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Table 2 MRI and clinical endpoints in the core (months 0–6) and extension phases (months 7–12) (MRI and clinical analysis populations)

From: Fingolimod (FTY720) therapy in Japanese patients with relapsing multiple sclerosis over 12 months: results of a phase 2 observational extension

  Continuous fingolimod groups Placebo to fingolimod switch groups
  Fingolimod 0.5 mg Fingolimod 1.25 mg Placebo-fingolimod 0.5 mg Placebo-fingolimod 1.25 mg
MRI outcomes (MRI analysis population) n = 45 n = 42 n = 23 n = 20
Patients free of Gd-enhancing lesions, n/totala (%)  
 Both months 3 and 6 35/45 (77.8) 37/42 (88.1) 6/23 (26.1) 11/20 (55.0)
 Both months 9 and 12 38/45 (84.4) 36/42 (85.7) 16/23 (69.6) 13/19 (68.4)
Number of Gd-enhancing lesions    
 Month 6 0.1 (0.32) 0.2 (1.08) 1.3 (1.84) 1.2 (1.96)
 Month 12 0.0 (0.15) 0.0 (0.15) 0.1 (0.31) 0.2 (0.54)
Patients free of new/newly enlarged T2 lesions, n/totala (%)  
 Months 0–6 30/45 (66.7) 24/42 (57.1) 5/23 (21.7) 10/19 (52.6)
 Months 7–12 39/45 (86.7) 37/42 (88.1) 13/21 (61.9) 11/17 (64.7)
Number of new/newly enlarged T2 lesions  
 Months 0–6 0.9 (2.1) 1.0 (2.0) 7.7 (14.5) 5.1 (6.8)
 Months 7–12 0.3 (1.1) 0.2 (0.5) 0.6 (1.2) 0.5 (0.9)
Clinical outcomes (clinical analysis population) n = 47 n = 46 n = 27 n = 23
Patients free of relapse, nb (%)  
 Months 0–6 38 (80.9) 38 (82.6) 18 (66.7) 14 (60.9)
 Months 7–12 42 (89.4) 41 (89.1) 24 (88.9) 21 (91.3)
Annualized relapse ratec  
 Months 0–6 0.47 0.39 0.97 1.22
 Months 7–12 0.23 0.28 0.26 0.21
EDSS score change from core baseline     
 Month 6 0.00 (0.36) −0.21 (0.59) 0.04 (1.00) 0.26 (0.78)
 Month 12 −0.02 (0.46) −0.02 (0.83) −0.32 (0.66) −0.11 (0.95)
  1. All values are means (standard deviations) unless otherwise indicated.
  2. aThe numerators (n) indicate the number of patients free of Gd-enhancing lesions or new/newly enlarged T2 lesions; the denominators (total) indicate the number of patients for whom MRI data were available. The percentages were calculated as n/total × 100.
  3. bAbsolute number of patients free of confirmed relapses.
  4. cCalculated as total number of confirmed relapses per treatment arm/total number of days on the study for all patients per treatment arm × 365.25.
  5. Abbreviations: EDSS Expanded Disability Status Scale; Gd gadolinium; MRI magnetic resonance imaging.