Outcomes
Fatigue, pre‐dose, Cancer
ADVERSE EVENTS, ADVERSE EVENT, CANCER
Patients were monitored for safety throughout the study. The adverse events (AEs) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03.BM assessments were performed at the end of cycles 1, 2, 4, and 6, then every three cycles thereafter. Responses were assessed by the investigator per modified 2006 IWG criteria for MDS.Blood samples were collected for venetoclax pharmacokinetics (PKs) analysis at 6 h post‐dose on Day 1 of cycle 1, pre‐dose and 2, 4, 6, 8, and 24 h post‐dose on Day 4 of cycle 2; and pre‐dose on Day 4 of cycles 3, 4, 6, and 8. Venetoclax concentrations from cycle 2, Day 4 were used to determine the At baseline, mutation analyses were performed with mononuclear cells (i.e., BM Patient‐reported outcomes (PROs) were assessed by Fatigue (PRO Measurement Information System [PROMIS] Fatigue Short Form [SF] 7a), Physical Function (PROMIS Physical Function SF 10a), Quality of Life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC‐QLQ‐C30]) and EuroQoL EQ‐5D‐5L. Data were collected at baseline and then on Day 1 of every other treatment cycle through cycle 15.