Demographics and disease characteristics at baseline
| Variable . | Substudy population* (n = 98) . | PCR population† (n = 476) . | ITT population (n = 553) . |
|---|---|---|---|
| Age, y | |||
| Mean | 48.2 | 48.0 | 48.2 |
| SD | 13.2 | 12.6 | 12.6 |
| Median | 50 | 51 | 50 |
| Q1, Q3 | 39, 59 | 39, 58 | 39, 58 |
| Range | 20-69 | 18-70 | 18-70 |
| Sex, n (%) | |||
| Male | 65 (66.3) | 296 (62.2) | 342 (61.8) |
| Female | 33 (33.7) | 180 (37.8) | 211 (38.2) |
| Race, n (%) | |||
| White | 92 (93.9) | 425 (89.3) | 494 (89.3) |
| Black | 5 (5.1) | 23 (4.8) | 28 (5.1) |
| Other | 1 (1.0) | 28 (5.9) | 31 (5.6) |
| Weight, kg | |||
| n | 95 | 467 | 540 |
| Mean | 78 | 80.4 | 80.4 |
| SD | 15.9 | 17.9 | 18.2 |
| Median | 76 | 78.5 | 78.7 |
| Q1, Q3 | 68, 87.9 | 68, 89.6 | 68, 89.5 |
| Range | 48-134 | 42.5-169.5 | 40.0-169.5 |
| ECOG performance status, n (%) | |||
| Missing data | 1 (1.0) | 4 (0.8) | 5 (0.9) |
| 0 | 76 (77.6) | 368 (77.3) | 425 (76.9) |
| 1 | 18 (18.4) | 96 (20.2) | 115 (20.8) |
| 2 | 3 (3.1) | 8 (1.7) | 8 (1.4) |
| Sokal risk group, n (%) | |||
| Low | 33 (33.7) | 175 (36.8) | 201 (36.3) |
| Intermediate | 23 (23.5) | 99 (20.8) | 111 (20.1) |
| High | 12 (12.2) | 63 (13.2) | 71 (12.8) |
| Not known | 30 (30.6) | 139 (29.2) | 170 (30.7) |
| Variable . | Substudy population* (n = 98) . | PCR population† (n = 476) . | ITT population (n = 553) . |
|---|---|---|---|
| Age, y | |||
| Mean | 48.2 | 48.0 | 48.2 |
| SD | 13.2 | 12.6 | 12.6 |
| Median | 50 | 51 | 50 |
| Q1, Q3 | 39, 59 | 39, 58 | 39, 58 |
| Range | 20-69 | 18-70 | 18-70 |
| Sex, n (%) | |||
| Male | 65 (66.3) | 296 (62.2) | 342 (61.8) |
| Female | 33 (33.7) | 180 (37.8) | 211 (38.2) |
| Race, n (%) | |||
| White | 92 (93.9) | 425 (89.3) | 494 (89.3) |
| Black | 5 (5.1) | 23 (4.8) | 28 (5.1) |
| Other | 1 (1.0) | 28 (5.9) | 31 (5.6) |
| Weight, kg | |||
| n | 95 | 467 | 540 |
| Mean | 78 | 80.4 | 80.4 |
| SD | 15.9 | 17.9 | 18.2 |
| Median | 76 | 78.5 | 78.7 |
| Q1, Q3 | 68, 87.9 | 68, 89.6 | 68, 89.5 |
| Range | 48-134 | 42.5-169.5 | 40.0-169.5 |
| ECOG performance status, n (%) | |||
| Missing data | 1 (1.0) | 4 (0.8) | 5 (0.9) |
| 0 | 76 (77.6) | 368 (77.3) | 425 (76.9) |
| 1 | 18 (18.4) | 96 (20.2) | 115 (20.8) |
| 2 | 3 (3.1) | 8 (1.7) | 8 (1.4) |
| Sokal risk group, n (%) | |||
| Low | 33 (33.7) | 175 (36.8) | 201 (36.3) |
| Intermediate | 23 (23.5) | 99 (20.8) | 111 (20.1) |
| High | 12 (12.2) | 63 (13.2) | 71 (12.8) |
| Not known | 30 (30.6) | 139 (29.2) | 170 (30.7) |
ECOG indicates Eastern Cooperative Oncology Group; ITT, intention to treat; PCR, polymerase chain reaction; Q1, quartile 1; Q3, quartile 3; and SD, standard deviation.
Substudy population; patients with PCR samples collected at regular intervals as part of preplanned substudies conducted at German, Australian, and New Zealand sites independent of cytogenetic response status.
PCR population; patients with at least 1 PCR sample, including patients from the substudy and nonsubstudy populations.