ArticleProceedings of the National Academy of Sciences of the United States of America2026
A pharmacovigilance data-driven approach to reveal high fatal adverse events following checkpoint immunotherapy.
Article in Proceedings of the National Academy of Sciences of the United States of America, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed.
- Reply to Revol et al.: Interpreting fatality-reporting signals in checkpoint immunotherapy.Proceedings of the National Academy of Sciences of the United States of America · 2026Article
- Disproportionality analysis to investigate fatal adverse events with immune checkpoint inhibitors: Proceed with extreme caution.Proceedings of the National Academy of Sciences of the United States of America · 2026Article
- Omics-based biomarkers of immune-related organ toxicities associated with immune checkpoint inhibitors: a scoping review and evidence map.Frontiers in immunology · 2026Article
Corrections and comments
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Authors and funding
18 authors.
Funding
Abstract
Immune checkpoint inhibitors (ICIs) have significantly improved the outcome of cancer treatment, but they also expose most patients to a variety of treatment-related adverse events (AEs). This study introduces a modified pharmacovigilance approach to identify "ICI-related high-mortality AEs", a subset of treatment-related complications that are disproportionately reported with elevated fatality during ICI therapy. Utilizing large-scale pharmacovigilance data from 148,972 ICI-treated cases in the FDA AEs Reporting System and 142,645 ICI-treated cases in the WHO global VigiBase, we found 63 types of ICI-related high-mortality AE, such as interstitial lung disease, myositis, and hepatic failure, which necessitate heightened clinical vigilance. Patients who experienced these events had significantly higher fatality reporting rates compared to other cases (36.25% vs. 10.66%). These findings were corroborated in the additional clinical datasets to ensure their generalizability. In summary, identifying these ICI-related high-mortality AEs provides crucial insights for developing proactive monitoring strategies and prioritizes specific events for prevention and intervention to mitigate fatality risk.
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Registered trials
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