Table 3 Adverse events (AEs) during the complete duration of the study (RCT + OLE)
Infliximab (n = 12) | Placebo (n = 14) | ||
|---|---|---|---|
Patients with | |||
Any adverse event (%) | 9 (75) | 8 (57.1) | |
Any infection (%) | 5 (41.6) | 4 (28.5) | |
Infusion reactions (%) | 5 (41.6) | 1 (7.4) | |
Serious AEsa | 0 (0.0) | 0 (0.0) | |
Infection related | |||
Varicella | 1 (8.3) | 1 (7.4) | |
Pharyngitis | 3 (25.0) | 4 (28.5) | |
Upper tract respiratory infections, including flu | 5 (41.6) | 5 (35.7) | |
Diarrhoea | 2 (16.6) | 2 (14.3) | |
Infusion related | |||
Fever | 3 (25.0) | 2 (14.3) | |
Headache | 1 (8.3) | 0 (0.0) | |
Dizziness | 1 (8.3) | 0 (0.0) | |
Paradoxical AEs | |||
Psoriasis | 1 (8.3) | 0 (0.0) | |
Back pain | 1 (8.3) | 0 (0.0) | |