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Narrative

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Source1

{
  "resourceType": "Evidence",
  "id": "267239",
  "meta": {
    "versionId": "9",
    "lastUpdated": "2025-12-11T20:35:21.032Z",
    "profile": [
      "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
    ]
  },
  "language": "en",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "url": "https://fevir.net/resources/Evidence/267239",
  "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": "267239",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    },
    {
      "type": {
        "text": "FEvIR Linking Identifier"
      },
      "system": "https://fevir.net/FLI",
      "value": "NCT03421379-secondaryOutcomeMeasure-2--OG001",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    }
  ],
  "name": "NCT03421379_secondaryOutcomeMeasure_2_OG001",
  "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 for Glucagon Hydrochloride Solution in NCT03421379",
  "citeAs": "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 [Database Entry: FHIR Evidence Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 267239. Revised 2025-12-11. Available at: https://fevir.net/resources/Evidence/267239. Computable resource at: https://fevir.net/resources/Evidence/267239#json.",
  "status": "active",
  "author": [
    {
      "name": "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
    }
  ],
  "publisher": "Computable Publishing LLC",
  "contact": [
    {
      "telecom": [
        {
          "system": "email",
          "value": "support@computablepublishing.com"
        }
      ]
    }
  ],
  "copyright": "https://creativecommons.org/licenses/by-nc-sa/4.0/",
  "description": "This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.",
  "variableDefinition": [
    {
      "description": "Glucagon Hydrochloride Solution",
      "note": [
        {
          "text": "Outcome Measure Population Description: All randomized participants who received at least one dose of study drug and had evaluable PK data."
        },
        {
          "text": "Outcome Measure Denominator Units: Participants"
        }
      ],
      "variableRole": "population",
      "observed": {
        "identifier": {
          "type": {
            "text": "ClinicalTrials.gov Outcome Measurement Group Id"
          },
          "value": "OG001"
        },
        "display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
      }
    },
    {
      "variableRole": "outcome",
      "observed": {
        "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)"
      }
    }
  ],
  "statistic": [
    {
      "statisticType": {
        "coding": [
          {
            "system": "https://fevir.net/sevco",
            "code": "STATO:0000396",
            "display": "geometric mean"
          }
        ]
      },
      "quantity": {
        "value": 3240,
        "unit": "Picogram*hour/milliliter (pg*h/mL)"
      },
      "sampleSize": {
        "knownDataCount": 68
      },
      "attributeEstimate": [
        {
          "type": {
            "text": "Geometric Coefficient of Variation"
          },
          "quantity": {
            "value": 32,
            "unit": "Picogram*hour/milliliter (pg*h/mL)"
          }
        }
      ]
    }
  ]
}