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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