Risk signal mining of adverse event related to axicabtagene ciloleucel based on FAERS database
Objective To analyze the occurrence of axicabtagene ciloleucel-related adverse events through FAERS database,and provide reference for clinical safety of drug use.Methods The adverse event data of axicabtagene ciloleucel from January 2018 to September 2023 were mined in FAERS database,and the relevant adverse events were analyzed and risk signals monitored by ROR and PRR.Results A total of 2 352 adverse events reports with axicabtagene ciloleucel as the primary suspect drug were collected,and 331 preferred terms(PT)were mined.After sorting out the duplicate PT,the threshold filter finally generated 182 PT,and the number of related reports was 3 686.The PT of 182 signals is classified,involving a total of 19 SOCs.According to the number of PT reports,the top 5 were neurological diseases,systemic diseases and reactions at the site of administration,social environment,various examinations,and vascular and lymphatic diseases.The most frequent adverse events of axicabtagene ciloleucel were neurotoxicity,fever,and disease progression.According to the signal intensity ranking,the top 5 are various neurological diseases,diseases of the blood and lymphatic system,various examinations,kidney and urinary system diseases,benign and malignant tumors of unknown nature.Antigen receptor T cell(CAR-T)-associated encephalopathy syndrome was strongly associated with neurotoxicity,which was basically consistent with the instructions,verifying the reliability of this study.Conclusion The common adverse event signals of axicabtagene ciloleucel are consistent with those recorded in the instructions,but it is necessary to be alert to adverse events not mentioned in the instructions and take preventive measures in time to ensure the safety of clinical use.
axicabtagene ciloleuceladverse drug event signalingdata miningneurological disordersantigen receptor T cell associated encephalopathy syndrome
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