Adverse event signal mining and analysis of inotuzumab ozogamicin based on FAERS database
Objective To mine the adverse drug event signals of inotuzumab ozogamicin based on FAERS database,and provide reference for rational use of inotuzumab ozogamicin.Methods Adverse event data of inotuzumab ozogamicin in FAERS database from its listing to 31 December 2023 were collected,and data mining was carried out using the reported ratio ratio method(ROR)and the medicines and healthcare products regulatory agency(MHRA)in the disproportional method.Results A total of 2 485 adverse event reports of inotuzumab ozogamicin were obtained.The age of the patients was 18—64 years old(39.32%),the gender was mainly male(49.74%),and the reporting country was mainly the United States(42.98%).A total of 72 adverse event signals were detected,involving 22 system organ class(SOC),mainly including general disorders and administration site conditions,immune system disorders,blood and lymphatic system disorders.The PT with higher frequency of adverse event occurrence is basically consistent with the drug instructions,such as venoocclusive liver disease,venoocclusive disease,platelet count decreased,pyrexia,blood bilirubin increased,sepsis.PT with strong ADE signals include venoocclusive disease,venoocclusive liver disease,neoplasm recurrence,splenic infarction,graft versus host disease,neoplasm progression,cytokine release syndrome.Conclusion Before using inotuzumab ozogamicin,medication evaluation should be done for patients,especially those with hepatic vein occlusion disease and severe persistent liver disease.During treatment,close attention should be paid to the patient's liver toxicity,and timely intervention should be taken in case of abnormality.
inotuzumab ozogamicinadverse drug eventdata miningRORMHRAvenous occlusive liver disease
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