Granulocyte count decreased, Platelet count decreased, Anaemia +3
Drugs: VENETOCLAX, AZACITIDINE, STERILE WATER
- Safetyreportversion
- 1
- Safetyreportid
- 27325211
- Primarysourcecountry
- CN
- Occurcountry
- CN
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- Transmissiondate
- 20261010
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- 1
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- Seriousnesslifethreatening
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- CN-ABBVIE-6955329
- Duplicate
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- Reportduplicate
- Duplicatesource
- Health authority
- Duplicatenumb
- TA26-1021991-AE00
- Primarysource
- Reportercountry
- CN
- Qualification
- 1
- Sender
- Sendertype
- 6
- Senderorganization
- ABBVIE
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 53
- Patientonsetageunit
- 801
- Patientweight
- 58
- Patientsex
- 2
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Granulocyte count decreased
- Reactionoutcome
- 2
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Platelet count decreased
- Reactionoutcome
- 2
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Anaemia
- Reactionoutcome
- 2
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Drug eruption
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Rash erythematous
- Reactionoutcome
- 1
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Pruritus allergic
- Reactionoutcome
- 3
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- VENETOCLAX
- Drugbatchnumb
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- Acute leukaemia
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- 102
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- Drugtreatmentduration
- 5
- Drugtreatmentdurationunit
- 804
- Actiondrug
- 6
- Drugadditional
- 4
- 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
- VENETOCLAX
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- 102
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- Actiondrug
- 6
- Drugadditional
- 4
- 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
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- Medicinalproduct
- VENETOCLAX
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- 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
- AZACITIDINE
- Drugbatchnumb
- 260204129
- Drugstructuredosagenumb
- 122
- Drugstructuredosageunit
- 003
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- 804
- Drugdosagetext
- AZACITIDINE FOR INJECTION
- Drugdosageform
- Injection
- Drugindication
- Acute leukaemia
- Drugstartdateformat
- 102
- Drugstartdate
- 20260727
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- 102
- Drugenddate
- 20260802
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- AZACITIDINE
- Harmonized identifiers (openFDA)
- Application number
- ANDA217453, ANDA209337, ANDA207518, ANDA215765, ANDA212128, ANDA215066, ANDA207475, ANDA212580, NDA214120, ANDA201537, ANDA207234, ANDA215905, NDA050794, NDA208216, ANDA211549
- Brand name
- AZACITIDINE, AZACITIDINE AZACITIDINE, ONUREG, VIDAZA
- Generic name
- AZACITIDINE, AZACITIDINE FOR
- Manufacturer name
- Reliance Life Sciences Private Limited, Hikma Pharmaceuticals USA Inc., Fresenius Kabi USA, LLC, Camber Pharmaceuticals, Inc., Meitheal Pharmaceuticals Inc., Dr. Reddy's Laboratories Inc., Eugia US LLC, Somerset Therapeutics LLC, Accord Healthcare Inc., Sandoz Inc, Celgene Corporation, Pilnova Pharma Inc, Panacea Biotec Limited, BluePoint Laboratories., MSN LABORATORIES PRIVATE LIMITED, Apotex Corp, BluePoint Laboratories, Civica, Inc., Amneal Pharmaceuticals LLC, NorthStar RxLLC, Armas Pharmaceuticals Inc.
- Product NDC
- 58458-002, 0143-9606, 63323-771, 31722-365, 71288-115, 43598-678, 55150-393, 70069-857, 16729-306, 0781-3491, 59572-730, 59572-740, 83774-102, 75907-225, 71288-153, 43598-305, 43817-906, 68001-620, 69539-112, 60505-6271, 59572-102, 68001-313, 43598-465, 72572-020, 70121-1237, 16714-927, 72485-201
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS, SUBCUTANEOUS, ORAL
- Substance name
- AZACITIDINE
- RxCUI
- 485246, 2396764, 2396770, 2396772, 2396774, 545206
- SPL ID
- 36422686-af0f-a4e1-e063-6294a90a1b44, 592a688f-2e42-4e91-a3ea-34befe2a4e07, 4becda8d-8042-4cf1-bef3-c0ec3c23eebe, 323f6641-3d42-70d0-e063-6294a90aaf61, bad343f5-0c12-47de-93e7-9b2af3670b7c, b7d42845-1888-66b9-77a0-c6f4902e21ac, e89b9510-86df-4095-b6d3-4eb05b613c4f, 3bc4f406-2e98-7169-e063-6394a90a81d9, 28604daf-46a3-ef6c-e063-6394a90a4b27, bf6cb4b7-d4ec-4124-862c-aaa6a32da511, 1b026a12-462b-40f3-81d8-099c1b111718, a531999b-865f-4e84-bd6f-818f8f377a3c, 2f09b4de-29f7-c302-3402-6303a8e2cc7d, 6b7269e4-757b-4209-b142-d3a2ba369bd4, 35e92030-ae2f-04b2-c3de-69f8c8da6b82, dcfb97f4-4218-4d97-ba28-4f97dabe4ac0, 4df05823-5b8c-e6c0-e063-6294a90a8d1b, 149556cf-d002-4d8b-875b-062561da3f44, f2b031f6-9ae2-fc0b-85a9-7a7c631e3f7b, 8cba79e2-11fa-4eb9-87e7-827ca781fbf3, 36080e4e-a0fe-ba15-e063-6394a90aed5c, 432d4f82-fcf0-c5f5-6da1-d55db90e59b0, e2e6729f-6e81-476f-af63-82c094d4f6ee, 38a5005c-7a0b-48c6-bba5-a996ccf1c847, 946ea9fe-07aa-b87b-d702-482df4bd4afe, ca345575-17a6-43a3-aa02-3d4bb9d136c5
- SPL set ID
- 5804d999-96eb-4fd1-b7d8-de7867c5f1d6, ff73515d-bd55-4eb5-992b-d2138c80887e, 3b594aba-e798-4105-b801-0b0d970747c1, f02c9bef-e47f-4b70-95f6-9341d87346ed, 97b0917a-03fa-4cc4-91cf-1bed57a988c9, d38a1247-28c8-a911-e691-a983a2f9a6e3, ecd108bd-bb5f-4b2e-ad91-210fca452e9b, 3bc4f406-2ec7-7169-e063-6394a90a81d9, 70140e11-33f1-2240-e053-2991aa0a0480, 7f89fcbd-d3f4-4112-8733-69baea41255e, 0e95e33f-8aba-4f19-b332-2416580d358b, 0095c67b-42f3-47e6-92db-f77843727bca, 060d56e7-1a24-87c1-7f40-149ecf424f7c, 3b96b508-046b-49ae-aefe-6d39c89a1d0e, 71d8d758-86c9-b571-aed1-719654fd4b82, 9abb489d-ce54-4140-83f6-b756f00b0967, cd9db533-8a49-4d01-99e2-b2db8db1ed38, d24f1fc5-17c6-4e0c-b852-72692e835cff, a6a5ca37-37e8-ab65-bc0b-9c0682ab52f7, 3495a71a-cc04-4776-851f-f185956f32af, 5f0f9ee3-a5b1-4a25-a34c-7f38c8433f4a, 33397835-15a9-d89f-bd75-8b915f5c4dbf, 2d15b3ec-ed08-48c6-a400-34e55974afad, 80a43736-0598-4e4b-85ba-e29daa290c8f, 81366ec1-9689-4857-ded6-3d6342fe5132, 5c0a2d5f-8c34-4c04-8425-7543965cedd4
- Package NDC
- 58458-002-02, 0143-9606-01, 63323-771-39, 31722-365-31, 71288-115-30, 43598-678-11, 55150-393-01, 70069-857-01, 16729-306-10, 0781-3491-94, 59572-730-14, 59572-730-07, 59572-740-14, 59572-740-07, 83774-102-01, 75907-225-11, 71288-153-95, 43598-305-62, 43817-906-01, 68001-620-54, 69539-112-01, 60505-6271-1, 59572-102-01, 68001-313-56, 43598-465-62, 72572-020-01, 70121-1237-1, 16714-927-01, 72485-201-01
- Nui
- N0000000233, N0000175595
- Pharm class moa
- Nucleic Acid Synthesis Inhibitors [MoA]
- Pharm class epc
- Nucleoside Metabolic Inhibitor [EPC]
- UNII
- M801H13NRU
- Drugcharacterization
- 2
- Medicinalproduct
- STERILE WATER
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- 8 ML
- Drugdosageform
- Injection
- Drugindication
- Vehicle solution use
- Drugstartdateformat
- 102
- Drugstartdate
- 20260727
- Drugenddateformat
- 102
- Drugenddate
- 20260906
- Drugtreatmentduration
- 42
- Drugtreatmentdurationunit
- 804
- Activesubstance
- Activesubstancename
- WATER
- Harmonized identifiers (openFDA)
- Application number
- ANDA209689, NDA018233, ANDA088400, NDA019869, NDA018801, NDA017866, NDA017428, ANDA211222, NDA019633, ANDA206369, ANDA216123, ANDA212735, NDA016734, NDA018313, NDA018632, ANDA211188
- Brand name
- STERILE WATER
- Generic name
- WATER, STERILE WATER, STERILE WATER FOR INJECTION
- Manufacturer name
- Becton Dickinson and Company, ICU Medical Inc., Fresenius Kabi USA, LLC, American Regent, Inc., Hospira, Inc., Baxter Healthcare Corporation, Chartwell RX, LLC, B. Braun Medical Inc., Hikma Pharmaceuticals USA Inc., Civica, Inc., Baxter Healthcare Company, Medefil, Inc.
- Product NDC
- 17271-750, 0990-7990, 63323-185, 65219-187, 0990-7118, 0517-3010, 0517-3005, 0517-3020, 0409-4887, 0338-0003, 0338-0004, 62135-833, 0264-7850, 0641-6147, 72572-747, 0409-0024, 17271-802, 0143-9339, 0264-7386, 0990-7973, 0990-6139, 0990-7139, 0338-0013, 65219-495, 65219-497, 65219-499, 64253-020, 0264-7385, 63323-178
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, IRRIGATION
- Substance name
- WATER
- SPL ID
- 287b9495-1d0c-45c7-9a84-c35a082717a9, 5e93a66c-3b06-4208-8b7c-a568fb3fd93c, 42c6c812-706a-425b-b8cb-931006e40484, 0a672bdf-163d-4af5-a791-f815de5b309c, 62e6c83e-4187-4dd0-9fb7-4788c3a4b432, b885fb92-786e-49bf-aed2-17b430e4743e, 055437a7-5be5-414a-a97a-946e2730fe12, 97390588-b679-4caa-b7f3-3d2e11074d0e, 10594df5-e2d0-a24e-e063-6394a90afe26, f7c681df-db56-42c6-846f-4e0672c4d553, 081540ac-58cf-437f-ba1b-86d5264ec3dc, 54c5a74f-9e9d-49cb-b263-7fffe486def7, 7c1a069a-7b47-4a53-a3d6-24c528a3797e, cab03cda-4660-4020-a3be-bf86242ff664, 2558c762-cdc9-4135-a83e-8d4c5c9d1afc, 5a720898-0d85-4a14-9507-d8835857bdc6, 90930d29-6b1a-438c-b719-c5e7484dcad5, 0d547c0b-bb85-4caa-a4e4-a11a617d2d15, 7cd9f528-a5da-4541-bb2a-28f3669a6b42, d23ead89-2b87-4348-a785-c10da979513d, 2b39b41d-419a-dab8-e063-6394a90a319a, ed933e44-2560-495b-879c-99c6a0bf8ba0, d40f0ff2-4abf-4030-b4e1-2b85ad7448a0
- SPL set ID
- 6e43c5a3-dad2-49ed-b500-964cb4563cc9, aab10f03-26ae-4dbc-a481-ef025e48b405, e71c6c83-d518-496c-b2ab-efd5987e4783, f42ac50f-0ec5-4713-a4c8-99d972d90bed, 1c0bbcb7-5ed6-4ee7-b297-080d3359474e, 78b35864-4bbc-4759-a5c1-7e4f25e22932, 2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, ef3e79c5-3f58-4b36-a296-64b7d9a651c1, 3681eeaa-807a-47ca-9fbc-61c2b682800a, 8fc8d87a-3951-4ac5-97df-c161ffc90475, 78ef7ad3-451d-43d0-a9b6-5cf0aadca003, 3f49eedf-5bf5-4a95-b704-c956d860ca04, 3a6422e1-feee-4095-8883-2b0837039e6e, cab03cda-4660-4020-a3be-bf86242ff664, b20a28b0-7dfa-42eb-9177-ec256d5a5ef7, d99f9133-e4d0-4dee-b611-dbc3f918b547, e3484bc6-ed7f-43ef-9d49-c131a8dff2dd, 8bcf5572-49e1-4302-9522-56f57904cb4a, fd823bef-c14c-4708-a18a-8aaa8470412f, 210dc9ab-d6ca-4552-ac19-1be17792d290, 99e99a50-82d5-aff6-e053-2a95a90a8c56, 8924e52e-8622-4ed6-a061-1908183e0a18, b45e9f1d-9c48-4b46-8541-d846b89540df
- Package NDC
- 17271-750-07, 0990-7990-09, 63323-185-07, 63323-185-10, 63323-185-09, 63323-185-50, 63323-185-08, 63323-185-20, 63323-185-04, 63323-185-05, 65219-187-01, 65219-187-10, 0990-7118-07, 0517-3005-01, 0517-3005-25, 0517-3010-01, 0517-3010-25, 0517-3020-01, 0517-3020-25, 0409-4887-25, 0409-4887-99, 0409-4887-31, 0409-4887-05, 0409-4887-17, 0409-4887-10, 0409-4887-32, 0409-4887-34, 0409-4887-23, 0409-4887-20, 0409-4887-24, 0409-4887-50, 0338-0003-44, 0338-0003-46, 0338-0003-47, 0338-0004-02, 0338-0004-03, 0338-0004-04, 0338-0004-05, 62135-833-84, 0264-7850-00 +42 more
- UNII
- 059QF0KO0R
- RxCUI
- 150985
- Summary
- Narrativeincludeclinical
- CASE EVENT DATE: 20260805