Table 1.
Baseline demographics and disease characteristics in CLARITY (placebo and cladribine tablets 3.5 mg/kg) and CLARITY Extension (CP 3.5 mg/kg).
| CLARITY | CLARITY Extension | ||
|---|---|---|---|
| Placebo (n = 437) | Cladribine tablets 3.5 mg/kg (n = 433) | CP 3.5 mg/kg (n = 98) | |
| Mean age, years | 38.7 ± 9.9 | 37.9 ± 10.3 | 38.1 ± 10.6 |
| Female, n (%) | 288 (65.9) | 298 (68.8) | 67 (68.4) |
| Mean disease duration, a years | 5.18 ± 5.45 | 4.68 ± 5.51 | 3.86 ± 4.68 |
| Previous disease-modifying therapy, n (%) | 132 (30.2) | 110 (25.4) | 18 (18.4) |
| Mean age at time of diagnosis, years | 33.6 ± 9.6 | 33.3 ± 9.7 | 34.3 ± 10.2 |
| Relapses in 12 months prior to study, n (%) | |||
| 0 | 0 | 0 | 0 |
| 1 | 306 (70.0) | 302 (69.7) | 69 (70.4) |
| 2 | 110 (25.2) | 106 (24.5) | 20 (20.4) |
| ⩾3 | 21 (4.8) | 25 (5.8) | 9 (9.2) |
| Median EDSS score at baseline (Min; Max) | 3.00 (0.0; 5.5) | 2.50 (0.0; 6.0) | 3.00 (0.0; 5.5) |
| Mean number of T1 Gd+ lesions at baseline | 0.8 ± 2.1 | 1.0 ± 2.7 | 1.2 ± 2.6 |
| Mean number of T2 lesions at baseline | 27.4 ± 17.7 | 25.3 ± 16.3 | 28.4 ± 20.8 |
CP: cladribine tablets in CLARITY and placebo in CLARITY Extension; CT: cladribine tablets; EDSS: Expanded Disability Status Scale; Gd+: gadolinium-enhancing; n: number of patients.
Data are mean ± SD, unless otherwise stated. Baseline is defined as the start of CLARITY.
a
Time since diagnosis.