Figure 1.

Qualification of the Weibull hazard model for tumor progression by stratified prediction‐corrected visual predictive check (pc‐VPC). The pc‐VPC shows 5 prediction bins at 50, 100, 200, 300, and 400 days (vertical dashed lines) after start of sorafenib treatment. For each time bin, light gray and dark gray fields represent the 90% prediction interval of the 1,000 simulated event rates for tumor progression in patients with average area under the curve (AUC) over the 12‐hour dosing interval during the entire treatment period (AUC_12AV) below and above the population median, respectively. Black horizontal bars indicate the respective simulated medians, and red horizontal bars show the observed rates of tumor progression in the two strata. Event rates are calculated cumulatively up to the time of the bin. Each of the 1,000 simulated trials used all 401 patients with centrally assessed tumor progression measurements, of whom 204 received initially placebo. CI, confidence interval.