Table 3

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 AEs337 (94.7)154 (92.2)
 Nasopharyngitis112 (31.5)51 (30.5)
 Lymphopenia/lymphocyte count decreased78 (21.9)42 (25.2)
 Headache69 (19.4)38 (22.8)
 Urinary tract infection40 (11.2)18 (10.8)
 Upper respiratory tract infection38 (10.7)21 (12.6)
 Influenza36 (10.1)17 (10.2)
 Back pain35 (9.8)18 (10.8)
 Cough33 (9.3)20 (12.0)
B. SAE, n (%) (at least two patients in either of the groups*)
Overall SAEs55 (15.4)21 (12.6)
 Basal cell carcinoma†6 (1.7)1 (0.6)
 Multiple sclerosis relapse4 (1.1)2 (1.2)
 Cholelithiasis4 (1.1)0
 Cystitis2 (0.6)0
 Breast cancer2 (0.6)0
 Spontaneous abortion2 (0.6)0
 Lower limb fracture2 (0.6)0
 Road traffic accident2 (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.