Numbers of patients/arm needed to perform PGB trials with statistical powers of 80% or 90% to detect treatment effects ranging from 50% to 80%
Treatment effects | No of scans | Statistical powers | ||||||
---|---|---|---|---|---|---|---|---|
80% | 90% | |||||||
Group A | Group B | Group C | Group A | Group B | Group C | |||
50% | 3 | 57 | 43 | 65 | 80 | 65 | 85 | |
6 | 50 | 38 | 62 | 70 | 55 | 80 | ||
60% | 3 | 42 | 32 | 48 | 58 | 45 | 62 | |
6 | 38 | 25 | 42 | 50 | 36 | 57 | ||
70% | 3 | 34 | 26 | 40 | 47 | 38 | 52 | |
6 | 29 | 22 | 36 | 38 | 32 | 46 | ||
80% | 3 | 25 | 19 | 30 | 35 | 28 | 40 | |
6 | 22 | 18 | 27 | 30 | 25 | 38 |
Group A: patients with RRMS not selected for MRI activity at entry;
Group B: patients with RRMS selected for MRI activity at entry;
Group C: patients with SPMS not selected for MRI activity at entry.
For further details and statistical analysis: see the text.