Table 7.
The probability of flagged trials for the AEs under three AEs with flat effect relationships and same effect for the rest with safety issues for scenario IV
| 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 | 0.25 | 0.26 | 0.26 |
| Unblinded | 0.74 | 0.57 | 0.28 | |
| Overall Rate | 0.19 | 0.15 | 0.07 | |
|
Signs of Pulmonary Dysfunctiona (π = 31%; πM = 25%) |
Blinded | 0.53 | 0.53 | 0.53 |
| Unblinded | 0.74 | 0.60 | 0.39 | |
| Overall Rate | 0.39 | 0.31 | 0.21 | |
|
Pneumoniaa (π = 48%; πM = 40%) |
Blinded | 0.56 | 0.57 | 0.58 |
| Unblinded | 0.75 | 0.61 | 0.41 | |
| Overall Rate | 0.43 | 0.35 | 0.24 | |
|
Critical decreased CPPa (< 60 mmHg) (π = 80%; πM = 75%) |
Blinded | 0.50 | 0.49 | 0.51 |
| Unblinded | 0.66 | 0.51 | 0.30 | |
| Overall Rate | 0.33 | 0.25 | 0.15 | |
|
Critical hypotensiona (MAP< 70 mmHg) (π = 80%; πM = 75%) |
Blinded | 0.49 | 0.50 | 0.51 |
| Unblinded | 0.66 | 0.51 | 0.29 | |
| Overall Rate | 0.32 | 0.26 | 0.15 | |
|
Seizures during HBO treatmenta (π = 1%; πM = 1%) |
Blinded | 0.21 | 0.22 | 0.22 |
| Unblinded | 0.74 | 0.56 | 0.28 | |
| Overall Rate | 0.16 | 0.12 | 0.06 | |
|
Hypercarbia during transportationa (PaCO2 > 45 mmHg) (π = 13%; πM = 10%) |
Blinded | 0.39 | 0.39 | 0.38 |
| Unblinded | 0.67 | 0.50 | 0.28 | |
| Overall Rate | 0.26 | 0.19 | 0.11 | |
(Assume the AE with a has a safety issue)