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Table 1 Baseline demographics and clinical characteristics of patients at entry to core study (extension randomized population)

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

Characteristic Fingolimod 0.5 mg (n = 47) Fingolimod 1.25 mg (n = 46) Placebo-fingolimod 0.5 mg (n = 27) Placebo-fingolimod 1.25 mg (n = 23)
Patient demographic     
Age, years     
 Mean (SD) 34.9 (9.0) 35.7 (8.8) 34.2 (9.1) 35.5 (8.4)
 Median (range) 34.0 (19–52) 36.0 (18–55) 34.0 (18–52) 34.0 (21–51)
Female, n (%) 33 (70.2) 31 (67.4) 19 (70.4) 14 (60.9)
BMI, kg/m2     
 Mean (SD) 21.8 (3.2) 22.0 (3.9) 21.0 (2.6) 20.7 (3.1)
 Median (range) 21.5 (15.1–32.6) 21.1 (18.1–36.2) 20.8 (15.0–26.2) 20.2 (13.8–28.8)
Disease characteristic     
Clinical pattern of MS, n (%)    
 Relapsing-remitting 44 (93.6) 45 (97.8) 27 (100.0) 23 (100.0)
 Secondary progressive 3 (6.4) 1 (2.2) 0 (0.0) 0 (0.0)
Duration of MS since first symptom, years
 Mean (SD) 8.2 (6.6) 7.6 (5.5) 8.4 (8.1) 8.4 (7.2)
 Median (range) 6.4 (1–26) 6.2 (0–21) 5.4 (1–27) 5.9 (1–24)
Number of relapses within previous year
 Mean (SD) 1.4 (0.9) 1.5 (1.0) 2.1 (2.1) 1.4 (0.7)
 Median (range) 1.0 (0–3) 1.0 (0–4) 2.0 (1–12) 1.0 (0–3)
Number of relapses within previous 2 years
 Mean (SD) 2.1 (1.3) 2.2 (1.6) 3.2 (4.0) 2.5 (1.4)
 Median (range) 2.0 (0–7) 2.0 (0–6) 2.0 (1–22) 2.0 (0–5)
EDSS score     
 Mean (SD) 2.4 (1.9) 1.9 (1.7) 1.9 (1.6) 2.4 (1.6)
 Median (range) 2.0 (0.0–6.0) 2.0 (0.0–6.0) 1.5 (0.0–5.0) 2.0 (0.0–5.5)
MRI characteristics     
Patients free of Gd-enhancing lesions
n (%) 28 (59.6) 22 (47.8) 13 (48.1) 17 (73.9)
Number of Gd-enhancing lesions     
 Mean (SD) 1.0 (1.59) 1.7 (2.42) 1.7 (2.45) 0.7 (1.49)
 Median (range) 0.0 (0–5) 1.0 (0–9) 1.0 (0–9) 0.0 (0–5)
Number of T2 lesions     
 Mean 30.3 (22.83) 34.6 (24.15) 28.9 (23.22) 33.3 (23.11)
 Median (range) 24.0 (4–100) 29.5 (5–119) 23.0 (3–98) 35.0 (1–91)
MS medication history     
Treatment-naïve patients, n (%) 16 (34.0) 21 (45.7) 16 (59.3) 8 (34.8)
Previously treated patients, n (%) 31 (66.0) 25 (54.3) 11 (40.7) 15 (65.2)
 Any interferon beta 30 (63.8) 25 (54.3) 10 (37.0) 14 (60.9)
 Other MS medications 9 (19.1) 6 (13.0) 2 (7.4) 3 (13.0)
  1. Abbreviations: BMI body mass index; EDSS Expanded Disability Status Scale; Gd gadolinium; MRI magnetic resonance imaging; MS multiple sclerosis; SD standard deviation.