Table 6.
The probability of flagged trials for the AEs under the same effect for three AEs with safety issue (No effect for the rest) for scenario III
| 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 | 0.10 | 0.10 | 0.11 |
| Unblinded | 0.68 | 0.48 | 0.27 | |
| Overall Rate | 0.07 | 0.05 | 0.03 | |
|
Signs of Pulmonary Dysfunctiona (π = 31%; πM = 25%) |
Blinded | 0.36 | 0.36 | 0.36 |
| Unblinded | 0.70 | 0.55 | 0.36 | |
| Overall Rate | 0.25 | 0.20 | 0.13 | |
|
Pneumoniaa (π = 48%; πM = 40%) |
Blinded | 0.41 | 0.40 | 0.41 |
| Unblinded | 0.68 | 0.57 | 0.37 | |
| Overall Rate | 0.28 | 0.23 | 0.15 | |
|
Critical decreased CPP (< 60 mmHg) (π = 75%; πM = 75%) |
Blinded | 0.15 | 0.16 | 0.15 |
| Unblinded | 0.49 | 0.34 | 0.17 | |
| Overall Rate | 0.07 | 0.05 | 0.02 | |
|
Critical hypotension (MAP< 70 mmHg) (π = 75%; πM = 75%) |
Blinded | 0.15 | 0.16 | 0.16 |
| Unblinded | 0.48 | 0.31 | 0.16 | |
| Overall Rate | 0.07 | 0.05 | 0.03 | |
|
Seizures during HBO treatment (π = 1%; πM = 1%) |
Blinded | 0.05 | 0.05 | 0.05 |
| Unblinded | 0.59 | 0.39 | 0.20 | |
| Overall Rate | 0.03 | 0.02 | 0.01 | |
|
Hypercarbia during transportation (PaCO2 > 45 mmHg) (π = 10%; πM = 10%) |
Blinded | 0.10 | 0.11 | 0.10 |
| Unblinded | 0.47 | 0.36 | 0.15 | |
| Overall Rate | 0.05 | 0.04 | 0.02 | |
(Assume the AE with a has a safety issue)