Table 2.
Efficacy outcomes in the double-blind period (full analysis set).
| Romiplostim | Placebo | P | |
|---|---|---|---|
| Primary endpoint | |||
| Duration of platelet response (platelet count ≥50 × 109/L), wk, median (min, max) | 2.0 (0, 6) | 1.0 (0, 2) | <.001 |
| (N = 151) | (N = 51) | ||
| Secondary efficacy endpoints following 6 weeks of therapy | |||
| Proportion of cases with platelet count increase ≥20 × 109/L from baseline, n (%) | 94 (67.1) (N = 140) |
5 (10.9) (N = 46) |
<.001 |
| Proportion of patients requiring emergency treatment to increase platelet count, n (%) | 2 (1.4) (N = 147) |
1 (2.0) (N = 50) |
>.999 |
| Proportion of patients with platelet count ≥100 × 109/L and no bleeding, n (%) | 21 (15.0) (N = 140) |
1 (2.2) (N = 46) |
.017 |
| Proportion of patients with platelet count ≥30 × 109/L and ≥2 fold increase from baseline showing no bleeding, n (%) | 69 (49.3) (N = 140) |
2 (4.3) (N = 46) |
<.001 |
| Change values of platelet count from baseline, mean ± SD | 42.8 ± 41.3 ×109/L (41.3) (N = 140) |
6.6 ± 28.5 ×109/L (28.5) (N = 46) |
<.001 |
| Proportion of patients with platelet response, n (%) | 70 (50.0) (N = 140) |
1 (2.2) (N = 46) |
<.001 |
P-value: Wilcoxon rank-sum test.