FDA FAERS Adverse Event Reports

{ "_id": "69d435bf3b3830196fa5845e", "safetyreportid": "25963993", "authoritynumb": null, "companynumb": "US-TRAVERE-2025TVT02012", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Tooth abscess", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "FILSPARI", "drugauthorizationnumb": "216403", "drugbatchnumb": null, "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "IgA nephropathy", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "SPARSENTAN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "TRAVERE THERAPEUTICS" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-19T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435bf3b3830196fa5845f", "safetyreportid": "25963997", "authoritynumb": "EU-AEMPS-1759442", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 46.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Immune-mediated dermatitis", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Immune-mediated nephritis", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Acute kidney injury", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "OXALIPLATIN", "drugauthorizationnumb": "078811", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 85.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "85MG/M2, HAS RECEIVED 3 CYCLES", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Adenocarcinoma gastric stage IV", "drugstartdateformat": "102", "drugstartdate": "2025-06-18T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-07-23T00:00:00", "drugtreatmentduration": 36.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "OXALIPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "KEYTRUDA", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "007", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 21.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2MG/KG EVERY 21 DAYS, HAS RECEIVED 2 CYCLES?FOA: CONCENTRATE FOR SOLUTION FOR INFUSION", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Adenocarcinoma gastric stage IV", "drugstartdateformat": "102", "drugstartdate": "2025-07-02T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-07-23T00:00:00", "drugtreatmentduration": 22.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "PEMBROLIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "400MG/M2, HAS RECEIVED 3 CYCLES", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Adenocarcinoma gastric stage IV", "drugstartdateformat": "102", "drugstartdate": "2025-06-18T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-07-23T00:00:00", "drugtreatmentduration": 36.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LEUCOVORIN CALCIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "400MG/M2", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Adenocarcinoma gastric stage IV", "drugstartdateformat": "102", "drugstartdate": "2025-06-18T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "LEUCOVORIN CALCIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250806" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FRESENIUS KABI" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435bf3b3830196fa58461", "safetyreportid": "25964004", "authoritynumb": null, "companynumb": "US-002147023-NVSC2025US160719", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Rash", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Rash erythematous", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "KISQALI", "drugauthorizationnumb": "209092", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RIBOCICLIB SUCCINATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "NOVARTIS" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435bf3b3830196fa5845d", "safetyreportid": "25963992", "authoritynumb": null, "companynumb": "US-IPSEN Group, Research and Development-2024-22477", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 60.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 96.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Enteritis leukopenic", "reactionoutcome": 4 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 160.8, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "PER CYCLE", "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": "042", "drugindication": "Cholangiocarcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ONIVYDE", "drugauthorizationnumb": "102799", "drugbatchnumb": null, "drugstructuredosagenumb": 160.8, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "PER CYCLE", "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2024-10-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-11-05T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRINOTECAN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 925.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "PER CYCLE", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Cholangiocarcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 925.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "PER CYCLE", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2024-10-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-11-05T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "PER CYCLE", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Cholangiocarcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2400.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "PER CYCLE", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2024-10-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-11-05T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ATROPINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 0.25, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "PER CYCLE", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ATROPINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "INSULIN ASPART", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "025", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE: 1 UNIT?FREQUENCY: BEFORE MEALS", "drugdosageform": null, "drugadministrationroute": "058", "drugindication": "Type 2 diabetes mellitus", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "INSULIN ASPART" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "INSULIN GLARGINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "025", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE: 15 UNITS?FREQUENCY: BEFORE BEDTIME (HS)", "drugdosageform": null, "drugadministrationroute": "058", "drugindication": "Type 2 diabetes mellitus", "drugstartdateformat": "602", "drugstartdate": "2018-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "INSULIN GLARGINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LOSARTAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 25.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Hypertension", "drugstartdateformat": "602", "drugstartdate": "2012-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LOSARTAN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 25.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Hypertension", "drugstartdateformat": "602", "drugstartdate": "2012-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20241101" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC." }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }

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{ "_id": "69d435bf3b3830196fa58456", "safetyreportid": "25963988", "authoritynumb": null, "companynumb": "PE-ROCHE-10000413328", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "PE", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Disease progression", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hepatic neoplasm", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Metastases to liver", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "KADCYLA", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Breast cancer metastatic", "drugstartdateformat": "602", "drugstartdate": "2023-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ADO-TRASTUZUMAB EMTANSINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "PE", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "PE", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ROCHE" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-19T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435bf3b3830196fa58453", "safetyreportid": "25963986", "authoritynumb": null, "companynumb": "US-TG THERAPEUTICS INC.-TGT006357", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Prostatic operation", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "UBLITUXIMAB", "drugauthorizationnumb": "761238", "drugbatchnumb": null, "drugstructuredosagenumb": 150.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "150 MILLIGRAM", "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": "042", "drugindication": "Relapsing multiple sclerosis", "drugstartdateformat": "102", "drugstartdate": "2023-07-07T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-07-07T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "UBLITUXIMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "UBLITUXIMAB", "drugauthorizationnumb": "761238", "drugbatchnumb": null, "drugstructuredosagenumb": 450.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "450 MILLIGRAM", "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-04-24T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-04-24T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "UBLITUXIMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251008" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "TG THERAPEUTICS" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }

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"literaturereference": "Xu M, Gao H, Zheng R, Wu H, Yuan K, Li J, Wang Q. Effect of liposomal bupivacaine for the suprascapular nerve combined with axillary nerve block on postoperative analgesia in patients undergoing shoulder surgery: a randomized, observer-blinded trial. 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