QIAO Lijuan,CHEN Jinhua,KANG Jian.Signal mining and analysis of adverse drug event signals of darolutamide[J].ZHONGGUO YAOFANG,2024,35(03):339-342. DOI: 10.6039/j.issn.1001-0408.2024.03.13.
Signal mining and analysis of adverse drug event signals of darolutamide
To explore and analyze the adverse drug event (ADE) signals of darolutamide and provide a reference for its clinical safe use.
METHODS
2
ADEs related to darotamide were collected based on the US FDA adverse event reporting system (FAERS) database from the third quarter of 2019 to the third quarter of 2022. Data mining and analysis were conducted by the report odds ratio (ROR) and proportional reporting ratio (PRR) methods.
RESULTS
2
A total of 565 ADE reports related to darolutamide were extracted, 356 ADE reports about darolutamide as the primary suspected drug were included, 38 ADE signals with darolutamide as the primary suspected drug were excavated, involving 15 system organ class (SOC), mainly concentrated in patients over 65 years old. The SOC of darotamide ADE signal mainly focused on various examinations, systemic diseases and various reactions at the administration site, benign/malignant tumors or those with unknown nature (including cystic and polypoid), kidney and urinary system diseases. A total of 13 ADE signals not mentioned in the instructions included increased prostate-specific antigen, dysphagia, cognitive impairment, erectile dysfunction, rhabdomyolysis, gynecomastia and decreased platelet count, etc.
CONCLUSIONS
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When using darolutamide, in addition to ADE in the drug instruction, we should pay close attention to potential ADE, such as increased prostate-specific antigen, rhabdomyolysis, gynecomastia and decreased platelet count, so as to avoid drug withdrawal or organ damage caused by ADE.
关键词
达罗他胺美国FDA不良事件报告系统报告比值比法比例报告比值法信号挖掘
Keywords
FDA adverse event reporting systemreport odds ratioproportional reporting ratiosignal mining
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