Table 2.
Baseline demographics and disease characteristics
| Time since stroke, ≤ 24 months | Time since stroke, > 24 months | |||
|---|---|---|---|---|
| OnabotulinumtoxinA (n = 80) | Placebo (n = 73) | OnabotulinumtoxinA (n = 153) | Placebo (n = 162) | |
| Mean (SD) age, years | 54.3 (11.9) | 55.7 (12.0) | 56.9 (12.9) | 57.5 (11.8) |
| Male, n (%) | 55 (68.8) | 52 (71.2) | 93 (60.8) | 103 (63.6) |
| Caucasian, n (%) | 68 (85.0) | 62 (84.9) | 116 (75.8) | 132 (81.5) |
| Mean (SD) weight, kg | 76.5 (14.8) | 77.9 (14.4) | 82.1 (18.9) | 80.3 (15.9) |
| Mean (SD) height, cm | 169.0 (8.0) | 168.9 (9.1) | 169.9 (9.6) | 170.2 (9.2) |
| Time since stroke, years | ||||
| Mean (SD) | 1.1 (0.5) | 1.1 (0.5) | 8.0 (6.5) | 7.0 (6.7) |
| Median (range) | 0.9 (0.4–2.0) | 1.0 (0.4–2.0) | 6.0 (2.1–38.4) | 4.8 (2.1–54.3) |
| Stroke severity, n (%)a | ||||
| Mild | 7 (8.8) | 10 (13.7) | 16 (10.5) | 15 (9.3) |
| Moderate | 55 (68.8) | 42 (57.5) | 105 (68.6) | 108 (66.7) |
| Severe | 18 (22.5) | 21 (28.8) | 32 (20.9) | 39 (24.1) |
| Limbs affected by spasticity, n (%) | ||||
| Right leg only | 4 (5.0) | 3 (4.1) | 9 (5.9) | 12 (7.4) |
| Left leg only | 9 (11.3) | 9 (12.3) | 14 (9.2) | 15 (9.3) |
| Right arm and right leg | 34 (42.5) | 29 (39.7) | 62 (40.5) | 63 (38.9) |
| Left arm and left leg | 33 (41.3) | 32 (43.8) | 68 (44.4) | 70 (43.2) |
| Other | 0 | 0 | 0 | 2 (1.2) |
SD standard deviation
aSeverity scores defined as mild: minor deficit, functionally non-impairing; moderate: moderate deficit, significantly interfering with activities of daily living; severe: dependent, requiring chronic care