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Table 3 Signal strength of reports of Faricimab at the SOC level in FAERS and JADER database

From: Safety profile of faricimab: a multi-source pharmacovigilance analysis using FAERS and JADER

SOC

n

ROR

(95%Cl)

PRR (χ2)

EBGM

(EBGM05)

IC

(IC025)

FAERS

General disorders and administration site conditions

2296

1.68 (1.6–1.76)*

1.5

(460.72)

1.5

(1.44)

0.58

(0.52)*

Injury, poisoning and procedural complications

2004

2.86

(2.72–3.01)*

2.44

(1872.5)*

2.44

(2.34)*

1.28

(1.21)*

Eye disorders

2920

24.41

(23.35–25.52)*

16.58

(43516.93)*

16.54

(15.93)*

4.05

(3.99)*

JADER

Eye disorders

138

154.03

(113.52–209)*

46.83

(6246.83)*

46.56

(34.31)*

5.54

(3.86)*

  1. SOC system organ class; n the number of reports; ROR reporting odds ratio; 95%CI 95% confidence interval; PRR proportional reporting ratio; χ2 chi-squared; IC information component; IC025 the lower limit of 95%CI of the IC; EBGM empirical Bayesian geometric mean; EBGM05 the lower limit of 95%CI of EBGM
  2. *Indicates statistically significant signals in algorithms. Notes: The SOCs that met at least one of the algorithm screening criterions are listed