Adverse Event Report

Report

reporttype2Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10055255serious1Date Last Updated03/04/2014receiptdateformat102companynumbUS-ROCHE-1374976occurcountryUSseriousnessother1duplicate1Date Received03/04/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Weight55.84SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionLung neoplasm malignantOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionLoss of consciousnessOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionFallOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionEye painOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionVisual acuity reducedOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionBalance disorderOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionWeight decreasedOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionHallucination, visualOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductLUCENTISdrugauthorizationnumb125156drugdosagetextA FEW YEAR AGOdrugadministrationroute065drugindicationAGE-RELATED MACULAR DEGENERATIONactiondrug5

openFDA Info on Medication

Application NumberBLA125156Brand NameLUCENTISGeneric NameRANIBIZUMABManufacturersGenentech, Inc.product_ndc50242-080, 50242-082Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVITREALActive IngredientsRANIBIZUMABRXCUI643193, 644301, 1306074, 1306076, 1864423, 1864425, 2045501, 2045502spl_idd9d384c9-63ec-44a5-8e41-23975ba171cespl_set_idde4e66cc-ca05-4dc9-8262-e00e9b41c36dPackage NDC 50242-080-01, 50242-080-03, 50242-080-02, 50242-080-86, 50242-080-88, 50242-082- ... NUIN0000193542, N0000193543Mechanism of ActionVascular Endothelial Growth Factor Inhibitors [MoA]Established Pharmacologic ClassVascular Endothelial Growth Factor Inhibitor [EPC]UNIIZL1R02VT79

2)

drugcharacterization2medicinalproductGABAPENTINdrugindicationCONVULSION

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

3)

drugcharacterization2medicinalproductFLEXERIL (UNITED STATES)drugindicationMUSCLE SPASMS

4)

drugcharacterization2medicinalproductZOLOFTdrugindicationDEPRESSION

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

5)

drugcharacterization2medicinalproductLORAZEPAMdrugindicationANXIETY

openFDA Info on Medication

Application Number ANDA076150, NDA018140, ANDA203572, ANDA074282, ANDA072755, ANDA090260, ANDA07502 ... Brand NameLORAZEPAM, ATIVANGeneric NameLORAZEPAMManufacturers International Medication Systems, Limited, West-Ward Pharmaceuticals Corp., Auro ... product_ndc 76329-8261, 0641-6207, 13107-083, 13107-084, 13107-085, 0409-6778, 0054-3532, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsLORAZEPAMRXCUI 238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 763028, 763029 ... spl_id decb713d-bc45-4bf5-8f61-c0e2f23051b0, eb500b8e-b94e-4900-bc8a-8217fc718704, e1fa ... spl_set_id 7dda070d-7809-46c4-8592-eb4e4c509707, b79b38ee-c29d-4099-964f-000031f47f5a, 5b85 ... Package NDC 76329-8261-1, 0641-6207-01, 0641-6207-25, 13107-083-10, 13107-083-01, 13107-083- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

Report Duplicate

duplicatesourceROCHEduplicatenumbUS-ROCHE-1374976

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use