Signal Mining of Adverse Events Induced by Sacituzumab Govitecan Based on FAERS
Objective To promote the rational use of sacituzumab govitecan in clinical practice.Methods The adverse drug event(ADE)reports related to sacituzumab govitecan from April 2020 to June 2023 were collected by the FDA's Adverse Event Reporting System(FAERS).The ADE signals were detected by the proportional reporting ratio(PRR)and reporting odds ratio(ROR)methods.The system organ classification(SOC)and preferred term(PT)in the Medical Dictionary for Regulatory Activities(MedDRA)were used for classification statistics and descriptive analysis.Results A total of 2 369 ADE reports with sacituzumab govitecan as the primary suspected drug were included,with female patients being the majority(85.69％);the main indication was triple-negative breast cancer(49.30％),the severe ADEs were the most(89.70％),and the main reporting country was the United States(35.42％).A total of 137 positive PT signals were detected simultaneously by PRR and ROR methods,involving 26 SOCs.The mined main ADEs induced by sacituzumab govitecan included neutropenia,febrile neutropenia,body mass fluctuations,diarrhea,alopecia,which were generally consistent with those in the drug instruction;however,the ADEs not recorded in the drug instruction included hepatic cytolysis,cholestasis,sepsis,colitis and increased heart rate,with a high signal number and strong signal intensity.Conclusion The ADEs induced by sacituzumab govitecan were generally consistent with those in the drug instruction,the hematological and gastrointestinal systems-related ADEs require clinical attention and timely intervention.
sacituzumab govitecanadverse drug eventdata miningFDA's Adverse Event Reporting System
万方数据
维普
