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| The data-mining of ADR signals for Sorafenib |
| ZHOU Jian1 CHEN Li2 |
1.Pharmacy Department, the Third People′s Hospital of Chengdu, Sichuan Province, Chengdu 610031, China;
2.Pharmacy Department, West China Second University Hospital, Sichuan Province, Chengdu 610041, China |
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Abstract Objective To excavate the adverse drug reaction signals of molecular targeted antitumor drug Sorafenib, in order to provide references for safety medicinal practice. Methods Conduct data-mining on the reporting odds ratio (ROR) and proportional reporting ratio (PRR) in measures of disproportionality to the reports in 17 quarters (Q4, 2012 -Q4, 2016) in FDA Adverse Event Reporting System (FAERS). Results Seven hundred and seventy-seven Sorafenib adverse drug reaction signals were obtained with ROR and PRR methods. After the secondary screening, 68 Sorafenib adverse drug reaction signals were obtained, which were mainly concentrated in tumors, hepatobiliary, gastrointestinal and skin diseases. Conclusion In this study, ROR and PRR are effectively used to extract the adverse drug reaction signals of Sorafenib. It is recommended that the appropriate attentions should be paid to the possible adverse reactions caused by Sorafenib.
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