Table 3.
TEAEs occurring in ≥10% of MS patients during the extension studies.
| Category/preferred term | Incidence of TEAEs, n (%) |
|
|---|---|---|
| MS-F203EXT (n = 269) | MS-F204EXT (n = 214) | |
| Any AE | 264 (98.1) | 205 (95.8) |
| AEs by severity | ||
| Mild | 16 (5.9) | 29 (13.6) |
| Moderate | 137 (50.9) | 120 (56.1) |
| Severe | 111 (41.3) | 56 (26.2) |
| Any serious AE | 94 (34.9) | 39 (18.2) |
| Deaths | 4 (1.5) | 1 (0.5) |
| Discontinuation due to AEs | 37 (13.8) | 7 (3.3) |
| Urinary tract infection | 112 (41.6) | 75 (35.0) |
| Fall | 107 (39.8) | 88 (41.1) |
| MS relapse | 87 (32.3) | 61 (28.5) |
| Arthralgia | 66 (24.5) | 33 (15.4) |
| Edema, peripheral | 53 (19.7) | 37 (17.3) |
| Back pain | 45 (16.7) | 23 (10.7) |
| Asthenia | 41 (15.2) | — |
| Pain in extremity | 53 (19.7) | 29 (13.6) |
| Insomnia | 40 (14.9) | — |
| Upper respiratory tract infection | 47 (17.5) | 31 (14.5) |
| Fatigue | 44 (16.4) | 37 (17.3) |
| Contusion | 31 (11.5) | 30 (14.0) |
| Dizziness | 28 (10.4) | 24 (11.2) |
| Muscular weakness | 35 (13.0) | 38 (17.8) |
| Cystitis | 28 (10.4) | — |
| Nausea | 40 (14.9) | 27 (12.6) |
| Muscle spasms | 34 (12.6) | — |
| Muscle spasticity | 42 (15.6) | 29 (13.6) |
| Nasopharyngitis | 37 (13.8) | — |
| Diarrhea | 28 (10.4) | — |
| Depression | 38 (14.1) | — |
| Headache | 28 (10.4) | — |
| Constipation | 27 (10.0) | — |
| Balance disorder | — | 23 (10.7) |
AEs: adverse events; MS: multiple sclerosis; TEAEs: treatment-emergent adverse events.