Efficacy
AML
EVENTS, REMISSION, AML
At the time of analysis, 28 of 30 patients had died. One patient was lost to follow-up after 5.1 months, and the one remaining living patient was followed for 24.7 months (Fig. In the 22 patients enrolled into the study with r/r AML, median OS was 3.0 months in the nintedanib and 3.6 months in the placebo arm, respectively (11/11 vs 10/11 events, HR 1.54, 95% CI, 0.61–3.86; log-rank Three out of all 30 patients (10%) achieved a CR, 2 in the placebo and 1 in the nintedanib arm (Fig. Due to the small number of responders, no statistics were computed for relapse-free survival (RFS), but all 3 responders experienced AML relapse after a remission duration of 5.1, 9.4, and 9.7 months. Likewise, no further subgroup analyses for molecularly defined subgroups were performed.