Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot 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
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<div xmlns="http://www.w3.org/1999/xhtml">[No data.]</div>
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<EvidenceVariable>
<id value="NCT03421379-drug------glucagon-nasal-powder"/>
<name value="NCT03421379_drug______glucagon_nasal_powder"/>
<title value="Glucagon Nasal Powder"/>
<status value="active"/>
<description value="Administered intranasally"/>
<note>
<text value="suggested alternative name: LY900018"/>
</note>
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<valueCodeableConcept>
<text value="DRUG"/>
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<contained>
<EvidenceVariable>
<id value="NCT03421379-drug------glucagon-hydrochloride-solution"/>
<name value="NCT03421379_drug______glucagon_hydrochloride_solution"/>
<title value="Glucagon Hydrochloride Solution"/>
<status value="active"/>
<description value="Administered IM"/>
<note>
<text value="suggested alternative name: GlucaGen®"/>
</note>
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<code>
<system
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<text value="DRUG"/>
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<contained>
<Location>
<id value="NCT03421379-Location-0"/>
<name
value="For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician."/>
<address>
<city value="Fukuoka"/>
<postalCode value="812-0025"/>
<country value="Japan"/>
</address>
<position>
<longitude value="130.41667"/>
<latitude value="33.6"/>
</position>
</Location>
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<contained>
<Location>
<id value="NCT03421379-Location-1"/>
<name
value="For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician."/>
<address>
<city value="Tokyo"/>
<postalCode value="130-0004"/>
<country value="Japan"/>
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<position>
<longitude value="139.69171"/>
<latitude value="35.6895"/>
</position>
</Location>
</contained>
<contained>
<Location>
<id value="NCT03421379-Location-2"/>
<name
value="For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician."/>
<address>
<city value="Tokyo"/>
<postalCode value="162-0053"/>
<country value="Japan"/>
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<latitude value="35.6895"/>
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<Location>
<id value="NCT03421379-Location-3"/>
<name
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<city value="Tokyo"/>
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<valueContactDetail>
<name value="Brian S. Alper"/>
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<citation
value="American Diabetes Association; Workgroup on Hypoglycemia. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005;28(5):1245-1249."/>
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<display
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<citation
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<display value="6. Glycemic Targets."/>
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value="GlucaGen (glucagon [rDNA origin] for injection) [Summary of Product Characteristics]. Bagsvaerd, Denmark: Novo Nordisk; revised 2015. Available at: https://www.medicines.org.uk/emc/medicine/4258#DOCREVISION. Accessed September 29, 2017."/>
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<citation
value="Glucagon G Novo for Injection [Package Insert]. Bagsvaerd, Denmark: Novo Nordisk; revised 2016. Available at: http://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/620023_7229402D1036_1_06. Accessed September 28, 2017."/>
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<citation
value="Glucagon G Novo for Injection [Interview Form]. Bagsvaerd, Denmark: Novo Nordisk; 2015. Available at: http://www.info.pmda.go.jp/go/interview/1/620023_7229402D1036_1_007_1F. Accessed September 28, 2017."/>
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<citation
value="GLUCAGON for Injection ITO [Package Insert]. Osaka, Japan: Kaigen Pharma Co., Ltd; 2016. Available at: http://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/130616_7229400D1088_1_11."/>
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<citation
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value="Polonsky WH, Fisher L, Hessler D, Johnson N. Emotional distress in the partners of type 1 diabetes adults: worries about hypoglycemia and other key concerns. Diabetes Technol Ther. 2016;18:292-297."/>
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<display
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<reference value="Citation/267499"/>
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<display
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<condition>
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<description
value="This ResearchStudy Resource was derived from data in the ClinicalTrials.gov record then modified for use to support an M11 Report."/>
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<type value="Location"/>
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<type value="Location"/>
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<site>
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<end value="2018-08-20"/>
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<start value="2017-10-26"/>
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<valueString
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value="Male patients must use an effective method of contraception for the duration of the study and for 28 days following the last study treatment. Female patients of childbearing potential must use one highly effective method of contraception (<1% failure rate; such as combined oral contraceptive pill, implanted contraceptives, or intrauterine device) or a combination of 2 effective methods of contraception (such as male or female condoms with spermicide [not approved in Japan], diaphragms with spermicide [not approved in Japan], or cervical sponges) during the study and for 28 days following the last study treatment. The patient may choose to use a double barrier method of contraception. Barrier protection methods without concomitant use of a spermicide are not a reliable or acceptable method. Thus, each barrier method must include use of a spermicide. It should be noted that the use of male and female condoms as a double barrier method is not considered acceptable due to the high failure rate when these methods are combined."/>
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<extension
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<valueString
value="Throughout the study, patients may undergo medical assessments and review of compliance with requirements before continuing in the study."/>
</extension>
<extension url="dietary">
<valueString
value="In both treatment periods, patients will fast for at least 8 hours prior to beginning the hypoglycemia induction procedure. Patients should not be given any calorie-containing food/drink during insulin-induced hypoglycemia and within 90 minutes of glucagon administration unless there is a safety concern. The patients will receive a carbohydrate-rich meal after completion of all pharmacokinetic (PK) blood sample collections, at 240 minutes post glucagon dose. Patients will be given access to calorie-free water up to 240 minutes post study treatment. While resident in the CRU, patients should not consume any food or caloric drinks other than that provided by the CRU. When not resident in the CRU, patients will be encouraged to follow their normal diets"/>
</extension>
<extension url="substances">
<valueString
value="Patients should refrain from caffeine-containing food/beverages (eg, cola, chocolate drinks, tea, and coffee) from Day -1 to discharge from CRU in each period. Patient alcohol intake should not exceed 21 units per week (males up to age 65) and 14 units per week (males over 65 and females) during the study. Patients must not consume alcohol from Day -2 to discharge from CRU in each period. Smoking will not be permitted when resident in the CRU."/>
</extension>
<extension url="activity">
<valueString
value="Patients are encouraged to maintain their regular exercise habits for the duration of the study. However, patients should avoid strenuous exercise 48 hours prior to admission or study visit. From the beginning of hypoglycemia induction to 240 minutes post study treatment, patients should remain recumbent or sitting on the bed."/>
</extension>
<extension url="other">
<valueString value="[Optional section not used here.]"/>
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</extension>
<extension url="http://example.org/fhir/extension/screen-failure">
<valueString
value="Individuals who do not meet the criteria for participation in this study (screen failure) may not be re-screened."/>
</extension>
<targetNumber value="20"/>
<actualNumber value="75"/>
<eligibility>🔗
<reference value="Group/267506"/>
<type value="Group"/>
<display value="M11 IGBJ Protocol Example Eligibility Criteria"/>
</eligibility>
</recruitment>
<comparisonGroup>
<linkId value="nasal"/>
<name value="Glucagon Nasal Powder"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-arm-type"/>
<code value="experimental"/>
<display value="Experimental"/>
</coding>
</type>
<description
value="A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally."/>
<intendedExposure>
<reference value="#NCT03421379-drug------glucagon-nasal-powder"/>
<type value="EvidenceVariable"/>
<display value="Drug: Glucagon Nasal Powder"/>
</intendedExposure>
</comparisonGroup>
<comparisonGroup>
<linkId value="solution"/>
<name value="Glucagon Hydrochloride Solution"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-arm-type"/>
<code value="active-comparator"/>
<display value="Active Comparator"/>
</coding>
</type>
<description
value="A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)"/>
<intendedExposure>
<reference
value="#NCT03421379-drug------glucagon-hydrochloride-solution"/>
<type value="EvidenceVariable"/>
<display value="Drug: Glucagon Hydrochloride Solution"/>
</intendedExposure>
</comparisonGroup>
<objective>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="label">
<valueString value="Proportion achieving treatment success"/>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="primary"/>
<display value="Primary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03421379-primaryOutcome-0"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display
value="The proportion of patients achieving treatment success defined as either an increase in PG to >70 mg/dL or an increase of >20 mg/dL from nadir within 30 minutes after administration of glucagon. The nadir is defined as the minimum PG value at the time of or within 10 minutes following glucagon administration."/>
</valueReference>
</extension>
<extension url="population">
<valueReference>🔗
<reference value="Group/267506"/>
<type value="Group"/>
<display value="M11 IGBJ Protocol Example Eligibility Criteria"/>
</valueReference>
</extension>
<extension url="interventionGroup">
<valueId value="nasal"/>
</extension>
<extension url="comparatorGroup">
<valueId value="solution"/>
</extension>
</extension>
<name value="Treatment success"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="primary"/>
<display value="Primary"/>
</coding>
</type>
<description
value="To demonstrate that 3 mg LY900018 is non-inferior to 1 mg IMG for the proportion of patients achieving treatment success from insulin-induced hypoglycemia using a non-inferiority margin of 10%"/>
</objective>
<objective>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="endpoint">
<valueReference>
<display value="serious adverse events (SAEs)"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="label">
<valueString value="treatment-emergent adverse events (TEAEs)"/>
</extension>
<extension url="endpoint">
<valueReference>
<display
value="treatment-emergent adverse events (TEAEs) (including gastrointestinal, nasal, and non-nasal AEs)"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="endpoint">
<valueReference>
<display value="vital signs"/>
</valueReference>
</extension>
</extension>
<name value="Safety and tolerability"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<description
value="To compare the safety and tolerability of 3 mg LY900018 with 1 mg IMG"/>
</objective>
<objective>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03421379-secondaryOutcome-0"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display
value="Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03421379-secondaryOutcome-1"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display
value="PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03421379-secondaryOutcome-2"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display
value="Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03421379-secondaryOutcome-3"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display
value="PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03421379-secondaryOutcome-4"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display
value="PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM"/>
</valueReference>
</extension>
</extension>
<name
value="To characterize the PK profile of 3 mg LY900018 compared to 1 mg IMG"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<description
value="PK parameters include AUC, Cmax, Tmax PD parameters include BGmax and Tmax"/>
</objective>
<objective>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="endpoint">
<valueReference>
<display value="Presence of anti-glucagon antibodies"/>
</valueReference>
</extension>
</extension>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="exploratory"/>
<display value="Exploratory"/>
</coding>
</type>
<description
value="Explore the formation of anti-glucagon antibodies to glucagon"/>
</objective>
<objective>
<name
value="To evaluate the recovery from clinical symptoms of hypoglycemia"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="exploratory"/>
<display value="Exploratory"/>
</coding>
</type>
<description value="Hypoglycemia symptoms questionnaire"/>
</objective>
<result>
<type value="EvidenceReport"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03421379 Results Report"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="Results Section for NCT03421379"/>
</result>
</ResearchStudy>
IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#2.0.0-ballot based on FHIR 6.0.0-ballot2. Generated 2024-11-21
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