| |
Median
|
Arms accruing at stage
|
Total
|
Differences in
|
|---|
|
Pts/yr
|
Median FFS (m)
|
Median OS (m)
|
1
|
2
|
3
|
4
|
Pts
|
Time (m)
|
Total pts
|
Time (m)
|
|---|
|
Reference
|
|
500
|
24
|
48
|
6
|
6
|
6
|
6
|
3411
|
82
|
0
|
0
|
|
Impact of accrual rate
|
|
350
|
24
|
48
|
6
|
6
|
6
|
6
|
2960
|
102
|
-451
|
20
|
|
500
|
24
|
48
|
6
|
6
|
6
|
6
|
3411
|
82
|
0
|
0
|
|
750
|
24
|
48
|
6
|
6
|
6
|
6
|
4046
|
65
|
635
|
-17
|
|
Impact of FFS event rates
|
|
500
|
18
|
36
|
6
|
6
|
6
|
6
|
3040
|
73
|
-371
|
-9
|
|
500
|
24
|
48
|
6
|
6
|
6
|
6
|
3411
|
82
|
0
|
0
|
|
500
|
30
|
60
|
6
|
6
|
6
|
6
|
3743
|
90
|
332
|
8
|
|
Impact of OS event rates
|
|
500
|
24
|
48
|
6
|
6
|
6
|
6
|
3411
|
82
|
0
|
0
|
|
500
|
24
|
60
|
6
|
6
|
6
|
6
|
3743
|
90
|
332
|
8
|
|
Impact of dropping arms
|
|
500
|
24
|
48
|
6
|
6
|
6
|
6
|
3411
|
82
|
0
|
0
|
|
500
|
24
|
48
|
6
|
6
|
6
|
2
|
3190
|
77
|
-221
|
-5
|
|
500
|
24
|
48
|
6
|
6
|
2
|
2
|
2983
|
72
|
-428
|
-10
|
|
500
|
24
|
48
|
6
|
2
|
2
|
2
|
2738
|
66
|
-673
|
-16
|
|
500
|
24
|
48
|
6
|
5
|
4
|
3
|
3133
|
75
|
-278
|
-7
|
- Difference = difference from reference scenario, FFS = failure-free survival, OS = overall survival, Pts = patients, M = months. This does not include the Pilot stage for safety, concentrating only the particular issues relating to the application of the MAMS activity and efficacy stages
