Table 1. Total required sample size for a 1:1 randomized trial designed to demonstrate superiority of IVIg compared with placebo at the 2-sided 5% significance level with 90% power*.
Absolute risk of progression, IVIg group | Absolute risk increase for placebo group compared with IVIg |
|||
---|---|---|---|---|
+5% | +7.5% | +10% | +15% | |
15% | 2,424 | 1,136 | 670 | 322 |
20% | 2,928 | 1,350 | 784 | 370 |
*Sample sizes are total sample sizes (i.e., for both groups combined) but do not account for loss-to-follow-up or increases in sample size that would be required if formal interim analyses with stopping boundaries are planned. IVIg, intravenous immunoglobulin.