Signal mining and analysis of adverse events of blinatumomab based on FAERS database
Objective To mine the adverse drug event signals of blinatumomab based on the FAERS,to provide a basis for clinical drug use.Methods Data of blinatumomab in FAERS from September 2014 to December 2023 were collected,and the signal mining was performed by using the ROR method and BCPNN method to analyze the occurrence of adverse drug event.Results A total of 250 adverse drug event signals were obtained,involving 19 system organ classifications(SOC),with a total of 5 013 cases reported.Accumulated SOC mainly included systemic diseases and various reactions at the site of administration,immune system diseases,various neurological diseases,blood and lymphatic system diseases,and various reactions.Adverse drug event signals with a high number of reports included fever,cytokine release syndrome,neurotoxicity,treatment non-responders,febrile neutropenia,and neutropenia.A total of 18 new findings of suspected adverse were found.Conclusion The common adverse reactions occurring in the real world with blinatumomab were consistent with the specification,but there were some newly found suspicious adverse reactions,which should be paid attention to in clinical diseases.
blinatumomabadverse drug eventssignal miningfevercytokine release syndromeneurotoxicity
NETL
NSTL
万方数据
