A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for venetoclax

Venetoclax (VEN) is the first selective small molecule Bcl-2 inhibitor approved by FDA and used in adult chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and some acute myeloid leukemia (AML). However, the long-term safety of VEN in large sample population was unknown. This study...

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Bibliographic Details
Published in:PloS one 2022-12, Vol.17 (12), p.e0278725-e0278725
Main Authors: Yang, Yang, Shu, Yamin, Chen, Guosong, Yin, Yanchao, Li, Feie, Li, Juan
Format: Article
Language:English
Subjects:
Acute myeloid leukemia
Adverse events
Algorithms
B cells
Bayes Theorem
Bayesian analysis
Bcl-2 protein
Biology and Life Sciences
Blood cancer
Care and treatment
Chronic lymphocytic leukemia
Clinical trials
Data mining
FDA approval
Health aspects
Hematology
Infarction
Leukemia
Lymphoma
Lymphomas
Marketing
Medicine and Health Sciences
Neural networks
Patient outcomes
Pharmacovigilance
Pleural effusion
Population studies
Proteins
Risk management
Safety
Squamous cell carcinoma
Statistical analysis
Thrombocytopenia
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Summary:Venetoclax (VEN) is the first selective small molecule Bcl-2 inhibitor approved by FDA and used in adult chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and some acute myeloid leukemia (AML). However, the long-term safety of VEN in large sample population was unknown. This study evaluated the adverse events (AEs) of VEN from FDA Adverse Event Reporting System (FAERS) since its approval in 2016 by data mining. The disproportionality analyses, including four algorithms of reporting odd ratio (ROR), proportional reporting ratio (PRR), bayesian configuration promotion neural network (BCPNN), and multi item gamma poisson shrinker (MGPS), were employed to quantify the signals of VEN-associated AEs. From the FAERS database, a total of 8,379,682 reports were collected during the study period. After removing the duplication, the number of reports with VEN as the primary suspect (PS) was 19,107. The 19,107 cases of AEs involved 27 organ systems, 256 significant PTs which conforming to the four algorithms. Unexpected serious AEs, such as pleural effusion, splenic infarction, atrial fibrillation, skin squamous cell carcinoma, etc., have signals. The median time of occurrence of AEs related to VEN was 31 days (inter quartile range [IQR] 7-131 days), and half of the reported AEs occurred within 1 month after administration. Our research has found new significant AEs signals of VEN, which improved its safety information in real-world after marketing approval, and contributed to its risk control of use in clinic.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0278725