Table 4 Change in efficacy measurements between TSC and placebo groups in the full analysis set (FAS)
Characteristics | TSC (N = 750) | Placebo (N = 250) | P values | |
|---|---|---|---|---|
Response rate (Percentage of patients with ≥50% reduction in frequency of headache), no. (%) | 4 weeks | 97 (13.0%) | 22 (8.9%) | 0.0794 |
8 weeks | 263 (36.7%) | 46 (18.9%) | < 0.0001 | |
12 weeks | 422 (62.1%) | 56 (23.9%) | < 0.0001 | |
16 weeks | 392 (70.8%) | 60 (26.3%) | < 0.0001 | |
Times of headache attacks per 4 weeks, mean ± SD | 4 weeks | 3.15 ± 1.09 | 3.15 ± 1.09 | 0.8647 |
8 weeks | 2.61 ± 1.00 | 3.02 ± 1.13 | < 0.0001 | |
12 weeks | 2.13 ± 1.00 | 2.85 ± 1.16 | < 0.0001 | |
16 weeks | 1.83 ± 0.92 | 2.89 ± 1.26 | < 0.0001 | |
VAS of headache, mean ± SD | 4 weeks | 3.88 ± 1.22 | 4.19 ± 1.25 | 0.0001 |
8 weeks | 3.17 ± 1.24 | 3.79 ± 1.23 | < 0.0001 | |
12 weeks | 2.59 ± 1.29 | 3.61 ± 1.36 | < 0.0001 | |
16 weeks | 2.29 ± 1.26 | 3.60 ± 1.45 | < 0.0001 | |
Days of acute analgesic use, mean ± SD, d | 4 weeks | 1.008 ± 1.29 | 1.350 ± 1.41 | 0.0003 |
8 weeks | 0.416 ± 0.80 | 0.856 ± 1.11 | < 0.0001 | |
12 weeks | 0.174 ± 0.51 | 0.671 ± 1.01 | < 0.0001 | |
16 weeks | 0.094 ± 0.38 | 0.754 ± 1.07 | < 0.0001 | |
Percentage of patients with ≥50% reduction in severity of headache, no. (%) | 4 weeks | 70 (9.4%) | 10 (4.1%) | 0.0044 |
8 weeks | 240 (33.5%) | 25 (10.3%) | < 0.0001 | |
12 weeks | 365 (53.7%) | 51 (21.8%) | < 0.0001 | |
16 weeks | 341 (61.6%) | 51 (22.4%) | < 0.0001 | |