Demographics and Disease Characteristics
| . | Group A . | Group B . | Placebo (%) . | ||
|---|---|---|---|---|---|
| PEG-rHuMGDF 2.5 μg/kg/d to Target (%) . | PEG-rHuMGDF 5 μg/kg/d to Target (%) . | PEG-rHuMGDF 2.5 μg/kg/d Single Dose [Day 8 only] (%) . | PEG-rHuMGDF 2.5 μg/kg/d [Days 8 to 14] (%) . | ||
| No. of patients | 24 | 24 | 12 | 14 | 34 |
| Age | |||||
| <60 yr | 17 (71) | 16 (67) | 8 (67) | 7 (50) | 23 (68) |
| ≥60 yr | 7 (29) | 8 (33) | 4 (33) | 7 (50) | 11 (32) |
| Median (yr) | 49 | 48 | 55 | 60 | 52 |
| Range | 19-71 | 20-77 | 21-78 | 17-71 | 20-75 |
| Sex | |||||
| Male | 11 (46) | 14 (58) | 5 (42) | 11 (79) | 16 (47) |
| Female | 13 (54) | 10 (42) | 7 (58) | 3 (21) | 18 (53) |
| ECOG status | |||||
| 0 | 2 (8) | 10 (42) | 3 (25) | 6 (43) | 6 (18) |
| 1 | 17 (71) | 10 (42) | 7 (58) | 7 (50) | 20 (59) |
| 2 | 4 (17) | 4 (17) | 2 (17) | 1 (7) | 6 (18) |
| 3 | 1 (4) | 0 (0) | 0 (0) | 0 (0) | 2 (6) |
| FAB subtype | |||||
| M0 | 1 (4) | 0 (0) | 1 (8) | 1 (7) | 0 (0) |
| M1 | 6 (25) | 4 (17) | 4 (33) | 2 (14) | 9 (26) |
| M2 | 6 (25) | 12 (50) | 2 (17) | 3 (21) | 9 (26) |
| M4 | 6 (25) | 5 (21) | 2 (17) | 1 (7) | 8 (24) |
| M5 | 3 (13) | 3 (13) | 1 (8) | 4 (29) | 6 (18) |
| M6 | 1 (4) | 0 (0) | 1 (8) | 1 (7) | 2 (6) |
| Not assessed | 1 (4) | 0 (0) | 1 (8) | 2 (14) | 0 (0) |
| Cytogenetic status | |||||
| Normal | 11 (46) | 9 (38) | 6 (50) | 5 (36) | 12 (35) |
| Abnormal* | 12 (50) | 12 (50) | 6 (50) | 7 (50) | 20 (59) |
| Good | 2 (8) | 3 (13) | 2 (17) | 1 (7) | 7 (35) |
| Intermediate | 1 (4) | 6 (25) | 3 (25) | 4 (29) | 5 (25) |
| Poor | 9 (38) | 3 (13) | 1 (8) | 2 (14) | 8 (40) |
| Not assessed | 1 (4) | 3 (13) | 0 (0) | 2 (14) | 2 (6) |
| . | Group A . | Group B . | Placebo (%) . | ||
|---|---|---|---|---|---|
| PEG-rHuMGDF 2.5 μg/kg/d to Target (%) . | PEG-rHuMGDF 5 μg/kg/d to Target (%) . | PEG-rHuMGDF 2.5 μg/kg/d Single Dose [Day 8 only] (%) . | PEG-rHuMGDF 2.5 μg/kg/d [Days 8 to 14] (%) . | ||
| No. of patients | 24 | 24 | 12 | 14 | 34 |
| Age | |||||
| <60 yr | 17 (71) | 16 (67) | 8 (67) | 7 (50) | 23 (68) |
| ≥60 yr | 7 (29) | 8 (33) | 4 (33) | 7 (50) | 11 (32) |
| Median (yr) | 49 | 48 | 55 | 60 | 52 |
| Range | 19-71 | 20-77 | 21-78 | 17-71 | 20-75 |
| Sex | |||||
| Male | 11 (46) | 14 (58) | 5 (42) | 11 (79) | 16 (47) |
| Female | 13 (54) | 10 (42) | 7 (58) | 3 (21) | 18 (53) |
| ECOG status | |||||
| 0 | 2 (8) | 10 (42) | 3 (25) | 6 (43) | 6 (18) |
| 1 | 17 (71) | 10 (42) | 7 (58) | 7 (50) | 20 (59) |
| 2 | 4 (17) | 4 (17) | 2 (17) | 1 (7) | 6 (18) |
| 3 | 1 (4) | 0 (0) | 0 (0) | 0 (0) | 2 (6) |
| FAB subtype | |||||
| M0 | 1 (4) | 0 (0) | 1 (8) | 1 (7) | 0 (0) |
| M1 | 6 (25) | 4 (17) | 4 (33) | 2 (14) | 9 (26) |
| M2 | 6 (25) | 12 (50) | 2 (17) | 3 (21) | 9 (26) |
| M4 | 6 (25) | 5 (21) | 2 (17) | 1 (7) | 8 (24) |
| M5 | 3 (13) | 3 (13) | 1 (8) | 4 (29) | 6 (18) |
| M6 | 1 (4) | 0 (0) | 1 (8) | 1 (7) | 2 (6) |
| Not assessed | 1 (4) | 0 (0) | 1 (8) | 2 (14) | 0 (0) |
| Cytogenetic status | |||||
| Normal | 11 (46) | 9 (38) | 6 (50) | 5 (36) | 12 (35) |
| Abnormal* | 12 (50) | 12 (50) | 6 (50) | 7 (50) | 20 (59) |
| Good | 2 (8) | 3 (13) | 2 (17) | 1 (7) | 7 (35) |
| Intermediate | 1 (4) | 6 (25) | 3 (25) | 4 (29) | 5 (25) |
| Poor | 9 (38) | 3 (13) | 1 (8) | 2 (14) | 8 (40) |
| Not assessed | 1 (4) | 3 (13) | 0 (0) | 2 (14) | 2 (6) |
Good: t(15,17), t(8,21), inv(16); Intermediate: abnormal; Poor: monosomy 5, 7, 7q-, 5q-, trisomy 8, 11q 23 abnormalities, complex abnormalities.