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Table 1 Baseline demographic and disease characteristics of the ITT population, East Asian subgroup, Japanese subgroup, and Eastern European Subgroup

From: A randomized placebo-controlled trial of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis from East Asia and other countries

 

ITT

East Asian subgroup

Japanese subgroup

Eastern European subgroup

Characteristic

Placebo

n = 113

DMFa

n = 111

Placebo

n = 72

DMFa

n = 70

Placebo

n = 58

DMFa

n = 56

Placebo

n = 41

DMFa

n = 41

Age (years), mean (SD)

36.0 (7.5)

37.3 (8.3)

36.6 (7.9)

37.5 (8.4)

36.4 (7.2)

38.4 (8.2)

35.0 (6.6)

37.0 (8.2)

Female (%)

74

70

79

79

79

79

66

56

BMI (kg/m2), mean (SD)

23.0 (4.3)

23.2 (4.1)

21.7 (3.4)

22.1 (3.3)

21.5 (3.6)

22.1 (3.5)

25.4 (4.7)

25.1 (4.6)

Country, n (%)

 Japan

58 (51)

56 (50)

58 (81)

56 (80)

58 (100)

56 (100)

0

0

 South Korea

10 (9)

10 (9)

10 (14)

10 (14)

0

0

0

0

 Taiwan

4 (4)

4 (4)

4 (6)

4 (6)

0

0

0

0

 Czech Republic

21 (19)

21 (19)

0

0

0

0

21 (51)

21 (51)

 Poland

20 (18)

20 (18)

0

0

0

0

20 (49)

20 (49)

Region

 East Asia

72 (64)

70 (63)

72 (100)

70 (100)

58 (100)

56 (100)

0

0

 Eastern Europe

41 (36)

41 (37)

0

0

0

0

41 (100)

41 (100)

Relapses in prior year, mean (SD)

1.4 (0.7)

1.4 (0.7)

1.3 (0.6)

1.4 (0.7)

1.3 (0.6)

1.5 (0.7)

1.5 (0.8)

1.5 (0.6)

Relapses in last 3 years, mean (SD)

2.3 (1.5)

2.5 (1.7)

2.3 (1.6)

2.6 (1.8)

2.3 (1.7)

2.7 (1.9)

2.3 (1.3)

2.3 (1.4)

Time since last relapse (months), mean (SD)

6.4 (6.5)

5.5 (4.7)

7.0 (7.7)

5.9 (5.6)

7.5 (8.4)

6.0 (6.0)

5.2 (3.6)

4.7 (2.4)

EDSS score, mean (SD)

1.9 (1.3)

2.2 (1.3)

1.8 (1.3)

1.9 (1.3)

1.8 (1.3)

1.9 (1.3)

2.1 (1.2)

2.6 (1.2)

EDSS score, median (min, max)

2.0 (0, 5)

2.0 (0, 5)

1.8 (0, 5)

2.0 (0, 4.5)

1.5 (0, 5)

2.0 (0, 4.5)

2.0 (0, 5)

2.5 (1, 5)

Any prior treatment for MS, n (%)

64 (57)

63 (57)

35 (49)

40 (57)

31 (53)

31 (55)

29 (71)

23 (56)

Number of Gd+ lesions, mean (SD)

1.5 (3.2)

1.6 (4.9)

1.8 (3.6)

1.3 (2.7)

1.6 (3.3)

1.3 (2.6)

1.1 (2.1)

2.0 (7.3)

T2 hyperintense lesion volume (cm3), mean (SD)

8.2 (10.3)

6.7 (7.7)

8.6 (9.5)

6.2 (7.5)

8.1 (8.9)

5.7 (7.3)

7.3 (11.5)

7.6 (8.1)

  1. Abbreviations: ITT intention-to-treat, SD standard deviation, BMI body mass index, EDSS Expanded Disability Status Scale, MS multiple sclerosis, Gd+ gadolinium-enhancing
  2. aDMF, delayed-release DMF
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