In the dose-escalation phase of the study, patients received between 50 mg and 750 mg of LDK378 per day. Most patients (83%) received at least 400 mg, the dose thought to be required for clinical activity. The maximum tolerated dose was 750 mg per day, although dose-limiting toxicities were observed in patients receiving 400 mg per day and higher. Common adverse events included nausea (59%), vomiting (54%), diarrhea (48%), fatigue (21%), and dyspnea (16%). Serious adverse events included one case each of transaminase elevation, vomiting, dehydration, and interstitial lung disease. These were all reversible after stopping treatment.