Table 3.
Power Projections for AMD Clinical Trial (Assumed placebo event rate = 0.17; n = 3060.)a
Rates of Progression to Advanced AMDb |
Approximate Power
|
|||||
---|---|---|---|---|---|---|
Situation (see below) | Placebo(n = 765) | Antioxidants (n = 765) | Zinc (n = 765) | Antioxidants + zinc (n = 765) | αc = 0.05 | αc = 0.01 |
1 | 0.162 | 0.128 | 0.128 | 0.094 | 0.87 | 0.68 |
2 | 0.163 | 0.109 | 0.109 | 0.109 | 0.84 | 0.65 |
3 | 0.170 | 0.170 | 0.116 | 0.170 | 0.84 | 0.65 |
4 | 0.164 | 0.164 | 0.117 | 0.117 | 0.86 | 0.67 |
Situation | Percent reduction | Due to |
---|---|---|
1 (Example: Main effects comparison: Antioxidants versus no antioxidants = 0.111 versus 0.145) | 25 | Antioxidants |
25 | Zinc | |
50 | Antioxidants and zinc (no interaction) | |
2 | 40 | Antioxidants |
40 | Zinc | |
40 | Antioxidants and zinc (negative interaction) | |
3 | 0 | Antioxidants |
40 | Zinc | |
0 | Antioxidants and zinc (negative interaction) | |
4 | 0 | Antioxidants |
35 | Zinc | |
35 | Antioxidants and zinc (no interaction) |
Calculated for 3600 participants with age-related macular changes; adjusted to 3060 for loss to followup and deaths prior to event.
Placebo rate of progression to advanced AMD of 0.17 is adjusted assuming 10% of participants would drop out and assume the placebo event rate and 10% of participants would drop in and assume the full treatment (antioxidants and zinc) event rate.
Two-sided α.