Treatment
toxicities, gastrointestinal toxicities
DISEASE PROGRESSION, DER
LDAC was applied subcutaneously at 20 mg twice daily on days 1 to 10 in 28-day cycles. Nintedanib or placebo tablets identical in appearance (Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany) were orally applied at 200 mg twice daily on days 1 to 28. Dose reductions to 150 mg or 100 mg nintedanib/placebo twice daily were allowed. As a general rule, non-hematological grade 3 toxicities should be followed by permanent dose reduction off nintedanib/placebo, unless effectively controlled with supportive therapy. Specific rules applied for gastrointestinal toxicities and liver enzyme elevations. Patients could continue treatment for up to 6 cycles of LDAC plus nintedanib/placebo, disease progression or relapse, intolerance, or request of treatment discontinuation by patient or investigator. Patients without disease progression after 6 cycles could enter oral maintenance treatment with nintedanib/placebo (up to 12 months from start of therapy).