Adverse Event Report

Report

Version of Safety Report ID5Safety Report ID10434542primarysourcecountryJPoccurcountryJPtransmissiondateformat102transmissiondate21/08/2015reporttype2serious1seriousnessdeath1seriousnesslifethreatening1receivedateformat102Date Received05/09/2014receiptdateformat102Date Last Updated11/05/2015fulfillexpeditecriteria1companynumbJP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-41006NBduplicate1

Report Duplicate

duplicatesourceBOEHRINGER INGELHEIMduplicatenumbJP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-41006NB

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age65Unit of Onset AgeyearsWeight51SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionHaemoptysisOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionPneumoniaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.0ReactionPulmonary oedemaOutcomeFatal

4)

reactionmeddraversionpt18.0ReactionDrug effect incompleteOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductGILOTRIFdrugauthorizationnumb201292drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MGdrugdosageformFILM COATED TABLETdrugadministrationroute065drugindicationLUNG ADENOCARCINOMAdrugstartdateformat102drugstartdate19/08/2014drugenddateformat102drugenddate25/08/2014actiondrug1

activesubstance

activesubstancenameAFATINIB

openFDA Info on Medication

Application NumberNDA201292Brand NameGILOTRIFGeneric NameAFATINIBManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0137, 0597-0141, 0597-0138Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAFATINIBRXCUI1430446, 1430449, 1430451, 1430453, 1430455, 1430457spl_id256c019d-6658-43f0-8ec5-2dee75f0e92dspl_set_idfd638e5e-8032-e7ca-0179-95e96ab5d387Package NDC0597-0141-30, 0597-0137-30, 0597-0137-90, 0597-0138-30, 0597-0138-95NUIN0000175605, N0000175076Established Pharmacologic ClassKinase Inhibitor [EPC]Mechanism of ActionProtein Kinase Inhibitors [MoA]UNII41UD74L59M

2)

drugcharacterization2medicinalproductMAXIPIMEdrugstructuredosagenumb2drugstructuredosageunit002drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 GdrugdosageformINJECTIONdrugadministrationroute042drugindicationPNEUMONIAdrugstartdateformat102drugstartdate25/08/2014drugenddateformat102drugenddate26/08/2014

activesubstance

activesubstancenameCEFEPIME HYDROCHLORIDE

3)

drugcharacterization2medicinalproductPREPENONdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MGdrugdosageformINJECTIONdrugadministrationroute042drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate19/08/2014

activesubstance

activesubstancenameMORPHINE HYDROCHLORIDE

4)

drugcharacterization2medicinalproductDEXARTdrugstructuredosagenumb6.6drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext6.6 MGdrugdosageformINJECTIONdrugadministrationroute042drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate14/08/2014drugenddateformat102drugenddate26/08/2014

activesubstance

activesubstancenameDEXAMETHASONE SODIUM PHOSPHATE

5)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MGdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate16/08/2014drugenddateformat102drugenddate26/08/2014

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

6)

drugcharacterization2medicinalproductTELEMINSOFTdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MGdrugadministrationroute054drugindicationCONSTIPATIONdrugstartdateformat102drugstartdate14/08/2014drugenddateformat102drugenddate26/08/2014

summary

narrativeincludeclinicalCASE EVENT DATE: 201408