Signal Detection of Chimeric Antigen Receptor T-cell Therapy Using the World Health Organization VigiBase Database

Objective: This study aimed to characterize adverse event reports associated with chimeric antigen receptor T-cell (CAR-T) therapy and to identify potential safety signals using the World Health Organization (WHO) global pharmacovigilance database.Methods: Individual case safety reports submitted to WHO VigiBase up to March 2025 were analyzed.Disproportionality analyses were performed by comparing reports involving CAR-T therapies with those involving Non-CAR-T drugs used as second-line or later treatments for hematologic malignancies, using reporting odds ratios, proportional reporting ratios, and information components.Detected signals were reviewed against product labeling approved by the Korean Ministry of Food and Drug Safety and the U.S. Food and Drug Administration.Results: Among 499,000 reports included in the analysis, 2,563 (0.51%) were associated with CAR-T therapy.A total of 103 preferred term-level safety signals were identified, predominantly involving neurological and infection-related events.Several high-disproportionality signals, including eosinophilic cellulitis, tumour pseudoprogression, human herpesvirus 6 encephalitis, and cardiorenal syndrome, among others, were not specified in current product labels.Conclusion: This study identified safety signals associated with CAR-T in real-world practice, confirming known adverse events and suggesting additional neurological and infection-related events beyond current product labeling.These findings highlight the need for ongoing pharmacovigilance and further clinical evaluation.(PeRM 2026;18:118-134)