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Table. 1.

Table. 1.

Definition and signal detection criteria of data mining indices

Number of reports Specific Adverse Event All other Adverse Events Total
Drug of interest A B A+B=E
Another drug C D C+D=F
Total A+C=G B+D=H A+B+C+D=I

Indices Definition Criteria for signal detection

Disproportionality ratio PRR (A/E)/(C/F) ROR ≥ 2, x2 ≥ 4, A ≥ 3
ROR (A/B)/(C/D) PRR ≥ 2, x2 ≥ 4, A ≥ 3
IC log2(A+0.5)/ ((E*G/I)+0.5)) IC under limit of 95% confidence interval ≥ 0

IC, information component; PRR, proportional reporting ratio; ROR, reporting odds ratio

Korean J Clin Pharm 2023;33:86-96 https://doi.org/10.24304/kjcp.2023.33.2.86
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