A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for alpelisib.
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ABSTRACT:
SUBMITTER: Lin Y
PROVIDER: S-EPMC10944239 | biostudies-literature | 2024 Mar
REPOSITORIES: biostudies-literature
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A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for alpelisib.
Lin Yu Y Zheng Xinlei X Chen Yan Y Nian Qichun Q Lin Li L Chen Maohua M
Heliyon 20240308 6
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 lacking. Our research scrutinizes the FDA database to assess alpelisib 's safety. We retrospectively analyzed data from April 2019 to June 2023 using four algorithms. Among 7,609,450 reports, 6692 implicate ...[more]
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