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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