{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 809
    }
  },
  "results": [
    {
      "safetyreportversion": "5",
      "safetyreportid": "10112049",
      "primarysourcecountry": "FR",
      "occurcountry": "FR",
      "transmissiondateformat": "102",
      "transmissiondate": "20160815",
      "reporttype": "1",
      "serious": "1",
      "seriousnesshospitalization": "1",
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      "receivedate": "20140425",
      "receiptdateformat": "102",
      "receiptdate": "20160621",
      "fulfillexpeditecriteria": "1",
      "companynumb": "FR-IPSEN BIOPHARMACEUTICALS, INC.-2014-1165",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "IPSEN",
        "duplicatenumb": "FR-IPSEN BIOPHARMACEUTICALS, INC.-2014-1165"
      },
      "primarysource": {
        "reportercountry": "FR",
        "qualification": "3",
        "literaturereference": "PINTURAUD M, LANNOY D, CARTIGNY M, CUVELIER E, LEFEVRE C, DECAUDIN B, ODOU P. USE OF METFORMIN AND MECASERMIN IN THE TREATMENT OF DONAHUE SYNDROME: ABOUT A CLINICAL CASE. INTERNATIONAL JOURNAL OF CLINICAL PHARMACY. 2016;6(38):586-587."
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
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        "receiverorganization": "FDA"
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      "patient": {
        "patientonsetage": "4",
        "patientonsetageunit": "802",
        "patientweight": "3.8",
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddraversionpt": "19.0",
            "reactionmeddrapt": "Condition aggravated",
            "reactionoutcome": "2"
          },
          {
            "reactionmeddraversionpt": "19.0",
            "reactionmeddrapt": "Wrong technique in product usage process",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "19.0",
            "reactionmeddrapt": "Hypertrophic cardiomyopathy",
            "reactionoutcome": "2"
          },
          {
            "reactionmeddraversionpt": "19.0",
            "reactionmeddrapt": "Lymphoid tissue hyperplasia",
            "reactionoutcome": "6"
          }
        ],
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            "actiondrug": "2",
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          },
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        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 20140312"
        }
      }
    }
  ]
}