Table 1.
Baseline patient demographics according to subgroups under evaluation (randomized population).
| Placebo (n=363) | Teriflunomide 7 mg (n=366) | Teriflunomide 14 mg (n=359) | |
|---|---|---|---|
| Patient demographics | |||
| Gender | |||
| Male | 88 (24.2) | 111 (30.3) | 104 (29.0) |
| Female | 275 (75.8) | 255 (69.7) | 255 (71.0) |
| Age | |||
| <38 years | 156 (43.0) | 171 (46.7) | 174 (48.5) |
| ≥38 years | 207 (57.0) | 195 (53.3) | 185 (51.5) |
| Region | |||
| Eastern Europe | 114 (31.4) | 116 (31.7) | 108 (30.1) |
| Western Europe | 167 (46.0) | 167 (45.6) | 170 (47.4) |
| Americas | 82 (22.6) | 83 (22.7) | 81 (22.6) |
| Disease characteristics | |||
| Expanded Disability Status Scale score | |||
| ≤3.5 | 281 (77.4) | 281 (76.8) | 277 (77.2) |
| >3.5 | 82 (22.6) | 85 (23.2) | 82 (22.8) |
| Relapses in past two years | |||
| ≤1 | 71 (19.6) | 74 (20.2) | 71 (19.8) |
| 2 | 186 (51.2) | 188 (51.4) | 192 (53.5) |
| 3 | 76 (20.9) | 64 (17.5) | 70 (19.5) |
| ≥4 | 30 (8.3) | 40 (10.9) | 26 (7.2) |
| MS subtype | |||
| Relapsing–remitting | 329 (90.6) | 333 (91.0) | 333 (92.8) |
| Secondary progressive/progressive relapsing | 34 (9.4) | 33 (9.0) | 26 (7.2) |
| Prior use of DMT in last two years | |||
| Yes | 90 (24.8) | 102 (27.9) | 102 (28.4) |
| No | 273 (75.2) | 264 (72.1) | 257 (71.6) |
| MRI characteristics | |||
| Gd-enhancing T1 lesions per scana | (n=359) | (n=360) | (n=355) |
| 0 | 222 (61.8) | 233 (64.7) | 230 (64.8) |
| ≥1 | 137 (38.2) | 127 (35.3) | 125 (35.2) |
| Total lesion volume | (n=358) | (n=360) | (n=355) |
| <13 mL | 183 (51.1) | 170 (47.2) | 183 (51.5) |
| ≥13 mL | 175 (48.9) | 190 (52.8) | 172 (48.5) |
DMT: disease-modifying therapy; Gd: gadolinium; MRI: magnetic resonance imaging; MS: multiple sclerosis.
All values are n (%) in the individual prospectively defined subgroup.
a
Data for Gd-enhancing lesions were missing for four patients in the placebo group, six patients in the 7 mg group and four patients in the 14 mg group.