Study design and patients

Full details on study design and eligibility criteria for the Viale-A ({"type":"clinical-trial","attrs":{"text":"NCT02993523","term_id":"NCT02993523"}}NCT02993523) and Viale-C ({"type":"clinical-trial","attrs":{"text":"NCT03069352","term_id":"NCT03069352"}}NCT03069352) Phase 3 clinical trials have been previously published [15, 18]. This secondary analysis utilized PRO data collected from these studies. Briefly, Viale-A and Viale-C are randomized, double-blind, placebo controlled, multicenter trials in patients ≥18 years of age with a confirmed diagnosis of untreated AML who were ineligible for intensive chemotherapy due to age or pre-defined comorbidities.

As previously described, patients in Viale-A were randomized 2:1 to receive venetoclax 400 mg orally once daily (QD) or placebo for 28 days, in combination with azacitidine 75 mg/m² subcutaneous (SC) or intravenous (IV) for 7 days [15]. Patients in Viale-C were randomized 2:1 to receive venetoclax 600 mg orally QD or placebo for 28 days, in combination with LDAC 20 mg/m² SC QD for 10 days [18]. Patients continued their assigned treatments in 28-day cycles, until documented disease progression per investigator assessment, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).