{ "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": 1 } }, "results": [ { "safetyreportversion": "2", "safetyreportid": "25531005", "primarysourcecountry": "EU", "occurcountry": "EU", "transmissiondateformat": "102", "transmissiondate": "20251020", "reporttype": "1", "serious": "1", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "1", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "2", "receivedateformat": "102", "receivedate": "20250708", "receiptdateformat": "102", "receiptdate": "20250715", "fulfillexpeditecriteria": "1", "companynumb": "EU-TEVA-VS-3348780", "duplicate": "1", "reportduplicate": { "duplicatesource": "Wipro", "duplicatenumb": "IN-Wipro-4054659-415422" }, "primarysource": { "reportercountry": "EU", "qualification": "3", "literaturereference": "Bagnato G, Stefoni V, Broccoli A, Argnani L, Pellegrini C, Casadei B, et al. Successful Bridging to Allogeneic Transplantation With Valemetostat in Two Refractory/relapsed Peripheral T-cell lymphoma patients. Mediterr-J-Hematol-Infect-Dis 2024; 16 (1):.; Bagnato G, Stefoni V, Broccoli A, Argnani L, Pellegrini C, Casadei B, et al. Successful Bridging to Allogeneic Transplantation With Valemetostat in Two Refractory/relapsed Peripheral T-cell lymphoma patients. Mediterr-J-Hematol-Infect-Dis 202..." }, "sender": { "sendertype": "6", "senderorganization": "TEVA" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "63", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "Lipase increased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "Dysphagia", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "GEMCITABINE", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "079160", "drugseparatedosagenumb": "1", "drugadministrationroute": "065", "drugindication": "Peripheral T-cell lymphoma unspecified", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "GEMCITABINE" }, "openfda": { "application_number": [ "ANDA212129", "ANDA213175", "NDA200795", "ANDA079183", "ANDA090799", "ANDA202485", "ANDA091365", "ANDA078339", "ANDA209077", "ANDA205242", "NDA219920", "NDA209604" ], "brand_name": [ "GEMCITABINE", "AVGEMSI" ], "generic_name": [ "GEMCITABINE HYDROCHLORIDE", "GEMCITABINE" ], "manufacturer_name": [ "Meitheal Pharmaceuticals Inc.", "Hikma Pharmaceuticals USA Inc.", "Hospira, Inc.", "Fresenius Kabi USA, LLC", "Sagent Pharmaceuticals", "Dr. Reddy's Laboratories Limited", "NorthStar Rx LLC", "Mylan Institutional LLC", "Avyxa Pharma, LLC", "BluePoint Laboratories" ], "product_ndc": [ "71288-117", "0143-9340", "0143-9341", "0143-9342", "0409-0181", "0409-0183", "0409-0182", "0409-0187", "63323-102", "63323-125", "25021-234", "25021-235", "71288-113", "71288-114", "55111-686", "55111-687", "63323-126", "0409-0185", "0409-0186", "25021-239", "16714-909", "16714-930", "67457-616", "67457-617", "67457-618", "83831-123", "83831-122", "83831-124", "68001-342", "68001-348", "68001-350", "68001-359" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "GEMCITABINE HYDROCHLORIDE" ], "rxcui": [ "1720960", "1720975", "1720977", "1719005", "1719000", "1719003", "2719761", "2719763", "1998783" ], "spl_id": [ "c5bbcd6c-28a2-4db0-86dd-4c9ce60a434f", "e9bd951d-0a47-409c-aa7c-2df9157d94e2", "3a284abb-8c57-47dc-a138-5a6e6ab92b05", "9788e02c-b92a-4ec3-a747-1574a3a76918", "4c447f74-d06c-459b-ba63-6b72aaf4fd2e", "595a8cf5-412a-482d-8d77-979741ee4912", "be3f7738-022f-4b20-94f3-40f5337997c1", "b696b925-51e8-48a8-881e-ae0a0373b3c2", "12d7e1d6-334a-7d1c-2db2-ea73c496d9ff", "ce96743d-23fc-4de4-9df1-b650d64f4cbc", "111b13bb-6793-4b33-b845-0dc9b46837de", "c0f06508-36d7-4325-a425-707d254d185b", "adf9b715-8cef-4a0d-ba30-d948b2b04272", "3907fd14-53af-499a-8334-94adb74142e0", "93d514c4-a877-475d-91e0-9cfb232d55ca", "303c41a6-c142-4cd2-b133-9e610845d5bf", "049982fe-a321-b868-e063-6294a90ae861" ], "spl_set_id": [ "73ae04d8-38f9-4d3d-b0c2-71d22af1fc86", "d80176fe-3e8b-48be-87c2-9c603013b3fa", "dc02a23b-3ff9-4441-aa91-8e9e629a7315", "a625c92b-c569-4b98-8d2e-2b3f5e12b34f", "d1f3951c-d13f-4662-ad4b-ecfc07f59104", "44bcc16c-341d-49e8-a1c6-95d084667aca", "c0b1b715-9ff8-43ca-9e49-465f1f380084", "a5949d02-29eb-4626-ad35-b7614bb0fa95", "eafcebc8-ddef-bb6b-fd0a-9d8b9962cdc4", "c550dd16-a5e8-44be-87f2-210c15bbb513", "d16907e7-a8c8-4039-ace4-cf4e24ba68c0", "e18ed1cb-7dd0-4001-bfda-17d1f4587fb8", "22af3507-4b4f-4cad-9d61-89ffc4aabbc7", "5af49a48-f1c0-467d-b5da-ac9f1ae8e34c", "06dd9d40-74fc-4409-93b1-a46be7126331", "e11eeff7-bcaf-4bf1-8da8-88138e01af84", "4031017d-d768-46de-8081-476bcb883f5e" ], "package_ndc": [ "71288-117-06", "71288-117-28", "71288-117-54", "0143-9340-01", "0143-9341-01", "0143-9342-01", "0409-0181-01", "0409-0183-01", "0409-0182-01", "0409-0187-01", "63323-102-94", "63323-125-94", "25021-234-10", "25021-235-50", "25021-235-51", "71288-117-91", "71288-117-92", "71288-117-93", "71288-113-10", "71288-114-50", "55111-686-07", "55111-687-25", "63323-102-13", "63323-125-53", "63323-126-03", "0409-0185-01", "0409-0186-01", "0409-0181-25", "0409-0182-25", "0409-0183-25", "25021-239-05", "25021-239-26", "25021-239-52", "16714-909-01", "16714-930-01", "67457-616-10", "67457-617-30", "67457-618-10", "83831-122-01", "83831-123-01", "83831-124-01", "68001-342-34", "68001-348-36", "68001-350-68", "68001-359-37" ], "unii": [ "U347PV74IL" ] } }, { "drugcharacterization": "1", "medicinalproduct": "TOLINAPANT", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": "90", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "0.5", "drugintervaldosagedefinition": "804", "drugdosagetext": "TOLINAPANT [ASTX-660]-FOR TWO CYCLES", "drugadministrationroute": "065", "drugindication": "Peripheral T-cell lymphoma unspecified", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "TOLINAPANT" } }, { "drugcharacterization": "1", "medicinalproduct": "CISPLATIN", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "074656", "drugseparatedosagenumb": "1", "drugadministrationroute": "065", "drugindication": "Peripheral T-cell lymphoma unspecified", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "CISPLATIN" }, "openfda": { "application_number": [ "ANDA074656", "ANDA075036", "ANDA207323", "NDA018057", "ANDA206774", "ANDA218868", "ANDA074735" ], "brand_name": [ "CISPLATIN" ], "generic_name": [ "CISPLATIN" ], "manufacturer_name": [ "Teva Parenteral Medicines, Inc.", "Hikma Pharmaceuticals USA Inc.", "Sagent Pharmaceuticals", "WG Critical Care, LLC", "BluePoint Laboratories", "Accord Healthcare Inc.", "Apotex Corp.", "FOSUN PHARMA USA INC", "Fresenius Kabi USA, LLC", "Gland Pharma Limited" ], "product_ndc": [ "0703-5747", "0703-5748", "0143-9504", "0143-9505", "25021-253", "44567-509", "44567-510", "44567-511", "68001-283", "16729-288", "60505-6279", "72266-252", "72266-253", "63323-103", "68083-162", "68083-163", "68001-608", "68001-609", "65219-359" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "CISPLATIN" ], "rxcui": [ "309311" ], "spl_id": [ "adf5773e-9095-4cb4-a90f-72cbf82f4493", "b463892e-6ca3-4c57-ae72-bdd3a7370a08", "bf489cd3-17a3-4398-ba7e-2cb9e87b9c13", "dd45d777-d4c1-40ee-b4f0-c9e001a15a8c", "11314cd7-5167-4699-e063-6394a90a93b8", "2860827e-1817-2b85-e063-6394a90a127e", "0e147fbc-5660-4d80-b834-f069e8487f59", "189a1ee6-231d-7e56-e063-6394a90abc01", "24604fc6-875c-4f70-973a-9cca93f9a7a7", "89007399-3c34-40d2-8068-a0b8e09cbef8", "0c3ef530-de61-73f7-e063-6294a90a9973", "a91e4890-e792-422b-92f3-8eb99c31aeb7" ], "spl_set_id": [ "a440f077-46f6-4688-a209-65bce38d1c92", "76aea034-6d58-4390-a164-36aa09c1f101", "00396546-6a80-4b9f-a5f8-c22c1d1bb173", "2bf8d2fb-80c8-401d-8e9b-d58463f5e954", "a60c5173-6bc0-4c9d-9674-b3f4d68f79ba", "b2b029f5-0d7e-4e7f-accc-b722aec34c68", "8d170f6f-37d7-41ce-aae2-33307a6ef3ae", "0219eae9-82b4-b779-e063-6394a90a311e", "de6302d5-85f0-4116-a709-57826c2c84fe", "a32820f7-9ff6-4c13-a96a-4483a943fe82", "0372598e-4837-43c6-b56f-63527ac94559", "851e111b-d7c9-4781-849b-3d036e13ce3f" ], "package_ndc": [ "0703-5747-11", "0703-5748-11", "0143-9505-01", "0143-9504-01", "25021-253-50", "25021-253-51", "44567-509-01", "44567-510-01", "44567-511-01", "68001-283-24", "68001-283-27", "68001-283-33", "68001-283-32", "16729-288-11", "16729-288-38", "60505-6279-0", "72266-252-01", "72266-253-01", "63323-103-51", "63323-103-65", "63323-103-64", "68083-162-01", "68083-163-01", "68001-608-24", "68001-609-33", "65219-359-50" ], "nui": [ "N0000175413", "N0000175073" ], "pharm_class_epc": [ "Platinum-based Drug [EPC]" ], "unii": [ "Q20Q21Q62J" ] } } ] } } ] }