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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