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Table 2 Disproportionality analysis of infection-related adverse events of IFX originator and biosimilar

From: Evaluation of adverse events focusing on infection associated with infliximab originator and biosimilar using a spontaneous reporting system database

 

IFX originator

IFX biosimilar

 

n

ROR (95% CI)

n

ROR (95% CI)

Pneumonia

230

3.65a (3.19–4.18)

42

4.67a (3.39–6.44)

Interstitial lung disease

148

2.34a (1.98–2.76)

20

2.16a (1.38–3.39)

Tuberculosis

114

26.9a (22.2–32.7)

6

8.88a (3.96–19.9)

Infection

112

3.54a (2.93–4.29)

7

1.48 (0.7–3.13)

Sepsis

53

2.41a (1.83–3.17)

13

4.12a (2.37–7.16)

  1. CI confidence interval, IFX infliximab, ROR reporting odds ratio
  2. a signal detected