Table 3.
Summary of results of statistical analysis to estimate dose proportionality after single doses of drisapersen.
| Parameter | n | Adjusted mean slope | Standard error | 90% Confidence interval for slopea, b |
|---|---|---|---|---|
| Drisapersen 3–9 mg/kg | ||||
| Cmax | 15 | 0.581 | 0.1712 | (0.278–0.884) |
| AUC(0–24) | 15 | 0.791 | 0.1505 | (0.524–1.057) |
| AUC(0–168) | 9 | 0.848 | 0.1107 | (0.638–1.058) |
| Drisapersen 3–6 mg/kg only (Post hoc analysis) | ||||
| Cmax | 12 | 0.705 | 0.2547 | (0.243–1.167) |
| AUC(0–24) | 12 | 0.977 | 0.2201 | (0.578–1.376) |
| AUC(0–168) | 7 | 0.939 | 0.1871 | (0.562–1.316) |
For single doses of drisapersen 3–9 mg/kg, dose proportional range was 0.797–1.203 for all parameters.
For single doses of drisapersen 3–6 mg/kg only, dose proportional range was 0.678–1.322 for all parameters.