Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10932829primarysourcecountryUStransmissiondateformat102transmissiondate21/07/2015reporttype1serious2receivedateformat102Date Received19/03/2015receiptdateformat102Date Last Updated19/03/2015fulfillexpeditecriteria2companynumb2014CT000197duplicate1

Report Duplicate

duplicatesourceCORCEPTduplicatenumb2014CT000197

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age48Unit of Onset AgeyearsWeight77.11SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionLack of spontaneous speech

2)

reactionmeddraversionpt18.0ReactionImpaired self-care

3)

reactionmeddraversionpt18.0ReactionWeight decreased

4)

reactionmeddraversionpt18.0ReactionSeizure

5)

reactionmeddraversionpt18.0ReactionGait disturbance

6)

reactionmeddraversionpt18.0ReactionFacial paresis

7)

reactionmeddraversionpt18.0ReactionTremor

8)

reactionmeddraversionpt18.0ReactionUrinary tract infection

9)

reactionmeddraversionpt18.0ReactionAmnesia

Drug

1)

drugcharacterization1medicinalproductKORLYMdrugauthorizationnumb202107drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition804drugadministrationroute048drugindicationCUSHING^S SYNDROMEdrugstartdateformat102drugstartdate24/07/2014drugadditional1

activesubstance

activesubstancenameMIFEPRISTONE

openFDA Info on Medication

Application NumberNDA202107Brand NameKORLYMGeneric NameMIFEPRISTONEManufacturersCorcept Therapeuticsproduct_ndc76346-073Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMIFEPRISTONERXCUI1245262, 1245268spl_id2ac2f6a0-8e01-4af5-8d1b-543e70d97cd7spl_set_id542f3fae-8bc8-4f00-9228-e4b66c9ad6a9Package NDC76346-073-01, 76346-073-02NUIN0000000115, N0000175841Mechanism of ActionProgestational Hormone Receptor Antagonists [MoA]Established Pharmacologic ClassProgestin Antagonist [EPC]UNII320T6RNW1F

2)

drugcharacterization2medicinalproductCYMBALTA

activesubstance

activesubstancenameDULOXETINE HYDROCHLORIDE

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)

drugcharacterization2medicinalproductLUNESTA

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

4)

drugcharacterization2medicinalproductABILIFY

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

5)

drugcharacterization2medicinalproductLOSARTAN

activesubstance

activesubstancenameLOSARTAN

6)

drugcharacterization2medicinalproductASA

activesubstance

activesubstancenameASPIRIN

summary

narrativeincludeclinicalCASE EVENT DATE: 20141107