Table 4 The probability of flagged trials for the AEs under the no effect for scenario I
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 therapy (π = 2%; πM = 2%) | Blinded | 0.02 | 0.02 | 0.01 |
Unblinded | 0.58 | 0.40 | 0.16 | |
Overall Rate | 0.01 | 0.01 | 0.00 | |
Signs of Pulmonary Dysfunction (π = 25%; πM = 25%) | Blinded | 0.05 | 0.05 | 0.06 |
Unblinded | 0.40 | 0.26 | 0.16 | |
Overall Rate | 0.02 | 0.01 | 0.01 | |
Pneumonia (π = 40%; πM = 40%) | Blinded | 0.06 | 0.06 | 0.06 |
Unblinded | 0.41 | 0.24 | 0.13 | |
Overall Rate | 0.03 | 0.02 | 0.01 | |
Critical decreased CPP (< 60 mmHg) (π = 75%; πM = 75%) | Blinded | 0.06 | 0.06 | 0.07 |
Unblinded | 0.45 | 0.30 | 0.16 | |
Overall Rate | 0.03 | 0.02 | 0.01 | |
Critical hypotension (MAP< 70 mmHg) (π = 75%; πM = 75%) | Blinded | 0.06 | 0.07 | 0.06 |
Unblinded | 0.44 | 0.31 | 0.16 | |
Overall Rate | 0.03 | 0.02 | 0.01 | |
Seizures during HBO treatment (π = 1%; πM = 1%) | Blinded | 0.01 | 0.01 | 0.01 |
Unblinded | 0.53 | 0.40 | 0.11 | |
Overall Rate | 0.00 | 0.00 | 0.00 | |
Hypercarbia during transportation (PaCO2 > 45 mmHg) (π = 10%; πM = 10%) | Blinded | 0.04 | 0.04 | 0.04 |
Unblinded | 0.41 | 0.27 | 0.14 | |
Overall Rate | 0.01 | 0.01 | 0.01 | |
Family-Wise Error Rate (FWER) | ||||
Overall Adverse Events | Blinded | 0.18 | 0.17 | 0.19 |
Unblinded | 0.57 | 0.44 | 0.25 | |
Overall Rate | 0.10 | 0.08 | 0.05 | |