Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10363416primarysourcecountryUStransmissiondateformat102transmissiondate02/10/2014reporttype1serious1seriousnesshospitalization1receivedateformat102Date Received06/03/2014receiptdateformat102Date Last Updated06/03/2014fulfillexpeditecriteria2companynumb163-21880-13061820duplicate1

Report Duplicate

duplicatesourceCELGENEduplicatenumb163-21880-13061820

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age66Unit of Onset AgeyearsWeight83.9SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionPneumonia

Drug

1)

drugcharacterization1medicinalproductREVLIMID (LENALIDOMIDE) (25 MILLIGRAM, CAPSULES)drugbatchnumbA0215Adrugauthorizationnumb21880drugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationPLASMA CELL MYELOMAdrugstartdateformat610drugstartdate/11/2008

2)

drugcharacterization2medicinalproductCYMBALTA

openFDA Info on Medication

Application NumberNDA021427Brand NameCYMBALTAGeneric NameDULOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3235, 0002-3240, 0002-3270Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDULOXETINE HYDROCHLORIDERXCUI596926, 596928, 596930, 596932, 596934, 615186spl_id892f05de-dd11-4ae3-9a85-ce9cfcbeaaccspl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

3)

drugcharacterization2medicinalproductCALCITRIOL (CAPSULES)

4)

drugcharacterization2medicinalproductAMLODIPINE BESYLATE (TABLETS)

5)

drugcharacterization2medicinalproductVALACYCLOVIR HCL (VALACICLOVIR HYDROCHLORIDE) (TABLETS)

6)

drugcharacterization2medicinalproductDEXAMETHASONE (TABLETS)

7)

drugcharacterization2medicinalproductLYRICA (PREGABALIN) (CAPSULES)

8)

drugcharacterization2medicinalproductPROCHLORPERAZINE (TABLETS)

9)

drugcharacterization2medicinalproductTOPROL XL (METOPROLOL SUCCINATE) (TABLETS)

10)

drugcharacterization2medicinalproductNEXIUM (ESOMEPRAZOLE) (CAPSULES)

11)

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

12)

drugcharacterization2medicinalproductOXYCONTIN (OXYCODONE HYDROCHLORIDE) (TABLETS)

13)

drugcharacterization2medicinalproductRENAGEL (SEVELAMER HYDROCHLORIDE) (TABLETS)

14)

drugcharacterization2medicinalproductVELCADE (BORTEZOMIB)

15)

drugcharacterization2medicinalproductASPIRINE (ACETYLSALICYLIC ACID) (CHEWABLE TABLET)