Methods

In the INPULSIS and INBUILD trials, patients were randomized to receive nintedanib 150 mg bid or placebo.
We present descriptive data on adverse events reported by the investigators, irrespective of causality, over 52 weeks of treatment (or until 28 days after last trial drug intake for patients who discontinued trial drug before week 52) and on the dose reductions and treatment interruptions used to manage adverse events.
Analyses were based on patients who received ≥1 dose of trial drug.