A pharmacovigilance data-driven approach to reveal high fatal adverse events following checkpoint immunotherapy - PubMed
3 hours ago
- #pharmacovigilance
- #immune checkpoint inhibitors
- #adverse events
- Immune checkpoint inhibitors (ICIs) improve cancer treatment outcomes but cause treatment-related adverse events (AEs).
- A pharmacovigilance approach identifies 'ICI-related high-mortality AEs' with elevated fatality rates.
- Analysis of FDA and WHO data (148,972 and 142,645 cases) reveals 63 high-mortality AEs, including interstitial lung disease, myositis, and hepatic failure.
- Fatality reporting rates for high-mortality AEs are significantly higher (36.25%) compared to other cases (10.66%).
- Findings are validated in additional clinical datasets for generalizability.
- Identified AEs help develop proactive monitoring strategies to mitigate fatality risks.