Adverse Drug Event Reporting Rates: Comparing FAERS to Clinical Trials

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Presented at the Association of Managed Care Pharmacy (AMCP) conference in March, 2017, this poster and abstract:

  •  Compares the rate of adverseamcp.png
    drug events (ADEs) for individual
    drugs from pre-approval clinical
    trials to post-approval reporting to
    FDA’s Adverse Event Reporting
    System (FAERS).
  • Provides a new methodology to
    calculate ADE reporting rates and
    examine whether reporting rates
    differ by indications.

Included in this Analysis:

  • 50 drugs
  • 4 indications
  • 1,000+ pII and pIII clinical trials
  • 20 years of FAERS data

Summary Conclusions:

  • Serious ADE reporting rates in FAERS vary widely by
    indication, with reporting rates in FAERS ranging from 0.7%
    to 47.3%.
  • Past estimates of a 10% reporting rate for serious ADEs in
    FAERS is no longer accurate, sufficient or appropriate for
    modern pharmacovigilance.

Learn more about Advera's Clinical Evidence database. 

Please note: This is an independent analysis conducted by Advera Health, based upon data and insight generated by the analytical tools of Evidex and other pertinent information gathered at the time of publication. This analysis is not sponsored or influenced by any third party. The inclusion of a particular company, drug, adverse event, class or indication in this report is determined wholly by our quantitative signaling and analytic systems along with our qualitative analysis work.