Table 3 Interim decision rules
Sample size | Interim decision | Condition for decision |
|---|---|---|
N < 500 | Futility | May be recommended by DSMB |
Expected success (mortality) | PPmort (current N) > 0.90 | |
Continue | PPmort (current N) < 0.90 | |
N ≥ 500 | Futility | PPVVFD (max N) < 0.10 |
Expected success (both endpoints) | PPVVFD (current N) > 0.95 AND PPmort (current N) > 0.95 | |
Expected success (VVFD only) | PPVVFD (current N) > 0.95 AND PPmort (max N) < 0.10 | |
Continue | otherwise |