Table 3.
Evaluable sample size estimates
PTB rate in Placebo Arm | PTB rate in ASA | % Red. | Sample size per group | PTB rate in ASA | % Red. | Sample size per group | PTB rate in ASA | % Red. | Sample size per group |
---|---|---|---|---|---|---|---|---|---|
Power = 80% (α = 0.05; β = 0.2) | |||||||||
8% | 4.8% | 40% | 918 | 6.0% | 25% | 2554 | 6.40% | 20% | 4096 |
10% | 6.0% | 40% | 721 | 7.5% | 25% | 2005 | 8.00% | 20% | 3213 |
12% | 7.2% | 40% | 591 | 9.0% | 25% | 1638 | 9.60% | 20% | 2625 |
14% | 8.4% | 40% | 497 | 10.0% | 25% | 1377 | 11.20% | 20% | 2204 |
Power = 90% (α = 0.05; β = 0.1) | |||||||||
8% | 4.8% | 40% | 1228 | 6.0% | 25% | 3419 | 6.40% | 20% | 5483 |
10% | 6.0% | 40% | 965 | 7.5% | 25% | 2683 | 8.00% | 20% | 4301 |
12% | 7.2% | 40% | 790 | 9.0% | 25% | 2193 | 9.60% | 20% | 3513 |
14% | 8.4% | 40% | 665 | 10.5% | 25% | 1842 | 11.20% | 20% | 2950 |