|
Required Sample Size for High-Risk Group Patients with Two Interim Analyses
|
|---|
| |
Power = 80%
|
Power = 90%
|
|---|
|
P1
|
P0 = 80%
|
P0 = 70%
|
P0 = 80%
|
P0 = 70%
|
|---|
|
70%
|
476
|
NA
|
660
|
NA
|
|
65%
|
222
|
2250
|
308
|
3122
|
|
60%
|
129
|
579
|
179
|
803
|
|
55%
|
84
|
262
|
117
|
363
|
|
50%
|
59
|
148
|
82
|
206
|
|
45%
|
43
|
95
|
60
|
131
|
|
40%
|
33
|
65
|
45
|
90
|
|
35%
|
NA
|
46
|
NA
|
64
|
- P0: 30 days mortality rate in standard arm. P1: 30 days mortality rate in treatment arm
- For 80% power: probability of rejection at each look: 1st look p < 0.002, futility look p > 0.835, 2nd look p < 0.015, futility look p > 0.312, final look p < 0.046
- For 90% power: probability of rejection at each look: 1st look p < 0.002, futility look p > 0.830, 2nd look p < 0.015, futility look p > 0.297, final look p < 0.046
- 1:1 randomization; ρ = 3.0. NA = Not Applicable
