Table 2.
Overall adverse event profile by study arm
| Adverse event | Vidofludimus (N = 122) | Placebo (N = 119) | Total (N = 241) |
|---|---|---|---|
| Any TEAE | 69 (56.6) | 70 (58.8) | 139 (57.7) |
| Any SAE | 1 (0.8) | 1 (0.8) | 2 (0.8) |
| Any TEAE related to: | |||
| Vidofludimus or placebo | 18 (14.8) | 29 (24.4) | 47 (19.5) |
| Methotrexate | 16 (13.1) | 18 (15.1) | 34 (14.1) |
| Folic acid | 7 (5.7) | 2 (1.7) | 9 (3.7) |
| Any study drug | 22 (18.0) | 30 (25.2) | 52 (21.6) |
| Any TEAE leading to withdrawal of: | |||
| Vidofludimus or placebo | 3 (2.5) | 5 (4.2) | 8 (3.3) |
| Methotrexate | 1 (0.8) | 1 (0.8) | 2 (0.8) |
| Folic acid | 1 (0.8) | 1 (0.8) | 2 (0.8) |
| Death | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Data are expressed as n (%)
N number of patients, SAE serious adverse event, TEAE treatment-emergent adverse event