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Table 2 Safety and Tolerability Endpoints as of September 23, 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 57 (0%)

0.0 (---, ---)

 

25 mg K-134

0 of 37 (0%)

0.0 (---, ---)

Resting Tachycardia

50 mg K-134

0 of 52 (0%)

0.0 (---, ---)

 

100 mg K-134

0 of 50 (0%)

0.0 (---, ---)

 

Cilostazol

0 of 53 (Z%)

 
 

Placebo

0 of 43 (0%)

0.0 (---, ---)

 

25 mg K-134

0 of 29 (0%)

0.0 (---, ---)

Ischemic ECG Changes

50 mg K-134

0 of 45 (0%)

0.0 (---, ---)

 

100 mg K-134

0 of 42 (0%)

0.0 (---, ---)

 

Cilostazol

0 of 44 (Z%)

 
 

Placebo

2 of 63 (3%)

0.021 (0.008, 0.050)

 

25 mg K-134

41 of 42 (98%)

**

Discontinuation

50 mg K-134

2 of 61 (3%)

0.055 (0.023, 0.13)

 

100 mg K-134

9 of 60 (15%)

0.14 (0.061, 0.28)

 

Cilostazol

5 of 57 (9%)

 
  1. *See text for definitions of safety and tolerability endpoints.
  2. **Nearly all patients discontinued due to arm dropping at previous analysis;
  3. 25 mg dose not included in logistic regression.
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ISSN: 1745-6215