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Source1

{
  "resourceType": "Evidence",
  "id": "267244",
  "meta": {
    "versionId": "9",
    "lastUpdated": "2025-12-11T20:35:21.032Z",
    "profile": [
      "http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence"
    ]
  },
  "language": "en",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "url": "https://fevir.net/resources/Evidence/267244",
  "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": "267244",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    },
    {
      "type": {
        "text": "FEvIR Linking Identifier"
      },
      "system": "https://fevir.net/FLI",
      "value": "NCT03421379-primaryOutcomeMeasure-0-OutcomeAnalysis-0-BetweenGroupAnalysis-OG000-OG001",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    }
  ],
  "name": "NCT03421379_primaryOutcomeMeasure_0_OutcomeAnalysis_0_BetweenGroupAnalysis_OG000_OG001",
  "title": "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",
  "citeAs": "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 [Database Entry: FHIR Evidence Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 267244. Revised 2025-12-11. Available at: https://fevir.net/resources/Evidence/267244. Computable resource at: https://fevir.net/resources/Evidence/267244#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": [
    {
      "note": [
        {
          "text": "All randomized participant who completed both treatment visits and had evaluable treatment success data."
        }
      ],
      "variableRole": "population",
      "intended": {
        "reference": "Group/267225",
        "type": "Group",
        "identifier": {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03421379 Eligibility Criteria",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        }
      }
    },
    {
      "description": "Group Assignment: Glucagon Nasal Powder vs. Glucagon Hydrochloride Solution",
      "variableRole": "exposure",
      "comparatorCategory": "Glucagon Hydrochloride Solution",
      "observed": {
        "display": "Group Assignment: A single dose of 3 mg glucagon nasal powder was administered intranasally vs. A single dose of 1 mg glucagon hydrochloride solution was administered IM"
      }
    },
    {
      "variableRole": "outcome",
      "observed": {
        "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)"
      }
    }
  ],
  "statistic": [
    {
      "note": [
        {
          "text": "Outcome Analysis NonInferiority Type: Non-Inferiority"
        },
        {
          "text": "Outcome Analysis NonInferiority Comment: The pre-defined non-inferiority margin is (10%)"
        }
      ],
      "statisticType": {
        "text": "Treatment Difference Wald's Method"
      },
      "quantity": {
        "value": 0,
        "unit": "percentage of participants"
      },
      "attributeEstimate": [
        {
          "note": [
            {
              "text": "CI Number of Sides: 2-Sided"
            }
          ],
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
                "code": "C53324",
                "display": "Confidence interval"
              }
            ]
          },
          "level": 0.95,
          "range": {
            "low": {
              "value": -1.47,
              "unit": "percentage of participants"
            },
            "high": {
              "value": 1.47,
              "unit": "percentage of participants"
            }
          }
        }
      ]
    }
  ]
}