Myelosuppression
Drugs: VENETOCLAX, DECITABINE
- Safetyreportversion
- 1
- Safetyreportid
- 27325212
- Primarysourcecountry
- CN
- Occurcountry
- CN
- Transmissiondateformat
- 102
- Transmissiondate
- 20261010
- Reporttype
- 1
- Serious
- 1
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 2
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 1
- Receivedateformat
- 102
- Receivedate
- 20260930
- Receiptdateformat
- 102
- Receiptdate
- 20260930
- Fulfillexpeditecriteria
- 1
- Companynumb
- CN-ABBVIE-6954370
- Duplicate
- 1
- Reportduplicate
- Duplicatesource
- Health authority
- Duplicatenumb
- TA26-1021982-AE00
- Duplicatesource
- Health authority
- Duplicatenumb
- 15541494748073164809207
- Primarysource
- Reportercountry
- CN
- Qualification
- 1
- Sender
- Sendertype
- 6
- Senderorganization
- ABBVIE
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 65
- Patientonsetageunit
- 801
- Patientweight
- 47
- Patientsex
- 2
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Myelosuppression
- Reactionoutcome
- 2
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- VENETOCLAX
- Drugbatchnumb
- 1356158
- Drugauthorizationnumb
- 208573
- Drugstructuredosagenumb
- 200
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- 200 MILLIGRAM
- Drugdosageform
- Tablet
- Drugindication
- Acute myeloid leukaemia
- Drugstartdateformat
- 102
- Drugstartdate
- 20260907
- Drugenddateformat
- 102
- Drugenddate
- 20260915
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- VENETOCLAX
- Harmonized identifiers (openFDA)
- Application number
- NDA208573
- Brand name
- VENCLEXTA
- Generic name
- VENETOCLAX
- Manufacturer name
- AbbVie Inc.
- Product NDC
- 0074-0561, 0074-0579, 0074-0576, 0074-0566
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- VENETOCLAX
- RxCUI
- 1747561, 1747567, 1747572, 1747574, 1747575, 1747577, 1747579, 1747580
- SPL ID
- 5d893369-497c-46ee-9b64-ee737fab4225
- SPL set ID
- b118a40d-6b56-cee3-10f6-ded821a97018
- Package NDC
- 0074-0579-28, 0074-0576-22, 0074-0576-11, 0074-0576-34, 0074-0576-30, 0074-0561-14, 0074-0561-11, 0074-0566-07, 0074-0566-11
- Nui
- N0000192515, N0000009176, N0000185503
- Pharm class epc
- BCL-2 Inhibitor [EPC]
- Pharm class pe
- Increased Cellular Death [PE]
- Pharm class moa
- P-Glycoprotein Inhibitors [MoA]
- UNII
- N54AIC43PW
- Drugcharacterization
- 1
- Medicinalproduct
- DECITABINE
- Drugbatchnumb
- 260308129
- Drugstructuredosagenumb
- 20
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- 20 MILLIGRAM
- Drugdosageform
- Infusion
- Drugadministrationroute
- 041
- Drugindication
- Acute myeloid leukaemia
- Drugstartdateformat
- 102
- Drugstartdate
- 20260907
- Drugenddateformat
- 102
- Drugenddate
- 20260911
- Drugtreatmentduration
- 5
- Drugtreatmentdurationunit
- 804
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- DECITABINE
- Harmonized identifiers (openFDA)
- Application number
- ANDA212959, ANDA203475, ANDA215355, ANDA212826, ANDA212265, ANDA205539, ANDA212117, ANDA214569, ANDA213472, ANDA206033, ANDA203131, ANDA204607, NDA205582
- Brand name
- DECITABINE
- Generic name
- DECITABINE
- Manufacturer name
- Meitheal Pharmaceuticals Inc., Accord Healthcare Inc., BluePoint Laboratories, Qilu Pharmaceutical Co., Ltd., Novadoz Pharmaceuticals LLC, Northstar Rx LLC, Gland Pharma Limited, Nivagen Pharmaceuticals, Inc., Eugia US LLC, Camber Pharmaceuticals, Inc., Sagent Pharmaceuticals, Hikma Pharmaceuticals USA Inc., Amneal Pharmaceuticals LLC, Dr. Reddy's Laboratories Inc., Mylan Institutional LLC, Sun Pharmaceutical Industries, Inc., Dr.Reddy's Laboratories Limited
- Product NDC
- 71288-119, 16729-224, 68001-642, 67184-0535, 72205-036, 72603-107, 68083-528, 75834-190, 55150-376, 31722-304, 68001-618, 25021-219, 0143-9385, 72205-031, 70121-1644, 68001-713, 43598-427, 67457-316, 47335-361, 55111-556
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- DECITABINE
- RxCUI
- 636631
- SPL ID
- b607f279-446f-43d6-b0ef-1d8e48366c87, 1cd33ab4-5938-ce87-e063-6394a90a7880, 3ff1337b-204f-2c46-e063-6394a90a4ebe, 0afb3dc7-6072-4a53-acc4-59589fb8491e, 2ca9d834-97c7-48db-a6ad-cdf530063b05, 1abbe952-58bc-4dbc-b06a-fb79167bcd66, 2e50eb33-f576-404d-8ef5-402f1d95acc0, 39a26b24-e9d4-4974-9788-d025c51fc94f, e20c2038-e61d-4c04-8b35-f2ff37a1b8d5, 2c794637-f383-49c6-9f3d-6bcc25e79e66, 1bc57ba5-cc43-192b-e063-6394a90a0b53, 3b490f98-eeec-b127-e063-6294a90aea54, 31a5ca50-bd81-4488-a666-38e784480d05, ae741566-f113-4678-972e-d2cbcd581f18, 414e2f5c-5d05-41b7-9c24-fc7be0ba974e, 5b9c6cb1-3315-4023-8a3b-9c92596d01f9, 5975fa95-f937-4e2d-e063-6394a90a0a46, 8911775c-4f88-acf0-5084-e879da9d1cd4, b47bee52-7718-749c-e053-2a95a90a0f38, ddc155a1-509c-4d7e-bab1-fa5891ef354e, 98cbf394-a6e4-c79a-a493-2a8ddd58d1a8
- SPL set ID
- a535a235-e1d2-4520-93fe-b7dd9b047784, b46df7d7-d98e-4c7e-b1ee-e03e258781c4, de303068-589e-4e0a-90ed-e60b2c1a2b56, 5b2dce6f-c715-47dc-971e-06244ccd7548, a1b43089-bc88-4ac6-bdee-9cc38ec30f4e, 1abbe952-58bc-4dbc-b06a-fb79167bcd66, a3771445-1c68-4883-a014-74f8793f3136, 39a26b24-e9d4-4974-9788-d025c51fc94f, 150537a8-10ac-422d-bf33-68b1a408e566, a99f92cf-88f9-469b-aa69-44831e0bd4ab, 5662c353-05d0-4bd8-87e4-c92ec9ca861e, 00caa305-fef4-471b-b9c3-4bcf5fe7b244, 749f8d8c-e378-42a1-b94a-136b606dadb4, 8c5d6067-16a1-43ab-9e52-a33c600a5c44, ae6c4580-3a3a-4c42-903a-1565d79521f8, 40e7ef72-8df5-4adf-a269-4ae1c26eb6f9, 5975fa81-1e29-4d56-e063-6394a90a9cd5, 358764ca-4c69-d516-af0c-bf8a348d26ca, 447a9fbd-106d-4ff6-8fd0-bb38a8c90e17, c155d6ba-9a16-406c-919e-65a149689ab9, 4e1f4eb4-19b2-eee8-3402-bd2ccf622791
- Package NDC
- 71288-119-20, 16729-224-05, 68001-642-41, 67184-0535-1, 72205-036-01, 72603-107-01, 71288-119-91, 68083-528-01, 75834-190-01, 55150-376-01, 31722-304-31, 68001-618-37, 25021-219-20, 0143-9385-01, 72205-031-01, 70121-1644-1, 68001-713-37, 43598-427-37, 67457-316-25, 47335-361-41, 47335-362-40, 55111-556-10
- Nui
- N0000000233, N0000175595
- Pharm class moa
- Nucleic Acid Synthesis Inhibitors [MoA]
- Pharm class epc
- Nucleoside Metabolic Inhibitor [EPC]
- UNII
- 776B62CQ27
- Summary
- Narrativeincludeclinical
- CASE EVENT DATE: 20260915