Table 3.
Difference in Percent of Days With Toxicity |
||||||
---|---|---|---|---|---|---|
N Per Group |
Equal (10% of Days) |
50% More (15% of Days) |
75% More (17.5% of Days) |
Double (20% of Days) |
Triple (30% of Days) |
Quadruple (40% of Days) |
50 | 5 | 6 | 6 | 6 | 9 | 14 |
100 | 5 | 6 | 6 | 7 | 13 | 24 |
150 | 5 | 6 | 7 | 8 | 17 | 31 |
200 | 5 | 6 | 7 | 8 | 20 | 41 |
300 | 5 | 7 | 7 | 10 | 26 | 57 |
500 | 4 | 7 | 8 | 14 | 42 | 78 |
1000 | 4 | 8 | 12 | 22 | 72 | 98 |
QALY = quality-adjusted life year.
Values in bold indicate at least 80% power.
If the overall survival time is the same, you need a quadruple of toxicity rates (from 10% to 40%) and samples of 500 events to have 80% power to detect a difference in QALYs.