| Fingolimod cohort N = 177 | Other DMTs cohort N = 87 |
---|---|---|
Safety profile, n (%) | ||
 Patients with any AE | 106 (59.9) | 44 (50.6) |
 Patients with any AE leading to drug discontinuation | 29 (16.4) | 5 (5.7) |
 Patients with an SAE | 10 (5.6) | 1 (1.1) |
 Deaths | 0 (0.0) | 0 (0.0) |
Most frequent AEs (≥3% of patients for any group; n [%]; preferred terms) | ||
 MS relapse | 19 (10.7) | 7 (8.0) |
 Lymphopaenia | 14 (7.9) | 0 (0.0) |
 Hepatic enzyme increased | 12 (6.8) | 0 (0.0) |
 Fatigue | 11 (6.2) | 6 (6.9) |
 Muscular weakness | 10 (5.6) | 5 (5.7) |
 Leukopaenia | 9 (5.1) | 3 (3.4) |
 Lymphocyte count decreased | 9 (5.1) | 0 (0.0) |
 Dizziness | 8 (4.5) | 2 (2.3) |
 Gait disturbance | 7 (4.0) | 6 (6.9) |
 MS worsening | 4 (2.3) | 4 (4.6) |
 Pain in extremity | 6 (3.4) | 2 (2.3) |
 Headache | 4 (2.3) | 3 (3.4) |
 Micturition urgency | 3 (1.7) | 3 (3.4) |
 Influenza | 0 (0.0) | 4 (4.6) |
 Paraesthesia | 0 (0.0) | 4 (4.6) |
Selected AEs, n (%) | ||
 Symptomatic bradyarrhythmia | 0 (0.0) | 0 (0.0) |
 Macular oedema | 0 (0.0) | 0 (0.0) |
 Increase in liver enzymes | 14 (8.9) | 2 (2.8) |
 Any infection | 4 (2.5) | 2 (2.8) |
 Other (any other AE) | 50 (31.6) | 28 (38.9) |