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 | |