Results
Patient disposition during double-blind period
Baseline characteristics
Pharmacokinetics of nintedanib
AUCT,SS, area under plasma concentration-time curve at steady state. gMean, geometric mean. gCV, geometric coefficient of variation.
Adverse events during double-blind period
% of patients with ≥1 such adverse event. Adverse events reported in >18% of patients in either treatment group based on preferred terms in the Medical Dictionary for Regulatory Activities (MedDRA). Data are based on adverse events with onset from first intake of trial drug until day prior to first intake of open-label nintedanib or last intake of randomised treatment plus 28 days (whichever occurred first). Mean (SD) exposure to trial drug during double-blind period was 22.3 (4.8) weeks in the nintedanib group and 22.6 (4.2) weeks in the placebo group.