Results
death
MAY, AML PROGRESSION, RECRUITMENT, DISEASE CHARACTERISTIC
On December 31, 2019, study enrollment was prematurely stopped due to slow recruitment. Between May 2017 and September 2019, 31 patients were enrolled and randomized. One patient withdrew consent before initiation of study treatment and was therefore excluded. Thirty patients (15 in each study arm) received at least one dose of nintedanib/placebo and were included in the safety and efficacy analyses. Details are given in the CONSORT flowchart (Fig. CONSORT flowchart. Patient outcome and overall survival. ( Patient demographics and baseline disease characteristics are shown in Table Patient characteristicsAbbreviations: Median (range) duration of treatment was 46 (9–211) days in the nintedanib and 55 (11–362) days in the placebo arm. In both arms, the median (range) number of treatment cycles initiated was 2 (1–6). One and two patients entered maintenance therapy in the nintedanib and placebo arm, respectively. For each patient, multiple reasons for study discontinuation could be reported. Primary reasons were: AML progression (nintedanib: 7; placebo: 8), death (nintedanib. 3; placebo: 3), AE (nintedanib: 3; placebo: 2), consent revoked (nintedanib: 3; placebo: 1), relapse (nintedanib: 1; placebo: 2), patient decision (nintedanib: 0; placebo: 1) and general physical health deterioration (nintedanib: 1; placebo: 0).