Adverse Event Report

Report

reporttype2Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10914740serious1Date Last Updated13/03/2015receiptdateformat102seriousnessdeath1companynumbUS-ASTELLAS-2015US007573occurcountryUSduplicate1Date Received13/03/2015transmissiondate21/07/2015primarysourcecountryUS

Primary Source

reportercountryGBqualification5

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionDeathOutcomeFatal

2)

reactionmeddraversionpt18.0ReactionOff label useOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductALTEPLASEdrugstructuredosagenumb.5drugstructuredosageunit003drugdosagetext0.5 MG, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameALTEPLASE

openFDA Info on Medication

Application NumberBLA103172Brand NameCATHFLO ACTIVASE, ACTIVASEGeneric NameALTEPLASEManufacturersGenentech, Inc.product_ndc50242-041, 50242-044, 50242-085Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsALTEPLASEspl_idc617df84-0248-429e-9d66-0ddecc5ac4e1, d0a497de-7f5a-47c7-a451-54493363ac91spl_set_id91ecdef2-95ff-42dd-a31c-c8a09cab3ad9, c669f77c-fa48-478b-a14b-80b20a0139c2Package NDC50242-041-64, 50242-041-10, 50242-044-13, 50242-085-27UNII1RXS4UE564RXCUI1804799, 1804802, 1804804, 1804806

2)

drugcharacterization2medicinalproductGLEEVECdrugdosagetextUNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameIMATINIB MESYLATE

openFDA Info on Medication

Application NumberNDA021588Brand NameGLEEVECGeneric NameIMATINIB MESYLATEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0401, 0078-0649Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsIMATINIB MESYLATERXCUI403878, 403879, 404588, 404589spl_ida77e5b72-5c99-437d-b698-cf1a11e36a0dspl_set_id211ef2da-2868-4a77-8055-1cb2cd78e24bPackage NDC0078-0401-34, 0078-0649-30UNII8A1O1M485B

3)

drugcharacterization2medicinalproductTEMODARdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameTEMOZOLOMIDE

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

4)

drugcharacterization2medicinalproductACCUTANEdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA202099Brand NameACCUTANEGeneric NameISOTRETINOINManufacturersJG Pharma Inc.product_ndc72143-231, 72143-232, 72143-234, 72143-233Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 206880, 206883, 206902, 403930, 2473107spl_ida599c5e2-aeaa-4667-b6fa-ddc56bbb71daspl_set_ida41ceb83-aaca-4f9d-ae33-c53b1ca71e41Package NDC 72143-231-10, 72143-231-30, 72143-232-10, 72143-232-30, 72143-234-10, 72143-234- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

5)

drugcharacterization2medicinalproductHYDROXYUREA.drugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameHYDROXYUREA

openFDA Info on Medication

Application NumberANDA213438, ANDA075143, NDA208843, NDA016295, ANDA075340Brand NameHYDROXYUREA, SIKLOS, HYDREA, DROXIAGeneric NameHYDROXYUREAManufacturers Leading Pharma, LLC, Teva Pharmaceuticals USA, Inc., Medunik, E.R. Squibb & Sons ... product_ndc 69315-164, 0555-0882, 71770-105, 71770-100, 71770-120, 0003-0830, 0003-6335, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROXYUREARXCUI 197797, 283475, 1999308, 1999314, 1999316, 105602, 200342, 200343, 200344, 21328 ... spl_id eef5a554-b405-425e-a3a0-504f5d57498d, 56110b70-3541-42ef-a8a9-c1f59b6fcfb1, 84d4 ... spl_set_id 4c4e1c2f-2143-44f3-8825-aeba42e755e4, b9514ae5-79ae-4cc2-9d7f-c8f7806d1694, 7695 ... Package NDC 69315-164-01, 0555-0882-02, 71770-100-60, 71770-120-30, 71770-105-60, 0003-0830- ... NUIN0000180853, M0022315Established Pharmacologic ClassAntimetabolite [EPC]Chemical StructureUrea [CS]UNIIX6Q56QN5QC

6)

drugcharacterization1medicinalproductERLOTINIBdrugauthorizationnumb021743drugdosagetextUNK, UNKNOWN FREQ.drugdosageformTABLETdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameERLOTINIB

openFDA Info on Medication

Application NumberANDA211960, ANDA213065, ANDA208488, ANDA210300, ANDA091059Brand NameERLOTINIBGeneric NameERLOTINIB HYDROCHLORIDE, ERLOTINIBManufacturers Armas Pharmaceuticals Inc., Cadila Healthcare Limited, Breckenridge Pharmaceutic ... product_ndc 72485-217, 70771-1521, 70771-1522, 70771-1523, 51991-890, 51991-891, 51991-892, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERLOTINIB HYDROCHLORIDE, ERLOTINIBRXCUI603208, 603203, 603206spl_id 35e3a161-752e-4479-b27c-3dc8efd3ca9e, 5624fa69-eae5-43bf-aa7e-379266edd77f, b219 ... spl_set_id 53cf8868-cfd8-4c6e-ad9d-3171ff1e4d8c, daaa1329-3a3f-439c-b13d-b301daa234d4, 3527 ... Package NDC 72485-217-30, 70771-1521-3, 70771-1521-9, 70771-1521-2, 70771-1521-7, 70771-1522 ... UNIIDA87705X9K, J4T82NDH7ENUIN0000175605, N0000175076Established Pharmacologic ClassKinase Inhibitor [EPC]Mechanism of ActionProtein Kinase Inhibitors [MoA]

7)

drugcharacterization1medicinalproductAVASTINdrugstructuredosagenumb245drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformFORMULATION UNKNOWNdrugadministrationroute042drugindicationBRAIN NEOPLASM MALIGNANTdrugstartdateformat102drugstartdate12/07/2006drugenddateformat102drugenddate06/09/2006

activesubstance

activesubstancenameBEVACIZUMAB

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

8)

drugcharacterization2medicinalproductVERAPAMILdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameVERAPAMIL HYDROCHLORIDE

9)

drugcharacterization2medicinalproductPROVIGILdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameMODAFINIL

openFDA Info on Medication

Application NumberNDA020717Brand NamePROVIGILGeneric NameMODAFINILManufacturersCephalon, Inc.product_ndc63459-101, 63459-201Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMODAFINILRXCUI205324, 213471, 226426, 260218spl_id72cde307-ca84-487d-a2df-2a04935edd3aspl_set_ide16c26ad-7bc2-d155-3a5d-da83ad6492c8Package NDC63459-101-01, 63459-101-30, 63459-201-01, 63459-201-30NUIN0000175729, N0000175651, N0000175769Physiologic/Pharmacodynamic EffectCentral Nervous System Stimulation [PE], Increased Sympathetic Activity [PE]Established Pharmacologic ClassSympathomimetic-like Agent [EPC]UNIIR3UK8X3U3D

10)

drugcharacterization2medicinalproductKEPPRAdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameLEVETIRACETAM

openFDA Info on Medication

Application NumberNDA021872, NDA021505, NDA021035, NDA022285Brand NameKEPPRA, KEPPRA XRGeneric NameLEVETIRACETAMManufacturersUCB, Inc.product_ndc 50474-002, 50474-001, 50474-594, 50474-595, 50474-596, 50474-597, 50474-598, 504 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsLEVETIRACETAMRXCUI 647121, 647123, 261335, 261336, 284391, 311288, 311289, 311290, 387003, 403884, ... spl_id 4a48c061-40c9-41d9-be30-e9521c3e03b5, f5f32bff-c998-43b5-920c-02f3fea3b46b, d6d8 ... spl_set_id c6d5784d-abf9-45fe-ac5a-d5c53bd50f7e, 3ca9df05-a506-4ec8-a4fe-320f1219ab21, 2919 ... Package NDC 50474-002-63, 50474-594-40, 50474-595-40, 50474-596-40, 50474-597-66, 50474-001- ... NUIN0000008486Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII44YRR34555

11)

drugcharacterization2medicinalproductETOPOSIDE.drugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameETOPOSIDE

openFDA Info on Medication

Application NumberANDA074513, ANDA074290, ANDA074529, ANDA075635, ANDA074983Brand NameETOPOSIDE, TOPOSARGeneric NameETOPOSIDEManufacturers Accord Healthcare Inc., Hikma Pharmaceuticals USA Inc., Teva Parenteral Medicine ... product_ndc 16729-114, 0143-9376, 0703-5653, 0703-5656, 0703-5657, 68001-265, 0143-9510, 014 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsETOPOSIDERXCUI310248, 206831, 197687spl_id aedd6610-7160-2001-e053-2995a90a16cf, 59f81d09-9385-478e-a1d7-19588a08a239, ac6e ... spl_set_id 4f850eb2-3542-43a0-90e8-bb37fa05cf15, e0cd61b9-2375-4e3d-a610-d87dad962468, c908 ... Package NDC 16729-114-31, 16729-114-32, 16729-114-08, 16729-114-11, 0143-9376-01, 0703-5653- ... NUIN0000175609, N0000000176Established Pharmacologic ClassTopoisomerase Inhibitor [EPC]Mechanism of ActionTopoisomerase Inhibitors [MoA]UNII6PLQ3CP4P3

Report Duplicate

duplicatesourceASTELLASduplicatenumbUS-ASTELLAS-2015US007573

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use