Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10373687primarysourcecountryUStransmissiondateformat102transmissiondate02/10/2014reporttype1serious1seriousnessother1receivedateformat102Date Received06/03/2014receiptdateformat102Date Last Updated06/03/2014fulfillexpeditecriteria2companynumb163-21880-13071798duplicate1

Report Duplicate

duplicatesourceCELGENEduplicatenumb163-21880-13071798

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age73Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionHead injury

2)

reactionmeddraversionpt17.0ReactionMemory impairment

3)

reactionmeddraversionpt17.0ReactionDrug dose omission

4)

reactionmeddraversionpt17.0ReactionFall

5)

reactionmeddraversionpt17.0ReactionDry eye

Drug

1)

drugcharacterization1medicinalproductREVLIMID (LENALIDOMIDE) (15 MILLIGRAM CAPSULES)drugbatchnumbA0189Bdrugauthorizationnumb21880drugstructuredosagenumb15drugstructuredosageunit003drugdosagetext21 IN 28 Ddrugadministrationroute048drugindicationPLASMA CELL MYELOMAdrugstartdateformat102drugstartdate03/01/2013

2)

drugcharacterization2medicinalproductAMLODIPINE BESYLATE (AMLODIPINE BESYLATE)

3)

drugcharacterization2medicinalproductPROMETHAZINE (PROMETHAZINE)

4)

drugcharacterization2medicinalproductASPIRIN (ACETYLSALICYLIC ACID) (ENTERIC-COATED TABLET)

5)

drugcharacterization2medicinalproductWARFARIN (WARFARIN)

6)

drugcharacterization2medicinalproductLUNESTA

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

7)

drugcharacterization2medicinalproductCOMPLETE MULTIVITAMINS (MULTIVITAMINS) (UNKNOWN)