PMID- 38074150
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231211
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 14
DP  - 2023
TI  - Adverse events in patients with advanced urothelial carcinoma treated with 
      erdafitinib: a retrospective pharmacovigilance study.
PG  - 1266890
LID - 10.3389/fphar.2023.1266890 [doi]
LID - 1266890
AB  - Purpose: On 12 April 2019, erdafitinib gained the first FDA approval as the 
      second-line treatment for adult patients with locally advanced or metastatic 
      urothelial cancer following progression during or after at least one previous 
      line of platinum-based chemotherapy. However, the long-term safety profile of 
      erdafitinib in a large patient population remains unexplored. The current study 
      aimed to assess the adverse events (AEs) associated with erdafitinib through data 
      mining of the US Food and Drug Administration Adverse Event Reporting System 
      (FAERS). Method: The reporting odds ratio (ROR), the proportional reporting ratio 
      (PRR), the Bayesian confidence propagation neural network (BCPNN), and the 
      multi-item gamma Poisson shrinker (MGPS) algorithms based on disproportionality 
      were employed to quantify the signals of erdafitinib-associated AEs. Results: A 
      total of 6,322,279 reports of AEs were retrieved from the FAERS database spanning 
      2019 to 2022, out of which, 700 reports of erdafitinib as the "primary suspected" 
      were identified. These erdafitinib-induced AEs were observed across 24 targeted 
      system organ classes (SOCs). After conforming to the four algorithms at the same 
      time, a total of 441 signals of erdafitinib-induced AEs were detected across 23 
      SOCs. Notably, signals associated with metabolism and nutrition disorders, eye 
      disorders, and skin and subcutaneous tissue disorders were among the most 
      prevalent. The median onset time for AEs was found to be 54 days [interquartile 
      range (IQR) 17-112 days], with a majority of AEs occurring within the initial 6 
      months after initiating erdafitinib (37.23% within the first month, 15.53% within 
      the second month, and 16.79% within the third month). Conclusion: The findings of 
      this study align with existing clinical observations, offering a comprehensive 
      long-term post-marketing safety evaluation of erdafitinib. The results provide 
      valuable evidence to enhance the understanding of erdafitinib's safety profile, 
      aiding further research and guiding clinical practice.
CI  - Copyright (c) 2023 Yuan, Li, Hou and Guo.
FAU - Yuan, Tengfei
AU  - Yuan T
AD  - Department of Urology, The First Hospital of Jilin University, Changchun, China.
FAU - Li, Faping
AU  - Li F
AD  - Department of Urology, The First Hospital of Jilin University, Changchun, China.
FAU - Hou, Yuchuan
AU  - Hou Y
AD  - Department of Urology, The First Hospital of Jilin University, Changchun, China.
FAU - Guo, Hui
AU  - Guo H
AD  - Department of Urology, The First Hospital of Jilin University, Changchun, China.
LA  - eng
PT  - Journal Article
DEP - 20231121
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC10702547
OTO - NOTNLM
OT  - FAERS
OT  - adverse event
OT  - data mining
OT  - erdafitinib
OT  - pharmacovigilance
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2023/12/11 06:45
MHDA- 2023/12/11 06:46
PMCR- 2023/11/21
CRDT- 2023/12/11 05:39
PHST- 2023/07/25 00:00 [received]
PHST- 2023/11/10 00:00 [accepted]
PHST- 2023/12/11 06:46 [medline]
PHST- 2023/12/11 06:45 [pubmed]
PHST- 2023/12/11 05:39 [entrez]
PHST- 2023/11/21 00:00 [pmc-release]
AID - 1266890 [pii]
AID - 10.3389/fphar.2023.1266890 [doi]
PST - epublish
SO  - Front Pharmacol. 2023 Nov 21;14:1266890. doi: 10.3389/fphar.2023.1266890. 
      eCollection 2023.