Table 6 Criteria used for signal detection.

From: Analysis of nationwide adverse event reports on Isoniazid and Rifampin in tuberculosis prevention and treatment in South Korea

Number of reports

Specific AEs

Other AEs

Study drug

A

B

Other drug

C

D

Parameters

Equation

Criteria of signal detection

PRR

{A/(A + B)}/{C/(C + D)}

PRR ≥ 2, χ2 ≥ 4 and occurrence of AEs cases ≥ 3

ROR

(A/B)/(C/D)

ROR ≥ 2, χ2 ≥ 4 and occurrence of AEs cases ≥ 3

IC

IC = log2P(E, D)/P(E)P(D)*

Lower limit of 95% CI ≥ 0

  1. AEs, adverse events; PRR, proportional reporting ratio; ROR, reporting odds ratio; IC, information component.
  2. *P(E, D): Probability of adverse event E after drug D, P(E)P(D): Product of probability of adverse event E and probability of drug D.
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