Data mining and analysis of security alert signals of ribociclib based on FDA adverse event reporting system database
Objective:To mine the security alert signals of ribociclib based on the FDA Adverse Event Reporting System(FAERS)database to provide a reference for the safety of clinical medication.Methods:The adverse drug event(ADE)signals data of ribociclib from the FAERS database from the second quarter of 2017 to the first quarter of 2023 were collected.The data mining was performed using the reporting odds ratio(ROR)and the bayesian confidence propagation neural network(BCPNN)in the proportional imbalance method.Results:A total of 54 160 ADE reports with ribociclib as the primary suspected drug were collected,and 312 ribociclib ADE signals were mined involving 13 systems.Among them,a total of 113 new signals were not mentioned in the instructions,accumulating 16 systems.Death occurred in 2 396 patients(20.72％).Significant differences were found in gender,weight and time to onset for fatal vs.non-fatal cases(P＜0.05).Pulmonary oedema,ascites,jaundice,and blood lactate dehydrogenase increased,etc.had higher risk of death.Conclusion:In the real world,it is necessary to comprehensively monitor and timely intervene the ADE of ribociclib.More attention should be paid to ADE with greater risk of death,including pulmonary oedema,ascites,jaundice,and increased blood lactate dehydrogenase,so as to guarantee the safety of treatment.
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