Adverse Event Report

Report

reporttype2Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10045902serious1Date Last Updated29/03/2014receiptdateformat102companynumbUS-ROCHE-1371643occurcountryUSseriousnessother1duplicate1Date Received29/03/2014transmissiondate02/10/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Weight77.18SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionDeafness bilateralOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionHypertensionOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionBack painOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionProtein urine presentOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductTEMODARdrugadministrationroute048drugindicationGLIOBLASTOMA MULTIFORME

openFDA Info on Medication

Application NumberNDA021029, NDA022277Brand NameTEMODARGeneric NameTEMOZOLOMIDEManufacturersMerck Sharp & Dohme Corp.product_ndc0085-1366, 0085-3004, 0085-1519, 0085-1425, 0085-1430, 0085-1417, 0085-1381Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsTEMOZOLOMIDERXCUI 261288, 261289, 261290, 261291, 313209, 313210, 313211, 317160, 700883, 700885, ... spl_id1230129b-4a56-46c4-b4e8-512870a4ff5bspl_set_id046a9011-3911-4d3f-a15f-fbb56d5aad56Package NDC 0085-3004-05, 0085-3004-03, 0085-3004-04, 0085-1519-05, 0085-1519-03, 0085-1519- ... NUIN0000000236, N0000175558Mechanism of ActionAlkylating Activity [MoA]Established Pharmacologic ClassAlkylating Drug [EPC]UNIIYF1K15M17Y

2)

drugcharacterization2medicinalproductVP-16drugadministrationroute048drugindicationGLIOBLASTOMA MULTIFORME

3)

drugcharacterization2medicinalproductSERTRALINEdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationDEPRESSION

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

4)

drugcharacterization2medicinalproductRITALINdrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationFATIGUE

openFDA Info on Medication

Application NumberNDA010187, NDA021284Brand NameRITALIN, RITALIN LAGeneric NameMETHYLPHENIDATE HYDROCHLORIDEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0439, 0078-0440, 0078-0441, 0078-0370, 0078-0371, 0078-0372, 0078-0424Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETHYLPHENIDATE HYDROCHLORIDERXCUI 1091150, 1091379, 1091392, 1091395, 1091497, 1091500, 1091143, 1091167, 1091182, ... spl_ida711cf71-e537-4e53-9680-4b7efb4347cb, c0d04ccb-a7f6-4d70-9b63-e6b78b425879spl_set_idc0bf0835-6a2f-4067-a158-8b86c4b0668a, effd952d-ac94-47bb-b107-589a4934dccaPackage NDC 0078-0439-05, 0078-0440-05, 0078-0441-05, 0078-0370-05, 0078-0371-05, 0078-0372- ... UNII4B3SC438HI

5)

drugcharacterization1medicinalproductAVASTINdrugbatchnumbUNKNOWNdrugauthorizationnumb125085drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformSOLUTION FOR INFUSIONdrugadministrationroute042drugindicationGLIOBLASTOMA MULTIFORMEdrugstartdateformat602drugstartdate//2012actiondrug5

openFDA Info on Medication

Application NumberBLA125085Brand NameAVASTINGeneric NameBEVACIZUMABManufacturersGenentech, Inc.product_ndc50242-060, 50242-061Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsBEVACIZUMABRXCUI1657066, 1657068, 1657073, 1657074spl_idfae4c2c2-fa31-44c5-807d-0c4f50bfdbffspl_set_id939b5d1f-9fb2-4499-80ef-0607aa6b114ePackage NDC50242-060-01, 50242-060-10, 50242-061-01, 50242-061-10NUIN0000193543, N0000178291, N0000193542Established Pharmacologic ClassVascular Endothelial Growth Factor Inhibitor [EPC]Mechanism of Action Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA], Vascula ... UNII2S9ZZM9Q9V

6)

drugcharacterization1medicinalproductAVASTINdrugbatchnumbUNKNOWNdrugauthorizationnumb125085drugseparatedosagenumb1drugintervaldosageunitnumb3drugintervaldosagedefinition803drugdosageformSOLUTION FOR INFUSIONdrugadministrationroute042drugstartdateformat602drugstartdate//2013actiondrug5

openFDA Info on Medication

Application NumberBLA125085Brand NameAVASTINGeneric NameBEVACIZUMABManufacturersGenentech, Inc.product_ndc50242-060, 50242-061Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsBEVACIZUMABRXCUI1657066, 1657068, 1657073, 1657074spl_idfae4c2c2-fa31-44c5-807d-0c4f50bfdbffspl_set_id939b5d1f-9fb2-4499-80ef-0607aa6b114ePackage NDC50242-060-01, 50242-060-10, 50242-061-01, 50242-061-10NUIN0000193543, N0000178291, N0000193542Established Pharmacologic ClassVascular Endothelial Growth Factor Inhibitor [EPC]Mechanism of Action Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA], Vascula ... UNII2S9ZZM9Q9V

Report Duplicate

duplicatesourceROCHEduplicatenumbUS-ROCHE-1371643

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use