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December 8, 2025BloodOpen Access

A post-marketing pharmacovigilance analysis of cardiotoxicities following chimeric antigen receptor T-cell therapy using the FDA adverse event reporting system

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Authors

CGChristopher Graham

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Overview

Pharmacovigilance analysis revealed trends in cardiac toxicities in hematological cancer patients receiving CAR-T therapy.

Key Points

  • The research aims to analyze cardiac adverse effects related to CAR-T therapy through FAERS.
  • Conducted a post-marketing pharmacovigilance analysis of cardiac AEs using FAERS data.
  • Identified individual case safety reports for approved CAR-T therapies.
  • Performed disproportionality analysis using Reported Odds Ratio (ROR) to assess associations.
  • Identified 1362 cardiac adverse events following CAR-T therapy in the FAERS database.
  • Most common AEs included arrythmias, heart failures, and cardiac arrests with male patients more affected.
  • Age and sex influenced the risk of specific cardiac AEs, highlighting the need for ongoing monitoring.

Cite This Study

Christopher Graham (2025) studied this question.

synapsesocial.com/papers/69362f364fa91c937236d30ahttps://doi.org/10.1182/blood-2025-6301
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Treatment-Related Myelodysplastic Syndrome and Acute Myeloid Leukemia Associated with CAR T-Cell Therapies : A Real-World FAERS Pharmacovigilance Study2026
  2. 2Real-world patterns of secondary malignancies and relapse following CAR T-cell therapy: A faers pharmacovigilance analysis2025
  3. 3Endocrine adverse events following CAR-T cell therapies: A pharmacovigilance analysis in the real-world setting utilizing the faers database2025
  4. 4Comparative safety profiles of bispecific T-cell engagers and CAR-T therapies: Real-world insights from the FDA adverse event reporting system database2025 · 1 citations
  5. 5Association of cardiotoxicity with chimeric antigen receptor T-cell (CAR-T) therapy: A systematic review.2026