Adverse Event Report

Report

reporttype2Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10033347serious1Date Last Updated25/03/2014receiptdateformat102companynumbUS-ROCHE-1366269occurcountryUSduplicate1Date Received25/03/2014seriousnesshospitalization1transmissiondate02/10/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age74Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionLung neoplasm malignantOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionPneumonectomyOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionFallOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionSternal fractureOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionDyspnoeaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductRITUXANdrugauthorizationnumb103705drugstructuredosagenumb1000drugstructuredosageunit003drugdosageformSOLUTION FOR INFUSIONdrugadministrationroute042drugindicationRHEUMATOID ARTHRITISdrugstartdateformat602drugstartdate//2010actiondrug1

openFDA Info on Medication

Application NumberBLA103705Brand NameRITUXANGeneric NameRITUXIMABManufacturersGenentech, Inc.product_ndc50242-051, 50242-053Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsRITUXIMABRXCUI1657862, 1657864, 1657867, 1657868spl_id96420224-93c7-480a-bb9b-7a43670dbb63spl_set_idb172773b-3905-4a1c-ad95-bab4b6126563Package NDC50242-051-21, 50242-051-10, 50242-053-06NUIN0000175078, N0000175657Mechanism of ActionCD20-directed Antibody Interactions [MoA]Established Pharmacologic ClassCD20-directed Cytolytic Antibody [EPC]UNII4F4X42SYQ6

2)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048

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

3)

drugcharacterization2medicinalproductPERCOCETdrugadministrationroute048drugindicationPAIN

openFDA Info on Medication

Application NumberANDA040330Brand NamePERCOCETGeneric NameOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENManufacturersEndo Pharmaceuticals Inc.product_ndc63481-623, 63481-627, 63481-628, 63481-629Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDE, ACETAMINOPHENRXCUI1049214, 1049221, 1049225, 1049625, 1049635, 1049637, 1049640, 1049642spl_id8a04ce2f-d576-469f-91bc-5ed75e27e47espl_set_id4dd36cf5-8f73-404a-8b1d-3bd53bd90c25Package NDC63481-627-70, 63481-623-70, 63481-623-85, 63481-628-70, 63481-629-70UNII362O9ITL9D, C1ENJ2TE6C

4)

drugcharacterization2medicinalproductNEXIUMdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMspl_id3797ceb7-550b-4e9a-8314-8e1e4995360b, ac4ba22b-f431-4ab4-b239-0e220ad804ddspl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43HRXCUI486501, 603536

5)

drugcharacterization2medicinalproductPREDNISONEdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationRHEUMATOID ARTHRITIS

openFDA Info on Medication

Application Number NDA202020, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA040584, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., GeneYork Pharmaceuticals Group LLC, Mylan Pharma ... product_ndc 75987-020, 75987-021, 75987-022, 71329-106, 0378-0640, 0378-0641, 0378-0642, 060 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id be29c86d-242b-42a7-9488-ecf6f76426cd, 4384c1d1-059b-4689-9f3d-1078de814ce8, 88a6 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, be50449f-3aa8-46b7-9246-2dbd5f04f2b1, fec0 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

Report Duplicate

duplicatesourceROCHEduplicatenumbUS-ROCHE-1366269

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use