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 adverse
drug events (ADEs) for individual
drugs from pre-approval clinical
trials to post-approval reporting to
FDA’s Adverse Event Reporting
- 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
- Serious ADE reporting rates in FAERS vary widely by
indication, with reporting rates in FAERS ranging from 0.7%
- Past estimates of a 10% reporting rate for serious ADEs in
FAERS is no longer accurate, sufficient or appropriate for
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.