Adverse Event Report

Report

Version of Safety Report ID4Safety Report ID10299185primarysourcecountryJPoccurcountryJPtransmissiondateformat102transmissiondate26/03/2015reporttype1serious1seriousnessdeath1seriousnessother1receivedateformat102Date Received11/07/2014receiptdateformat102Date Last Updated13/08/2014fulfillexpeditecriteria1companynumbJP-BRISTOL-MYERS SQUIBB COMPANY-21194535duplicate1

Report Duplicate

duplicatesourceBRISTOL MYERS SQUIBBduplicatenumbJP-BRISTOL-MYERS SQUIBB COMPANY-21194535

Primary Source

reportercountryJPqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age46Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionDeliriumOutcomeFatal

2)

reactionmeddraversionpt17.1ReactionCardiac hypertrophyOutcomeUnknown

3)

reactionmeddraversionpt17.1ReactionPyrexiaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductABILIFYdrugstructuredosagenumb24drugstructuredosageunit003drugdosagetextABILIFY 12MG TABSdrugdosageformTABLETdrugadministrationroute048drugindicationBIPOLAR DISORDERdrugstartdateformat102drugstartdate03/07/2014

activesubstance

activesubstancenameARIPIPRAZOLE

openFDA Info on Medication

Application NumberNDA021436Brand NameABILIFYGeneric NameARIPIPRAZOLEManufacturersOtsuka America Pharmaceutical, Inc.product_ndc 59148-006, 59148-007, 59148-008, 59148-009, 59148-010, 59148-011, 59148-013, 591 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsARIPIPRAZOLERXCUI 349490, 349545, 349547, 349553, 352307, 352308, 352309, 352310, 402131, 404602, ... spl_idfa6e0346-2760-404e-bfea-23fc6403cdffspl_set_idc040bd1d-45b7-49f2-93ea-aed7220b30acPackage NDC 59148-006-13, 59148-006-92, 59148-007-13, 59148-007-35, 59148-007-94, 59148-008- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNII82VFR53I78

2)

drugcharacterization1medicinalproductREMERONdrugstructuredosagenumb45drugstructuredosageunit003drugdosagetextINTRPTD ON 03JUL14: 15MG?TABS;30MG:15MAY2014-28MAY2014drugadministrationroute048drugstartdateformat102drugstartdate08/05/2014drugenddateformat102drugenddate03/07/2014actiondrug1

activesubstance

activesubstancenameMIRTAZAPINE

openFDA Info on Medication

Application NumberNDA020415Brand NameREMERONGeneric NameMIRTAZAPINEManufacturersOrganon LLCproduct_ndc78206-160, 78206-161, 78206-156, 78206-158, 78206-159Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMIRTAZAPINEspl_id3dc49c6b-23a6-41ed-909e-98b5c179130fspl_set_id98ad1917-a094-44f5-a28f-a64a8cfcd887Package NDC 78206-160-01, 78206-161-01, 78206-156-99, 78206-156-01, 78206-158-99, 78206-158- ... UNIIA051Q2099Q

3)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextTABSdrugadministrationroute048drugstartdateformat102drugstartdate03/07/2014

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20140704