Table 1 Treatment exposure of patients in the safety data set.

Cycles received, mean ± sd

3.7 ± 2.0

4.4 ± 1.9

0.021^a

 Yes

58 (72%)

66 (82%)

0.10^b

 No (drop-outs)

23 (28%)

14 (18%)

 Before 1st efficacy evaluation

5 (6%)

8 (10%)

0.029^b

 After 1st efficacy evaluation

18 (22%)

6 (8%)

 1 cycle

13 (16%)

9 (11%)

0.027^b

 2 cycles

19 (23%)

11 (14%)

 3 cycles

7 (9%)

2 (3%)

 4 cycles

9 (11%)

15 (19%)

 5 cycles

5 (6%)

1 (1%)

 6 cycles

28 (35%)

42 (53%)

 Cycle 1

(85 ± 14)%

(90 ± 31)%

0.004^a

 Cycle 2

(81 ± 19)%

(88 ± 14)%

0.018^a

 Cycle 3

(80 ± 17)%

(80 ± 16)%

0.94^a

 Cycle 4

(81 ± 15)%

(82 ± 15)%

0.52^a

 Cycle 5

(80 ± 17)%

(82 ± 19)%

0.25^a

 Cycle 6

(91 ± 13)%

(93 ± 14)%

0.48^a

 <65 years

(81 ± 12)%

(85 ± 9)%

0.07^a

 ≥65 years

(83 ± 13)%

(81 ± 13)%

0.60^a