Adverse Event Report

Report

reporttype2Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10245263serious1Date Last Updated18/06/2014receiptdateformat102seriousnessdeath1companynumbUS-ROCHE-1415768occurcountryUSseriousnessother1duplicate1Date Received18/06/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

SexUnknown

Reaction

1)

reactionmeddraversionpt17.0ReactionPancreatitisOutcomeFatal

2)

reactionmeddraversionpt17.0ReactionLeukopeniaOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionNeutropeniaOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionAmylase increasedOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionLipase increasedOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionAnaemiaOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionHypotensionOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionFatigueOutcomeUnknown

9)

reactionmeddraversionpt17.0ReactionDehydrationOutcomeUnknown

10)

reactionmeddraversionpt17.0ReactionDysphagiaOutcomeUnknown

11)

reactionmeddraversionpt17.0ReactionVomitingOutcomeUnknown

12)

reactionmeddraversionpt17.0ReactionBlood alkaline phosphatase increasedOutcomeUnknown

13)

reactionmeddraversionpt17.0ReactionAspartate aminotransferase increasedOutcomeUnknown

14)

reactionmeddraversionpt17.0ReactionAlanine aminotransferase increasedOutcomeUnknown

15)

reactionmeddraversionpt17.0ReactionFebrile neutropeniaOutcomeUnknown

16)

reactionmeddraversionpt17.0ReactionNeutropenic infectionOutcomeUnknown

17)

reactionmeddraversionpt17.0ReactionInfectionOutcomeUnknown

18)

reactionmeddraversionpt17.0ReactionHypertriglyceridaemiaOutcomeUnknown

19)

reactionmeddraversionpt17.0ReactionHypokalaemiaOutcomeUnknown

20)

reactionmeddraversionpt17.0ReactionHyponatraemiaOutcomeUnknown

21)

reactionmeddraversionpt17.0ReactionMuscular weaknessOutcomeUnknown

22)

reactionmeddraversionpt17.0ReactionPeripheral motor neuropathyOutcomeUnknown

23)

reactionmeddraversionpt17.0ReactionCoughOutcomeUnknown

24)

reactionmeddraversionpt17.0ReactionDyspnoeaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductINTERFERON ALFA-2Adrugauthorizationnumb103145drugdosagetext6 MILLION UNITS/M2 ON DAYS 1 AND 2 OF EACH WEEK FOR 6 WEEKSdrugadministrationroute058drugindicationSMALL CELL LUNG CANCER RECURRENT

openFDA Info on Medication

Brand NameGUNA-INF ALPHAGeneric NameINTERFERON ALFA-2AManufacturersGuna spaproduct_ndc17089-456Product TypeHUMAN OTC DRUGRouteORALActive IngredientsINTERFERON ALFA-2Aspl_id7e91f7fb-2a2f-4682-e053-2991aa0a1c5cspl_set_idf96495b5-1ffe-432c-adcf-b2db9cfd1405Package NDC17089-456-18NUIM0025711, N0000175521Chemical StructureInterferon-alpha [CS]Established Pharmacologic ClassInterferon alpha [EPC]UNII47RRR83SK7

2)

drugcharacterization1medicinalproductISOTRETINOINdrugstructuredosagenumb1drugstructuredosageunit007drugdosagetextON DAYS 1 AND 2 OF EACH WEEK FOR 6 WEEKSdrugadministrationroute048drugindicationSMALL CELL LUNG CANCER RECURRENT

openFDA Info on Medication

Application Number NDA211913, NDA021951, ANDA202099, ANDA076356, ANDA076135, ANDA075945, ANDA076485 ... Brand Name ABSORICA LD, ABSORICA, ZENATANE, ACCUTANE, CLARAVIS, ISOTRETINOIN, AMNESTEEM, MY ... Generic NameISOTRETINOINManufacturers Sun Pharmaceutical Industries, Inc., Dr. Reddy's Laboratories Limited, JG Pharma ... product_ndc 10631-002, 10631-115, 10631-116, 10631-117, 10631-118, 10631-133, 10631-134, 106 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI 197843, 197844, 197845, 403930, 1299203, 1300006, 1300014, 1300016, 1547561, 154 ... spl_id a8d4793a-5043-40e1-b623-35812733499f, 1f5178c1-0f6f-824d-d0ee-1b973377ccc6, a599 ... spl_set_id 3ef0cff8-19c1-4441-b780-fca6c7ee1615, 27b3cf26-f22e-5b70-1c24-009933b7c6ee, a41c ... Package NDC 10631-115-69, 10631-115-31, 10631-116-69, 10631-116-31, 10631-117-69, 10631-117- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

3)

drugcharacterization1medicinalproductPACLITAXELdrugstructuredosagenumb75drugstructuredosageunit009drugdosagetextON DAY 2 OF EACH WEEK FOR 6 WEEKSdrugadministrationroute042drugindicationSMALL CELL LUNG CANCER RECURRENT

openFDA Info on Medication

Application Number NDA021660, NDA020262, ANDA075184, ANDA076131, ANDA090130, ANDA207326, ANDA213434 ... Brand NameABRAXANE, PACLITAXEL, PACLITAXEL PACLITAXELGeneric NamePACLITAXELManufacturers Abraxis BioScience, LLC, WG Critical Care, LLC, Teva Parenteral Medicines, Inc., ... product_ndc 68817-134, 44567-504, 44567-505, 44567-506, 0703-3213, 0703-3216, 0703-3218, 617 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsPACLITAXELRXCUI583214, 583218, 312199spl_id ded1c865-fae3-449f-b76f-5776d2281ab7, 0ebbb53f-8a07-4843-bb37-2110e16e1f3e, 18ee ... spl_set_id 24d10449-2936-4cd3-b7db-a7683db721e4, 4dbbb7c8-a4b5-484d-a2a4-4d925010fc44, fbd3 ... Package NDC 68817-134-50, 44567-504-01, 44567-505-01, 44567-506-01, 0703-3213-81, 0703-3216- ... NUIN0000175085, N0000175592Physiologic/Pharmacodynamic EffectMicrotubule Inhibition [PE]Established Pharmacologic ClassMicrotubule Inhibitor [EPC]UNIIP88XT4IS4D

Report Duplicate

duplicatesourceROCHEduplicatenumbUS-ROCHE-1415768

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use