Research Article

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

Table 1

Scenarios used to investigate the influence of selection of time points.

DesignationMaximum total number
of time points
Number of time points in time window
0 < t < 2 h2 h ≤ t ≤ 4 h4 h < t ≤ 8 h8 h < t ≤ 24 h

AllAllAllAllAllAll
Equi 88At most 2At most 2At most 2At most 2
Few 7At most 2At most 1At most 2At most 2
Exclude 6At most 2NoneAt most 2At most 2
Sparse4At most 1At most 1At most 1At most 1