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Table 1 SDR criteria for both scenarios and the three data sources

From: Investigating Overlap in Signals from EVDAS, FAERS, and VigiBase®

ScenarioSDR selection
EVDASFAERSVigiBase®
1ROR02.5 > 1 AND
N ≥ 5 AND
PT on IME list
ROR02.5 > 1 AND
N ≥ 5 AND
PT on IME list
ROR02.5 > 1 AND
N ≥ 5 AND
PT on IME list
2SDR All = yesEB05 ≥ 2 AND
PT on IME list
EB05 ≥ 2 AND
PT on IME list
  1. EB05 lower boundary of the 90% confidence interval of the empirical Bayesian geometric mean, EVDAS EudraVigilance Data Analysis System, FAERS FDA Adverse Event Reporting System, FDA Food and Drug Administration, IME important medical event, PT Preferred Term in MedDRA®, ROR02.5 lower boundary of the 95% confidence interval of the reporting odds ratio, SDR signal of disproportionate reporting