Patient characteristics
| Characteristic . | Arm A: G3139 (n = 254) . | Arm B: control (n = 252) . | Total (N = 506) . | P . |
|---|---|---|---|---|
| Age, y | .92 | |||
| Mean (SD) | 69.8 (6.4) | 69.7 (6.3) | 69.7 (6.4) | |
| Median | 69.6 | 68.8 | 69.0 | |
| Range* | 60.1-88.3 | 48.5-86.6 | 48.5-88.3 | |
| Age group | .65 | |||
| <70 | 137 (53.9) | 141 (56.0) | 278 (54.9) | |
| ≥70 | 117 (46.1) | 111 (44.0) | 228 (45.1) | |
| Sex | .87 | |||
| Female | 99 (39.0) | 100 (39.7) | 199 (39.3) | |
| Male | 155 (61.0) | 152 (60.3) | 307 (60.7) | |
| Race | .78 | |||
| American Indian or Alaska Native | 2 (0.8) | 2 (0.8) | 4 (0.8) | |
| Asian | 4 (1.6) | 1 (0.4) | 5 (1.0) | |
| Black or African American | 11 (4.3) | 11 (4.4) | 22 (4.3) | |
| Native Hawaiian or Pacific Islander | 1 (0.4) | 1 (0.4) | 2 (0.4) | |
| Not reported | 1 (0.4) | 0 (0.0) | 1 (0.2) | |
| Unknown | 8 (3.1) | 11 (4.4) | 19 (3.8) | |
| White | 227 (89.4) | 226 (89.7) | 453 (89.5) | |
| Ethnicity | .66 | |||
| Hispanic or Latino | 6 (2.4) | 5 (2.0) | 11 (2.2) | |
| Non-Hispanic | 232 (91.3) | 226 (89.7) | 458 (90.5) | |
| Unknown | 16 (6.3) | 21 (8.3) | 37 (7.3) | |
| Performance status | .01 | |||
| 0 | 87 (34.3) | 64 (25.4) | 151 (29.8) | |
| 1 | 137 (53.9) | 143 (56.7) | 280 (55.3) | |
| 2 | 22 (8.7) | 41 (16.3) | 63 (12.5) | |
| 3 | 8 (3.1) | 4 (1.6) | 12 (2.4) | |
| Disease type | .30 | |||
| Post-MDS | 55 (21.7) | 42 (16.7) | 97 (19.2) | |
| De novo AML | 186 (73.2) | 193 (76.6) | 379 (74.9) | |
| Therapy-related AML | 13 (5.1) | 17 (6.7) | 30 (5.9) |
| Characteristic . | Arm A: G3139 (n = 254) . | Arm B: control (n = 252) . | Total (N = 506) . | P . |
|---|---|---|---|---|
| Age, y | .92 | |||
| Mean (SD) | 69.8 (6.4) | 69.7 (6.3) | 69.7 (6.4) | |
| Median | 69.6 | 68.8 | 69.0 | |
| Range* | 60.1-88.3 | 48.5-86.6 | 48.5-88.3 | |
| Age group | .65 | |||
| <70 | 137 (53.9) | 141 (56.0) | 278 (54.9) | |
| ≥70 | 117 (46.1) | 111 (44.0) | 228 (45.1) | |
| Sex | .87 | |||
| Female | 99 (39.0) | 100 (39.7) | 199 (39.3) | |
| Male | 155 (61.0) | 152 (60.3) | 307 (60.7) | |
| Race | .78 | |||
| American Indian or Alaska Native | 2 (0.8) | 2 (0.8) | 4 (0.8) | |
| Asian | 4 (1.6) | 1 (0.4) | 5 (1.0) | |
| Black or African American | 11 (4.3) | 11 (4.4) | 22 (4.3) | |
| Native Hawaiian or Pacific Islander | 1 (0.4) | 1 (0.4) | 2 (0.4) | |
| Not reported | 1 (0.4) | 0 (0.0) | 1 (0.2) | |
| Unknown | 8 (3.1) | 11 (4.4) | 19 (3.8) | |
| White | 227 (89.4) | 226 (89.7) | 453 (89.5) | |
| Ethnicity | .66 | |||
| Hispanic or Latino | 6 (2.4) | 5 (2.0) | 11 (2.2) | |
| Non-Hispanic | 232 (91.3) | 226 (89.7) | 458 (90.5) | |
| Unknown | 16 (6.3) | 21 (8.3) | 37 (7.3) | |
| Performance status | .01 | |||
| 0 | 87 (34.3) | 64 (25.4) | 151 (29.8) | |
| 1 | 137 (53.9) | 143 (56.7) | 280 (55.3) | |
| 2 | 22 (8.7) | 41 (16.3) | 63 (12.5) | |
| 3 | 8 (3.1) | 4 (1.6) | 12 (2.4) | |
| Disease type | .30 | |||
| Post-MDS | 55 (21.7) | 42 (16.7) | 97 (19.2) | |
| De novo AML | 186 (73.2) | 193 (76.6) | 379 (74.9) | |
| Therapy-related AML | 13 (5.1) | 17 (6.7) | 30 (5.9) |
Data are given as n (%) unless otherwise indicated.
SD, standard deviation.
One patient (age 48.5 y) was registered in error and randomized but not treated. This patient was included in all intent-to-treat analyses.