Table 2.

Baseline demographic and disease characteristics

CharacteristicN = 841
Median age, (range), y 67 (18-100) 
Age categories, n (%)  
<40 y 59 (7.0) 
≥40 y to <65 y 285 (33.9) 
≥65 y to <75 y 308 (36.6) 
≥75 y 189 (22.5) 
Sex, n (%)  
Male 416 (49.5) 
Female 425 (50.5) 
Race, n (%)  
White 538 (64.0) 
Asian 82 (9.7) 
Black 42 (5.0) 
Other or unknown 179 (21.3) 
Ethnicity, n (%)  
Hispanic/Latino 49 (5.8) 
Not Hispanic/Latino 577 (68.6) 
Not reported or unknown 215 (25.6) 
Baseline ECOG PS 0-1, n (%) 682 (81.2) 
Pre-existing cardiac disorder, n (%) 293 (34.8) 
Pre-existing pulmonary disorder, n (%) 395 (47.0) 
Baseline total bilirubin >1.5 × ULN, n (%) 10 (1.2) 
Baseline creatinine clearance <45 mL/min, n (%) 41 (4.9) 
Disease status  
Untreated AML, n (%) 33 (3.9) 
Primary refractory AML, n (%) 329 (39.1) 
Untreated relapse AML, n (%) 369 (43.9) 
Refractory relapse AML, n (%) 110 (13.1) 
Median number of relapses (range) 1 (0-3) 
Prior stem cell transplantation, n (%) 144 (17.1) 
Transfusion dependent at baseline, n (%)  543 (64.6) 
CharacteristicN = 841
Median age, (range), y 67 (18-100) 
Age categories, n (%)  
<40 y 59 (7.0) 
≥40 y to <65 y 285 (33.9) 
≥65 y to <75 y 308 (36.6) 
≥75 y 189 (22.5) 
Sex, n (%)  
Male 416 (49.5) 
Female 425 (50.5) 
Race, n (%)  
White 538 (64.0) 
Asian 82 (9.7) 
Black 42 (5.0) 
Other or unknown 179 (21.3) 
Ethnicity, n (%)  
Hispanic/Latino 49 (5.8) 
Not Hispanic/Latino 577 (68.6) 
Not reported or unknown 215 (25.6) 
Baseline ECOG PS 0-1, n (%) 682 (81.2) 
Pre-existing cardiac disorder, n (%) 293 (34.8) 
Pre-existing pulmonary disorder, n (%) 395 (47.0) 
Baseline total bilirubin >1.5 × ULN, n (%) 10 (1.2) 
Baseline creatinine clearance <45 mL/min, n (%) 41 (4.9) 
Disease status  
Untreated AML, n (%) 33 (3.9) 
Primary refractory AML, n (%) 329 (39.1) 
Untreated relapse AML, n (%) 369 (43.9) 
Refractory relapse AML, n (%) 110 (13.1) 
Median number of relapses (range) 1 (0-3) 
Prior stem cell transplantation, n (%) 144 (17.1) 
Transfusion dependent at baseline, n (%)  543 (64.6) 

ECOG PS, Eastern Cooperative Oncology Group performance status; ULN, upper limit of normal.

Patients were defined as transfusion dependent at baseline if they received any red blood cell or platelet transfusion within 56 days before the first dose of study drug.

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