Fig. 1.

Planned inclusion and dosing progression for hepatic impaired subjects according to assessment of adverse events (AEs) and exposure (C _max) for afatinib measured by interim pharmacokinetics. AE adverse event. The bold lines indicate the trial pathway if there was no drug-related toxicity and plasma exposure (C _max) did not exceed defined thresholds. Dotted lines indicate stopping points if drug-related toxicity was observed. Thin lines indicate alternative trial pathways. The flow chart does not display the inclusion of matched healthy subjects