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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.
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BMC Neurology

ISSN: 1471-2377

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