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Table 3 Incidence of AEs

From: Infliximab for pediatric patients with ulcerative colitis: a phase 3, open-label, uncontrolled, multicenter trial in Japan

 

All

n = 21

6 to < 12 years

n = 4

12 to 17 years

n = 17

Mean duration of follow-up (days)

176.7

169

179

Mean number of infusions

4.3

  

AEs, n (%)

20 (95.2)

4 (100.0)

16 (94.1)

ADRs, n (%)

15 (71.4)

3 (75.0)

12 (70.6)

AEs leading to discontinuation of IFX, n (%)

1 (4.8)

0 (0.0)

1 (5.9)

SAEs, n (%)

3 (14.3)

0 (0.0)

3 (17.6)

Serious ADRs, n (%)

1 (4.8)

0 (0.0)

1 (5.9)

Infections, n (%)

13 (61.9)

4 (100)

9 (52.9)

Serious infections, n (%)

1 (4.8)

0 (0.0)

1 (5.9)

Infusion reactions, n (%)

2 (9.5)

0 (0.0)

2 (11.8)

Serious infusion reactions, n (%)

0 (0.0)

0 (0.0)

0 (0.0)

  1. ADR Adverse drug reaction, AE Adverse event, IFX Infliximab, SAE Serious adverse event