{
  "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": "2026-04-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 27601
    }
  },
  "results": [
    {
      "safetyreportversion": "2",
      "safetyreportid": "10003612",
      "primarysourcecountry": "CA",
      "occurcountry": "CA",
      "transmissiondateformat": "102",
      "transmissiondate": "20141002",
      "reporttype": "2",
      "serious": "1",
      "seriousnessdeath": "1",
      "seriousnessother": "1",
      "receivedateformat": "102",
      "receivedate": "20140312",
      "receiptdateformat": "102",
      "receiptdate": "20140312",
      "fulfillexpeditecriteria": "1",
      "companynumb": "PHHY2013CA006477",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "NOVARTIS",
        "duplicatenumb": "PHHY2013CA006477"
      },
      "primarysource": {
        "reportercountry": "COUNTRY NOT SPECIFIED",
        "qualification": "5"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Death",
            "reactionoutcome": "5"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Pleural effusion",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Blister",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Hypothyroidism",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Blood potassium decreased",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Anaemia",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Nausea",
            "reactionoutcome": "1"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Vomiting",
            "reactionoutcome": "1"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Constipation",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Blood pressure increased",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Fluid retention",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Pollakiuria",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Local swelling",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Joint swelling",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Swelling",
            "reactionoutcome": "6"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "GLEEVEC",
            "drugauthorizationnumb": "021588",
            "drugstructuredosagenumb": "400",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosagetext": "400 MG, QD",
            "drugdosageform": "TABLET",
            "drugadministrationroute": "048",
            "drugindication": "GASTROINTESTINAL STROMAL TUMOUR",
            "drugstartdateformat": "610",
            "drugstartdate": "201208",
            "actiondrug": "5",
            "drugrecurreadministration": "3",
            "openfda": {
              "application_number": [
                "NDA021588"
              ],
              "brand_name": [
                "GLEEVEC"
              ],
              "generic_name": [
                "IMATINIB MESYLATE"
              ],
              "manufacturer_name": [
                "Novartis Pharmaceuticals Corporation"
              ],
              "product_ndc": [
                "0078-0401",
                "0078-0649",
                "0078-1490"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "IMATINIB MESYLATE"
              ],
              "rxcui": [
                "403878",
                "403879",
                "404588",
                "404589"
              ],
              "spl_id": [
                "cbc7561e-5e16-4e05-9c07-52626c43eafc"
              ],
              "spl_set_id": [
                "211ef2da-2868-4a77-8055-1cb2cd78e24b"
              ],
              "package_ndc": [
                "0078-0401-34",
                "0078-0649-30",
                "0078-0649-26",
                "0078-0649-13",
                "0078-1490-26",
                "0078-1490-13"
              ],
              "unii": [
                "8A1O1M485B"
              ]
            }
          }
        ]
      }
    }
  ]
}