Type of Assessment | Variables |
---|---|
Long-term effectiveness | • Overall survival • Progression-free survival • Time to progression to AML • AML-free survival |
Short-term effectiveness | • Complete remission marrow • Partial remission marrow • Complete remission peripheral blood • Progressive disease • Transfusion independence • Erythroid response • Platelet response • Neutrophil response • Progression/relapse after hematologic improvement • Cytogenetic response |
Safety | • Type, frequency, and duration and outcomes of SAEs • Onset of SPM and other events of interest • AEs that lead to treatment discontinuation • Deaths/reasons for deaths |