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Packagehl7.fhir.uv.ebm
Resource TypeComposition
IdComposition-568060.json
FHIR VersionR6

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Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: Composition 568060

version: 10; Last updated: 2026-08-05 15:16:08+0000

Profile: M11ReportSection03

Artifact Description:

Example of M11ReportSection03 Profile

ArtifactPublicationStatus: Active

url: https://fevir.net/resources/Composition/568060

identifier: FEvIR Object Identifier/568060

status: Final

type: CeSHarP Report

category: section3-estimands

date: 2026-08-05 15:16:08+0000

author: Brian S. Alper, MD, MSPH

title: M11 Report Section 3 (Trial Objectives and Associated Estimands) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

custodian: Computable Publishing LLC

relatesTo

type: Derived from

target: A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

relatesTo

type: Cite As

target:

M11 Report Section 3 (Trial Objectives and Associated Estimands) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568060. Revised 2026-08-05. Available at: https://fevir.net/resources/Composition/568060. Computable resource at: https://fevir.net/resources/Composition/568060#json.


Source1

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    ]
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  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
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      "valueMarkdown": "Example of M11ReportSection03 Profile"
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        }
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  "title": "M11 Report Section 3 (Trial Objectives and Associated Estimands) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example",
  "custodian": {
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      "targetMarkdown": "M11 Report Section 3 (Trial Objectives and Associated Estimands) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568060. Revised 2026-08-05. Available at: https://fevir.net/resources/Composition/568060. Computable resource at: https://fevir.net/resources/Composition/568060#json."
    }
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  "section": [
    {
      "title": "3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS",
      "code": {
        "coding": [
          {
            "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
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              }
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            "text": "3.1-Primary-Objective(s)-and-Associated-Estimand(s)"
          },
          "section": [
            {
              "title": "3.1.1 Primary Objective 1",
              "code": {
                "coding": [
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                "display": "Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia (NCT03421379)"
              },
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                "status": "additional",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Primary objective label: Treatment success</p><p>Primary objective description:To demonstrate that 3 mg LY900018 is non-inferior to 1 mg IMG for the proportion of patients achieving treatment success from insulin-induced hypoglycemia using a non-inferiority margin of 10%</p><table><tbody><tr><th>Type</th><th>Primary</th></tr><tr><td>Population</td><td>Study Population.</td></tr><tr><td>Treatment</td><td>Glucagon Nasal Powder (Experimental)</td></tr><tr><td>Treatment</td><td>Glucagon Hydrochloride Solution (Active Comparator)</td></tr><tr><td>Endpoint</td><td><p>Proportion achieving treatment success</p><p>Endpoint title: Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia (NCT03421379)</p><p>Outcome description: The proportion of patients achieving treatment success defined as either an increase in PG to &gt;70 mg/dL or an increase of &gt;20 mg/dL from nadir within 30 minutes after administration of glucagon. The nadir is defined as the minimum PG value at the time of or within 10 minutes following glucagon administration.</p></td></tr><tr><td>Population-level Summary</td><td>risk difference</td></tr></tbody></table></div>"
              },
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                    "value": "NCT03421379-primaryOutcome-0",
                    "assigner": {
                      "display": "Computable Publishing LLC"
                    }
                  },
                  "display": "Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia (NCT03421379)"
                },
                {
                  "reference": "Group/267506",
                  "type": "Group",
                  "display": "M11 IGBJ Protocol Example Eligibility Criteria"
                },
                {
                  "reference": "Group/370701",
                  "type": "Group",
                  "display": "Glucagon Nasal Powder (Experimental)"
                },
                {
                  "reference": "Group/370702",
                  "type": "Group",
                  "display": "Glucagon Hydrochloride Solution (Active Comparator)"
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              ]
            }
          ]
        },
        {
          "title": "3.2 Secondary Objective(s) and Associated Estimand(s)",
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                "display": "ICH M11 Protocol Section 3.2 Secondary Objective(s) and Associated Estimand(s)"
              }
            ],
            "text": "3.2-Secondary-Objective(s)-and-Associated-Estimand(s)"
          },
          "section": [
            {
              "title": "3.2.1 Secondary Objective 1",
              "code": {
                "coding": [
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                    "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                    "code": "C218530",
                    "display": "ICH M11 Protocol Section 3.2.1 Secondary Objective"
                  }
                ]
              },
              "focus": {
                "display": "serious adverse events (SAEs)"
              },
              "text": {
                "status": "additional",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Secondary objective label: Safety and tolerability</p><p>Secondary objective description: To compare the safety and tolerability of 3 mg LY900018 with 1 mg IMG</p><table><tbody><tr><th>Estimand Characteristic</th><th>Description</th></tr><tr><td>Endpoint</td><td><p>serious adverse events (SAEs)</p></td></tr></tbody></table></div>"
              },
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                    "display": "ICH M11 Protocol Section 3.2.1 Secondary Objective"
                  }
                ]
              },
              "focus": {
                "display": "treatment-emergent adverse events (TEAEs)"
              },
              "text": {
                "status": "additional",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Secondary objective label: Safety and tolerability</p><p>Secondary objective description: To compare the safety and tolerability of 3 mg LY900018 with 1 mg IMG</p><table><tbody><tr><th>Estimand Characteristic</th><th>Description</th></tr><tr><td>Endpoint</td><td><p>treatment-emergent adverse events (TEAEs)</p><p>Outcome description: treatment-emergent adverse events (TEAEs) (including gastrointestinal, nasal, and non-nasal AEs)</p></td></tr></tbody></table></div>"
              },
              "entry": [
                {
                  "display": "treatment-emergent adverse events (TEAEs)"
                }
              ]
            },
            {
              "title": "3.2.1 Secondary Objective 3",
              "code": {
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                    "display": "ICH M11 Protocol Section 3.2.1 Secondary Objective"
                  }
                ]
              },
              "focus": {
                "display": "vital signs"
              },
              "text": {
                "status": "generated",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><table><tbody><tr><th>Estimand Characteristic</th><th>Description</th></tr><tr><td>Endpoint</td><td><p>vital signs</p></td></tr></tbody></table></div>"
              },
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              ]
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                  }
                },
                "display": "Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) (NCT03421379)"
              },
              "text": {
                "status": "additional",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Secondary objective label: To characterize the PK profile of 3 mg LY900018 compared to 1 mg IMG</p><p>Secondary objective description: PK parameters include AUC, Cmax, Tmax PD parameters include BGmax and Tmax</p><table><tbody><tr><th>Estimand Characteristic</th><th>Description</th></tr><tr><td>Endpoint</td><td><p>Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) (NCT03421379)</p></td></tr></tbody></table></div>"
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                }
              ]
            },
            {
              "title": "3.2.1 Secondary Objective 5",
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              },
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                "type": "EvidenceVariable",
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                  "type": {
                    "text": "FEvIR Linking Identifier"
                  },
                  "system": "https://fevir.net/FLI",
                  "value": "NCT03421379-secondaryOutcome-1",
                  "assigner": {
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                  }
                },
                "display": "PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)"
              },
              "text": {
                "status": "generated",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><table><tbody><tr><th>Estimand Characteristic</th><th>Description</th></tr><tr><td>Endpoint</td><td><p>PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)</p></td></tr></tbody></table></div>"
              },
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                  "type": "EvidenceVariable",
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                    "system": "https://fevir.net/FLI",
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                    }
                  },
                  "display": "PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)"
                }
              ]
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              "title": "3.2.1 Secondary Objective 6",
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                },
                "display": "Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)"
              },
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                }
              ]
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            {
              "title": "3.2.1 Secondary Objective 7",
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                "display": "PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)"
              },
              "text": {
                "status": "additional",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Secondary objective label: To characterize the PK profile of 3 mg LY900018 compared to 1 mg IMG</p><p>Secondary objective description: PK parameters include AUC, Cmax, Tmax PD parameters include BGmax and Tmax</p><table><tbody><tr><th>Estimand Characteristic</th><th>Description</th></tr><tr><td>Endpoint</td><td><p>PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)</p></td></tr></tbody></table></div>"
              },
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                  "display": "PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)"
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              ]
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            {
              "title": "3.2.1 Secondary Objective 8",
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                  "system": "https://fevir.net/FLI",
                  "value": "NCT03421379-secondaryOutcome-4",
                  "assigner": {
                    "display": "Computable Publishing LLC"
                  }
                },
                "display": "PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)"
              },
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              },
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                  "type": "EvidenceVariable",
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                }
              ]
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          ]
        },
        {
          "title": "3.3 Exploratory Objective(s)",
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            ],
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          "text": {
            "status": "empty",
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                  }
                ]
              },
              "focus": {
                "display": "Presence of anti-glucagon antibodies"
              },
              "text": {
                "status": "additional",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><div><p>   </p>\n</div>\n<div><strong>Exploratory Objectives</strong>\n    <p><strong>Description </strong>Explore the formation of anti-glucagon antibodies to glucagon</p>\n    <p><strong>Outcome Measures:</strong></p>\n    <p><strong>Unnamed outcome measure</strong></p>\n    <table>\n        <tbody>\n            <tr>\n                <td><strong>Endpoint</strong></td>\n                <td>Presence of anti-glucagon antibodies</td>\n            </tr>\n        </tbody>\n    </table><p>      </p>\n    <p><strong>Name: </strong>To evaluate the recovery from clinical symptoms of hypoglycemia</p>\n    <p><strong>Description </strong>Hypoglycemia symptoms questionnaire</p></div></div>"
              },
              "entry": [
                {
                  "display": "Presence of anti-glucagon antibodies"
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              ]
            }
          ]
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    }
  ]
}