Table 3.
Most frequent treatment-emergent adverse events by system organ class (frequency > 2.0% in either treatment arm)
| TEAEs by MedDRA SOC | Vidofludimus (N = 122) | Placebo (N = 119) | Total (N = 241) |
|---|---|---|---|
| Infections and infestations | 27 (22.1) | 36 (30.3) | 63 (26.1) |
| Nervous system disorders | 22 (18.0) | 24 (20.2) | 46 (19.1) |
| Musculoskeletal and connective tissue disorders | 19 (15.6) | 16 (13.4) | 35 (14.5) |
| Gastrointestinal disorders | 18 (14.8) | 15 (12.6) | 33 (13.7) |
| Investigations | 10 (8.2) | 8 (6.7) | 18 (7.5) |
| Skin and subcutaneous tissue disorders | 8 (6.6) | 4 (3.4) | 12 (5.0) |
| Respiratory, thoracic and mediastinal disorders | 7 (5.7) | 5 (4.2) | 12 (5.0) |
| Metabolism and nutrition disorders | 3 (2.5) | 6 (5.0) | 9 (3.7) |
| General disorders and administration site conditions | 6 (4.9) | 5 (4.2) | 11 (4.6) |
| Renal and urinary disorders | 6 (4.9) | 5 (4.2) | 11 (4.6) |
| Vascular disorders | 4 (3.3) | 3 (2.5) | 7 (2.9) |
| Psychiatric disorders | 4 (3.3) | 1 (0.8) | 5 (2.1) |
| Eye disorders | 3 (2.5) | 2 (1.7) | 5 (2.1) |
| Ear and labyrinth disorders | 1 (0.8) | 3 (2.5) | 4 (1.7) |
| Hepatobiliary disorders | 1 (0.8) | 3 (2.5) | 4 (1.7) |
Data are expressed as n (%)
MedDRA Medical Dictionary for Regulatory Activities, N number of patients, SOC system organ class, TEAEs treatment-emergent adverse events