Interim analysis (i) | Stopping boundaries | Number of patients recruited | |||
---|---|---|---|---|---|
adrenaline better | placebo better | B1 interim analysis schedulea | B2 interim analysis schedule | B3 interim analysis schedule | |
1 | 0.9999 | 0.99999 | 50 | 50 | 500 |
2 | 0.9998 | 0.99999 | 400 | 300 | 1000 |
3 | 0.9997 | 0.99998 | 1100 | 600 | 1500 |
4 | 0.9996 | 0.9998 | 1800 | 1000 | 2000 |
5 | 0.9995 | 0.9997 | 2400 | 1450 | 2500 |
6 | 0.9994 | 0.9996 | 3100 | 1900 | 3000 |
7 | 0.9993 | 0.9995 | 3800 | 2650 | 3500 |
8 | 0.9992 | 0.9994 | 4500 | 3650 | 4000 |
9 | 0.9991 | 0.9993 | 5200 | 5000 | 4500 |
10 | 0.999 | 0.9992 | 5900 | 6500 | 5000 |
11 | 0.998 | 0.999 | NA | 7000 | 5500 |
12 | 0.996 | 0.998 | NA | 7500 | 6000 |
13 | 0.994 | 0.997 | NA | NA | 6500 |
14 | 0.992 | 0.996 | NA | NA | 7000 |
15 | 0.99 | 0.994 | NA | NA | 7500 |
Final analysisb | 0.977 | 0.977 | Max 8000 | Max 8000 | Max 8000 |