AEs in 10% or more patients (A), and SAEs in two or more patients (B) in the extension phase (M13–EOS)
| Fingolimod 0.5 mg (N=356) | IFN-switch fingolimod 0.5 mg (N=167) | |
|---|---|---|
| A. AE, n (%) (at least 10% in either of the groups*) | ||
| Overall AEs | 337 (94.7) | 154 (92.2) |
| Nasopharyngitis | 112 (31.5) | 51 (30.5) |
| Lymphopenia/lymphocyte count decreased | 78 (21.9) | 42 (25.2) |
| Headache | 69 (19.4) | 38 (22.8) |
| Urinary tract infection | 40 (11.2) | 18 (10.8) |
| Upper respiratory tract infection | 38 (10.7) | 21 (12.6) |
| Influenza | 36 (10.1) | 17 (10.2) |
| Back pain | 35 (9.8) | 18 (10.8) |
| Cough | 33 (9.3) | 20 (12.0) |
| B. SAE, n (%) (at least two patients in either of the groups*) | ||
| Overall SAEs | 55 (15.4) | 21 (12.6) |
| Basal cell carcinoma† | 6 (1.7) | 1 (0.6) |
| Multiple sclerosis relapse | 4 (1.1) | 2 (1.2) |
| Cholelithiasis | 4 (1.1) | 0 |
| Cystitis | 2 (0.6) | 0 |
| Breast cancer | 2 (0.6) | 0 |
| Spontaneous abortion | 2 (0.6) | 0 |
| Lower limb fracture | 2 (0.6) | 0 |
| Road traffic accident | 2 (0.6) | 0 |
*Results for fingolimod 1.25 mg and IFNβ-1a/fingolimod 1.25 mg are provided in the online supplementary table S2.
†An additional case of basal cell carcinoma was reported as AE, but not SAE.
AE, adverse events; EOS, end of study; IFN, interferon; M, month; SAEs, serious AEs.