The Power of Phase I Studies to Detect Clinical Relevant QTc Prolongation: A Resampling Simulation Study

Figure 1

Fraction of negative studies by number of subjects per treatment arm. (a) and (b) Analysis with a model with a treatment effect; (c) and (d) analysis with a model without a treatment effect. Shaded range is considered acceptable.

(a)

(b)

(c)

(d)