Safety evaluation
DLTs, toxicities, failure, primary disease, disability or incapacity
ADVERSE EVENTS, EVENTS, COMPLICATIONS
Relative dose intensity (in percentage) was calculated as a proportion of dose intensity/planned dose intensity (proportion of dose administered/total treatment duration). Safety assessments were completed by documenting the AEs, ECOG PS, laboratory data, body weight, vital signs, and the results of 12 lead ECGs. Serious adverse events (SAEs) were defined as any AEs that caused mortality, were life-threatening, required hospitalization or prolonged existing hospitalization, caused disability or incapacity, or represented other medical conditions. Patients were followed up until the AEs resolved.Patients were evaluated for DLT during the first 28 days of cycle 1, defined as any nonhematological AEs of grade ≥ 3 unless attributed to the primary disease course, complications, or concomitant medications. Nonhematological toxicities classified as DLTs were grade 4 AST/ALT, grade 3 AST/ALT lasting ≥ 3 days, grade 3 AST/ALT with grade ≥ 2 total bilirubin, or an inability to complete at least 75% of the prescribed milademetan doses in cycle 1 (28 days) due to grade ≥ 2 events. Hematological toxicities classified as DLTs included failure to recover neutrophil and platelet counts to ≥ 500/mm