Modified intent-to-treat population | |||||||
Response | BP (n = 71) | EP (n = 76) | Difference | 90 % CI | P value by CMH test | ||
No. | % | No. | % | ||||
CR | 1 | 1.4 | 0 | 0 | |||
PR | 41 | 57.7 | 35 | 46.1 | |||
SD | 17 | 23.9 | 28 | 36.8 | |||
PD | 4 | 5.6 | 5 | 6.6 | |||
NE | 8 | 11.3 | 8 | 10.5 | |||
CR + PR | 42 | 59.2 | 35 | 46.1 | 13.1 | −0.3 to 26.5 | .214 |
CR + PR + SD | 59 | 83.1 | 63 | 82.9 | 0.2 | −10.0 to 10.4 | .826 |
Per protocol population | |||||||
Response | BP (n = 57) | EP (n = 63) | Difference | 90 % CI | P value by CMH test | ||
No. | % | No. | % | ||||
CR | 1 | 1.8 | 0 | 0 | |||
PR | 40 | 70.2 | 34 | 54.0 | |||
SD | 9 | 15.8 | 21 | 33.3 | |||
PD | 3 | 5.3 | 3 | 4.8 | |||
NE | 4 | 7.0 | 5 | 7.9 | |||
CR + PR | 41 | 71.9 | 34 | 54.0 | 18.0 | 3.7 to 32.2 | .061 |
CR + PR + SD | 50 | 87.7 | 55 | 87.3 | 0.4 | −0.95 to 10.4 | .978 |