Table 1.

Signal detection algorithms and corresponding thresholds applied

Signal detection algorithm	Applied thresholda	Institution where the method and the respective threshold is currently used
Number of reports	≥5	NA
PRR	PRR lower bound 95 % CI ≥1 and n ≥ 5 reports	European Medicines Agency (EMA)
EBGM	EB05 CI ≥1.8, n ≥ 3 reports, and EBGM ≥2.5	Medicines and Healthcare products Regulatory Agency (MHRA)

CI confidence interval, EB05 lower bound of the 95 % confidence interval, EBGM empirical Bayes geometric mean, NA not available, PRR proportional reporting ratio

^aThresholds were obtained from Candore et al. [23]