Table 1.
Baseline characteristics of the datasets used in this study compared to the original FREEDOMS and FREEDOMS II trials.
| Characteristics | FREEDOMS and FREEDOMS II (n = 2355) |
Baseline dataset (n = 1907) |
M24 dataset (n = 1351) |
|---|---|---|---|
| Women, n | 1733 | 1362 | 980 |
| Placebo/ | |||
| Fingolimod 0.5 mg/ | 773/783/799 | 631/635/641 | 444/467/440 |
| Fingolimod 1.25 mg | |||
| Age, years | |||
| Mean ± SD | 38.6 ± 8.8 | 38.5 ± 8.8 | 38.3 ± 8.8 |
| Median (range) | 39 (17–57) | 39 (17–57) | 39 (17–57) |
| DD, years | |||
| Mean ± SD | 9.3 ± 7.4 | 9.1 ± 7.3 | 8.9 ± 7.2 |
| Median (range) | 8 (0–50) | 7 (0–50) | 7 (0–50) |
| EDSS score | |||
| Mean ± SD | 2.4 ± 1.3 | 2.4 ± 1.3 | 2.4 ± 1.3 |
| Median (range) | 2 (0–6.5) | 2 (0–6) | 2 (0–6) |
| T2w lesion volume, mL | |||
| Mean ± SD | 5.9 ± 7.8 | 5.7 ± 7.6 | 5.6 ± 7.2 |
| Median (range) | 3 (0–69) | 3 (0–69) | 3 (0–55) |
| Normalized brain volume, mL | |||
| Mean ± SD | 1518 ± 84 | 1520 ± 84 | 1523 ± 80 |
| Median (range) | 1522 (1144–1764) | 1524 (1144–1756) | 1528 (1217–1756) |
DD: disease duration; EDSS: Expanded Disability Status Scale; M: month; SD: standard deviation; T2w: T2 weighted.