Table 2 Progression-free and overall survival analysis (from time of study randomization)

Confirmed progression-free survival

 N at risk

25

23^a

 N events

16

18

 Median (95% CI)

8.9 (3.4, 24.6)

9.2 (4.1, 20.9)

 1-year PFS, % (95% CI)

50% (27%, 69%)

38% (18%, 58%)

 Hazard ratio (95% CI)

0.94 (0.46, 1.87)

 P value

P = 0.85

Progression-free survival including clinical assessments

 N at risk

25

23^a

 N events

19

19

 Median (95% CI)

6.2 (3.2, 18.7)

9.17 (2.5, 20.9)

 1-year PFS, % (95% CI)

43% (23%, 63%)

37% (17%, 56%)

 Hazard ratio (95% CI)

0.83 (0.42, 1.59)

 P value

P = 0.57

Overall survival

 N at risk

25

24

 N events

14

15

 Median (95% CI)

26.4 (17.8, 46.7)

33.8 (12.8, 47.6)

 2-year OS, % (95% CI)

61% (36%, 78%)

50% (28%, 69%)

 Hazard ratio

0.98 (0.46, 2.05)

 P value

P = 0.96