Table 2 Number of deaths, expected number of subjects, and significance level of testing at each preplanned analysis of the primary outcome
Number of deaths | Expected number of subjects | Significance level α | |
|---|---|---|---|
Single analysis | 263 | 546 | 5% |
Interim analyses: | |||
First analysis | 90 | 187 | 0.15% |
Second analysis | 180 | 373 | 1.81% |
Final analysis | 270 | 560* | 4.37% |