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Post-Marketing Surveillance of CAR-T-Cell Therapies: Analysis of the FDA Adverse Event Reporting System (FAERS) Database.

Michele FusaroliValentina IsgròPaola Maria CutroneoCarmen FerrajoloValentina CirilloFrancesca Del BufaloEmanuel RaschiElisabetta PoluzziGianluca Trifirò
Published in: Drug safety (2022)
Our study confirms the well-known adverse drug reactions and detects potentially emerging safety issues specific for each chimeric antigen receptor T-cell therapy, also providing insights into a stronger role for tisa-cel in inducing some immunodeficiency-related events (e.g., hypogammaglobulinemia, infections) and coagulopathies, and for axi-cel in neurotoxicity.
Keyphrases
  • adverse drug
  • cell therapy
  • electronic health record
  • stem cells
  • mesenchymal stem cells
  • emergency department
  • drug induced
  • public health
  • single cell
  • bone marrow