Example AEs (True Proportion; Expected Event Rate) | Blinded: Proportion with signal for early termination Unblinded: Termination Proportion with confirmed by unblinded data | (Pcrit1, Pcrit2) | ||
---|---|---|---|---|
(0.9, 0.7) | (0.9, 0.8) | (0.9, 0.9) | ||
Pneumothorax Induced by HBO therapya (π = 3%; πM = 2%) | Blinded | 0.28 | 0.27 | 0.28 |
Unblinded | 0.79 | 0.62 | 0.33 | |
Overall Rate | 0.23 | 0.17 | 0.09 | |
Signs of Pulmonary Dysfunctiona (π = 31%; πM = 25%) | Blinded | 0.55 | 0.54 | 0.54 |
Unblinded | 0.76 | 0.63 | 0.42 | |
Overall Rate | 0.42 | 0.34 | 0.23 | |
Pneumoniaa (π = 48%; πM = 40%) | Blinded | 0.58 | 0.59 | 0.59 |
Unblinded | 0.75 | 0.65 | 0.44 | |
Overall Rate | 0.44 | 0.39 | 0.26 | |
Critical decreased CPPa (< 60 mmHg) (π = 80%; πM = 75%) | Blinded | 0.55 | 0.55 | 0.56 |
Unblinded | 0.76 | 0.60 | 0.39 | |
Overall Rate | 0.42 | 0.33 | 0.22 | |
Critical hypotensiona (MAP< 70 mmHg) (π = 80%; πM = 75%) | Blinded | 0.56 | 0.56 | 0.54 |
Unblinded | 0.77 | 0.61 | 0.39 | |
Overall Rate | 0.43 | 0.34 | 0.21 | |
Seizures during HBO treatmenta (π = 1%; πM = 1%) | Blinded | 0.23 | 0.23 | 0.23 |
Unblinded | 0.79 | 0.61 | 0.31 | |
Overall Rate | 0.19 | 0.14 | 0.07 | |
Hypercarbia during transportationa (PaCO2 > 45 mmHg) (π = 13%; πM = 10%) | Blinded | 0.44 | 0.43 | 0.43 |
Unblinded | 0.77 | 0.62 | 0.40 | |
Overall Rate | 0.33 | 0.26 | 0.17 |