{
  "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": 1754
    }
  },
  "results": [
    {
      "safetyreportversion": "1",
      "safetyreportid": "13530025",
      "primarysourcecountry": "US",
      "occurcountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20170830",
      "reporttype": "1",
      "serious": "2",
      "receivedateformat": "102",
      "receivedate": "20170509",
      "receiptdateformat": "102",
      "receiptdate": "20170509",
      "fulfillexpeditecriteria": "2",
      "companynumb": "US-EMD SERONO-8155280",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "EMD SERONO INC",
        "duplicatenumb": "US-EMD SERONO-8155280"
      },
      "primarysource": {
        "reportercountry": "US",
        "qualification": "1"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientsex": "1",
        "reaction": [
          {
            "reactionmeddraversionpt": "20.0",
            "reactionmeddrapt": "Bradycardia",
            "reactionoutcome": "1"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "BAVENCIO",
            "drugauthorizationnumb": "761049",
            "drugstructuredosagenumb": "10",
            "drugstructuredosageunit": "007",
            "drugdosageform": "SOLUTION FOR INFUSION",
            "drugadministrationroute": "042",
            "drugindication": "NEUROENDOCRINE CARCINOMA OF THE SKIN",
            "actiondrug": "5",
            "drugadditional": "3",
            "activesubstance": {
              "activesubstancename": "AVELUMAB"
            },
            "openfda": {
              "application_number": [
                "BLA761049"
              ],
              "brand_name": [
                "BAVENCIO"
              ],
              "generic_name": [
                "AVELUMAB"
              ],
              "manufacturer_name": [
                "EMD Serono, Inc."
              ],
              "product_ndc": [
                "44087-3535"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "INTRAVENOUS"
              ],
              "substance_name": [
                "AVELUMAB"
              ],
              "rxcui": [
                "1875542",
                "1875547"
              ],
              "spl_id": [
                "8e1f3b1c-5aab-408c-930e-619daa6afa8a"
              ],
              "spl_set_id": [
                "5cd725a1-2fa4-408a-a651-57a7b84b2118"
              ],
              "package_ndc": [
                "44087-3535-1"
              ],
              "nui": [
                "N0000193338",
                "N0000193337",
                "N0000193336",
                "M0001357"
              ],
              "pharm_class_epc": [
                "Programmed Death Ligand-1 Blocker [EPC]"
              ],
              "pharm_class_moa": [
                "Programmed Death Ligand-1 Antagonists [MoA]",
                "Programmed Death Ligand-1-directed Antibody Interactions [MoA]"
              ],
              "pharm_class_cs": [
                "Antibodies, Monoclonal [CS]"
              ],
              "unii": [
                "KXG2PJ551I"
              ]
            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 20170419"
        }
      }
    }
  ]
}