FHIR © HL7.org  |  FHIRsmith 4.0.1  |  Server Home  |  XIG Home  |  XIG Stats  | 

FHIR IG analytics

Packagehl7.fhir.uv.ebm
Resource TypeComposition
IdComposition-399873.json
FHIR VersionR6

Resources that use this resource

No resources found


Resources that this resource uses

No resources found


Narrative

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

Generated Narrative: Composition 399873

version: 5; Last updated: 2025-12-11 20:35:21+0000; Language: en

Profile: OutcomeMeasureReport

url: https://fevir.net/resources/Composition/399873

identifier: FEvIR Object Identifier/399873, FEvIR Linking Identifier/NCT03421379-outcome-measure-report

status: Final

type: Outcome Measure Report

date: 2025-12-11 20:35:21+0000

author: [No author listed.]

title: Outcome Measures Report for NCT03421379

custodian: Computable Publishing LLC

RelatesTos

-TypeTarget[x]
*Cite As

Outcome Measures Report for NCT03421379 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 399873. Revised 2025-12-11. Available at: https://fevir.net/resources/Composition/399873. Computable resource at: https://fevir.net/resources/Composition/399873#json.


Source1

{
  "resourceType": "Composition",
  "id": "399873",
  "meta": {
    "versionId": "5",
    "lastUpdated": "2025-12-11T20:35:21.032Z",
    "profile": [
      "http://hl7.org/fhir/uv/ebm/StructureDefinition/outcome-measure-report"
    ]
  },
  "language": "en",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "url": "https://fevir.net/resources/Composition/399873",
  "identifier": [
    {
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
            "code": "ACSN",
            "display": "Accession ID"
          }
        ],
        "text": "FEvIR Object Identifier"
      },
      "system": "https://fevir.net/FOI",
      "value": "399873",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    },
    {
      "type": {
        "text": "FEvIR Linking Identifier"
      },
      "system": "https://fevir.net/FLI",
      "value": "NCT03421379-outcome-measure-report",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    }
  ],
  "status": "final",
  "type": {
    "coding": [
      {
        "system": "https://fevir.net/resources/CodeSystem/179423",
        "code": "OutcomeMeasureReport",
        "display": "OutcomeMeasureReport"
      }
    ],
    "text": "Outcome Measure Report"
  },
  "date": "2025-12-11T20:35:21.032Z",
  "author": [
    {
      "display": "[No author listed.]"
    }
  ],
  "title": "Outcome Measures Report for NCT03421379",
  "custodian": {
    "reference": "Organization/118079",
    "type": "Organization",
    "display": "Computable Publishing LLC"
  },
  "relatesTo": [
    {
      "type": "cite-as",
      "targetMarkdown": "Outcome Measures Report for NCT03421379 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 399873. Revised 2025-12-11. Available at: https://fevir.net/resources/Composition/399873. Computable resource at: https://fevir.net/resources/Composition/399873#json."
    }
  ],
  "section": [
    {
      "title": "Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration",
      "focus": {
        "reference": "EvidenceVariable/267226",
        "type": "EvidenceVariable",
        "identifier": {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03421379-primaryOutcome-0",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        },
        "display": "Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration (NCT03421379)"
      },
      "section": [
        {
          "title": "Outcome Measure Population Description",
          "code": {
            "text": "OutcomeMeasurePopulationDescription"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">All randomized participant who completed both treatment visits and had evaluable treatment success data.</div>"
          }
        },
        {
          "title": "Outcome Measure Reporting Status",
          "code": {
            "text": "OutcomeMeasureReportingStatus"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Posted</div>"
          }
        },
        {
          "title": "Outcome Measure Time Frame",
          "code": {
            "text": "OutcomeMeasureTimeFrame"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Pre-dose up to 30 minutes post each glucagon administration</div>"
          }
        },
        {
          "title": "Outcome Group List",
          "code": {
            "text": "OutcomeGroupList"
          },
          "section": [
            {
              "title": "Glucagon Nasal Powder",
              "code": {
                "text": "OG000"
              },
              "text": {
                "status": "generated",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 3 mg glucagon nasal powder was administered intranasally</div>"
              },
              "entry": [
                {
                  "display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
                }
              ]
            },
            {
              "title": "Glucagon Hydrochloride Solution",
              "code": {
                "text": "OG001"
              },
              "text": {
                "status": "generated",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 1 mg glucagon hydrochloride solution was administered IM</div>"
              },
              "entry": [
                {
                  "display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
                }
              ]
            }
          ]
        },
        {
          "title": "Outcome Class List",
          "code": {
            "text": "OutcomeClassList"
          },
          "section": [
            {
              "title": "Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration (NCT03421379)",
              "code": {
                "coding": [
                  {
                    "system": "https://fevir.net/resources/CodeSystem/179423",
                    "code": "results",
                    "display": "Results"
                  }
                ]
              },
              "focus": {
                "reference": "EvidenceVariable/267226",
                "type": "EvidenceVariable",
                "identifier": {
                  "type": {
                    "text": "FEvIR Linking Identifier"
                  },
                  "system": "https://fevir.net/FLI",
                  "value": "NCT03421379-primaryOutcome-0",
                  "assigner": {
                    "display": "Computable Publishing LLC"
                  }
                },
                "display": "Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration (NCT03421379)"
              },
              "entry": [
                {
                  "reference": "Evidence/267232",
                  "type": "Evidence",
                  "identifier": {
                    "type": {
                      "text": "FEvIR Linking Identifier"
                    },
                    "system": "https://fevir.net/FLI",
                    "value": "NCT03421379-primaryOutcomeMeasure-0--OG000",
                    "assigner": {
                      "display": "Computable Publishing LLC"
                    }
                  },
                  "display": "Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration for Glucagon Nasal Powder in NCT03421379"
                },
                {
                  "reference": "Evidence/267233",
                  "type": "Evidence",
                  "identifier": {
                    "type": {
                      "text": "FEvIR Linking Identifier"
                    },
                    "system": "https://fevir.net/FLI",
                    "value": "NCT03421379-primaryOutcomeMeasure-0--OG001",
                    "assigner": {
                      "display": "Computable Publishing LLC"
                    }
                  },
                  "display": "Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration for Glucagon Hydrochloride Solution in NCT03421379"
                },
                {
                  "reference": "Evidence/267244",
                  "type": "Evidence",
                  "identifier": {
                    "type": {
                      "text": "FEvIR Linking Identifier"
                    },
                    "system": "https://fevir.net/FLI",
                    "value": "NCT03421379-primaryOutcomeMeasure-0-OutcomeAnalysis-0-BetweenGroupAnalysis-OG000-OG001",
                    "assigner": {
                      "display": "Computable Publishing LLC"
                    }
                  },
                  "display": "Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration Statistical Analysis for Glucagon Nasal Powder vs Glucagon Hydrochloride Solution in NCT03421379"
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "title": "Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration",
      "focus": {
        "reference": "EvidenceVariable/267227",
        "type": "EvidenceVariable",
        "identifier": {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03421379-secondaryOutcome-0",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        },
        "display": "Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)"
      },
      "section": [
        {
          "title": "Outcome Measure Population Description",
          "code": {
            "text": "OutcomeMeasurePopulationDescription"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">All randomized patients who receive at least 1 dose of the study drug and have evaluable PD data.</div>"
          }
        },
        {
          "title": "Outcome Measure Reporting Status",
          "code": {
            "text": "OutcomeMeasureReportingStatus"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Posted</div>"
          }
        },
        {
          "title": "Outcome Measure Time Frame",
          "code": {
            "text": "OutcomeMeasureTimeFrame"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration</div>"
          }
        },
        {
          "title": "Outcome Group List",
          "code": {
            "text": "OutcomeGroupList"
          },
          "section": [
            {
              "title": "Glucagon Nasal Powder",
              "code": {
                "text": "OG000"
              },
              "text": {
                "status": "generated",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 3 mg glucagon nasal powder was administered intranasally</div>"
              },
              "entry": [
                {
                  "display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
                }
              ]
            },
            {
              "title": "Glucagon Hydrochloride Solution",
              "code": {
                "text": "OG001"
              },
              "text": {
                "status": "generated",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 1 mg glucagon hydrochloride solution was administered IM</div>"
              },
              "entry": [
                {
                  "display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
                }
              ]
            }
          ]
        },
        {
          "title": "Outcome Class List",
          "code": {
            "text": "OutcomeClassList"
          },
          "section": [
            {
              "title": "Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)",
              "code": {
                "coding": [
                  {
                    "system": "https://fevir.net/resources/CodeSystem/179423",
                    "code": "results",
                    "display": "Results"
                  }
                ]
              },
              "focus": {
                "reference": "EvidenceVariable/267227",
                "type": "EvidenceVariable",
                "identifier": {
                  "type": {
                    "text": "FEvIR Linking Identifier"
                  },
                  "system": "https://fevir.net/FLI",
                  "value": "NCT03421379-secondaryOutcome-0",
                  "assigner": {
                    "display": "Computable Publishing LLC"
                  }
                },
                "display": "Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)"
              },
              "entry": [
                {
                  "reference": "Evidence/267234",
                  "type": "Evidence",
                  "identifier": {
                    "type": {
                      "text": "FEvIR Linking Identifier"
                    },
                    "system": "https://fevir.net/FLI",
                    "value": "NCT03421379-secondaryOutcomeMeasure-0--OG000",
                    "assigner": {
                      "display": "Computable Publishing LLC"
                    }
                  },
                  "display": "Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Nasal Powder in NCT03421379"
                },
                {
                  "reference": "Evidence/267235",
                  "type": "Evidence",
                  "identifier": {
                    "type": {
                      "text": "FEvIR Linking Identifier"
                    },
                    "system": "https://fevir.net/FLI",
                    "value": "NCT03421379-secondaryOutcomeMeasure-0--OG001",
                    "assigner": {
                      "display": "Computable Publishing LLC"
                    }
                  },
                  "display": "Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Hydrochloride Solution in NCT03421379"
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "title": "PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration",
      "focus": {
        "reference": "EvidenceVariable/267228",
        "type": "EvidenceVariable",
        "identifier": {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03421379-secondaryOutcome-1",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        },
        "display": "PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)"
      },
      "section": [
        {
          "title": "Outcome Measure Population Description",
          "code": {
            "text": "OutcomeMeasurePopulationDescription"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">All randomized participants who received at least one dose of study drug and had evaluable PD data.</div>"
          }
        },
        {
          "title": "Outcome Measure Reporting Status",
          "code": {
            "text": "OutcomeMeasureReportingStatus"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Posted</div>"
          }
        },
        {
          "title": "Outcome Measure Time Frame",
          "code": {
            "text": "OutcomeMeasureTimeFrame"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration</div>"
          }
        },
        {
          "title": "Outcome Group List",
          "code": {
            "text": "OutcomeGroupList"
          },
          "section": [
            {
              "title": "Glucagon Nasal Powder",
              "code": {
                "text": "OG000"
              },
              "text": {
                "status": "generated",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 3 mg glucagon nasal powder was administered intranasally</div>"
              },
              "entry": [
                {
                  "display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
                }
              ]
            },
            {
              "title": "Glucagon Hydrochloride Solution",
              "code": {
                "text": "OG001"
              },
              "text": {
                "status": "generated",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 1 mg glucagon hydrochloride solution was administered IM</div>"
              },
              "entry": [
                {
                  "display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
                }
              ]
            }
          ]
        },
        {
          "title": "Outcome Class List",
          "code": {
            "text": "OutcomeClassList"
          },
          "section": [
            {
              "title": "PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)",
              "code": {
                "coding": [
                  {
                    "system": "https://fevir.net/resources/CodeSystem/179423",
                    "code": "results",
                    "display": "Results"
                  }
                ]
              },
              "focus": {
                "reference": "EvidenceVariable/267228",
                "type": "EvidenceVariable",
                "identifier": {
                  "type": {
                    "text": "FEvIR Linking Identifier"
                  },
                  "system": "https://fevir.net/FLI",
                  "value": "NCT03421379-secondaryOutcome-1",
                  "assigner": {
                    "display": "Computable Publishing LLC"
                  }
                },
                "display": "PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)"
              },
              "entry": [
                {
                  "reference": "Evidence/267236",
                  "type": "Evidence",
                  "identifier": {
                    "type": {
                      "text": "FEvIR Linking Identifier"
                    },
                    "system": "https://fevir.net/FLI",
                    "value": "NCT03421379-secondaryOutcomeMeasure-1--OG000",
                    "assigner": {
                      "display": "Computable Publishing LLC"
                    }
                  },
                  "display": "PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Nasal Powder in NCT03421379"
                },
                {
                  "reference": "Evidence/267237",
                  "type": "Evidence",
                  "identifier": {
                    "type": {
                      "text": "FEvIR Linking Identifier"
                    },
                    "system": "https://fevir.net/FLI",
                    "value": "NCT03421379-secondaryOutcomeMeasure-1--OG001",
                    "assigner": {
                      "display": "Computable Publishing LLC"
                    }
                  },
                  "display": "PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Hydrochloride Solution in NCT03421379"
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "title": "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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration",
      "focus": {
        "reference": "EvidenceVariable/267229",
        "type": "EvidenceVariable",
        "identifier": {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03421379-secondaryOutcome-2",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        },
        "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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)"
      },
      "section": [
        {
          "title": "Outcome Measure Population Description",
          "code": {
            "text": "OutcomeMeasurePopulationDescription"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">All randomized participants who received at least one dose of study drug and had evaluable PK data.</div>"
          }
        },
        {
          "title": "Outcome Measure Reporting Status",
          "code": {
            "text": "OutcomeMeasureReportingStatus"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Posted</div>"
          }
        },
        {
          "title": "Outcome Measure Time Frame",
          "code": {
            "text": "OutcomeMeasureTimeFrame"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration</div>"
          }
        },
        {
          "title": "Outcome Group List",
          "code": {
            "text": "OutcomeGroupList"
          },
          "section": [
            {
              "title": "Glucagon Nasal Powder",
              "code": {
                "text": "OG000"
              },
              "text": {
                "status": "generated",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 3 mg glucagon nasal powder was administered intranasally</div>"
              },
              "entry": [
                {
                  "display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
                }
              ]
            },
            {
              "title": "Glucagon Hydrochloride Solution",
              "code": {
                "text": "OG001"
              },
              "text": {
                "status": "generated",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 1 mg glucagon hydrochloride solution was administered IM</div>"
              },
              "entry": [
                {
                  "display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
                }
              ]
            }
          ]
        },
        {
          "title": "Outcome Class List",
          "code": {
            "text": "OutcomeClassList"
          },
          "section": [
            {
              "title": "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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)",
              "code": {
                "coding": [
                  {
                    "system": "https://fevir.net/resources/CodeSystem/179423",
                    "code": "results",
                    "display": "Results"
                  }
                ]
              },
              "focus": {
                "reference": "EvidenceVariable/267229",
                "type": "EvidenceVariable",
                "identifier": {
                  "type": {
                    "text": "FEvIR Linking Identifier"
                  },
                  "system": "https://fevir.net/FLI",
                  "value": "NCT03421379-secondaryOutcome-2",
                  "assigner": {
                    "display": "Computable Publishing LLC"
                  }
                },
                "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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)"
              },
              "entry": [
                {
                  "reference": "Evidence/267238",
                  "type": "Evidence",
                  "identifier": {
                    "type": {
                      "text": "FEvIR Linking Identifier"
                    },
                    "system": "https://fevir.net/FLI",
                    "value": "NCT03421379-secondaryOutcomeMeasure-2--OG000",
                    "assigner": {
                      "display": "Computable Publishing LLC"
                    }
                  },
                  "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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Nasal Powder in NCT03421379"
                },
                {
                  "reference": "Evidence/267239",
                  "type": "Evidence",
                  "identifier": {
                    "type": {
                      "text": "FEvIR Linking Identifier"
                    },
                    "system": "https://fevir.net/FLI",
                    "value": "NCT03421379-secondaryOutcomeMeasure-2--OG001",
                    "assigner": {
                      "display": "Computable Publishing LLC"
                    }
                  },
                  "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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Hydrochloride Solution in NCT03421379"
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "title": "PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration",
      "focus": {
        "reference": "EvidenceVariable/267230",
        "type": "EvidenceVariable",
        "identifier": {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03421379-secondaryOutcome-3",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        },
        "display": "PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)"
      },
      "section": [
        {
          "title": "Outcome Measure Population Description",
          "code": {
            "text": "OutcomeMeasurePopulationDescription"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">All randomized participants who received at least one dose of study drug and had evaluable PK data.</div>"
          }
        },
        {
          "title": "Outcome Measure Reporting Status",
          "code": {
            "text": "OutcomeMeasureReportingStatus"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Posted</div>"
          }
        },
        {
          "title": "Outcome Measure Time Frame",
          "code": {
            "text": "OutcomeMeasureTimeFrame"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration</div>"
          }
        },
        {
          "title": "Outcome Group List",
          "code": {
            "text": "OutcomeGroupList"
          },
          "section": [
            {
              "title": "Glucagon Nasal Powder",
              "code": {
                "text": "OG000"
              },
              "text": {
                "status": "generated",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 3 mg glucagon nasal powder was administered intranasally</div>"
              },
              "entry": [
                {
                  "display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
                }
              ]
            },
            {
              "title": "Glucagon Hydrochloride Solution",
              "code": {
                "text": "OG001"
              },
              "text": {
                "status": "generated",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 1 mg glucagon hydrochloride solution was administered IM</div>"
              },
              "entry": [
                {
                  "display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
                }
              ]
            }
          ]
        },
        {
          "title": "Outcome Class List",
          "code": {
            "text": "OutcomeClassList"
          },
          "section": [
            {
              "title": "PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)",
              "code": {
                "coding": [
                  {
                    "system": "https://fevir.net/resources/CodeSystem/179423",
                    "code": "results",
                    "display": "Results"
                  }
                ]
              },
              "focus": {
                "reference": "EvidenceVariable/267230",
                "type": "EvidenceVariable",
                "identifier": {
                  "type": {
                    "text": "FEvIR Linking Identifier"
                  },
                  "system": "https://fevir.net/FLI",
                  "value": "NCT03421379-secondaryOutcome-3",
                  "assigner": {
                    "display": "Computable Publishing LLC"
                  }
                },
                "display": "PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)"
              },
              "entry": [
                {
                  "reference": "Evidence/267240",
                  "type": "Evidence",
                  "identifier": {
                    "type": {
                      "text": "FEvIR Linking Identifier"
                    },
                    "system": "https://fevir.net/FLI",
                    "value": "NCT03421379-secondaryOutcomeMeasure-3--OG000",
                    "assigner": {
                      "display": "Computable Publishing LLC"
                    }
                  },
                  "display": "PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Nasal Powder in NCT03421379"
                },
                {
                  "reference": "Evidence/267241",
                  "type": "Evidence",
                  "identifier": {
                    "type": {
                      "text": "FEvIR Linking Identifier"
                    },
                    "system": "https://fevir.net/FLI",
                    "value": "NCT03421379-secondaryOutcomeMeasure-3--OG001",
                    "assigner": {
                      "display": "Computable Publishing LLC"
                    }
                  },
                  "display": "PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Hydrochloride Solution in NCT03421379"
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "title": "PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration",
      "focus": {
        "reference": "EvidenceVariable/267231",
        "type": "EvidenceVariable",
        "identifier": {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)"
      },
      "section": [
        {
          "title": "Outcome Measure Population Description",
          "code": {
            "text": "OutcomeMeasurePopulationDescription"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">All randomized participants who received at least one dose of study drug and had evaluable PK data.</div>"
          }
        },
        {
          "title": "Outcome Measure Reporting Status",
          "code": {
            "text": "OutcomeMeasureReportingStatus"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Posted</div>"
          }
        },
        {
          "title": "Outcome Measure Time Frame",
          "code": {
            "text": "OutcomeMeasureTimeFrame"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration</div>"
          }
        },
        {
          "title": "Outcome Group List",
          "code": {
            "text": "OutcomeGroupList"
          },
          "section": [
            {
              "title": "Glucagon Nasal Powder",
              "code": {
                "text": "OG000"
              },
              "text": {
                "status": "generated",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 3 mg glucagon nasal powder was administered intranasally</div>"
              },
              "entry": [
                {
                  "display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
                }
              ]
            },
            {
              "title": "Glucagon Hydrochloride Solution",
              "code": {
                "text": "OG001"
              },
              "text": {
                "status": "generated",
                "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 1 mg glucagon hydrochloride solution was administered IM</div>"
              },
              "entry": [
                {
                  "display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
                }
              ]
            }
          ]
        },
        {
          "title": "Outcome Class List",
          "code": {
            "text": "OutcomeClassList"
          },
          "section": [
            {
              "title": "PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)",
              "code": {
                "coding": [
                  {
                    "system": "https://fevir.net/resources/CodeSystem/179423",
                    "code": "results",
                    "display": "Results"
                  }
                ]
              },
              "focus": {
                "reference": "EvidenceVariable/267231",
                "type": "EvidenceVariable",
                "identifier": {
                  "type": {
                    "text": "FEvIR Linking Identifier"
                  },
                  "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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)"
              },
              "entry": [
                {
                  "reference": "Evidence/267242",
                  "type": "Evidence",
                  "identifier": {
                    "type": {
                      "text": "FEvIR Linking Identifier"
                    },
                    "system": "https://fevir.net/FLI",
                    "value": "NCT03421379-secondaryOutcomeMeasure-4--OG000",
                    "assigner": {
                      "display": "Computable Publishing LLC"
                    }
                  },
                  "display": "PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Nasal Powder in NCT03421379"
                },
                {
                  "reference": "Evidence/267243",
                  "type": "Evidence",
                  "identifier": {
                    "type": {
                      "text": "FEvIR Linking Identifier"
                    },
                    "system": "https://fevir.net/FLI",
                    "value": "NCT03421379-secondaryOutcomeMeasure-4--OG001",
                    "assigner": {
                      "display": "Computable Publishing LLC"
                    }
                  },
                  "display": "PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Hydrochloride Solution in NCT03421379"
                }
              ]
            }
          ]
        }
      ]
    }
  ]
}