ArticleTherapeutic advances in drug safety2025
A post-marketing disproportionality analysis of the safety of ribociclib based on the FDA Adverse Event Reporting System.
Article in Therapeutic advances in drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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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
2 citing papers in PubMed.
- Assessing the risk of adverse drug events from combining aromatase inhibitors with CDK4/6 inhibitors using the FAERS and JADER databases.Frontiers in medicine · 2026Article
- Polypharmacy driven synergistic toxicities in elderly breast cancer chemotherapy drug management and adverse drug reactions: a mini review.Frontiers in pharmacology · 2025Review
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Although there are reports of adverse events (AEs) of cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors, the safety of ribociclib alone has not yet been comprehensively evaluated in real-world clinical practice. Objectives: To investigate the overall real-world safety profile of ribociclib by mining data from the FDA Adverse Event Reporting System (FAERS). Design: A retrospective disproportionality analysis was conducted based on the FAERS database. Methods: We processed reports from the first quarter of 2017 to the second quarter of 2023 and applied disproportionality analysis using four different methods: reporting odds ratio, Medicines and Healthcare Products Regulatory Agency, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker. Results: A total of 12,885 AE reports of ribociclib as the primary suspect were enrolled. 48.81% of AEs occur within 60 days of ribociclib administration. Blood and lymphatic system disorders and abnormalities in investigation at the system organ class level showed statistically significant signals in all four methods. Nausea ( Conclusion: This study utilized the FAERS database to analyze real-world AE signals associated with ribociclib following its market approval. We characterized the clinical profiles of reported AEs and found some significant signals consistent with previous clinical trials. In addition, several AEs not included in the drug label or exhibiting unexpected severity were detected. These findings provide valuable insights for clinicians and highlight directions for further causality-focused research to validate the observed results.
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