Table 5 Definition and criteria of signal detection for each indicator.

From: Frequently reported adverse events of rebamipide compared to other drugs for peptic ulcer and gastroesophageal reflux disease

 

Definition

Criteria of signal detection

PRR

(A/(A + B))/(C/(C + D))

PRR ≥ 2, chi-squared ≥ 4, and A ≥ 3

ROR

(A/B)/(C/D)

ROR ≥ 2, chi-squared ≥ 4, and A ≥ 3

IC

Log2(P(AE, drug)/P(AE) × P(drug))

Under limit of 95% confidence interval ≥ 0

  1. IC information component, PRR proportional reporting ratio, ROR reporting odds ratio.
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