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Table 1 Safety and Tolerability Endpoints at Time of Interim Analysis on July 10, 2009*

From: Application of adaptive design and decision making to a phase II trial of a phosphodiesterase inhibitor for the treatment of intermittent claudication

Endpoint

Trial Arm

Observed Rate

Model-based Rate (80% CI)

 

Placebo

0 of 30 (0%)

0.0 (---, ---)

 

25 mg K-134

0 of 29 (0%)

0.0 (---, ---)

Resting Tachycardia

50 mg K-134

0 of 30 (0%)

0.0 (---, ---)

 

100 mg K-134

0 of 26 (0%)

0.0 (---, ---)

 

Cilostazol

0 of 28 (0%)

 
 

Placebo

0 of 20 (0%)

0.0 (---, ---)

 

25 mg K-134

0 of 14 (0%)

0.0 (---, ---)

Ischemic ECG Changes

50 mg K-134

0 of 19 (0%)

0.0 (---, ---)

 

100 mg K-134

0 of 10 (0%)

0.0 (---, ---)

 

Cilostazol

0 of 15 (0%)

 
 

Placebo

0 of 32 (0%)

0.009 (0.002, 0.038)

 

25 mg K-134

1 of 28 (4%)

0.018 (0.004, 0.072)

Discontinuation

50 mg K-134

1 of 32 (3%)

0.035 (0.009, 0.13)

 

100 mg K-134

3 of 25 (12%)

0.12 (0.032, 0.37)

 

Cilostazol

1 of 27 (0%)

 
  1. *See text for definitions of safety and tolerability endpoints.