Table 3.
Statistical assessment of dose proportionality for bleselumab (PKAS)
| Dose range (mg/kg) | Visit | Parameter | Slope estimate (95% CI) |
|---|---|---|---|
| 0.1–3.0 | Baseline (day 1) | AUC336, μg·h/ml | 2.92 (2.59, 3.24) |
| Cmax, μg/ml | 1.67 (1.53, 1.81) | ||
| Day 15 | AUC336, μg·h/ml | 2.67 (2.24, 3.11) | |
| Cmax, μg/ml | 1.58 (1.41, 1.74) | ||
| Day 29 | AUC336, μg·h/ml | 2.88 (2.47, 3.29) | |
| Cmax, μg/ml | 1.68 (1.50, 1.87) |
Dose proportionality was concluded if the 95% confidence interval for the slope included 1. AUC336, area under the concentration–time curve over 336 hours; CI, confidence interval; Cmax, maximum concentration; PKAS, pharmacokinetics‐analysis set.