Statistical analysis
deaths
AML
The primary objective was to demonstrate that glasdegib combined with cytarabine and daunorubicin (intensive study) or azacitidine (non-intensive study) is superior to placebo in prolonging OS in patients with untreated AML. Efficacy was assessed in all randomized patients (full analysis set). Safety was assessed in all patients who received at least one dose of study drug. Pharmacokinetic and biomarker data were analyzed in relevant patient sets as described in the study protocol [As previously described [The planned sample size for the non-intensive study was 320 patients; 320 patients with 220 deaths would provide 90% power to detect an improvement in OS with HR = 0.64 (translated from a median OS of 10.4 months vs. 16.2 months) using a one-sided log-rank test at a significance level of 0.025 and a two-look group-sequential design. The median OS of 10.4 months was based on a study of patients ≥65 years of age with untreated AML and >30% bone marrow blasts [