{
  "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": 97399
    }
  },
  "results": [
    {
      "safetyreportversion": "1",
      "safetyreportid": "10003586",
      "primarysourcecountry": "NL",
      "occurcountry": "NL",
      "transmissiondateformat": "102",
      "transmissiondate": "20141002",
      "reporttype": "1",
      "serious": "1",
      "seriousnesshospitalization": "1",
      "receivedateformat": "102",
      "receivedate": "20140312",
      "receiptdateformat": "102",
      "receiptdate": "20140312",
      "fulfillexpeditecriteria": "1",
      "companynumb": "NL-AMGEN-NLDSP2013092296",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "AMGEN",
        "duplicatenumb": "NL-AMGEN-NLDSP2013092296"
      },
      "primarysource": {
        "reportercountry": "NL",
        "qualification": "3"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientonsetage": "58",
        "patientonsetageunit": "801",
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Surgery",
            "reactionoutcome": "1"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "NEULASTA",
            "drugauthorizationnumb": "125031",
            "drugstructuredosagenumb": "6",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "3",
            "drugintervaldosagedefinition": "803",
            "drugdosagetext": "6 MG, 1X3W",
            "drugdosageform": "SOLUTION FOR INJECTION",
            "drugadministrationroute": "058",
            "drugindication": "PROPHYLAXIS",
            "drugstartdateformat": "102",
            "drugstartdate": "20130220",
            "actiondrug": "5",
            "openfda": {
              "application_number": [
                "BLA125031"
              ],
              "brand_name": [
                "NEULASTA"
              ],
              "generic_name": [
                "PEGFILGRASTIM"
              ],
              "manufacturer_name": [
                "Amgen, Inc"
              ],
              "product_ndc": [
                "55513-099",
                "55513-192",
                "55513-190"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "SUBCUTANEOUS"
              ],
              "substance_name": [
                "PEGFILGRASTIM"
              ],
              "rxcui": [
                "727539",
                "727542",
                "2549331",
                "2549333",
                "2739503",
                "2739504"
              ],
              "spl_id": [
                "0a35b49f-339b-4651-829a-4e84fb3a0759"
              ],
              "spl_set_id": [
                "fdfe5d72-6b80-435a-afa4-c5d74dd852ce"
              ],
              "package_ndc": [
                "55513-192-01",
                "55513-190-01",
                "55513-099-01"
              ],
              "nui": [
                "M0024696",
                "N0000009451",
                "N0000175666"
              ],
              "pharm_class_cs": [
                "Granulocyte Colony-Stimulating Factor [CS]"
              ],
              "pharm_class_pe": [
                "Increased Myeloid Cell Production [PE]"
              ],
              "pharm_class_epc": [
                "Leukocyte Growth Factor [EPC]"
              ],
              "unii": [
                "3A58010674"
              ]
            }
          }
        ]
      }
    }
  ]
}