M11 Report Section 6 (Trial Intervention) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example - TTL 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
: M11 Report Section 6 (Trial Intervention) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

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@prefix fhir: <http://hl7.org/fhir/> .
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@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

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  fhir:section ( [
fhir:title [ fhir:v "Trial Intervention and Concomitant Therapy" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [
fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
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fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This study involves a comparison of 3 mg of LY900018 administered once nasally to 1 mg glucagon administered IM (comparator). Table IGBJ.2 shows the study treatment information. Table IGBJ.2 Study Treatments Treatment Name LLY900018 GlucaGen Dosage Formulation Dry powder Dry powder Dosage Levels 3 mg glucagon 1 mg glucagon Route of Administration Intranasal Intramuscular Dosing Instructions Administer a single nasal dose Administer a single intramuscular upon hypoglycemia onset injection upon hypoglycemia onset.</p></div>"^^rdf:XMLLiteral ]     ] ;
    ( fhir:section [
fhir:title [ fhir:v "Description of Investigational Trial Intervention" ] ;
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        ( fhir:coding [
fhir:system [
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fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This study involves a comparison of 3 mg of LY900018 administered once nasally to 1 mg glucagon administered IM (comparator).</p></div>"^^rdf:XMLLiteral ]       ]     ] [
fhir:title [ fhir:v "Rationale for Investigational Trial Intervention Dose and Regimen" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [
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fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Results from studies in both pediatric and adult populations confirm that, while the physiological response to glucagon does appear to saturate between the 2- and 3-mg LY900018 doses, the lower 2-mg dose may not always elicit the maximum response needed in an emergency situation of severe hypoglycemia. The 3-mg dose provides more consistent clinical efficacy compared to the 2-mg dose and is similarly well tolerated in both pediatric and adult patients. The 1-mg dose of IMG is selected as the approved dose for the rescue treatment of hypoglycemia in Japan. Based on LY900018 exposure, efficacy, and safety, the 3-mg dose was selected for the Phase 3 studies. Therefore, in the current study, the 3-mg LY900018 dose will be used to compare against 1 mg IMG.</p></div>"^^rdf:XMLLiteral ]       ]     ] [
fhir:title [ fhir:v "Investigational Trial Intervention Administration" ] ;
fhir:code [
        ( fhir:coding [
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fhir:code [ fhir:v "C218563" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 6.3 Investigational Trial Intervention Administration" ]         ] ) ;
fhir:text [ fhir:v "section6.3-dosing-and-administration" ]       ] ;
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fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>The procedure for insulin-induced hypoglycemia will require an IV infusion of diluted human regular insulin (0.3 U/mL by diluting 15 U human regular insulin [100 U/mL] into 50 mL saline). Details regarding hypoglycemia induction and glucagon administration procedures are included in Sections 9.2.1 and 9.2.2, respectively. The investigator or designee is responsible for: • explaining the correct use of the investigational products to the site personnel • verifying that instructions are followed properly • maintaining accurate records of investigational product dispensing and collection • and returning all unused medication to Lilly or its designee at the end of the stud The manufactured drug product provided for use in the study includes a nasal delivery device as part of the investigational drug product. The device component of the investigational drug product is inserted into the nasal cavity to deliver the contained drug constituent. The hypoglycemia induction procedure should be initiated at approximately the same time at each treatment visit. Insulin IV infusion will be given until PG is &lt; 60 mg/dL. At this point, insulin infusion will be stopped and, approximately 5 minutes later, a single glucagon dose (LY900018 or IMG) will be administered. The doses will be administered at approximately the same times on each day. The actual time of all dose administrations will be recorded in the patient’s case report form (CRF).</p></div>"^^rdf:XMLLiteral ]       ]     ] [
fhir:title [ fhir:v "Investigational Trial Intervention Dose Modification" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [
fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
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fhir:code [ fhir:v "C218564" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 6.4 Investigational Trial Intervention Dose Modification" ]         ] ) ;
fhir:text [ fhir:v "section6.4-dose-modification" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Not applicable.</p></div>"^^rdf:XMLLiteral ]       ]     ] [
fhir:title [ fhir:v "Management of Investigational Trial Intervention Overdose" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [
fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
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fhir:code [ fhir:v "C218565" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 6.5 Management of Investigational Trial Intervention Overdose" ]         ] ) ;
fhir:text [ fhir:v "section6.5-management-of-overdose" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>For the purposes of this study, an overdose of LY900018 or IMG is considered any dose that is higher than the assigned dose. Refer to the LY900018 IB and GlucaGen Summary of Product Characteristics for more information. See Section 8.4.8 Safety Monitoring.</p></div>"^^rdf:XMLLiteral ]       ]     ] [
fhir:title [ fhir:v "Preparation, Storage, Handling and Accountability of Investigational Trial Intervention" ] ;
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fhir:code [ fhir:v "C218566" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention" ]         ] ) ;
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fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>See Section 6.4 above.</p></div>"^^rdf:XMLLiteral ]         ]       ] [
fhir:title [ fhir:v "Storage and Handling of Investigational Trial Intervention" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [
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fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>The investigator or designee must confirm appropriate temperature conditions have been maintained, as communicated by the sponsor, during transit for all investigational product received and any discrepancies are reported and resolved before use of the study treatment. All investigational products should be stored in an environmentally-controlled and monitored (manual or automated) area in accordance with the labeled storage conditions with access limited to the investigator and authorized site staff. Only participants enrolled in the study may receive investigational product or study materials, and only authorized site staff may supply or administer investigational product.</p></div>"^^rdf:XMLLiteral ]         ]       ] [
fhir:title [ fhir:v "Accountability of Investigational Trial Intervention" ] ;
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fhir:code [ fhir:v "C218569" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 6.6.3 Accountability of Investigational Trial Intervention" ]           ] ) ;
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fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>The investigator, institution, or the head of the medical institution (where applicable) is responsible for study treatment accountability, reconciliation, and record maintenance (such as receipt, reconciliation, and final disposition records)</p></div>"^^rdf:XMLLiteral ]         ]       ] )     ] [
fhir:title [ fhir:v "Investigational Trial Intervention Assignment, Randomisation and Blinding" ] ;
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fhir:code [ fhir:v "C218570" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding" ]         ] ) ;
fhir:text [ fhir:v "section6.7-assignment-randomisation-blinding" ]       ] ;
fhir:text [
fhir:status [ fhir:v "empty" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[No text is intended here (heading only).]</div>"^^rdf:XMLLiteral ]       ] ;
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fhir:code [
          ( fhir:coding [
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fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
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fhir:code [ fhir:v "C218571" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 6.7.1 Participant Assignment to Investigational Trial Intervention" ]           ] ) ;
fhir:text [ fhir:v "section6.7.1-assignment" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Prior to the study drug administration on Period 1 Day 1, patients will be randomly assigned to a treatment sequence (either LY900018 in Period 1 and IMG in Period 2, or vice versa).</p></div>"^^rdf:XMLLiteral ]         ]       ] [
fhir:title [ fhir:v "Randomisation" ] ;
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fhir:code [ fhir:v "C218572" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 6.7.2 Randomisation" ]           ] ) ;
fhir:text [ fhir:v "section6.7.2-randomisation" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>The treatment sequence to be administered for each enrolled patient will be determined according to a randomization table.</p></div>"^^rdf:XMLLiteral ]         ]       ] [
fhir:title [ fhir:v "Measures to Maintain Blinding" ] ;
fhir:code [
          ( fhir:coding [
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fhir:code [ fhir:v "C218573" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 6.7.3 Measures to Maintain Blinding" ]           ] ) ;
fhir:text [ fhir:v "section6.7.3-blinding" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This is an open-label study. However, the treatment assignment list for all randomized patients will not be shared with those responsible for doing either the treatment response assessments or making the decision to take additional action to raise patients’ PG concentrations post-glucagon administration. The intent is to minimize any potential bias in administering additional rescue treatment for hypoglycemia.</p></div>"^^rdf:XMLLiteral ]         ]       ] [
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fhir:display [ fhir:v "ICH M11 Protocol Section 6.7.4 Emergency Unblinding at the Site" ]           ] ) ;
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fhir:text [
fhir:status [ fhir:v "empty" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Describe the criteria for breaking the trial blind or participant code. Describe the circumstances that would require breaking the blind, either for an individual participant or all participants, and specify who will be responsible for this decision. Include the procedure for emergency unblinding as well as documentation of unblinding. Indicate to whom the intentional and unplanned unblinding should be reported.]</div>"^^rdf:XMLLiteral ]         ]       ] )     ] [
fhir:title [ fhir:v "Investigational Trial Intervention Adherence" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [
fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>           ] ;
fhir:code [ fhir:v "C218575" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 6.8 Investigational Trial Intervention Adherence" ]         ] ) ;
fhir:text [ fhir:v "section6.8-intervention-adherence" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>The investigational product will be administered at the clinical site, and documentation of treatment administration will occur at the site. No specific study data will be collected for analysis of treatment compliance</p></div>"^^rdf:XMLLiteral ]       ]     ] [
fhir:title [ fhir:v "Description of Non-Investigational Trial Intervention" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [
fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>           ] ;
fhir:code [ fhir:v "C218576" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 6.9 Description of Noninvestigational Trial Intervention" ]         ] ) ;
fhir:text [ fhir:v "section6.9-noninvestigational-interventions" ]       ] ;
fhir:text [
fhir:status [ fhir:v "empty" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[As stated in Section 6 Trial Intervention and Concomitant Therapy, noninvestigational interventions are pre-specified products used in the trial but are not part of trial objectives and hence, are not investigational trial interventions.]</div>"^^rdf:XMLLiteral ]       ] ;
      ( fhir:section [
fhir:title [ fhir:v "Background Trial Intervention" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [
fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>             ] ;
fhir:code [ fhir:v "C218577" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 6.9.1 Background Trial Intervention" ]           ] ) ;
fhir:text [ fhir:v "section6.9.1-background-intervention" ]         ] ;
fhir:text [
fhir:status [ fhir:v "empty" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Describe any background intervention(s), including administration and any conditions for use.]</div>"^^rdf:XMLLiteral ]         ]       ] [
fhir:title [ fhir:v "Rescue Therapy" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [
fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>             ] ;
fhir:code [ fhir:v "C218578" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 6.9.2 Rescue Therapy" ]           ] ) ;
fhir:text [ fhir:v "section6.9.2-rescue-therapy" ]         ] ;
fhir:text [
fhir:status [ fhir:v "empty" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[List all permitted rescue medications, treatments, and/or procedures, including any relevant instructions on administration and any conditions of use. If administration of rescue therapy leads to the temporary discontinuation of trial intervention or a participant’s withdrawal from the trial, refer to Section 7 Participant Discontinuation of Trial Intervention and Discontinuation or Withdrawal from Trial.]</div>"^^rdf:XMLLiteral ]         ]       ] [
fhir:title [ fhir:v "Other Noninvestigational Trial Intervention" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [
fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>             ] ;
fhir:code [ fhir:v "C218579" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 6.9.3 Other Noninvestigational Trial Intervention" ]           ] ) ;
fhir:text [ fhir:v "section6.9.3-other-therapy" ]         ] ;
fhir:text [
fhir:status [ fhir:v "empty" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[If applicable, describe the use of any other noninvestigational trial intervention, e.g., challenge agents or diagnostics.]</div>"^^rdf:XMLLiteral ]         ]       ] )     ] [
fhir:title [ fhir:v "Concomitant Therapy" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [
fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>           ] ;
fhir:code [ fhir:v "C218580" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 6.10 Concomitant Therapy" ]         ] ) ;
fhir:text [ fhir:v "section6.10-concomitant-therapy" ]       ] ;
fhir:text [
fhir:status [ fhir:v "empty" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Specify the concomitant medications, supplements, complementary and alternative therapies, treatments, and/or procedures which are prohibited or permitted during the trial and include details about when the information will be collected (e.g., during screening, at each visit). When appropriate to separate the content, subheadings may be used.]</div>"^^rdf:XMLLiteral ]       ] ;
      ( fhir:section [
fhir:title [ fhir:v "Prohibited Concomitant Therapy" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [
fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>             ] ;
fhir:code [ fhir:v "C218581" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 6.10.1 Prohibited Concomitant Therapy" ]           ] ) ;
fhir:text [ fhir:v "section6.10.1-prohibited-concomitant-therapy" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>The following concomitant medications are prohibited to use during the course of the study: beta-blocker, indomethacin, warfarin, and anti-cholinergic drugs. The following concomitant medications that affect gastric motility can be used during the study but should be washed out before 7 days of each period and not taken while in the CRU: pro-motility medications (eg, metoclopramide, domperidone), opiate medications (eg, morphine), and medications with anti-emetic effects (eg, promethazine, prochlorperazine). In general, concomitant medication should be avoided; however, acetaminophen (1 g, maximum 2 g/24 hours) may be administered at the discretion of the investigator for treatment of headaches, etc. If the need for concomitant medication (other than acetaminophen) arises, inclusion or continuation of the patients may be at the discretion of the investigator after consultation with a Lilly clinical pharmacologist (CP) or CRP. Any medication used during the course of the study must be documented.</p></div>"^^rdf:XMLLiteral ]         ]       ] [
fhir:title [ fhir:v "Permitted Concomitant Therapy" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [
fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>             ] ;
fhir:code [ fhir:v "C218582" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 6.10.2 Permitted Concomitant Therapy" ]           ] ) ;
fhir:text [ fhir:v "section6.10.2-permitted-concomitant-therapy" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Patients on stable concomitant medication at the time of study entry should continue their regular, unchanged dose throughout the study. These medications include stable regimen for 3 months of the anti-hyperglycemic therapy (for example, insulins and OAMs) as well as anti-hypertensive and anti-lipidemic medications. In addition to the physical examination, investigators should review the insulin regimen for all patients enrolled into the study to confirm acceptability to undergo the procedure to induce hypoglycemia (see Schedule of Activities; Section 2). For patients using basal insulin, the last basal insulin injection should occur no later than 12 hours prior to the insulin-induced hypoglycemia procedure, and the basal dose should not be changed. Patients may inject basal insulin any time after the last PK sample is collected on Day 1 in each period. For patients using prandial insulin, the last prandial insulin injection should occur no later than 6 hours prior to the insulin-induced hypoglycemia procedure. Patients may inject prandial insulin after the last PK sample is collected and before the meal on Day 1 in each period. The first prandial insulin dose for an individual patient after insulin-induced hypoglycemia procedure should be determined by the investigator based on the PG before meal and carbohydrate intake. For patients using an insulin pump, a continuous subcutaneous insulin infusion by pump should be discontinued prior to procedure to induce hypoglycemia. Patients may start subcutaneous insulin infusion after the last PK sample is collected and before the meal on Day 1 in each period. The insulin dose should be determined by the investigator based on the PG before meal and carbohydrate intake. For patients using OAMs, the last dose should occur no later than 12 hours prior to the insulin-induced hypoglycemia procedure. Patients may start OAM after the last PK sample is collected on Day 1 in each period</p></div>"^^rdf:XMLLiteral ]         ]       ] )     ] )
  ] ) . #