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A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for alpelisib

In this study, we delved into the safety profile of alpelisib, an FDA-approved treatment for hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, and PIK3CA-Related Overgrowth Spectrum (PROS). Despite its approval, real-world, long-term safety data is lackin...

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Autori principali: Yu Lin, Xinlei Zheng, Yan Chen, Qichun Nian, Li Lin, Maohua Chen
Natura: Artigo
Lingua:Inglês
Pubblicazione: Elsevier 2024-03-01
Serie:Heliyon
Soggetti:
Alpelisib
Adverse event
FAERS database
Disproportionality analysis
Pharmacovigilance
Accesso online:http://www.sciencedirect.com/science/article/pii/S2405844024035606
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