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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.