A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for alpelisib
© 2024 The Authors. Published by Elsevier Ltd..
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 implicated alpelisib as the primary suspected drug, uncovering adverse events (AEs) across 26 organ systems. Notably, we identified 21 previously unlisted AEs. Furthermore, differences in AEs emerged between patients with PIK3CA-mutated breast cancer and those with PROS. This study provides vital insights for healthcare professionals to navigate AEs in clinical practice and informs future research for enhancing alpelisib 's safety profile.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:10 |
|---|---|
| Enthalten in: |
Heliyon - 10(2024), 6 vom: 30. März, Seite e27529 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Lin, Yu [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Adverse event |
|---|
| Anmerkungen: |
Date Revised 19.03.2024 published: Electronic-eCollection Citation Status PubMed-not-MEDLINE |
|---|
| doi: |
10.1016/j.heliyon.2024.e27529 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM369865561 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM369865561 | ||
| 003 | DE-627 | ||
| 005 | 20240319233314.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240318s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.heliyon.2024.e27529 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1336.xml |
| 035 | |a (DE-627)NLM369865561 | ||
| 035 | |a (NLM)38496864 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Lin, Yu |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for alpelisib |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 19.03.2024 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © 2024 The Authors. Published by Elsevier Ltd. | ||
| 520 | |a 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 implicated alpelisib as the primary suspected drug, uncovering adverse events (AEs) across 26 organ systems. Notably, we identified 21 previously unlisted AEs. Furthermore, differences in AEs emerged between patients with PIK3CA-mutated breast cancer and those with PROS. This study provides vital insights for healthcare professionals to navigate AEs in clinical practice and informs future research for enhancing alpelisib 's safety profile | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Adverse event | |
| 650 | 4 | |a Alpelisib | |
| 650 | 4 | |a Disproportionality analysis | |
| 650 | 4 | |a FAERS database | |
| 650 | 4 | |a Pharmacovigilance | |
| 700 | 1 | |a Zheng, Xinlei |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Yan |e verfasserin |4 aut | |
| 700 | 1 | |a Nian, Qichun |e verfasserin |4 aut | |
| 700 | 1 | |a Lin, Li |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Maohua |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Heliyon |d 2015 |g 10(2024), 6 vom: 30. März, Seite e27529 |w (DE-627)NLM255913095 |x 2405-8440 |7 nnns |
| 773 | 1 | 8 | |g volume:10 |g year:2024 |g number:6 |g day:30 |g month:03 |g pages:e27529 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.heliyon.2024.e27529 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 10 |j 2024 |e 6 |b 30 |c 03 |h e27529 | ||