Risk signal mining for siponimod based on the FDA Adverse Event Reporting System(FAERS)database
Objective The risk signals of siponimod were mined using the FDA Adverse Event Reporting System(FAERS)database to provide reference for clinical drug safety.Method To extract adverse drug event(ADE)reports for siponimod from the FAERS database from January 1,2019 to December 31,2022,and the preferred term(PT)and systematic organ classification(SOC)of the standardized adverse event terminology set in the International Dictionary of Medical Terms(23.1 edition)were used to classify and standardize the ADE reports of siponimod.The report odds ratio(ROR)method and proportional report ratio(PRR)method were used to mine the risk signal of ADE report of siponimod.Result From January 1,2019 to December 31,2022,the FAERS database received a total of 6435 ADE reports from Sinimod,of which 1426(22.16%)were male and 4603(71.53%)were female,and 406 cases(6.31%)were without gender information.A total of 243 risk signals were screened according to the criteria for ADE positive signals.Among them,the PT of number of reports ranked top 5 were fatigue,headache,dizziness,gait disorder,and decreased lymphocyte count.The SOC involved included systemic diseases,various reactions at the administration site,various neurological diseases,and various examinations.The PT of the signal intensity orders ranked top 5 were lung tumors,dyslipidemia,positive oligoclonal zone in cerebrospinal fluid,decreased lymphocyte count,and increased lymphocyte count.The SOC involved included benign,malignant and unknown tumors and various examinations.Dyslipidemia,lumbar radiculopathy,and paraplegia are not mentioned in the drug label.Conclusion In addition to the existing common adverse reactions in the drug instructions,clinical attention should be paid to the adverse reactions not mentioned in the instructions to ensure the safety of patients.
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