|
Required Sample Size for Intermediate-Risk Group Patients with No Interim Analysis
|
|---|
|
Effect Size
| |
α = 0.05 with 1:1 Group Ratio
|
α = 0.05 with 1:2 Group Ratio
|
|---|
|
Power
|
80%
|
90%
|
80%
|
90%
|
|---|
|
10%
|
N1
|
303
|
420
|
226
|
313
|
|
N2
|
303
|
420
|
452
|
626
|
|
Total
|
606
|
840
|
678
|
939
|
|
15%
|
N1
|
134
|
186
|
100
|
139
|
|
N2
|
134
|
186
|
200
|
278
|
|
Total
|
268
|
372
|
300
|
417
|
|
20%
|
N1
|
75
|
103
|
56
|
78
|
|
N2
|
75
|
103
|
112
|
156
|
|
Total
|
150
|
206
|
168
|
234
|
|
25%
|
N1
|
47
|
65
|
35
|
49
|
|
N2
|
47
|
65
|
70
|
98
|
|
Total
|
94
|
130
|
105
|
147
|
|
30%
|
N1
|
31
|
43
|
24
|
33
|
|
N2
|
31
|
43
|
48
|
66
|
|
Total
|
62
|
86
|
72
|
99
|
|
35%
|
N1
|
22
|
30
|
17
|
24
|
|
N2
|
22
|
30
|
34
|
48
|
|
Total
|
44
|
60
|
51
|
72
|
|
40%
|
N1
|
16
|
22
|
13
|
18
|
|
N2
|
16
|
22
|
26
|
36
|
|
Total
|
32
|
44
|
39
|
54
|
- N1: sample size for the standard care arm. N2: sample size for the treatment arm
- Response rate = 40%
