherAdverseEvent-4"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-4"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Diarrhoea as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Diarrhoea as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Gastrointestinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-5-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-5-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-5-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_5_EG000</p><p><b>title</b>: Nausea as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-5">EvidenceVariable Nausea as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0704</p><p><b>numberOfEvents</b>: 5</p><p><b>numberAffected</b>: 5</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-5-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-5-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-5-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_5_EG001</p><p><b>title</b>: Nausea as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-5">EvidenceVariable Nausea as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.1571</p><p><b>numberOfEvents</b>: 11</p><p><b>numberAffected</b>: 11</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-5</b></p><a name="399874/NCT03421379-OtherAdverseEvent-5"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-5"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Nausea as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Nausea as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Gastrointestinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-6-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-6-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-6-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_6_EG000</p><p><b>title</b>: Toothache as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-6">EvidenceVariable Toothache as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0141</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-6-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-6-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-6-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_6_EG001</p><p><b>title</b>: Toothache as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-6">EvidenceVariable Toothache as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0143</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-6</b></p><a name="399874/NCT03421379-OtherAdverseEvent-6"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-6"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Toothache as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Toothache as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Gastrointestinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-7-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-7-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-7-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_7_EG000</p><p><b>title</b>: Vomiting as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-7">EvidenceVariable Vomiting as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0282</p><p><b>numberOfEvents</b>: 2</p><p><b>numberAffected</b>: 2</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-7-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-7-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-7-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_7_EG001</p><p><b>title</b>: Vomiting as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-7">EvidenceVariable Vomiting as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0571</p><p><b>numberOfEvents</b>: 5</p><p><b>numberAffected</b>: 4</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-7</b></p><a name="399874/NCT03421379-OtherAdverseEvent-7"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-7"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Vomiting as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Vomiting as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Gastrointestinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-8-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-8-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-8-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_8_EG000</p><p><b>title</b>: Feeling abnormal as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-8">EvidenceVariable Feeling abnormal as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-8-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-8-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-8-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_8_EG001</p><p><b>title</b>: Feeling abnormal as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-8">EvidenceVariable Feeling abnormal as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0143</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-8</b></p><a name="399874/NCT03421379-OtherAdverseEvent-8"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-8"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Feeling abnormal as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Feeling abnormal as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">General disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-9-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-9-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-9-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_9_EG000</p><p><b>title</b>: Cystitis as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-9">EvidenceVariable Cystitis as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-9-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-9-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-9-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_9_EG001</p><p><b>title</b>: Cystitis as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-9">EvidenceVariable Cystitis as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0143</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-9</b></p><a name="399874/NCT03421379-OtherAdverseEvent-9"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-9"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Cystitis as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Cystitis as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Infections and infestations</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-10-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-10-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-10-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_10_EG000</p><p><b>title</b>: Blood pressure decreased as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-10">EvidenceVariable Blood pressure decreased as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0141</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-10-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-10-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-10-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_10_EG001</p><p><b>title</b>: Blood pressure decreased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-10">EvidenceVariable Blood pressure decreased as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0286</p><p><b>numberOfEvents</b>: 2</p><p><b>numberAffected</b>: 2</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-10</b></p><a name="399874/NCT03421379-OtherAdverseEvent-10"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-10"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Blood pressure decreased as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Blood pressure decreased as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Investigations</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-11-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-11-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-11-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_11_EG000</p><p><b>title</b>: Blood pressure increased as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-11">EvidenceVariable Blood pressure increased as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0563</p><p><b>numberOfEvents</b>: 4</p><p><b>numberAffected</b>: 4</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-11-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-11-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-11-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_11_EG001</p><p><b>title</b>: Blood pressure increased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-11">EvidenceVariable Blood pressure increased as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-11</b></p><a name="399874/NCT03421379-OtherAdverseEvent-11"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-11"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Blood pressure increased as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Blood pressure increased as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Investigations</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-12-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-12-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-12-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_12_EG000</p><p><b>title</b>: Back pain as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-12">EvidenceVariable Back pain as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0141</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-12-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-12-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-12-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_12_EG001</p><p><b>title</b>: Back pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-12">EvidenceVariable Back pain as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-12</b></p><a name="399874/NCT03421379-OtherAdverseEvent-12"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-12"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Back pain as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Back pain as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Musculoskeletal and connective tissue disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-13-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-13-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-13-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_13_EG000</p><p><b>title</b>: Headache as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-13">EvidenceVariable Headache as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0141</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-13-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-13-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-13-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_13_EG001</p><p><b>title</b>: Headache as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-13">EvidenceVariable Headache as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0143</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-13</b></p><a name="399874/NCT03421379-OtherAdverseEvent-13"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-13"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Headache as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Headache as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Nervous system disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-14-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-14-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-14-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_14_EG000</p><p><b>title</b>: Nasal congestion as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-14">EvidenceVariable Nasal congestion as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0141</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-14-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-14-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-14-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_14_EG001</p><p><b>title</b>: Nasal congestion as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-14">EvidenceVariable Nasal congestion as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-14</b></p><a name="399874/NCT03421379-OtherAdverseEvent-14"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-14"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Nasal congestion as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Nasal congestion as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Respiratory, thoracic and mediastinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-15-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-15-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-15-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_15_EG000</p><p><b>title</b>: Nasal pruritus as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-15">EvidenceVariable Nasal pruritus as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0141</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-15-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-15-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-15-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_15_EG001</p><p><b>title</b>: Nasal pruritus as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-15">EvidenceVariable Nasal pruritus as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-15</b></p><a name="399874/NCT03421379-OtherAdverseEvent-15"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-15"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Nasal pruritus as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Nasal pruritus as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Respiratory, thoracic and mediastinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-16-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-16-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-16-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_16_EG000</p><p><b>title</b>: Oropharyngeal pain as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-16">EvidenceVariable Oropharyngeal pain as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0141</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-16-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-16-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-16-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_16_EG001</p><p><b>title</b>: Oropharyngeal pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-16">EvidenceVariable Oropharyngeal pain as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-16</b></p><a name="399874/NCT03421379-OtherAdverseEvent-16"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-16"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Oropharyngeal pain as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Oropharyngeal pain as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Respiratory, thoracic and mediastinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-17-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-17-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-17-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_17_EG000</p><p><b>title</b>: Rhinalgia as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-17">EvidenceVariable Rhinalgia as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0845</p><p><b>numberOfEvents</b>: 6</p><p><b>numberAffected</b>: 6</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-17-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-17-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-17-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_17_EG001</p><p><b>title</b>: Rhinalgia as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-17">EvidenceVariable Rhinalgia as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-17</b></p><a name="399874/NCT03421379-OtherAdverseEvent-17"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-17"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Rhinalgia as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Rhinalgia as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Respiratory, thoracic and mediastinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-18-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-18-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-18-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_18_EG000</p><p><b>title</b>: Cold sweat as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-18">EvidenceVariable Cold sweat as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-18-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-18-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-18-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_18_EG001</p><p><b>title</b>: Cold sweat as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-18">EvidenceVariable Cold sweat as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0143</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-18</b></p><a name="399874/NCT03421379-OtherAdverseEvent-18"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-18"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Cold sweat as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Cold sweat as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Skin and subcutaneous tissue disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-19-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-19-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-19-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_19_EG000</p><p><b>title</b>: Hot flush as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-19">EvidenceVariable Hot flush as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-19-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-19-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-19-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_19_EG001</p><p><b>title</b>: Hot flush as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-19">EvidenceVariable Hot flush as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0143</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-19</b></p><a name="399874/NCT03421379-OtherAdverseEvent-19"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-19"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Hot flush as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Hot flush as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Vascular disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-20-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-20-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-20-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_20_EG000</p><p><b>title</b>: Hypertension as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-20">EvidenceVariable Hypertension as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-20-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-20-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-20-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_20_EG001</p><p><b>title</b>: Hypertension as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-20">EvidenceVariable Hypertension as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0143</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-20</b></p><a name="399874/NCT03421379-OtherAdverseEvent-20"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-20"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Hypertension as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Hypertension as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Vascular disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-21-EG000</b></p><a name="399874/NCT03421379-OtherAdverseEvent-21-EG000"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-21-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_21_EG000</p><p><b>title</b>: Peripheral coldness as other adverse event for Glucagon Nasal Powder in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Nasal Powder</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 3 mg glucagon nasal powder was administered intranasally</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-21">EvidenceVariable Peripheral coldness as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>71</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-21-EG001</b></p><a name="399874/NCT03421379-OtherAdverseEvent-21-EG001"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-21-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_OtherAdverseEvent_21_EG001</p><p><b>title</b>: Peripheral coldness as other adverse event for Glucagon Hydrochloride Solution in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants who received at least one dose of study drug.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc399874/NCT03421379-OtherAdverseEvent-21">EvidenceVariable Peripheral coldness as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0143</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>70</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-21</b></p><a name="399874/NCT03421379-OtherAdverseEvent-21"> </a><a name="hc399874/NCT03421379-OtherAdverseEvent-21"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Peripheral coldness as other adverse event</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Peripheral coldness as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 18.1</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Vascular disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>From Baseline to End of Follow-up (Up to 2 Months)</td></tr></table></blockquote></div>
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        <quantity>
          <value value="0.0845"/>
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      <name value="NCT03421379_OtherAdverseEvent_17_EG001"/>
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             value="Rhinalgia as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
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    <EvidenceVariable>
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        <profile
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      <title value="Rhinalgia as other adverse event"/>
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        <concept>
          <text value="Rhinalgia as other adverse event"/>
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          <text value="Adverse event assessment type"/>
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      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
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      </definitionModifier>
      <handling value="boolean"/>
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        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Respiratory, thoracic and mediastinal disorders"/>
      </classifier>
      <timing>
        <text value="From Baseline to End of Follow-up (Up to 2 Months)"/>
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  </contained>
  <contained>
    <Evidence>
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      <meta>
        <profile
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      <name value="NCT03421379_OtherAdverseEvent_18_EG000"/>
      <title
             value="Cold sweat as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
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      <variableDefinition>
        <description value="Glucagon Nasal Powder"/>
        <variableRole value="population"/>
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          <display
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      <variableDefinition>
        <note>
          <text
                value="All randomized participants who received at least one dose of study drug."/>
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        <variableRole value="outcome"/>
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          <reference value="#NCT03421379-OtherAdverseEvent-18"/>
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    <Evidence>
      <id value="NCT03421379-OtherAdverseEvent-18-EG001"/>
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        <profile
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      <name value="NCT03421379_OtherAdverseEvent_18_EG001"/>
      <title
             value="Cold sweat as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
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          <text
                value="All randomized participants who received at least one dose of study drug."/>
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          <reference value="#NCT03421379-OtherAdverseEvent-18"/>
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          <value value="0.0143"/>
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        <profile
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      <title value="Cold sweat as other adverse event"/>
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        <text value="Skin and subcutaneous tissue disorders"/>
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        <text value="From Baseline to End of Follow-up (Up to 2 Months)"/>
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        <profile
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      <name value="NCT03421379_OtherAdverseEvent_19_EG000"/>
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        <statisticType>
          <text value="Percentage"/>
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          <value value="0"/>
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          <knownDataCount value="71"/>
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  <contained>
    <Evidence>
      <id value="NCT03421379-OtherAdverseEvent-19-EG001"/>
      <meta>
        <profile
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      <name value="NCT03421379_OtherAdverseEvent_19_EG001"/>
      <title
             value="Hot flush as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Glucagon Hydrochloride Solution"/>
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        <note>
          <text
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        </note>
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          <reference value="#NCT03421379-OtherAdverseEvent-19"/>
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          <text value="Percentage"/>
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          <value value="0.0143"/>
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          <knownDataCount value="70"/>
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    <EvidenceVariable>
      <id value="NCT03421379-OtherAdverseEvent-19"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
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      <title value="Hot flush as other adverse event"/>
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      <definitionModifier>
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          <text value="Adverse event assessment type"/>
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        <text value="Other Adverse Event"/>
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      <classifier>
        <text value="Vascular disorders"/>
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      <timing>
        <text value="From Baseline to End of Follow-up (Up to 2 Months)"/>
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  <contained>
    <Evidence>
      <id value="NCT03421379-OtherAdverseEvent-20-EG000"/>
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        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
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      <name value="NCT03421379_OtherAdverseEvent_20_EG000"/>
      <title
             value="Hypertension as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
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      <variableDefinition>
        <description value="Glucagon Nasal Powder"/>
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          <display
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      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="All randomized participants who received at least one dose of study drug."/>
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        <variableRole value="outcome"/>
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          <text value="Percentage"/>
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        <numberOfEvents value="0"/>
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          <knownDataCount value="71"/>
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    <Evidence>
      <id value="NCT03421379-OtherAdverseEvent-20-EG001"/>
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        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
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      <name value="NCT03421379_OtherAdverseEvent_20_EG001"/>
      <title
             value="Hypertension as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
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          <display
                   value="A single dose of 1 mg glucagon hydrochloride solution was administered IM"/>
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        <note>
          <text
                value="All randomized participants who received at least one dose of study drug."/>
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        <variableRole value="outcome"/>
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          <text value="Percentage"/>
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          <knownDataCount value="70"/>
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      </statistic>
    </Evidence>
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  <contained>
    <EvidenceVariable>
      <id value="NCT03421379-OtherAdverseEvent-20"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Hypertension as other adverse event"/>
      <status value="active"/>
      <definition>
        <concept>
          <text value="Hypertension as other adverse event"/>
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      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
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        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
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      <handling value="boolean"/>
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        <text value="Other Adverse Event"/>
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      <classifier>
        <text value="Vascular disorders"/>
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      <timing>
        <text value="From Baseline to End of Follow-up (Up to 2 Months)"/>
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    </EvidenceVariable>
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  <contained>
    <Evidence>
      <id value="NCT03421379-OtherAdverseEvent-21-EG000"/>
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        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03421379_OtherAdverseEvent_21_EG000"/>
      <title
             value="Peripheral coldness as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Glucagon Nasal Powder"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="A single dose of 3 mg glucagon nasal powder was administered intranasally"/>
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      <variableDefinition>
        <note>
          <text
                value="All randomized participants who received at least one dose of study drug."/>
        </note>
        <variableRole value="outcome"/>
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          <reference value="#NCT03421379-OtherAdverseEvent-21"/>
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          <text value="Percentage"/>
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  <contained>
    <Evidence>
      <id value="NCT03421379-OtherAdverseEvent-21-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03421379_OtherAdverseEvent_21_EG001"/>
      <title
             value="Peripheral coldness as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Glucagon Hydrochloride Solution"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="A single dose of 1 mg glucagon hydrochloride solution was administered IM"/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="All randomized participants who received at least one dose of study drug."/>
        </note>
        <variableRole value="outcome"/>
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          <reference value="#NCT03421379-OtherAdverseEvent-21"/>
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          <text value="Percentage"/>
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          <value value="0.0143"/>
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        <numberOfEvents value="1"/>
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          <knownDataCount value="70"/>
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      <id value="NCT03421379-OtherAdverseEvent-21"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Peripheral coldness as other adverse event"/>
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      <definition>
        <concept>
          <text value="Peripheral coldness as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
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            <system value="http://hl7.org/fhir/definition-method"/>
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        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
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          <text value="MedDRA 18.1"/>
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      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
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      <classifier>
        <text value="Vascular disorders"/>
      </classifier>
      <timing>
        <text value="From Baseline to End of Follow-up (Up to 2 Months)"/>
      </timing>
    </EvidenceVariable>
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        <display value="Accession ID"/>
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    <assigner>
      <display value="Computable Publishing LLC"/>
    </assigner>
  </identifier>
  <identifier>
    <type>
      <text value="FEvIR Linking Identifier"/>
    </type>
    <system value="https://fevir.net/FLI"/>
    <value value="NCT03421379-adverse-events-report"/>
    <assigner>
      <display value="Computable Publishing LLC"/>
    </assigner>
  </identifier>
  <status value="final"/>
  <type>
    <coding>
      <system value="https://fevir.net/resources/CodeSystem/179423"/>
      <code value="OutcomeMeasureReport"/>
      <display value="OutcomeMeasureReport"/>
    </coding>
    <text value="Outcome Measure Report"/>
  </type>
  <date value="2025-12-11T20:35:21.032Z"/>
  <author>
    <display value="[No author listed.]"/>
  </author>
  <title value="Adverse Events Report for NCT03421379"/>
  <custodian>🔗 
    <reference value="Organization/118079"/>
    <type value="Organization"/>
    <display value="Computable Publishing LLC"/>
  </custodian>
  <relatesTo>
    <type value="cite-as"/>
    <targetMarkdown
                    value="Adverse Events Report for NCT03421379 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 399874. Revised 2025-12-11. Available at: https://fevir.net/resources/Composition/399874. Computable resource at: https://fevir.net/resources/Composition/399874#json."/>
  </relatesTo>
  <section>
    <title value="Events Frequency Threshold"/>
    <code>
      <text value="EventsFrequencyThreshold"/>
    </code>
    <text>
      <status value="generated"/>
      <div xmlns="http://www.w3.org/1999/xhtml">0%</div>
    </text>
  </section>
  <section>
    <title value="Events Time Frame"/>
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      <text value="EventsTimeFrame"/>
    </code>
    <text>
      <status value="generated"/>
      <div xmlns="http://www.w3.org/1999/xhtml">From Baseline to End of Follow-up (Up to 2 Months)</div>
    </text>
  </section>
  <section>
    <title value="Events Description"/>
    <code>
      <text value="EventsDescription"/>
    </code>
    <text>
      <status value="generated"/>
      <div xmlns="http://www.w3.org/1999/xhtml">All randomized participants who received at least one dose of study drug.</div>
    </text>
  </section>
  <section>
    <title value="Glucagon Nasal Powder"/>
    <code>
      <text value="EG000 Glucagon Nasal Powder"/>
    </code>
    <section>
      <title value="Event Group Description"/>
      <code>
        <text value="EventGroupDescription"/>
      </code>
      <text>
        <status value="generated"/>
        <div xmlns="http://www.w3.org/1999/xhtml">A single dose of 3 mg glucagon nasal powder was administered intranasally</div>
      </text>
    </section>
  </section>
  <section>
    <title value="Glucagon Hydrochloride Solution"/>
    <code>
      <text value="EG001 Glucagon Hydrochloride Solution"/>
    </code>
    <section>
      <title value="Event Group Description"/>
      <code>
        <text value="EventGroupDescription"/>
      </code>
      <text>
        <status value="generated"/>
        <div xmlns="http://www.w3.org/1999/xhtml">A single dose of 1 mg glucagon hydrochloride solution was administered IM</div>
      </text>
    </section>
  </section>
  <section>
    <title value="Total Mortality"/>
    <code>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="results"/>
        <display value="Results"/>
      </coding>
      <text value="Total Mortality"/>
    </code>
    <focus>
      <reference value="#NCT03421379-AllCauseMortality"/>
      <type value="EvidenceVariable"/>
      <display value="All-cause mortality (timeframe for NCT03421379)"/>
    </focus>
    <entry>
      <reference value="#NCT03421379-AllCauseMortality-EG000"/>
      <type value="Evidence"/>
      <display
               value="All-cause mortality for Glucagon Nasal Powder in NCT03421379"/>
    </entry>
    <entry>
      <reference value="#NCT03421379-AllCauseMortality-EG001"/>
      <type value="Evidence"/>
      <display
               value="All-cause mortality for Glucagon Hydrochloride Solution in NCT03421379"/>
    </entry>
  </section>
  <section>
    <title value="Total Serious Events"/>
    <code>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="results"/>
        <display value="Results"/>
      </coding>
      <text value="Total Serious Events"/>
    </code>
    <focus>
      <reference value="#NCT03421379-SeriousAdverseEvents"/>
      <type value="EvidenceVariable"/>
      <display value="Serious Adverse Events (timeframe for NCT03421379)"/>
    </focus>
    <entry>
      <reference value="#NCT03421379-SeriousAdverseEvents-EG000"/>
      <type value="Evidence"/>
      <display
               value="Serious Adverse Events for Glucagon Nasal Powder in NCT03421379"/>
    </entry>
    <entry>
      <reference value="#NCT03421379-SeriousAdverseEvents-EG001"/>
      <type value="Evidence"/>
      <display
               value="Serious Adverse Events for Glucagon Hydrochloride Solution in NCT03421379"/>
    </entry>
  </section>
  <section>
    <title value="Total Other Events"/>
    <code>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="results"/>
        <display value="Results"/>
      </coding>
      <text value="Total Other Events"/>
    </code>
    <focus>
      <reference value="#NCT03421379-OtherAdverseEvents"/>
      <type value="EvidenceVariable"/>
      <display value="Other Adverse Events (timeframe for NCT03421379)"/>
    </focus>
    <entry>
      <reference value="#NCT03421379-OtherAdverseEvents-EG000"/>
      <type value="Evidence"/>
      <display
               value="Other Adverse Events for Glucagon Nasal Powder in NCT03421379"/>
    </entry>
    <entry>
      <reference value="#NCT03421379-OtherAdverseEvents-EG001"/>
      <type value="Evidence"/>
      <display
               value="Other Adverse Events for Glucagon Hydrochloride Solution in NCT03421379"/>
    </entry>
  </section>
  <section>
    <title value="Serious Event List"/>
    <code>
      <text value="SeriousEventList"/>
    </code>
    <section>
      <title value="Vertigo positional"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-SeriousAdverseEvent-0"/>
        <type value="EvidenceVariable"/>
        <display value="Vertigo positional as serious adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-SeriousAdverseEvent-0-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Vertigo positional as serious adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-SeriousAdverseEvent-0-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Vertigo positional as serious adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
  </section>
  <section>
    <title value="Other Event List"/>
    <code>
      <text value="OtherEventList"/>
    </code>
    <section>
      <title value="Ear pain"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-0"/>
        <type value="EvidenceVariable"/>
        <display value="Ear pain as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-0-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Ear pain as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-0-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Ear pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Eye pain"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-1"/>
        <type value="EvidenceVariable"/>
        <display value="Eye pain as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-1-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Eye pain as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-1-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Eye pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Eye pruritus"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-2"/>
        <type value="EvidenceVariable"/>
        <display value="Eye pruritus as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-2-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Eye pruritus as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-2-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Eye pruritus as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Lacrimation increased"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-3"/>
        <type value="EvidenceVariable"/>
        <display value="Lacrimation increased as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-3-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Lacrimation increased as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-3-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Lacrimation increased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Diarrhoea"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-4"/>
        <type value="EvidenceVariable"/>
        <display value="Diarrhoea as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-4-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Diarrhoea as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-4-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Diarrhoea as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Nausea"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-5"/>
        <type value="EvidenceVariable"/>
        <display value="Nausea as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-5-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Nausea as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-5-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Nausea as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Toothache"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-6"/>
        <type value="EvidenceVariable"/>
        <display value="Toothache as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-6-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Toothache as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-6-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Toothache as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Vomiting"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-7"/>
        <type value="EvidenceVariable"/>
        <display value="Vomiting as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-7-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Vomiting as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-7-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Vomiting as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Feeling abnormal"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-8"/>
        <type value="EvidenceVariable"/>
        <display value="Feeling abnormal as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-8-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Feeling abnormal as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-8-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Feeling abnormal as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Cystitis"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-9"/>
        <type value="EvidenceVariable"/>
        <display value="Cystitis as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-9-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Cystitis as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-9-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Cystitis as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Blood pressure decreased"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-10"/>
        <type value="EvidenceVariable"/>
        <display value="Blood pressure decreased as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-10-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Blood pressure decreased as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-10-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Blood pressure decreased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Blood pressure increased"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-11"/>
        <type value="EvidenceVariable"/>
        <display value="Blood pressure increased as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-11-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Blood pressure increased as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-11-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Blood pressure increased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Back pain"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-12"/>
        <type value="EvidenceVariable"/>
        <display value="Back pain as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-12-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Back pain as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-12-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Back pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Headache"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-13"/>
        <type value="EvidenceVariable"/>
        <display value="Headache as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-13-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Headache as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-13-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Headache as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Nasal congestion"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-14"/>
        <type value="EvidenceVariable"/>
        <display value="Nasal congestion as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-14-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Nasal congestion as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-14-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Nasal congestion as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Nasal pruritus"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-15"/>
        <type value="EvidenceVariable"/>
        <display value="Nasal pruritus as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-15-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Nasal pruritus as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-15-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Nasal pruritus as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Oropharyngeal pain"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-16"/>
        <type value="EvidenceVariable"/>
        <display value="Oropharyngeal pain as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-16-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Oropharyngeal pain as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-16-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Oropharyngeal pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Rhinalgia"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-17"/>
        <type value="EvidenceVariable"/>
        <display value="Rhinalgia as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-17-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Rhinalgia as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-17-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Rhinalgia as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Cold sweat"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-18"/>
        <type value="EvidenceVariable"/>
        <display value="Cold sweat as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-18-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Cold sweat as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-18-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Cold sweat as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Hot flush"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-19"/>
        <type value="EvidenceVariable"/>
        <display value="Hot flush as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-19-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Hot flush as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-19-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Hot flush as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Hypertension"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-20"/>
        <type value="EvidenceVariable"/>
        <display value="Hypertension as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-20-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Hypertension as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-20-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Hypertension as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
    <section>
      <title value="Peripheral coldness"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03421379-OtherAdverseEvent-21"/>
        <type value="EvidenceVariable"/>
        <display value="Peripheral coldness as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-21-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Peripheral coldness as other adverse event for Glucagon Nasal Powder in NCT03421379"/>
      </entry>
      <entry>
        <reference value="#NCT03421379-OtherAdverseEvent-21-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Peripheral coldness as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"/>
      </entry>
    </section>
  </section>
</Composition>