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

Int J Med Sci. 2011;8(6):487-91. doi: 10.7150/ijms.8.487. Epub 2011 Aug 16.


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.

Keywords: AERS; adverse event; pharmacovigilance; platinum agent.

MeSH terms

  • Acute Kidney Injury / chemically induced
  • Adverse Drug Reaction Reporting Systems / statistics & numerical data*
  • Algorithms
  • Antineoplastic Agents / adverse effects
  • Bayes Theorem
  • Carboplatin / adverse effects
  • Cisplatin / adverse effects
  • Data Mining
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Gastrointestinal Diseases / chemically induced
  • Hematologic Diseases / chemically induced
  • Humans
  • Organoplatinum Compounds / adverse effects*
  • Oxaliplatin
  • Peripheral Nervous System Diseases / chemically induced
  • Reproducibility of Results
  • Sensation Disorders / chemically induced
  • United States / epidemiology
  • United States Food and Drug Administration


  • Antineoplastic Agents
  • Organoplatinum Compounds
  • Oxaliplatin
  • Carboplatin
  • Cisplatin