Adverse Event Report

Report

reporttype2Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10524517serious1Date Last Updated17/10/2014receiptdateformat102seriousnessdeath1companynumbUS-CELGENE-USA-2014102867occurcountryUSseriousnessother1duplicate1Date Received17/10/2014transmissiondate28/05/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification3literaturereference PENAS-PRADO M, FISCH M, LAGRONE L. RANDOMIZED PHASE II ADJUVANT FACTORIAL STUDY ...

Patient

Reaction

1)

reactionmeddraversionpt18.0ReactionMuscular weaknessOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionHypertriglyceridaemiaOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionErythema multiformeOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionSyncopeOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionHaemoglobin decreasedOutcomeUnknown

6)

reactionmeddraversionpt18.0ReactionHeadacheOutcomeUnknown

7)

reactionmeddraversionpt18.0ReactionGastrointestinal disorderOutcomeUnknown

8)

reactionmeddraversionpt18.0ReactionSinus bradycardiaOutcomeUnknown

9)

reactionmeddraversionpt18.0ReactionEmbolismOutcomeUnknown

10)

reactionmeddraversionpt18.0ReactionBlood cholesterol increasedOutcomeUnknown

11)

reactionmeddraversionpt18.0ReactionPulmonary embolismOutcomeFatal

12)

reactionmeddraversionpt18.0ReactionWhite blood cell count decreasedOutcomeUnknown

13)

reactionmeddraversionpt18.0ReactionNeutrophil count decreasedOutcomeUnknown

14)

reactionmeddraversionpt18.0ReactionRashOutcomeUnknown

15)

reactionmeddraversionpt18.0ReactionPyrexiaOutcomeUnknown

16)

reactionmeddraversionpt18.0ReactionConstipationOutcomeUnknown

17)

reactionmeddraversionpt18.0ReactionPain in extremityOutcomeUnknown

18)

reactionmeddraversionpt18.0ReactionNervous system disorderOutcomeUnknown

19)

reactionmeddraversionpt18.0ReactionLymphopeniaOutcomeUnknown

20)

reactionmeddraversionpt18.0ReactionBlood disorderOutcomeUnknown

21)

reactionmeddraversionpt18.0ReactionAlanine aminotransferase increasedOutcomeUnknown

22)

reactionmeddraversionpt18.0ReactionDyspnoeaOutcomeUnknown

23)

reactionmeddraversionpt18.0ReactionAtaxiaOutcomeUnknown

24)

reactionmeddraversionpt18.0ReactionAspartate aminotransferase increasedOutcomeUnknown

25)

reactionmeddraversionpt18.0ReactionInfectionOutcomeUnknown

26)

reactionmeddraversionpt18.0ReactionFatigueOutcomeUnknown

27)

reactionmeddraversionpt18.0ReactionPlatelet count decreasedOutcomeUnknown

28)

reactionmeddraversionpt18.0ReactionLaboratory test abnormalOutcomeUnknown

29)

reactionmeddraversionpt18.0ReactionPneumonitisOutcomeUnknown

30)

reactionmeddraversionpt18.0ReactionOpportunistic infectionOutcomeUnknown

31)

reactionmeddraversionpt18.0ReactionDizzinessOutcomeUnknown

32)

reactionmeddraversionpt18.0ReactionGranulocyte count decreasedOutcomeUnknown

33)

reactionmeddraversionpt18.0ReactionLung disorderOutcomeUnknown

34)

reactionmeddraversionpt18.0ReactionWeight decreasedOutcomeUnknown

35)

reactionmeddraversionpt18.0ReactionDry skinOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductTEMOZOLOMIDE.drugstructuredosagenumb75drugstructuredosageunit009drugdosageformUNKNOWNdrugadministrationroute065drugindicationGLIOBLASTOMAactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameTEMOZOLOMIDE

openFDA Info on Medication

Application Number ANDA203898, ANDA201528, ANDA203490, ANDA206309, NDA021029, NDA022277, ANDA206750 ... Brand NameTEMOZOLOMIDE, TEMODARGeneric NameTEMOZOLOMIDEManufacturers Lannett Company, Inc., Accord Healthcare Inc., ANI Pharmaceuticals, Inc., Rising ... product_ndc 62175-240, 62175-241, 62175-242, 62175-243, 62175-244, 62175-245, 16729-048, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsTEMOZOLOMIDERXCUI 313209, 313210, 313211, 317160, 700883, 700885, 261288, 261289, 261290, 261291, ... spl_id b12e949c-4e4d-468f-b348-a63e89eb7d99, acd44f2e-b1d6-a584-e053-2a95a90a4785, 662b ... spl_set_id efca7a56-528c-4081-96ae-2927162d3b70, 2d599ccf-8e63-4ff1-aa52-4809744ea97a, 4311 ... Package NDC 62175-240-19, 62175-240-24, 62175-241-19, 62175-241-24, 62175-242-19, 62175-242- ... NUIN0000000236, N0000175558Mechanism of ActionAlkylating Activity [MoA]Established Pharmacologic ClassAlkylating Drug [EPC]UNIIYF1K15M17Y

2)

drugcharacterization1medicinalproductTEMOZOLOMIDE.drugstructuredosagenumb150drugstructuredosageunit009drugdosageformUNKNOWNdrugadministrationroute065actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameTEMOZOLOMIDE

openFDA Info on Medication

Application Number ANDA203898, ANDA201528, ANDA203490, ANDA206309, NDA021029, NDA022277, ANDA206750 ... Brand NameTEMOZOLOMIDE, TEMODARGeneric NameTEMOZOLOMIDEManufacturers Lannett Company, Inc., Accord Healthcare Inc., ANI Pharmaceuticals, Inc., Rising ... product_ndc 62175-240, 62175-241, 62175-242, 62175-243, 62175-244, 62175-245, 16729-048, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsTEMOZOLOMIDERXCUI 313209, 313210, 313211, 317160, 700883, 700885, 261288, 261289, 261290, 261291, ... spl_id b12e949c-4e4d-468f-b348-a63e89eb7d99, acd44f2e-b1d6-a584-e053-2a95a90a4785, 662b ... spl_set_id efca7a56-528c-4081-96ae-2927162d3b70, 2d599ccf-8e63-4ff1-aa52-4809744ea97a, 4311 ... Package NDC 62175-240-19, 62175-240-24, 62175-241-19, 62175-241-24, 62175-242-19, 62175-242- ... NUIN0000000236, N0000175558Mechanism of ActionAlkylating Activity [MoA]Established Pharmacologic ClassAlkylating Drug [EPC]UNIIYF1K15M17Y

3)

drugcharacterization2medicinalproductWARFARINdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameWARFARIN

openFDA Info on Medication

Application NumberANDA090935, ANDA202202Brand NameWARFARIN SODIUMGeneric NameWARFARINManufacturersExelan Pharmaceuticals Inc., Amneal Pharmaceuticals LLCproduct_ndc 76282-327, 76282-328, 76282-329, 76282-330, 76282-331, 76282-332, 76282-333, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsWARFARIN SODIUMRXCUI855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 855344spl_id45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5, f0ce7015-9133-4b90-a624-77fb776fbfa7spl_set_idc0cc4511-e656-4b6d-96cd-e02e76173b9d, 558b7a0d-5490-4c1b-802e-3ab3f1efe760Package NDC 76282-327-01, 76282-327-10, 76282-328-01, 76282-328-10, 76282-329-01, 76282-329- ... UNII6153CWM0CL

4)

drugcharacterization1medicinalproductTHALOMIDdrugauthorizationnumb020785drugstructuredosagenumb300drugstructuredosageunit003drugdosageformCapsulesdrugadministrationroute048actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameTHALIDOMIDE

openFDA Info on Medication

Application NumberNDA020785Brand NameTHALOMIDGeneric NameTHALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-205, 59572-210, 59572-215, 59572-220Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTHALIDOMIDERXCUI200390, 213360, 360176, 360177, 404449, 404450, 700416, 700418spl_id9e85c2fe-3d8f-4296-afc3-c2762a3e997fspl_set_id2eda833b-1357-4ed4-a093-194524fcb061Package NDC 59572-205-14, 59572-205-94, 59572-205-17, 59572-205-97, 59572-210-15, 59572-210- ... NUIN0000008663Physiologic/Pharmacodynamic EffectDecreased Immunologically Active Molecule Activity [PE]UNII4Z8R6ORS6L

5)

drugcharacterization1medicinalproductTHALOMIDdrugauthorizationnumb020785drugstructuredosagenumb400drugstructuredosageunit003drugdosageformCapsulesdrugadministrationroute048actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameTHALIDOMIDE

openFDA Info on Medication

Application NumberNDA020785Brand NameTHALOMIDGeneric NameTHALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-205, 59572-210, 59572-215, 59572-220Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTHALIDOMIDERXCUI200390, 213360, 360176, 360177, 404449, 404450, 700416, 700418spl_id9e85c2fe-3d8f-4296-afc3-c2762a3e997fspl_set_id2eda833b-1357-4ed4-a093-194524fcb061Package NDC 59572-205-14, 59572-205-94, 59572-205-17, 59572-205-97, 59572-210-15, 59572-210- ... NUIN0000008663Physiologic/Pharmacodynamic EffectDecreased Immunologically Active Molecule Activity [PE]UNII4Z8R6ORS6L

6)

drugcharacterization1medicinalproductISOTRETINOINdrugstructuredosagenumb40drugstructuredosageunit009drugdosageformUNKNOWNdrugadministrationroute048drugindicationGLIOBLASTOMAactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameISOTRETINOIN

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

7)

drugcharacterization1medicinalproductCELECOXIB.drugstructuredosagenumb400drugstructuredosageunit003drugdosageformUNKNOWNdrugadministrationroute048drugindicationGLIOBLASTOMAdrugrecurreadministration3

activesubstance

activesubstancenameCELECOXIB

openFDA Info on Medication

Application Number ANDA206827, ANDA202240, ANDA210071, ANDA213598, ANDA078857, ANDA207061, ANDA2074 ... Brand NameCELECOXIB, GENERIC DRUG, CELEBREX, ELYXYBGeneric NameCELECOXIBManufacturers Aurobindo Pharma Limited, Lupin Pharmaceuticals, Inc., Westminster Pharmaceutica ... product_ndc 65862-907, 65862-908, 65862-909, 65862-910, 68180-395, 68180-396, 68180-397, 681 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCELECOXIBRXCUI205322, 205323, 349514, 686379, 213468, 213469, 352314, 686381, 2373454, 2373460spl_id 2c7a25a6-20f1-4f77-b50b-69f7cbf7a61a, 333b6f4b-c4ec-4a14-bb70-bc255cedefa5, 43a1 ... spl_set_id 1e811c3a-5653-4617-b958-380802cc443a, 560017b1-daf8-464e-b86f-0a75c78002ec, cb0b ... Package NDC 65862-907-60, 65862-907-99, 65862-908-01, 65862-908-05, 65862-908-99, 65862-909- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIJCX84Q7J1L

8)

drugcharacterization1medicinalproductTHALOMIDdrugauthorizationnumb020785drugstructuredosagenumb200drugstructuredosageunit003drugdosageformCapsulesdrugadministrationroute048drugindicationGLIOBLASTOMAactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameTHALIDOMIDE

openFDA Info on Medication

Application NumberNDA020785Brand NameTHALOMIDGeneric NameTHALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-205, 59572-210, 59572-215, 59572-220Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTHALIDOMIDERXCUI200390, 213360, 360176, 360177, 404449, 404450, 700416, 700418spl_id9e85c2fe-3d8f-4296-afc3-c2762a3e997fspl_set_id2eda833b-1357-4ed4-a093-194524fcb061Package NDC 59572-205-14, 59572-205-94, 59572-205-17, 59572-205-97, 59572-210-15, 59572-210- ... NUIN0000008663Physiologic/Pharmacodynamic EffectDecreased Immunologically Active Molecule Activity [PE]UNII4Z8R6ORS6L

Report Duplicate

duplicatesourceCELGENEduplicatenumbUS-CELGENE-USA-2014102867

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use