| Endpoint |
Control N=347 |
B 7.5mg/kgN=345 |
B 15mg/kgN=351 |
|
| PFS general Hazard ratio (95%CI) |
|
0.75(0.62,0.90)P=0.002 |
0.82(0.68,0.98)P=0.03 |
| Median PFS general (mos) |
6.1 |
6.7 |
6.5 |
| PFS censoring for NPT Hazard ratio (95%CI) |
|
0.70(0.58,0.85) P=0.0004 |
0.78(0.64,0.95) P=0.0125 |
| Response rate (%) |
20 |
34 |
30 |
| Response duration (mos) |
4.7 |
6.1 |
6.1 |
Grade 3 AEs (%) |
75 |
76 |
81 |
Grade 3 hypertension (%) |
2 |
6 |
9 |
Grade 3 haemoptysis (%) |
<1 |
1.5 |
<1 |
| AEs leading to death (%) |
4 |
4 |
5 |
|