Table A1.
Study Drug Exposure
Drug Exposure Factor | Placebo (n = 47) | Linifanib 7.5 mg (n = 42)* | Linifanib 12.5 mg (n = 47) |
---|---|---|---|
Treatment duration, days | |||
Median | 159.0 | 153.0 | 126.0 |
Range | 2.0-465.0 | 6.0-525.0 | 6.0-503.0 |
Dose-intensity, % | |||
Median | 100.0 | 99.5 | 94.9 |
Range | 63.4-119.5 | 60.3-104.6 | 51.9-100.0 |
Dose modifications | |||
No. of patients | 35 | 23 | 22 |
% | 74.5 | 54.8 | 46.8 |
Any dose interruption | |||
No. of patients | 12 | 19 | 25 |
% | 25.5 | 45.2 | 53.2 |
Any dose reduction | |||
No. of patients | 1 | 6 | 16 |
% | 2.1 | 14.3 | 34.0 |
Paclitaxel | |||
No. of cycles | |||
Median | 6.0 | 5.0 | 5.0 |
Range | 1.0-6.0 | 1.0-6.0 | 1.0-6.0 |
Six cycles | |||
No. of patients | 28 | 19 | 20 |
% | 59.6 | 45.2 | 43.5 |
Carboplatin | |||
No. of cycles | |||
Median | 6.0 | 5.0 | 5.0 |
Range | 1.0-6.0 | 1.0-6.0 | 1.0-6.0 |
Six cycles | |||
No. of patients | 29 | 19 | 20 |
% | 61.7 | 45.2 | 42.6 |
Two patients did not receive a dose of linifanib and were not included in the exposure or safety analyses.