Signal mining of antineoplastic agents-associated thrombosis based on FAERS database
Objective The data mining and analysis of antineoplastic agents-associated thrombosis were conducted to ensure their safe clinical application.Methods Thrombotic events were extracted from the FDA adverse event reporting system(FAERS)database,covering the period from the first quarter of 2004 to the third quarter of 2023.Subsequently,the screening process was conducted to identify events specifically associated with thrombosis caused by antineoplastic agents.The suspicious risk signals where antineoplastic agents were identified as the primary suspect(PS)were screened by the reporting odds ratio(ROR)method.Results A total of 19 098 events and 296 suspicious risk signals were obtained,involving 98 antineoplastic agents.Among these agents,53 did not have thrombotic adverse events listed in their drug instructions.The antineoplastic agent with the largest number of reports was lenalidomide(n=3 742,ROR=3.40),and the largest ROR value was thioguanine(n=4,ROR=30.11).The most frequently observed antineoplastic agents associated with thrombosis were targeted agents(n=6 445,ROR=10.03),with EGFR-targeted agents being the most commonly reported,particularly cetuximab(n=534).Cytotoxic drugs,which primarily act on DNA structures,such as cisplatin(n=635),were the second most common category of antineoplastic agents associated with thrombosis.The median time of occurrence of antineoplastic agents-related thrombus was 1.93 months(75.71％),which mainly occurred within three months after the first medication,and the second month(45.71％)accounted for a relatively high proportion.The median time of thrombotic adverse events was the shortest(1.75 months)for cytotoxic drugs,while the median time of thrombotic adverse events for hormone antitumor drugs(3.84 months)and bone preserving drugs(6.33 months)were longer.Conclusion Targeted agents are the primary class of drugs linked to thrombotic events,surpassing traditional chemotherapy drugs by a significant margin.With emerging anti-tumor drugs constantly being introduced to the market,clinicians must remain vigilant of the potential risk of thrombosis posed by such medications.The three months after the first drug use is the key monitoring period,medical personnel should be vigilant and take countermeasures at any time.
FDA adverse event reporting system(FAERS)signal miningantineoplastic agentsthrombosistargeted agents
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