Adverse Event Profiles of Platinum Agents: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS, and Reproducibility of Clinical Observations

作者：Sakaeda Toshiyuki^*; Kadoyama Kaori; Okuno Yasushi

来源：International Journal of Medical Sciences, 2011, 8(6): 487-491.

DOI：10.7150/ijms.8.487

• adverse event
• AERS
• platinum agent
• pharmacovigilance

Objective: Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to confirm platinum agent-associated adverse events, and to clarify the rank-order of these drugs in terms of susceptibility.
Methods: After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving cisplatin (CDDP), carboplatin (CBDCA), or oxaliplatin (L-OHP) were analyzed. Authorized pharmacovigilance tools were used for the quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean.
Results: Based on 1,644,220 AERs from 2004 to 2009, CDDP, CBDCA, and L-OHP all proved to cause nausea, vomiting, acute renal failure, neutropenia, thrombocytopenia, and peripheral sensory neuropathy. Higher susceptibility to nausea was found for CDDP than CBDCA and L-OHP. Acute renal failure was also more predominant for CDDP, and CBDCA did not increase the blood level of creatinine. A stronger association with thrombocytopenia was suggested for CBDCA. Susceptibility to peripheral sensory neuropathy was greatest for L-OHP, but less extensive for CDDP and CBDCA.
Conclusion: The results obtained herein were consistent with clinical observations, suggesting the usefulness of the FDA's adverse event reporting system, AERS, and the data mining method used herein.

• 出版日期2011