Malignant neoplasm progression, Dyspnoea, Blood lactate dehydrogenase increased
Drugs: BELANTAMAB MAFODOTIN, POMALIDOMIDE, DEXAMETHASONE
- Safetyreportversion
- 1
- Safetyreportid
- 27325221
- Primarysourcecountry
- EU
- Occurcountry
- EU
- Transmissiondateformat
- 102
- Transmissiondate
- 20261008
- 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
- EU-GLAXOSMITHKLINE INC-ES2026124416
- Primarysource
- Reportercountry
- EU
- Qualification
- 1
- Sender
- Sendertype
- 6
- Senderorganization
- GLAXOSMITHKLINE
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 71
- Patientonsetageunit
- 801
- Patientsex
- 1
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Malignant neoplasm progression
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Dyspnoea
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Blood lactate dehydrogenase increased
- Reactionoutcome
- 6
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- BELANTAMAB MAFODOTIN
- Drugbatchnumb
- UNK
- Drugauthorizationnumb
- 761440
- Drugstructuredosagenumb
- 2.5
- Drugstructuredosageunit
- 007
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- 2.5 MG/KG
- Drugindication
- Plasma cell myeloma
- Actiondrug
- 4
- Drugrecurreadministration
- 3
- Activesubstance
- Activesubstancename
- BELANTAMAB MAFODOTIN
- Drugcharacterization
- 2
- Medicinalproduct
- POMALIDOMIDE
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugindication
- Product used for unknown indication
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- POMALIDOMIDE
- Harmonized identifiers (openFDA)
- Application number
- ANDA210232, ANDA210111, ANDA209956, ANDA210249, ANDA213234, ANDA219718, ANDA210164, ANDA210236, ANDA220741, NDA204026
- Brand name
- POMALIDOMIDE, POMALYST
- Generic name
- POMALIDOMIDE
- Manufacturer name
- Sun Pharmaceutical Industries, Inc., Natco Pharma Limited, Teva Pharmaceuticals, Inc., Aurobindo Pharma Limited, Dr. Reddy's Laboratories Inc., Cipla USA Inc., Apotex Corp., Breckenridge Pharmaceutical, Inc., Camber Pharmaceuticals, Inc., Sandoz Inc, Celgene Corporation
- Product NDC
- 70095-057, 70095-058, 70095-059, 70095-060, 63850-0131, 63850-0132, 63850-0133, 63850-0134, 0480-2601, 0480-4018, 0480-4022, 0480-4035, 59651-194, 59651-195, 59651-196, 59651-197, 43598-517, 43598-520, 43598-519, 43598-518, 69097-036, 69097-037, 69097-038, 69097-039, 60505-4497, 60505-4498, 60505-4499, 60505-4500, 51991-342, 51991-343, 51991-344, 51991-346, 31722-770, 31722-771, 31722-772, 31722-773, 0781-2354, 0781-2358, 0781-2366, 0781-2369 +4 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- POMALIDOMIDE
- RxCUI
- 1369718, 1369726, 1369730, 1369734, 1369724, 1369728, 1369732, 1369736
- SPL ID
- 5a6cdeaf-06a4-d9db-e063-6294a90a906e, 0169dbda-53df-4cd9-b989-ff7544f1bdf5, 35c82741-852e-4c33-ab34-02eb6b9aa318, 1539fbf9-8281-4c7b-827b-9f53b50d9042, b991ba5e-18e6-8b03-22f1-e409f4db8ccc, d7629b96-2ace-4a2e-a70c-e73d41a990f9, 79028ff4-3130-88ed-e3fc-18a7d9a779b8, 44621941-eb2e-421f-bcf0-ed39d4de70f4, 4c3e8f7f-ef41-3672-e063-6294a90ac5d6, 4fcd4978-b2d1-4d1a-b239-717cddb8be1f, 4410582a-a5f3-429f-a7ca-5c17fb5560bf
- SPL set ID
- 3c222961-5398-4185-b2d0-defe90230094, 0169dbda-53df-4cd9-b989-ff7544f1bdf5, dee932c5-0c7c-45f0-b2bb-c027badee537, 1539fbf9-8281-4c7b-827b-9f53b50d9042, 84678d19-fd8d-268e-2fe6-88e21195fcca, a0c16478-1a0c-4be0-be75-cb9e4543d71a, b1a1c713-d23b-5ede-1ae0-0bbba47221df, 41400b90-b64e-447b-90f3-1cad58050eba, 52676691-e171-467c-ae55-b5dcc14062a4, 4fcd4978-b2d1-4d1a-b239-717cddb8be1f, 2b25ef01-5c9e-11e1-b86c-0800200c9a66
- Package NDC
- 70095-057-01, 70095-057-02, 70095-058-01, 70095-058-02, 70095-059-01, 70095-059-02, 70095-060-01, 70095-060-02, 63850-0131-1, 63850-0131-2, 63850-0132-1, 63850-0132-2, 63850-0133-1, 63850-0133-2, 63850-0134-1, 63850-0134-2, 0480-4018-21, 0480-4022-21, 0480-2601-21, 0480-4035-21, 59651-194-21, 59651-194-01, 59651-195-21, 59651-195-01, 59651-196-21, 59651-196-01, 59651-197-21, 59651-197-01, 43598-520-21, 43598-520-01, 43598-519-21, 43598-519-01, 43598-518-21, 43598-518-01, 43598-517-21, 43598-517-01, 69097-036-81, 69097-036-07, 69097-037-81, 69097-037-07 +48 more
- Nui
- N0000184014
- Pharm class epc
- Thalidomide Analog [EPC]
- UNII
- D2UX06XLB5
- Drugcharacterization
- 2
- Medicinalproduct
- DEXAMETHASONE
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugindication
- Product used for unknown indication
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- DEXAMETHASONE
- Harmonized identifiers (openFDA)
- Application number
- ANDA216283, NDA022315, ANDA217695, ANDA216282, ANDA088481, ANDA216284, ANDA084754, ANDA217001, ANDA215106, ANDA215604, ANDA217696, ANDA201270, ANDA088149, ANDA091188, ANDA218372, ANDA080399, NDA013422, ANDA090891, ANDA088248, ANDA084612, ANDA216295, NDA211379, ANDA217538, NDA208742
- Brand name
- DEXAMETHASONE, OZURDEX, DEXAMETHASONE 1.5 MG, MAXIDEX, HEMADY, DEXTENZA
- Generic name
- DEXAMETHASONE, DEXAMETHASONE 1.5 MG
- Manufacturer name
- Zydus Lifesciences Limited, Allergan, Inc., Apotex Corp., Alvogen Inc., Viona Pharmaceuticals Inc, Marlex Pharmaceuticals, Inc, Bionpharma Inc.,, Kesin Pharma Corporation, Amneal Pharmaceuticals NY LLC, ANI Pharmaceuticals, Inc., Larken Laboratories, Inc., Pangea Pharmaceuticals, LLC, NorthStar Rx LLC, Chartwell RX, LLC, Advagen Pharma Ltd., Kanchan Healthcare Inc, Prasco Laboratories, Harrow Eye, LLC, PD-Rx Pharmaceuticals, Inc., Rising Pharma Holdings, Inc., Hikma Pharmaceuticals USA, Inc., Edenbridge Pharmaceuticals LLC., Ocular Therapeutix, Inc.
- Product NDC
- 70771-1701, 0023-3348, 60505-6249, 60505-6250, 60505-6251, 60505-6252, 60505-6253, 60505-6254, 60505-6255, 70771-1699, 70771-1700, 70771-1704, 70771-1705, 70771-1707, 47781-914, 47781-916, 72578-166, 70771-1706, 10135-795, 69452-277, 69452-278, 81033-010, 60219-2043, 60219-2044, 70954-398, 70954-401, 70954-403, 70954-404, 70954-402, 70954-399, 68047-702, 81279-117, 72603-187, 72603-189, 72603-190, 72603-188, 72603-213, 72603-212, 62135-114, 72888-235 +38 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL, INTRAVITREAL, OPHTHALMIC, INTRACANALICULAR
- Substance name
- DEXAMETHASONE
- RxCUI
- 197581, 854177, 854181, 197577, 197579, 197580, 197582, 197583, 343033, 309686, 759481, 759697, 846192, 197576, 205669, 309692, 309684, 2261802, 2286261, 2108015, 2108020
- SPL ID
- 6a9c20d5-8b08-4b8e-b422-705383158851, 007c310d-2cfe-4c54-a27e-693e0d7fa78a, 4267b6d1-37d3-7ed2-7a89-251185401d0d, ebc1bd42-82a5-40dc-ab21-b8d5252518b3, f5d1d20f-dcb0-9ddf-b436-165cf014f5fa, 57d9469e-8d0d-4a58-a56c-3c266fe36b74, 232c68af-fb83-4b93-9e16-9803c8e680c0, 59cae836-8f84-4276-9289-73ae101b8ddf, 2f9dcbaf-165e-5594-e063-6394a90a9dc5, 43e2a256-e024-5661-e063-6394a90af0e9, 574d26cb-6ade-4619-be52-ef855081c8da, 75141974-8862-4da7-9253-a338cb1fdb84, 4134ccdd-0287-cdf7-e063-6394a90a766d, 55650684-ad57-08dc-e063-6394a90a25bf, 132845af-9ab6-2327-e063-6294a90a6673, 13a14c37-eaf1-7848-e063-6394a90a5479, 99311cd0-f11e-4313-bb8c-eeb09fdcb3f4, 5d9b22ca-c619-4ee3-98eb-74544d0d5cb3, a155a827-9fc0-4452-888e-379cb34a661e, 64545c32-2309-4fa4-9d9e-bfecf16244b0, 4137ff08-7529-5862-e063-6294a90aade5, 34661206-e37a-6ce7-e063-6394a90aaf85, 4589a128-79eb-aa64-e063-6294a90a953b, 0b2ad1c2-aa4a-4741-ae0b-645a3943dd77, 0bde0d4d-9482-444f-8fa2-07344fc0e5ad, 286734bc-8329-4f44-a20b-610cf7b67591, e60a85d0-638c-48aa-af07-b34be3c2a334, d3488fd8-88b2-4f73-9fa4-fbcf14ddd972, 4fcc51f0-654d-a3a8-e063-6394a90aac9a, 2f9d9872-68d7-cdc2-e063-6294a90a6463, ad2305a4-f888-4800-a31e-1fff3ffee20d, 7118fc32-96e3-49b2-8a41-75d457faca08
- SPL set ID
- 1e84a609-22a0-41b9-83a0-c45019c8cf9a, 4b204f44-6e8a-4d17-803c-268f0b04679f, bfaa71cb-e517-8d94-f64b-8cdbf7b8fbf2, 522a1a49-5540-4245-a15f-e3cdc0a97a5e, 9ab26af9-8196-e3d3-76a3-75227fd4e1c3, 360d3af0-8f69-4e82-ab5f-1f70cc2025d4, e9012a11-6219-4272-aea2-b7328bbcf523, 7b51ffce-ec64-4b49-8870-b9666537c541, 3166db4f-66a5-496a-a194-3cc01b7347d3, 43e2a24a-4465-5787-e063-6394a90a0b81, ac71f888-c83a-46a5-921c-1ebdf6cfadc1, fe8cf911-84ef-47be-acb8-0501b546299b, 7b997c26-e6a3-403c-93fb-b1290cf5dbad, a41e6e26-9ebb-4b06-866e-a24af21c644c, 05c77a4c-c508-babd-e063-6294a90a450a, 3746066a-3c87-4238-945a-6dfb4d01a072, 3c1729db-8ba3-4cba-9eff-ab4ae2c061c2, 5d9b22ca-c619-4ee3-98eb-74544d0d5cb3, 02f7bf9c-1aa3-4734-8a3e-1f49498055d7, bfce6b49-f7ff-4ec7-9580-b730f0a207d7, fcc75691-974e-4a67-b9d7-64dde72b5595, 35e47fcd-e020-43e5-8322-41f8060d220d, a8d6792e-757e-4dc6-adf5-0d9211075428, 93bb34a7-c8ca-4dab-b2a0-cbe011e1090c, 7cf5c17c-a80b-4547-83b2-0d53e2b933f7, b15200fb-1826-472b-a907-e677a272513b, b9eb9a30-c1da-4d38-8ea8-616a254e2afc, 6b9cf32c-6d60-4853-bbfd-2304ffc2c129, 37607468-0331-44c0-9bb4-5c614c7b69d4, 401ec088-984a-49ab-b317-747c2b9b9e22, 7514e6b8-c33f-4fbf-8810-ef520e1eb4bd, 86afd383-7d6b-48f0-a803-9446fa1ded10
- Package NDC
- 70771-1701-1, 0023-3348-07, 0023-3348-08, 60505-6249-1, 60505-6249-7, 60505-6250-1, 60505-6250-7, 60505-6251-1, 60505-6251-7, 60505-6252-1, 60505-6252-7, 60505-6253-1, 60505-6253-7, 60505-6254-1, 60505-6254-7, 60505-6255-1, 60505-6255-7, 70771-1699-1, 70771-1700-1, 70771-1704-1, 70771-1705-1, 70771-1707-1, 47781-914-01, 47781-914-13, 47781-914-51, 47781-916-01, 72578-166-01, 70771-1706-1, 10135-795-71, 69452-277-20, 69452-278-20, 81033-010-05, 81033-010-24, 60219-2043-1, 60219-2044-1, 70954-401-10, 70954-403-10, 70954-403-20, 70954-403-30, 70954-404-10 +65 more
- Nui
- N0000175576, N0000175450
- Pharm class epc
- Corticosteroid [EPC]
- Pharm class moa
- Corticosteroid Hormone Receptor Agonists [MoA]
- UNII
- 7S5I7G3JQL
- Summary
- Narrativeincludeclinical
- CASE EVENT DATE: 20260909