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Packagehl7.fhir.uv.ebm
Resource TypeComposition
IdComposition-399872.json
FHIR VersionR6

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Resources that this resource uses

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Narrative

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

Generated Narrative: Composition 399872

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

Profile: BaselineMeasureReport

url: https://fevir.net/resources/Composition/399872

identifier: FEvIR Object Identifier/399872, FEvIR Linking Identifier/NCT03421379-baseline-measure-report

status: Final

type: Baseline Measure Report

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

author: [No author listed.]

title: Baseline Characteristics Report for NCT03421379

custodian: Computable Publishing LLC

RelatesTos

-TypeTarget[x]
*Cite As

Baseline Characteristics Report for NCT03421379 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 399872. Revised 2025-12-11. Available at: https://fevir.net/resources/Composition/399872. Computable resource at: https://fevir.net/resources/Composition/399872#json.


Generated Narrative: EvidenceVariable #NCT03421379-BaselineMeasure-0

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Age, Continuous

status: Active

Definitions

-Concept
*Age, Continuous

handling: extension

classifier: Baseline Measure

Timings

-Offset[x]
*No display for Duration (value: 0)

Generated Narrative: EvidenceVariable #NCT03421379-BaselineMeasure-1

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Sex: Female, Male

status: Active

Definitions

-Concept
*Sex: Female, Male

handling: extension

category

name: Female

category

name: Male

classifier: Baseline Measure

Timings

-Offset[x]
*No display for Duration (value: 0)

Generated Narrative: EvidenceVariable #NCT03421379-BaselineMeasure-2

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Ethnicity (NIH/OMB)

status: Active

Definitions

-Concept
*Ethnicity (NIH/OMB)

handling: extension

category

name: Hispanic or Latino

category

name: Not Hispanic or Latino

category

name: Unknown or Not Reported

classifier: Baseline Measure

Timings

-Offset[x]
*No display for Duration (value: 0)

Generated Narrative: EvidenceVariable #NCT03421379-BaselineMeasure-3

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Race (NIH/OMB)

status: Active

Definitions

-Concept
*Race (NIH/OMB)

handling: extension

category

name: American Indian or Alaska Native

category

name: Asian

category

name: Native Hawaiian or Other Pacific Islander

category

name: Black or African American

category

name: White

category

name: More than one race

category

name: Unknown or Not Reported

classifier: Baseline Measure

Timings

-Offset[x]
*No display for Duration (value: 0)

Generated Narrative: EvidenceVariable #NCT03421379-BaselineMeasure-4

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Region of Enrollment

status: Active

Definitions

-Concept
*Region of Enrollment

handling: extension

Categories

-Name
*Japan

classifier: Baseline Measure

Timings

-Offset[x]
*No display for Duration (value: 0)

Generated Narrative: Group #BG000

Profile: ExposureGroup

name: Glucagon Nasal Powder/Glucagon Hydrochloride Solution

description:

A single dose of 3 mg glucagon nasal powder was administered intranasally

type: Person

membership: Enumerated

code: Participants

quantity: 33

Characteristics

-CodeValue[x]Exclude
*Research Study from which this is a baseline groupNCT03421379false

Generated Narrative: Group #BG001

Profile: ExposureGroup

name: Glucagon Hydrochloride Solution/Glucagon Nasal Powder

description:

A single dose of 1 mg glucagon hydrochloride solution was administered IM

type: Person

membership: Enumerated

code: Participants

quantity: 39

Characteristics

-CodeValue[x]Exclude
*Research Study from which this is a baseline groupNCT03421379false

Generated Narrative: Group #BG002

Profile: ExposureGroup

name: Total

description:

Total of all reporting groups

type: Person

membership: Enumerated

code: Participants

quantity: 72

Characteristics

-CodeValue[x]Exclude
*Research Study from which this is a baseline groupNCT03421379false

Generated Narrative: Evidence #NCT03421379-BaselineMeasure-0-BG000

name: NCT03421379_BaselineMeasure_0_BG000

title: Age, Continuous for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379

status: Active

variableDefinition

note:

Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.

variableRole: Population

observed: Glucagon Nasal Powder/Glucagon Hydrochloride Solution

variableDefinition

variableRole: Outcome

observed: Age, Continuous

statistic

statisticType: mean

quantity: 41.7 years

SampleSizes

-KnownDataCount
*33

AttributeEstimates

-TypeQuantity
*Standard Deviation11.6 years

Generated Narrative: Evidence #NCT03421379-BaselineMeasure-0-BG001

name: NCT03421379_BaselineMeasure_0_BG001

title: Age, Continuous for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379

status: Active

variableDefinition

note:

Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.

variableRole: Population

observed: Glucagon Hydrochloride Solution/Glucagon Nasal Powder

variableDefinition

variableRole: Outcome

observed: Age, Continuous

statistic

statisticType: mean

quantity: 57.5 years

SampleSizes

-KnownDataCount
*39

AttributeEstimates

-TypeQuantity
*Standard Deviation9.2 years

Generated Narrative: Evidence #NCT03421379-BaselineMeasure-0-BG002

name: NCT03421379_BaselineMeasure_0_BG002

title: Age, Continuous for Total at baseline in NCT03421379

status: Active

variableDefinition

note:

Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Age, Continuous

statistic

statisticType: mean

quantity: 50.2 years

SampleSizes

-KnownDataCount
*72

AttributeEstimates

-TypeQuantity
*Standard Deviation13 years

Generated Narrative: Evidence #NCT03421379-BaselineMeasure-1-BG000

name: NCT03421379_BaselineMeasure_1_BG000

title: Sex: Female, Male for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379

status: Active

variableDefinition

note:

Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.

variableRole: Population

observed: Glucagon Nasal Powder/Glucagon Hydrochloride Solution

variableDefinition

variableRole: Outcome

observed: Sex: Female, Male

statistic

statisticType: Count of Participants

category: Female

quantity: 13 Participants

SampleSizes

-KnownDataCount
*33

statistic

statisticType: Count of Participants

category: Male

quantity: 20 Participants

SampleSizes

-KnownDataCount
*33

Generated Narrative: Evidence #NCT03421379-BaselineMeasure-1-BG001

name: NCT03421379_BaselineMeasure_1_BG001

title: Sex: Female, Male for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379

status: Active

variableDefinition

note:

Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.

variableRole: Population

observed: Glucagon Hydrochloride Solution/Glucagon Nasal Powder

variableDefinition

variableRole: Outcome

observed: Sex: Female, Male

statistic

statisticType: Count of Participants

category: Female

quantity: 9 Participants

SampleSizes

-KnownDataCount
*39

statistic

statisticType: Count of Participants

category: Male

quantity: 30 Participants

SampleSizes

-KnownDataCount
*39

Generated Narrative: Evidence #NCT03421379-BaselineMeasure-1-BG002

name: NCT03421379_BaselineMeasure_1_BG002

title: Sex: Female, Male for Total at baseline in NCT03421379

status: Active

variableDefinition

note:

Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Sex: Female, Male

statistic

statisticType: Count of Participants

category: Female

quantity: 22 Participants

SampleSizes

-KnownDataCount
*72

statistic

statisticType: Count of Participants

category: Male

quantity: 50 Participants

SampleSizes

-KnownDataCount
*72

Generated Narrative: Evidence #NCT03421379-BaselineMeasure-2-BG000

name: NCT03421379_BaselineMeasure_2_BG000

title: Ethnicity (NIH/OMB) for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379

status: Active

variableDefinition

note:

Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.

variableRole: Population

observed: Glucagon Nasal Powder/Glucagon Hydrochloride Solution

variableDefinition

variableRole: Outcome

observed: Ethnicity (NIH/OMB)

statistic

statisticType: Count of Participants

category: Hispanic or Latino

quantity: 0 Participants

SampleSizes

-KnownDataCount
*33

statistic

statisticType: Count of Participants

category: Not Hispanic or Latino

quantity: 33 Participants

SampleSizes

-KnownDataCount
*33

statistic

statisticType: Count of Participants

category: Unknown or Not Reported

quantity: 0 Participants

SampleSizes

-KnownDataCount
*33

Generated Narrative: Evidence #NCT03421379-BaselineMeasure-2-BG001

name: NCT03421379_BaselineMeasure_2_BG001

title: Ethnicity (NIH/OMB) for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379

status: Active

variableDefinition

note:

Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.

variableRole: Population

observed: Glucagon Hydrochloride Solution/Glucagon Nasal Powder

variableDefinition

variableRole: Outcome

observed: Ethnicity (NIH/OMB)

statistic

statisticType: Count of Participants

category: Hispanic or Latino

quantity: 0 Participants

SampleSizes

-KnownDataCount
*39

statistic

statisticType: Count of Participants

category: Not Hispanic or Latino

quantity: 39 Participants

SampleSizes

-KnownDataCount
*39

statistic

statisticType: Count of Participants

category: Unknown or Not Reported

quantity: 0 Participants

SampleSizes

-KnownDataCount
*39

Generated Narrative: Evidence #NCT03421379-BaselineMeasure-2-BG002

name: NCT03421379_BaselineMeasure_2_BG002

title: Ethnicity (NIH/OMB) for Total at baseline in NCT03421379

status: Active

variableDefinition

note:

Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Ethnicity (NIH/OMB)

statistic

statisticType: Count of Participants

category: Hispanic or Latino

quantity: 0 Participants

SampleSizes

-KnownDataCount
*72

statistic

statisticType: Count of Participants

category: Not Hispanic or Latino

quantity: 72 Participants

SampleSizes

-KnownDataCount
*72

statistic

statisticType: Count of Participants

category: Unknown or Not Reported

quantity: 0 Participants

SampleSizes

-KnownDataCount
*72

Generated Narrative: Evidence #NCT03421379-BaselineMeasure-3-BG000

name: NCT03421379_BaselineMeasure_3_BG000

title: Race (NIH/OMB) for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379

status: Active

variableDefinition

note:

Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.

variableRole: Population

observed: Glucagon Nasal Powder/Glucagon Hydrochloride Solution

variableDefinition

variableRole: Outcome

observed: Race (NIH/OMB)

statistic

statisticType: Count of Participants

category: American Indian or Alaska Native

quantity: 0 Participants

SampleSizes

-KnownDataCount
*33

statistic

statisticType: Count of Participants

category: Asian

quantity: 33 Participants

SampleSizes

-KnownDataCount
*33

statistic

statisticType: Count of Participants

category: Native Hawaiian or Other Pacific Islander

quantity: 0 Participants

SampleSizes

-KnownDataCount
*33

statistic

statisticType: Count of Participants

category: Black or African American

quantity: 0 Participants

SampleSizes

-KnownDataCount
*33

statistic

statisticType: Count of Participants

category: White

quantity: 0 Participants

SampleSizes

-KnownDataCount
*33

statistic

statisticType: Count of Participants

category: More than one race

quantity: 0 Participants

SampleSizes

-KnownDataCount
*33

statistic

statisticType: Count of Participants

category: Unknown or Not Reported

quantity: 0 Participants

SampleSizes

-KnownDataCount
*33

Generated Narrative: Evidence #NCT03421379-BaselineMeasure-3-BG001

name: NCT03421379_BaselineMeasure_3_BG001

title: Race (NIH/OMB) for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379

status: Active

variableDefinition

note:

Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.

variableRole: Population

observed: Glucagon Hydrochloride Solution/Glucagon Nasal Powder

variableDefinition

variableRole: Outcome

observed: Race (NIH/OMB)

statistic

statisticType: Count of Participants

category: American Indian or Alaska Native

quantity: 0 Participants

SampleSizes

-KnownDataCount
*39

statistic

statisticType: Count of Participants

category: Asian

quantity: 39 Participants

SampleSizes

-KnownDataCount
*39

statistic

statisticType: Count of Participants

category: Native Hawaiian or Other Pacific Islander

quantity: 0 Participants

SampleSizes

-KnownDataCount
*39

statistic

statisticType: Count of Participants

category: Black or African American

quantity: 0 Participants

SampleSizes

-KnownDataCount
*39

statistic

statisticType: Count of Participants

category: White

quantity: 0 Participants

SampleSizes

-KnownDataCount
*39

statistic

statisticType: Count of Participants

category: More than one race

quantity: 0 Participants

SampleSizes

-KnownDataCount
*39

statistic

statisticType: Count of Participants

category: Unknown or Not Reported

quantity: 0 Participants

SampleSizes

-KnownDataCount
*39

Generated Narrative: Evidence #NCT03421379-BaselineMeasure-3-BG002

name: NCT03421379_BaselineMeasure_3_BG002

title: Race (NIH/OMB) for Total at baseline in NCT03421379

status: Active

variableDefinition

note:

Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Race (NIH/OMB)

statistic

statisticType: Count of Participants

category: American Indian or Alaska Native

quantity: 0 Participants

SampleSizes

-KnownDataCount
*72

statistic

statisticType: Count of Participants

category: Asian

quantity: 72 Participants

SampleSizes

-KnownDataCount
*72

statistic

statisticType: Count of Participants

category: Native Hawaiian or Other Pacific Islander

quantity: 0 Participants

SampleSizes

-KnownDataCount
*72

statistic

statisticType: Count of Participants

category: Black or African American

quantity: 0 Participants

SampleSizes

-KnownDataCount
*72

statistic

statisticType: Count of Participants

category: White

quantity: 0 Participants

SampleSizes

-KnownDataCount
*72

statistic

statisticType: Count of Participants

category: More than one race

quantity: 0 Participants

SampleSizes

-KnownDataCount
*72

statistic

statisticType: Count of Participants

category: Unknown or Not Reported

quantity: 0 Participants

SampleSizes

-KnownDataCount
*72

Generated Narrative: Evidence #NCT03421379-BaselineMeasure-4-BG000

name: NCT03421379_BaselineMeasure_4_BG000

title: Region of Enrollment for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379

status: Active

variableDefinition

note:

Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.

variableRole: Population

observed: Glucagon Nasal Powder/Glucagon Hydrochloride Solution

variableDefinition

variableRole: Outcome

observed: Region of Enrollment

statistic

statisticType: Number (see protocol for details)

category: Japan

quantity: 33 participants

SampleSizes

-KnownDataCount
*33

Generated Narrative: Evidence #NCT03421379-BaselineMeasure-4-BG001

name: NCT03421379_BaselineMeasure_4_BG001

title: Region of Enrollment for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379

status: Active

variableDefinition

note:

Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.

variableRole: Population

observed: Glucagon Hydrochloride Solution/Glucagon Nasal Powder

variableDefinition

variableRole: Outcome

observed: Region of Enrollment

statistic

statisticType: Number (see protocol for details)

category: Japan

quantity: 39 participants

SampleSizes

-KnownDataCount
*39

Generated Narrative: Evidence #NCT03421379-BaselineMeasure-4-BG002

name: NCT03421379_BaselineMeasure_4_BG002

title: Region of Enrollment for Total at baseline in NCT03421379

status: Active

variableDefinition

note:

Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Region of Enrollment

statistic

statisticType: Number (see protocol for details)

category: Japan

quantity: 72 participants

SampleSizes

-KnownDataCount
*72

Source1

{
  "resourceType": "Composition",
  "id": "399872",
  "meta": {
    "versionId": "5",
    "lastUpdated": "2025-12-11T20:35:21.032Z",
    "profile": [
      "http://hl7.org/fhir/uv/ebm/StructureDefinition/baseline-measure-report"
    ]
  },
  "language": "en",
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "contained": [
    {
      "resourceType": "EvidenceVariable",
      "id": "NCT03421379-BaselineMeasure-0",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/evidence-variable-handling-detail",
          "valueCodeableConcept": {
            "coding": [
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                "code": "evidence-variable-handling-not-specified",
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              }
            ]
          }
        }
      ],
      "title": "Age, Continuous",
      "status": "active",
      "definition": {
        "concept": {
          "text": "Age, Continuous"
        }
      },
      "handling": "extension",
      "classifier": [
        {
          "text": "Baseline Measure"
        }
      ],
      "timing": {
        "offsetDuration": {
          "value": 0
        }
      }
    },
    {
      "resourceType": "EvidenceVariable",
      "id": "NCT03421379-BaselineMeasure-1",
      "meta": {
        "profile": [
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        ]
      },
      "extension": [
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          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/evidence-variable-handling-detail",
          "valueCodeableConcept": {
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        }
      ],
      "title": "Sex: Female, Male",
      "status": "active",
      "definition": {
        "concept": {
          "text": "Sex: Female, Male"
        }
      },
      "handling": "extension",
      "category": [
        {
          "name": "Female"
        },
        {
          "name": "Male"
        }
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      "classifier": [
        {
          "text": "Baseline Measure"
        }
      ],
      "timing": {
        "offsetDuration": {
          "value": 0
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      }
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    {
      "resourceType": "EvidenceVariable",
      "id": "NCT03421379-BaselineMeasure-2",
      "meta": {
        "profile": [
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        ]
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      "extension": [
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          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/evidence-variable-handling-detail",
          "valueCodeableConcept": {
            "coding": [
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                "code": "evidence-variable-handling-not-specified",
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              }
            ]
          }
        }
      ],
      "title": "Ethnicity (NIH/OMB)",
      "status": "active",
      "definition": {
        "concept": {
          "text": "Ethnicity (NIH/OMB)"
        }
      },
      "handling": "extension",
      "category": [
        {
          "name": "Hispanic or Latino"
        },
        {
          "name": "Not Hispanic or Latino"
        },
        {
          "name": "Unknown or Not Reported"
        }
      ],
      "classifier": [
        {
          "text": "Baseline Measure"
        }
      ],
      "timing": {
        "offsetDuration": {
          "value": 0
        }
      }
    },
    {
      "resourceType": "EvidenceVariable",
      "id": "NCT03421379-BaselineMeasure-3",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
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      },
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/evidence-variable-handling-detail",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "evidence-variable-handling-not-specified",
                "display": "Evidence variable handling not specified"
              }
            ]
          }
        }
      ],
      "title": "Race (NIH/OMB)",
      "status": "active",
      "definition": {
        "concept": {
          "text": "Race (NIH/OMB)"
        }
      },
      "handling": "extension",
      "category": [
        {
          "name": "American Indian or Alaska Native"
        },
        {
          "name": "Asian"
        },
        {
          "name": "Native Hawaiian or Other Pacific Islander"
        },
        {
          "name": "Black or African American"
        },
        {
          "name": "White"
        },
        {
          "name": "More than one race"
        },
        {
          "name": "Unknown or Not Reported"
        }
      ],
      "classifier": [
        {
          "text": "Baseline Measure"
        }
      ],
      "timing": {
        "offsetDuration": {
          "value": 0
        }
      }
    },
    {
      "resourceType": "EvidenceVariable",
      "id": "NCT03421379-BaselineMeasure-4",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/evidence-variable-handling-detail",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "evidence-variable-handling-not-specified",
                "display": "Evidence variable handling not specified"
              }
            ]
          }
        }
      ],
      "title": "Region of Enrollment",
      "status": "active",
      "definition": {
        "concept": {
          "text": "Region of Enrollment"
        }
      },
      "handling": "extension",
      "category": [
        {
          "name": "Japan"
        }
      ],
      "classifier": [
        {
          "text": "Baseline Measure"
        }
      ],
      "timing": {
        "offsetDuration": {
          "value": 0
        }
      }
    },
    {
      "resourceType": "Group",
      "id": "BG000",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/exposure-group"
        ]
      },
      "name": "Glucagon Nasal Powder/Glucagon Hydrochloride Solution",
      "description": "A single dose of 3 mg glucagon nasal powder was administered intranasally",
      "type": "person",
      "membership": "enumerated",
      "code": {
        "text": "Participants"
      },
      "quantity": 33,
      "characteristic": [
        {
          "code": {
            "text": "Research Study from which this is a baseline group"
          },
          "valueReference": {
            "display": "NCT03421379"
          },
          "exclude": false
        }
      ]
    },
    {
      "resourceType": "Group",
      "id": "BG001",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/exposure-group"
        ]
      },
      "name": "Glucagon Hydrochloride Solution/Glucagon Nasal Powder",
      "description": "A single dose of 1 mg glucagon hydrochloride solution was administered IM",
      "type": "person",
      "membership": "enumerated",
      "code": {
        "text": "Participants"
      },
      "quantity": 39,
      "characteristic": [
        {
          "code": {
            "text": "Research Study from which this is a baseline group"
          },
          "valueReference": {
            "display": "NCT03421379"
          },
          "exclude": false
        }
      ]
    },
    {
      "resourceType": "Group",
      "id": "BG002",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/exposure-group"
        ]
      },
      "name": "Total",
      "description": "Total of all reporting groups",
      "type": "person",
      "membership": "enumerated",
      "code": {
        "text": "Participants"
      },
      "quantity": 72,
      "characteristic": [
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                "system": "https://fevir.net/sevco",
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                "system": "https://fevir.net/sevco",
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          "category": {
            "text": "Native Hawaiian or Other Pacific Islander"
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          "quantity": {
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            "text": "Count of Participants"
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          "category": {
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          "quantity": {
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                "system": "https://fevir.net/sevco",
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            ],
            "text": "Count of Participants"
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          "category": {
            "text": "White"
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          "quantity": {
            "value": 0,
            "unit": "Participants"
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          "sampleSize": {
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          }
        },
        {
          "statisticType": {
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                "system": "https://fevir.net/sevco",
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            ],
            "text": "Count of Participants"
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          "category": {
            "text": "More than one race"
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          "quantity": {
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            "unit": "Participants"
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          "sampleSize": {
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          }
        },
        {
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            ],
            "text": "Count of Participants"
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          "category": {
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          "quantity": {
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          "sampleSize": {
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          }
        }
      ]
    },
    {
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      },
      "name": "NCT03421379_BaselineMeasure_3_BG002",
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        {
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        {
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        }
      ],
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            ],
            "text": "Count of Participants"
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          "category": {
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          "quantity": {
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            "unit": "Participants"
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          "sampleSize": {
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        },
        {
          "statisticType": {
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                "system": "https://fevir.net/sevco",
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            ],
            "text": "Count of Participants"
          },
          "category": {
            "text": "Native Hawaiian or Other Pacific Islander"
          },
          "quantity": {
            "value": 0,
            "unit": "Participants"
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          "sampleSize": {
            "knownDataCount": 72
          }
        },
        {
          "statisticType": {
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            ],
            "text": "Count of Participants"
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          "category": {
            "text": "Black or African American"
          },
          "quantity": {
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            "unit": "Participants"
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          }
        },
        {
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                "system": "https://fevir.net/sevco",
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            ],
            "text": "Count of Participants"
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          "category": {
            "text": "White"
          },
          "quantity": {
            "value": 0,
            "unit": "Participants"
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          "sampleSize": {
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          }
        },
        {
          "statisticType": {
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                "system": "https://fevir.net/sevco",
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            ],
            "text": "Count of Participants"
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          "category": {
            "text": "More than one race"
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          "quantity": {
            "value": 0,
            "unit": "Participants"
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          "sampleSize": {
            "knownDataCount": 72
          }
        },
        {
          "statisticType": {
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                "system": "https://fevir.net/sevco",
                "code": "STATO:0000047",
                "display": "count"
              }
            ],
            "text": "Count of Participants"
          },
          "category": {
            "text": "Unknown or Not Reported"
          },
          "quantity": {
            "value": 0,
            "unit": "Participants"
          },
          "sampleSize": {
            "knownDataCount": 72
          }
        }
      ]
    },
    {
      "resourceType": "Evidence",
      "id": "NCT03421379-BaselineMeasure-4-BG000",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name": "NCT03421379_BaselineMeasure_4_BG000",
      "title": "Region of Enrollment for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379",
      "status": "active",
      "variableDefinition": [
        {
          "note": [
            {
              "text": "Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug."
            }
          ],
          "variableRole": "population",
          "observed": {
            "reference": "#BG000",
            "type": "Group",
            "display": "Glucagon Nasal Powder/Glucagon Hydrochloride Solution"
          }
        },
        {
          "variableRole": "outcome",
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            "reference": "#NCT03421379-BaselineMeasure-4",
            "type": "EvidenceVariable",
            "display": "Region of Enrollment"
          }
        }
      ],
      "statistic": [
        {
          "statisticType": {
            "text": "Number (see protocol for details)"
          },
          "category": {
            "text": "Japan"
          },
          "quantity": {
            "value": 33,
            "unit": "participants"
          },
          "sampleSize": {
            "knownDataCount": 33
          }
        }
      ]
    },
    {
      "resourceType": "Evidence",
      "id": "NCT03421379-BaselineMeasure-4-BG001",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name": "NCT03421379_BaselineMeasure_4_BG001",
      "title": "Region of Enrollment for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379",
      "status": "active",
      "variableDefinition": [
        {
          "note": [
            {
              "text": "Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug."
            }
          ],
          "variableRole": "population",
          "observed": {
            "reference": "#BG001",
            "type": "Group",
            "display": "Glucagon Hydrochloride Solution/Glucagon Nasal Powder"
          }
        },
        {
          "variableRole": "outcome",
          "observed": {
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            "type": "EvidenceVariable",
            "display": "Region of Enrollment"
          }
        }
      ],
      "statistic": [
        {
          "statisticType": {
            "text": "Number (see protocol for details)"
          },
          "category": {
            "text": "Japan"
          },
          "quantity": {
            "value": 39,
            "unit": "participants"
          },
          "sampleSize": {
            "knownDataCount": 39
          }
        }
      ]
    },
    {
      "resourceType": "Evidence",
      "id": "NCT03421379-BaselineMeasure-4-BG002",
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        "profile": [
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      },
      "name": "NCT03421379_BaselineMeasure_4_BG002",
      "title": "Region of Enrollment for Total at baseline in NCT03421379",
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      "variableDefinition": [
        {
          "note": [
            {
              "text": "Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug."
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          ],
          "variableRole": "population",
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            "reference": "#BG002",
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          }
        },
        {
          "variableRole": "outcome",
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        }
      ],
      "statistic": [
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          "statisticType": {
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          },
          "quantity": {
            "value": 72,
            "unit": "participants"
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          "sampleSize": {
            "knownDataCount": 72
          }
        }
      ]
    }
  ],
  "url": "https://fevir.net/resources/Composition/399872",
  "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": "399872",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    },
    {
      "type": {
        "text": "FEvIR Linking Identifier"
      },
      "system": "https://fevir.net/FLI",
      "value": "NCT03421379-baseline-measure-report",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    }
  ],
  "status": "final",
  "type": {
    "coding": [
      {
        "system": "https://fevir.net/resources/CodeSystem/179423",
        "code": "BaselineMeasureReport",
        "display": "BaselineMeasureReport"
      }
    ],
    "text": "Baseline Measure Report"
  },
  "date": "2025-12-11T20:35:21.032Z",
  "author": [
    {
      "display": "[No author listed.]"
    }
  ],
  "title": "Baseline Characteristics Report for NCT03421379",
  "custodian": {
    "reference": "Organization/118079",
    "type": "Organization",
    "display": "Computable Publishing LLC"
  },
  "relatesTo": [
    {
      "type": "cite-as",
      "targetMarkdown": "Baseline Characteristics Report for NCT03421379 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 399872. Revised 2025-12-11. Available at: https://fevir.net/resources/Composition/399872. Computable resource at: https://fevir.net/resources/Composition/399872#json."
    }
  ],
  "section": [
    {
      "title": "Baseline Reporting Population Description",
      "code": {
        "text": "BaselinePopulationDescription"
      },
      "text": {
        "status": "generated",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">All randomized participants who received at least one dose of study drug.</div>"
      }
    },
    {
      "title": "Baseline Group List",
      "code": {
        "text": "BaselineGroupList"
      },
      "text": {
        "status": "generated",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Glucagon Nasal Powder/Glucagon Hydrochloride Solution, Glucagon Hydrochloride Solution/Glucagon Nasal Powder, Total</div>"
      },
      "entry": [
        {
          "reference": "#BG000",
          "type": "Group",
          "display": "Glucagon Nasal Powder/Glucagon Hydrochloride Solution"
        },
        {
          "reference": "#BG001",
          "type": "Group",
          "display": "Glucagon Hydrochloride Solution/Glucagon Nasal Powder"
        },
        {
          "reference": "#BG002",
          "type": "Group",
          "display": "Total"
        }
      ]
    },
    {
      "title": "Age, Continuous",
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          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ]
      },
      "focus": {
        "reference": "#NCT03421379-BaselineMeasure-0",
        "type": "EvidenceVariable",
        "display": "Age, Continuous"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03421379-BaselineMeasure-0-BG000",
          "type": "Evidence",
          "display": "Age, Continuous for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379"
        },
        {
          "reference": "#NCT03421379-BaselineMeasure-0-BG001",
          "type": "Evidence",
          "display": "Age, Continuous for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379"
        },
        {
          "reference": "#NCT03421379-BaselineMeasure-0-BG002",
          "type": "Evidence",
          "display": "Age, Continuous for Total at baseline in NCT03421379"
        }
      ]
    },
    {
      "title": "Sex: Female, Male",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ]
      },
      "focus": {
        "reference": "#NCT03421379-BaselineMeasure-1",
        "type": "EvidenceVariable",
        "display": "Sex: Female, Male"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03421379-BaselineMeasure-1-BG000",
          "type": "Evidence",
          "display": "Sex: Female, Male for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379"
        },
        {
          "reference": "#NCT03421379-BaselineMeasure-1-BG001",
          "type": "Evidence",
          "display": "Sex: Female, Male for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379"
        },
        {
          "reference": "#NCT03421379-BaselineMeasure-1-BG002",
          "type": "Evidence",
          "display": "Sex: Female, Male for Total at baseline in NCT03421379"
        }
      ],
      "section": [
        {
          "title": "Baseline Measure Calculate Percent",
          "code": {
            "text": "BaselineMeasureCalculatePct"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">False</div>"
          }
        }
      ]
    },
    {
      "title": "Ethnicity (NIH/OMB)",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ]
      },
      "focus": {
        "reference": "#NCT03421379-BaselineMeasure-2",
        "type": "EvidenceVariable",
        "display": "Ethnicity (NIH/OMB)"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03421379-BaselineMeasure-2-BG000",
          "type": "Evidence",
          "display": "Ethnicity (NIH/OMB) for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379"
        },
        {
          "reference": "#NCT03421379-BaselineMeasure-2-BG001",
          "type": "Evidence",
          "display": "Ethnicity (NIH/OMB) for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379"
        },
        {
          "reference": "#NCT03421379-BaselineMeasure-2-BG002",
          "type": "Evidence",
          "display": "Ethnicity (NIH/OMB) for Total at baseline in NCT03421379"
        }
      ],
      "section": [
        {
          "title": "Baseline Measure Calculate Percent",
          "code": {
            "text": "BaselineMeasureCalculatePct"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">False</div>"
          }
        }
      ]
    },
    {
      "title": "Race (NIH/OMB)",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ]
      },
      "focus": {
        "reference": "#NCT03421379-BaselineMeasure-3",
        "type": "EvidenceVariable",
        "display": "Race (NIH/OMB)"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03421379-BaselineMeasure-3-BG000",
          "type": "Evidence",
          "display": "Race (NIH/OMB) for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379"
        },
        {
          "reference": "#NCT03421379-BaselineMeasure-3-BG001",
          "type": "Evidence",
          "display": "Race (NIH/OMB) for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379"
        },
        {
          "reference": "#NCT03421379-BaselineMeasure-3-BG002",
          "type": "Evidence",
          "display": "Race (NIH/OMB) for Total at baseline in NCT03421379"
        }
      ],
      "section": [
        {
          "title": "Baseline Measure Calculate Percent",
          "code": {
            "text": "BaselineMeasureCalculatePct"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">False</div>"
          }
        }
      ]
    },
    {
      "title": "Region of Enrollment",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ]
      },
      "focus": {
        "reference": "#NCT03421379-BaselineMeasure-4",
        "type": "EvidenceVariable",
        "display": "Region of Enrollment"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03421379-BaselineMeasure-4-BG000",
          "type": "Evidence",
          "display": "Region of Enrollment for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379"
        },
        {
          "reference": "#NCT03421379-BaselineMeasure-4-BG001",
          "type": "Evidence",
          "display": "Region of Enrollment for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379"
        },
        {
          "reference": "#NCT03421379-BaselineMeasure-4-BG002",
          "type": "Evidence",
          "display": "Region of Enrollment for Total at baseline in NCT03421379"
        }
      ]
    }
  ]
}