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) | |
RCT randomized controlled trial phase, OLE open-label extension phase
aSerious adverse events monitored included, death, life-threatening condition, hospital admission, hospital stay extension and disability