Mining and analyzing adverse event signals of Venecola based on OpenFDA
Objective:To provide a reference for the safe and rational clinical use of the novel antineoplastic drug vene-toclax(VEN)by analyzing its adverse drug event(ADE)signals.Methods:The OpenFDA public data open access project was used to retrieve the adverse event data of venetoclax from April 2016 to March 2023 in the FDA adverse event reporting system(FAERS)database,and the ratio of reported ratios(ROR)method,the United Kingdom's Medicines and Healthcare products Regulatory Agency(MHRA)comprehensive standard method,the Bayesian credible interval progression The neural network(BCPNN)method and polynomial gamma Poisson distribution shrinkage(MGPS)method were used to mine and analyse the ADE signals of venetoclax.Results:Among 29 849 reports collected from the FAERS database,336 veneto-clax-related ADE reports were identified,involving a total of 27 system organ classifications(SOCs).The SOCs with a higher number of occurrences were,in order,systemic diseases and various reactions at the site of administration,various exam-inations,infections and invasive diseases,various injuries,poisonings and operation complications,gastrointestinal system diseases,blood and lymphatic system diseases,and so on.Excluding the factors of the primary disease itself and the adverse reactions not unrelated to drugs,the common ADE mainly included decreased platelet count,infectious pneumonia,fever and so on.The incidence of serious ADE(e.g.hospitalization,deaths and life-threatening)was higher.Meanwhile,the newly identified suspected ADEs not mentioned in the specification of venetoclax were coronavirus disease 2019(COVID-19),atrial fibrillation,pleural effusion,and fungal pneumonia.Conclusions:The results of this study are consistent with clinical trials,but also identified potential new ADE signals for venetoclax.The results of this study may provide valuable evidence for the clinical use of venetoclax and further safety studies.
国家科技期刊平台
NSTL
万方数据
