Table 1 Baseline demographics and clinical characteristics of patients treated with glasdegib or placebo plus cytarabine and daunorubicin in the intensive study, or with glasdegib or placebo plus azacitidine in the non-intensive study.
Intensive study | Non-intensive study | |||||
|---|---|---|---|---|---|---|
Glasdegib + cytarabine + daunorubicin (n = 201) | Placebo + cytarabine + daunorubicin (n = 203) | Total (N = 404) | Glasdegib + azacitidine (n = 163) | Placebo + azacitidine (n = 162) | Total (N = 325) | |
Age, years | ||||||
Median (range) | 59 (19–78) | 59 (19–86) | 59 (19–86) | 73 (47–90) | 73 (56–94) | 73 (47–94) |
≥65, n (%) | 57 (28.4) | 62 (30.5) | 119 (29.5) | 147 (90.2) | 145 (89.5) | 292 (89.8) |
Sex, n (%) | ||||||
Male | 130 (64.7) | 106 (52.2) | 236 (58.4) | 97 (59.5) | 89 (54.9) | 186 (57.2) |
Female | 71 (35.3) | 97 (47.8) | 168 (41.6) | 66 (40.5) | 73 (45.1) | 139 (42.8) |
Race | ||||||
White | 110 (54.7) | 123 (60.6) | 233 (57.7) | 97 (59.5) | 99 (61.1) | 196 (60.3) |
Black or African American | 3 (1.5) | 3 (1.5) | 6 (1.5) | 1 (0.6) | 7 (4.3) | 8 (2.5) |
Asian | 66 (32.8) | 57 (28.1) | 123 (30.4) | 51 (31.3) | 44 (27.2) | 95 (29.2) |
American Indian or Alaska native | 1 (0.5) | 0 | 1 (0.2) | 0 | 0 | 0 |
Multiracial | 1 (0.5) | 0 | 1 (0.2) | 0 | 0 | 0 |
Not reported | 20 (10.0) | 20 (9.9) | 40 (9.9) | 14 (8.6) | 12 (7.4) | 26 (8.0) |
ECOG PS, n (%) | ||||||
0 | 87 (43.3) | 85 (41.9) | 172 (42.6) | 43 (26.4) | 38 (23.5) | 81 (24.9) |
1 | 93 (46.3) | 98 (48.3) | 191 (47.3) | 80 (49.1) | 78 (48.1) | 158 (48.6) |
2 | 15 (7.5) | 16 (7.9) | 31 (7.7) | 36 (22.1) | 37 (22.8) | 73 (22.5) |
3 | 4 (2.0) | 1 (0.5) | 5 (1.2) | 3 (1.8) | 8 (4.9) | 11 (3.4) |
4 | 0 | 0 | 0 | 1 (0.6) | 1 (0.6) | 2 (0.6) |
Not reported | 2 (1.0) | 3 (1.5) | 5 (1.2) | 0 | 0 | 0 |
Primary AML diagnosis, n | 199 | 203 | 402 | 163 | 162 | 325 |
De novo | 158 (78.6) | 169 (83.3) | 327 (80.9) | 118 (72.4) | 120 (74.1) | 238 (73.2) |
Secondary | 41 (20.4) | 34 (16.7) | 75 (18.6) | 45 (27.6) | 42 (25.9) | 87 (26.8) |
Time since onset, median (range), months | 0.23 (0.03–27.14) | 0.23 (0.03–93.67) | 0.23 (0.03–93.67) | 0.46 (0.03–2.33) | 0.49 (0.03–37.85) | 0.46 (0.03–37.85) |
ELN risk group, n (%) | ||||||
Favorable | 15 (7.5) | 17 (8.4) | 32 (7.9) | 8 (4.9) | 7 (4.3) | 15 (4.6) |
Intermediate | 161 (80.1) | 161 (79.3) | 322 (79.7) | 123 (75.5) | 124 (76.5) | 247 (76.0) |
Adverse | 25 (12.4) | 25 (12.3) | 50 (12.4) | 32 (19.6) | 31 (19.1) | 63 (19.4) |
