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Table 5 Safety Stopping Rules

From: Design of the exhale airway stents for emphysema (EASE) trial: an endoscopic procedure for reducing hyperinflation

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