{
  "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": 1
    }
  },
  "results": [
    {
      "safetyreportversion": "2",
      "safetyreportid": "19048552",
      "primarysourcecountry": "US",
      "occurcountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20210717",
      "reporttype": "2",
      "serious": "1",
      "seriousnesshospitalization": "1",
      "receivedateformat": "102",
      "receivedate": "20210323",
      "receiptdateformat": "102",
      "receiptdate": "20210420",
      "fulfillexpeditecriteria": "1",
      "companynumb": "US-JNJFOC-20210332130",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "JOHNSON AND JOHNSON",
        "duplicatenumb": "US-JNJFOC-20210332130"
      },
      "primarysource": {
        "reportercountry": "US",
        "qualification": "1"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientonsetage": "7",
        "patientonsetageunit": "801",
        "patientagegroup": "3",
        "patientweight": "19.5",
        "patientsex": "1",
        "reaction": [
          {
            "reactionmeddraversionpt": "24.0",
            "reactionmeddrapt": "Febrile neutropenia",
            "reactionoutcome": "1"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "2",
            "medicinalproduct": "ZOFRAN",
            "drugdosageform": "UNKNOWN",
            "drugadministrationroute": "065",
            "drugindication": "DECREASED APPETITE",
            "activesubstance": {
              "activesubstancename": "ONDANSETRON HYDROCHLORIDE"
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "DARATUMUMAB",
            "drugauthorizationnumb": "761036",
            "drugstructuredosagenumb": "304",
            "drugstructuredosageunit": "003",
            "drugdosageform": "CONCENTRATE FOR SOLUTION FOR INFUSION",
            "drugadministrationroute": "042",
            "drugindication": "T-CELL LYMPHOMA RECURRENT",
            "drugstartdateformat": "102",
            "drugstartdate": "20210104",
            "drugenddateformat": "102",
            "drugenddate": "20210301",
            "actiondrug": "6",
            "activesubstance": {
              "activesubstancename": "DARATUMUMAB"
            },
            "openfda": {
              "application_number": [
                "BLA761036"
              ],
              "brand_name": [
                "DARZALEX",
                "DARZALEX IV"
              ],
              "generic_name": [
                "DARATUMUMAB"
              ],
              "manufacturer_name": [
                "Janssen Biotech, Inc."
              ],
              "product_ndc": [
                "57894-502",
                "57894-505"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "INTRAVENOUS"
              ],
              "substance_name": [
                "DARATUMUMAB"
              ],
              "spl_id": [
                "a47a0bd7-3709-44e0-98ab-e2306b5887fe"
              ],
              "spl_set_id": [
                "a4d0efe9-5e54-467e-9eb4-56fa7d53b60b"
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              "package_ndc": [
                "57894-502-05",
                "57894-502-20",
                "57894-505-05",
                "57894-505-20"
              ],
              "nui": [
                "N0000192336",
                "N0000192335",
                "M0001357"
              ],
              "pharm_class_epc": [
                "CD38-directed Cytolytic Antibody [EPC]"
              ],
              "pharm_class_moa": [
                "CD38-directed Antibody Interactions [MoA]"
              ],
              "pharm_class_cs": [
                "Antibodies, Monoclonal [CS]"
              ],
              "unii": [
                "4Z63YK6E0E"
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          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "SYNDROS",
            "drugdosageform": "UNKNOWN",
            "drugadministrationroute": "065",
            "drugindication": "DECREASED APPETITE",
            "activesubstance": {
              "activesubstancename": "DRONABINOL"
            },
            "openfda": {
              "application_number": [
                "NDA205525"
              ],
              "brand_name": [
                "SYNDROS"
              ],
              "generic_name": [
                "DRONABINOL"
              ],
              "manufacturer_name": [
                "Wellhouse Pharma, LLC",
                "Benuvia Operations, LLC"
              ],
              "product_ndc": [
                "85776-201",
                "78613-201"
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              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "DRONABINOL"
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              "rxcui": [
                "1928948",
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              "spl_set_id": [
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                "a7801c70-995d-46a2-91ee-141ef427c6b5"
              ],
              "package_ndc": [
                "85776-201-30",
                "78613-201-30"
              ],
              "nui": [
                "N0000175782",
                "M0003267"
              ],
              "pharm_class_epc": [
                "Cannabinoid [EPC]"
              ],
              "pharm_class_cs": [
                "Cannabinoids [CS]"
              ],
              "unii": [
                "7J8897W37S"
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            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 20210315"
        }
      }
    }
  ]
}