Table 1. Demographic and Baseline Disease Characteristics of Randomized Participants.
Characteristic | Mean (SD) | |||
---|---|---|---|---|
Fingolimod groups | GA, 20 mg, group | Total | ||
0.5 mg | 0.25 mg | |||
Participants, No. | 352 | 370 | 342 | 1064 |
Age, y | 40.3 (11.1) | 38.9 (11.0) | 39.6 (10.8) | 39.6 (11.0) |
Female sex, No. (%) | 264 (75.0) | 276 (74.6) | 252 (73.7) | 792 (74.4) |
Race, No. (%) | ||||
White | 268 (76.1) | 279 (75.4) | 243 (71.1) | 790 (74.2) |
Black | 34 (9.7) | 43 (11.6) | 41 (12.0) | 118 (11.1) |
American Indian | 8 (2.3) | 7 (1.9) | 9 (2.6) | 24 (2.3) |
Asian | 0 | 1 (0.3) | 0 | 1 (0.1) |
Pacific Islander | 0 | 1 (0.3) | 0 | 1 (0.1) |
Other | 42 (11.9) | 39 (10.5) | 49 (14.3) | 130 (12.2) |
Duration of MS since diagnosis, y | 4.3 (5.9) | 4.6 (6.4) | 4.7 (6.2) | 4.5 (6.2) |
Previous MS therapy, No. (%) | 182 (51.7) | 195 (52.7) | 188 (55.0) | 565 (53.1) |
Relapses in the last year before screening | 1.4 (0.8) | 1.3 (0.7) | 1.4 (0.8) | 1.3 (0.8) |
Relapses in the last 2 y before screening | 2.2 (1.6) | 2.1 (1.3) | 2.2 (1.5) | 2.1 (1.5) |
EDSS score | 2.74 (1.46) | 2.55 (1.41) | 2.73 (1.42) | 2.67 (1.43) |
MSFC z score | –0.02 (0.68) | 0.01 (0.70) | 0.05 (0.66) | 0.01 (0.68) |
Participants without gadolinium-enhancing T1 lesions, No. (%) | 227 (64.9) | 232 (63.0) | 219 (64.2) | 678 (64.0) |
Gadolinium-enhancing T1 lesions | ||||
Count | 1.7 (5.5) | 2.1 (8.1) | 1.6 (5.5) | 1.8 (6.5) |
Volume, mL | 0.30 (1.06) | 0.32 (1.41) | 0.22 (0.83) | 0.28 (1.13) |
T1 hypointense lesion volume, mL | 3.3 (5.3) | 3.2 (5.4) | 2.7 (4.1) | 3.1 (5.0) |
T2 lesion volume, mL | 10.3 (12.2) | 10.2 (13.0) | 8.8 (9.9) | 9.8 (11.8) |
Normalized brain volume, mL | 1502.2 (86.6) | 1512.6 (94.2) | 1509.6 (90.6) | 1508.2 (90.6) |
Abbreviations: EDSS, Expanded Disability Status Scale; GA, glatiramer acetate; MS, multiple sclerosis; MSFC, Multiple Sclerosis Functional Composite.