Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11009577primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/08/2015reporttype2serious1seriousnessdeath1seriousnessother1receivedateformat102Date Received10/04/2015receiptdateformat102Date Last Updated10/04/2015fulfillexpeditecriteria1companynumbUS-ASTELLAS-2015US011006duplicate1

Report Duplicate

duplicatesourceASTELLASduplicatenumbUS-ASTELLAS-2015US011006

Primary Source

reportercountryGBqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionVasogenic cerebral oedemaOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionLymphocytosisOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionDizzinessOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionMalignant neoplasm progressionOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionContusionOutcomeUnknown

6)

reactionmeddraversionpt18.0ReactionBalance disorderOutcomeUnknown

7)

reactionmeddraversionpt18.0ReactionVisual acuity reducedOutcomeUnknown

8)

reactionmeddraversionpt18.0ReactionDisturbance in attentionOutcomeUnknown

9)

reactionmeddraversionpt18.0ReactionHaematomaOutcomeUnknown

10)

reactionmeddraversionpt18.0ReactionOff label useOutcomeUnknown

11)

reactionmeddraversionpt18.0ReactionMuscular weaknessOutcomeUnknown

12)

reactionmeddraversionpt18.0ReactionCoughOutcomeUnknown

13)

reactionmeddraversionpt18.0ReactionBrain oedemaOutcomeUnknown

14)

reactionmeddraversionpt18.0ReactionConstipationOutcomeUnknown

15)

reactionmeddraversionpt18.0ReactionDyspnoeaOutcomeUnknown

16)

reactionmeddraversionpt18.0ReactionDeathOutcomeFatal

17)

reactionmeddraversionpt18.0ReactionPoor quality sleepOutcomeUnknown

18)

reactionmeddraversionpt18.0ReactionPetechiaeOutcomeUnknown

19)

reactionmeddraversionpt18.0ReactionNasal ulcerOutcomeUnknown

20)

reactionmeddraversionpt18.0ReactionVisual impairmentOutcomeUnknown

21)

reactionmeddraversionpt18.0ReactionBack painOutcomeUnknown

22)

reactionmeddraversionpt18.0ReactionBone painOutcomeUnknown

23)

reactionmeddraversionpt18.0ReactionAstheniaOutcomeUnknown

24)

reactionmeddraversionpt18.0ReactionChest painOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductAVASTINdrugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformFORMULATION UNKNOWNdrugadministrationroute042drugindicationLUNG NEOPLASM MALIGNANTdrugstartdateformat102drugstartdate13/06/2005

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

2)

drugcharacterization1medicinalproductAVASTINdrugdosageformFORMULATION UNKNOWNdrugindicationRENAL CANCER

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

3)

drugcharacterization2medicinalproductDECADRONdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameDEXAMETHASONE

4)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

5)

drugcharacterization2medicinalproductTEMAZEPAM.drugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameTEMAZEPAM

openFDA Info on Medication

Application Number ANDA203482, ANDA071620, ANDA211542, ANDA071456, ANDA071457, ANDA201781, ANDA0785 ... Brand NameTEMAZEPAM, RESTORILGeneric NameTEMAZEPAMManufacturers Amneal Pharmaceuticals LLC, Actavis Pharma, Inc., Alembic Pharmaceuticals Limite ... product_ndc 65162-556, 65162-583, 65162-584, 65162-557, 0228-2076, 0228-2077, 46708-379, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTEMAZEPAMRXCUI198241, 198242, 198243, 485489, 208463, 208464, 208465, 539384spl_id 59b42c1d-f7af-495b-a68e-aba450acc091, 588073ce-4e6f-40fb-bd1f-26fd40c7589f, 2676 ... spl_set_id be68c6e0-17ad-40fe-9bc1-58abe24b53f6, a4370eb4-b00d-4247-af8d-980e59fbbec6, db83 ... Package NDC 65162-583-03, 65162-583-10, 65162-583-50, 65162-583-11, 65162-556-03, 65162-556- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIICHB1QD2QSS

6)

drugcharacterization1medicinalproductERLOTINIBdrugauthorizationnumb021743drugstructuredosagenumb100drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048drugindicationPRODUCT 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)

drugcharacterization2medicinalproductACYCLOVIR /00587301/drugstructuredosagenumb200drugstructuredosageunit003drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameACYCLOVIR