Table 5 Safety Stopping Rules
Adverse Event | Stopping Rule |
|---|---|
Major hemoptysis | > 3 of first 100 subjects then |
> 3% subjects or | |
> 2 subjects/study site | |
Respiratory failure | > 15 of first 100 subjects then |
> 15% subjects or | |
> 2 subjects/study site | |
Pneumothorax | > 4 of first 20 subjects then |
> 20% subjects or | |
> 2 subjects/study site | |
Death | ≥2 of first 66 subjects within 30 days post procedure or >3% thereafter |