Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10050232serious1Date Last Updated16/04/2014receiptdateformat102companynumbUS-DENDREON CORPORATION-2014PROUSA03589occurcountryUSseriousnessother1duplicate1Date Received01/04/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age86Unit of Onset AgeyearsWeight72.2SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionParalysisOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionInfusion related reactionOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionChillsOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionAstheniaOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductPROVENGEdrugbatchnumb313411-1drugauthorizationnumb125197drugstructuredosagenumb250drugstructuredosageunit012drugdosagetext250 ML, SINGLEdrugdosageformSUSPENSIONdrugadministrationroute042drugindicationPROSTATE CANCER METASTATICdrugstartdateformat102drugstartdate20/02/2014drugenddateformat102drugenddate20/02/2014actiondrug1

2)

drugcharacterization1medicinalproductPROVENGEdrugbatchnumb313411-2drugauthorizationnumb125197drugstructuredosagenumb250drugstructuredosageunit012drugdosagetext250 ML, SINGLEdrugdosageformSUSPENSIONdrugadministrationroute042drugstartdateformat102drugstartdate06/03/2014drugenddateformat102drugenddate06/03/2014actiondrug1

3)

drugcharacterization2medicinalproductALLOPURINOLdrugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100 MG, UNKdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

openFDA Info on Medication

Application Number NDA020298, ANDA203154, ANDA071450, ANDA204467, NDA018832, NDA018877, NDA016084, ... Brand NameALOPRIM, ALLOPURINOL, ZYLOPRIMGeneric NameALLOPURINOLManufacturers Mylan Institutional LLC, Accord Healthcare Inc., Sun Pharmaceutical Industries, ... product_ndc 67457-978, 16729-134, 16729-135, 53489-156, 53489-157, 23155-693, 23155-694, 059 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsALLOPURINOL SODIUM, ALLOPURINOLRXCUI252931, 261265, 197319, 197320, 213995, 213998spl_id 2acff21e-7d8f-4b03-b7b7-9400f54f66ac, 9010eb1b-3580-b221-e053-2995a90a3feb, a9f5 ... spl_set_id 018525b1-e37d-4ff2-9dc3-36b3d90ac3e0, 682dd8b8-fc6e-47c5-95b7-82d7ad96b750, fd8f ... Package NDC 67457-978-50, 16729-134-10, 16729-134-01, 16729-134-16, 16729-134-17, 16729-135- ... UNII428673RC2Z, 63CZ7GJN5INUIN0000175698, N0000000206Established Pharmacologic ClassXanthine Oxidase Inhibitor [EPC]Mechanism of ActionXanthine Oxidase Inhibitors [MoA]

4)

drugcharacterization2medicinalproductATENOLOLdrugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MG, BIDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

openFDA Info on Medication

Application Number NDA018240, ANDA078512, ANDA213136, ANDA077443, ANDA076900, ANDA074052, ANDA07302 ... Brand NameTENORMIN, ATENOLOLGeneric NameATENOLOLManufacturers Almatica Pharma LLC, Aurobindo Pharma Limited, Unichem Pharmaceuticals (USA), In ... product_ndc 52427-429, 52427-430, 52427-431, 65862-168, 65862-169, 65862-170, 29300-410, 293 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATENOLOLRXCUI150750, 152414, 197379, 197380, 197381, 201322spl_id 70291313-c4f6-7c2a-cd07-04fd6a07b634, 2f8a6d3c-fbcd-4b11-aa14-d0522fa7600e, d850 ... spl_set_id 746db603-a6e1-4dc3-c2d8-92314419098c, 1b8a4689-3916-4f4b-b54a-bbb4e322d79b, 35d9 ... Package NDC 52427-429-90, 52427-430-90, 52427-431-90, 65862-168-01, 65862-168-99, 65862-169- ... NUIN0000000161, N0000175556Mechanism of ActionAdrenergic beta-Antagonists [MoA]Established Pharmacologic Classbeta-Adrenergic Blocker [EPC]UNII50VV3VW0TI

5)

drugcharacterization2medicinalproductCHLORTHALIDONEdrugstructuredosagenumb12.5drugstructuredosageunit003drugdosagetext12.5 MG, BIDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

openFDA Info on Medication

Application Number ANDA211627, ANDA213412, ANDA207204, ANDA210742, ANDA207813, ANDA089286, ANDA2110 ... Brand NameCHLORTHALIDONEGeneric NameCHLORTHALIDONEManufacturers Unichem Pharmaceuticals (USA), Inc., Ascend Laboratories, LLC, Amneal Pharmaceut ... product_ndc 29300-333, 29300-334, 67877-696, 67877-697, 65162-247, 65162-250, 55801-146, 558 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCHLORTHALIDONERXCUI197499, 197500spl_id 40725204-0a44-49bd-99f5-a2949ecbe118, eea96cb7-4637-4520-967e-50950ee925d7, 162c ... spl_set_id 01065eda-7515-46bc-b858-a062c3aa35bd, d104583e-e983-4230-b6d1-4455ee1060a5, c4c1 ... Package NDC 29300-333-10, 29300-333-01, 29300-334-01, 29300-334-10, 67877-696-01, 67877-696- ... NUIN0000175359, N0000175420Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide-like Diuretic [EPC]UNIIQ0MQD1073Q

6)

drugcharacterization2medicinalproductECOTRINdrugstructuredosagenumb325drugstructuredosageunit003drugdosagetext325 MG, UNKdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

openFDA Info on Medication

Application Numberpart343Brand NameECOTRINGeneric NameASPIRINManufacturersMedtech Products Inc.product_ndc63029-311Product TypeHUMAN OTC DRUGRouteORALActive IngredientsASPIRINRXCUI308416, 1189781spl_idcc0a7913-1a98-46d0-9713-44993ef50dbaspl_set_id222d187b-aae6-410b-baeb-b2bd42f5c676Package NDC 63029-311-01, 63029-311-14, 63029-311-65, 63029-311-75, 63029-311-32, 63029-311- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E

7)

drugcharacterization2medicinalproductGABAPENTINdrugstructuredosagenumb300drugstructuredosageunit003drugdosagetext300 MG, BIDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 6e41ce47-a6cc-4c34-84f1-305747df38c2, 5fc4 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

8)

drugcharacterization2medicinalproductLUPRON DEPOT-PEDdrugstructuredosagenumb11.25drugstructuredosageunit003drugdosagetext11.25 MG, EVERY 4 MONTHSdrugadministrationroute030drugindicationPROSTATE CANCER METASTATICdrugrecurreadministration3

openFDA Info on Medication

Application NumberNDA020263Brand NameLUPRON DEPOT-PEDGeneric NameLEUPROLIDE ACETATEManufacturersAbbVie Inc.product_ndc0074-2108, 0074-2282, 0074-2440, 0074-3779, 0074-9694Product TypeHUMAN PRESCRIPTION DRUGRXCUI 1115447, 1115449, 1115454, 1115456, 1115462, 1115464, 1115472, 1115473, 1946519, ... spl_ide4a68d8d-292d-85b4-f6e5-40f0badb7222spl_set_ide99f47d2-da10-3127-ecb3-e5d942ae6e81Package NDC0074-2282-03, 0074-2440-03, 0074-2108-03, 0074-3779-03, 0074-9694-03

9)

drugcharacterization2medicinalproductMEGESTROLdrugstructuredosagenumb120drugstructuredosageunit003drugdosagetext120 MG, QDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

10)

drugcharacterization2medicinalproductOCUVITEdrugdosagetext2 UNK, BIDdrugindicationDRY EYEdrugrecurreadministration3

11)

drugcharacterization2medicinalproductOMEPRAZOLEdrugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, ACdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA075757, ANDA206877, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, AC ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., OHM ... product_ndc 46122-281, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 62175-136, 078 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, 8c9d9c38-9da6-4f99-9f08-26ec4693fa55, ce5c ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c ... Package NDC 46122-281-04, 46122-281-74, 63981-915-55, 57483-740-01, 57483-740-42, 51660-029- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

12)

drugcharacterization2medicinalproductOS-CAL + Ddrugdosagetext1 TABLET, UNKdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

13)

drugcharacterization2medicinalproductPOTASSIUM CITRATE/CITRIC ACIDdrugdosagetext2 UNK, BIDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

14)

drugcharacterization2medicinalproductPRESERVISION AREDSdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

15)

drugcharacterization2medicinalproductSIMVASTATINdrugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, HSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

openFDA Info on Medication

Application Number NDA206679, ANDA078155, ANDA077691, ANDA078103, ANDA090383, ANDA078034, ANDA07783 ... Brand NameFLOLIPID, SIMVASTATIN, ZOCORGeneric NameSIMVASTATINManufacturers Salerno Pharmaceuticals Co., Accord Healthcare, Inc., NorthStar Rx LLC, Lupin Ph ... product_ndc 29273-401, 29273-402, 16729-004, 16729-156, 16729-005, 16729-006, 16729-007, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSIMVASTATINRXCUI 1790679, 1944262, 1944264, 1944266, 198211, 200345, 312961, 312962, 314231, 1044 ... spl_id 37ec6157-4088-4638-8eba-74a6aa1238d3, a467e8e1-fe36-61f4-e053-2a95a90a3c3c, 81d3 ... spl_set_id 6ee17d10-6eb1-452a-99e8-02381368b3fe, 871251c0-36a1-4a32-9eab-ff6c1e925ca9, 0376 ... Package NDC 29273-401-04, 29273-402-04, 16729-156-10, 16729-156-15, 16729-156-17, 16729-004- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNIIAGG2FN16EV

16)

drugcharacterization2medicinalproductCYANOCOBALAMINdrugstructuredosagenumb1000drugstructuredosageunit004drugdosagetext1000 ?G, UNKdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

openFDA Info on Medication

Application Number ANDA206503, ANDA213874, ANDA209255, ANDA080515, NDA021642, ANDA080737, ANDA20942 ... Brand Name CYANOCOBALAMIN, VITAMIN DEFICIENCY SYSTEM, COCO12, NASCOBAL, VITAMIN DEFICIENCY ... Generic NameCYANOCOBALAMINManufacturers Somerset Therapeutics, LLC, AuroMedics Pharma LLC, Vitruvias Therapeutics, West- ... product_ndc 70069-005, 70069-172, 55150-364, 69680-112, 69680-113, 69680-121, 0143-9619, 014 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteINTRAMUSCULAR, SUBCUTANEOUS, TOPICAL, NASALActive IngredientsCYANOCOBALAMINRXCUI309594, 861113, 861115, 797544spl_id f24e1ba1-2063-44bf-958e-d3fad248436d, db84d0ea-5c15-47f5-bbe2-8d455e75695e, 47ad ... spl_set_id 41ac0dc1-0a71-4c69-8e25-ba838f5f16a3, db84d0ea-5c15-47f5-bbe2-8d455e75695e, 2117 ... Package NDC 70069-005-01, 70069-005-10, 70069-172-01, 70069-172-10, 70069-172-25, 55150-364- ... NUIM0022794, N0000175951Chemical StructureVitamin B 12 [CS]Established Pharmacologic ClassVitamin B12 [EPC]UNIIP6YC3EG204

17)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, QDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

18)

drugcharacterization2medicinalproductNITROFURANTOINdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, UNKdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

openFDA Info on Medication

Application Number ANDA201693, ANDA205180, ANDA207372, ANDA208516, ANDA091095, NDA009175, ANDA20135 ... Brand NameNITROFURANTOIN, NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), FURADANTINGeneric NameNITROFURANTOIN, NITROFURANTOIN MONOHYDRATE/MACROCRYSTALSManufacturers Lupin Pharmaceuticals,Inc., Actavis Pharma, Inc., Amneal Pharmaceuticals LLC, No ... product_ndc 43386-450, 0472-1992, 65162-478, 40032-450, 68001-423, 0591-3684, 0591-3685, 059 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNITROFURANTOIN, NITROFURANTOIN MONOHYDRATERXCUI311989, 1648755, 311994, 311995, 1648759, 207790spl_id 1f547df0-9394-4f76-9a8e-9815e0631278, daa2705a-a5a4-407a-9333-8693d3afe00b, 18fd ... spl_set_id 93c37857-38f1-4e2e-acb8-4846840e3e85, d8c5b015-626e-4d57-9b91-392fb53575fa, 55c7 ... Package NDC 43386-450-11, 0472-1992-08, 65162-478-10, 40032-450-11, 68001-423-00, 0591-3684- ... NUIN0000175494, M0014892Established Pharmacologic ClassNitrofuran Antibacterial [EPC]Chemical StructureNitrofurans [CS]UNII927AH8112L, E1QI2CQQ1I

Report Duplicate

duplicatesourceDENDREONduplicatenumbUS-DENDREON CORPORATION-2014PROUSA03589

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use