Characteristics of the 240 Eligible Patients at Study Entry
| Characteristic . | GM-CSF Group (N = 114) . | Placebo Group (N = 126) . | P Value . | ||
|---|---|---|---|---|---|
| No. . | % . | No. . | % . | ||
| Median age (yr) | 66 | 66.5 | .30* | ||
| Age group (yr) | |||||
| 55-64 | 50 | 44 | 55 | 44 | .54-151 |
| 65-75 | 64 | 56 | 71 | 56 | |
| Sex (male/female) | 58 | 56 | 69 | 57 | .55-151 |
| Performance status | |||||
| 0-1 | 79 | 69 | 87 | 69 | .84-151 |
| 2-3-4 | 35 | 31 | 39 | 31 | |
| FAB classification | |||||
| M0 | 10 | 9 | 10 | 8 | .80-151 |
| M1 | 30 | 26 | 43 | 34 | |
| M2 | 29 | 25 | 30 | 24 | |
| M3 | 5 | 4 | 2 | 2 | |
| M4 | 20 | 18 | 20 | 16 | |
| M5 | 14 | 12 | 13 | 10 | |
| M6 | 5 | 4 | 5 | 4 | |
| M7 | 0 | 0 | 1 | 1 | |
| Unclassified | 1 | 1 | 2 | 2 | |
| White blood cell count (/μL) | |||||
| <30,000 | 86 | 75 | 93 | 74 | .88-151 |
| >30,000 | 28 | 25 | 33 | 26 | |
| Hemoglobin median value (g/dL) | 9.2 | 9 | .16* | ||
| Median platelet count (×1,000/μL) | 69 | 62 | .27* | ||
| Cytogenetic analysis | |||||
| Missing | |||||
| Not done | 12 | 11 | 14 | 11 | .83-151 |
| Not assessable | 22 | 19 | 28 | 22 | |
| Normal | 41 | 36 | 44 | 35 | |
| Abnormal | |||||
| Favorable | 6 | 5 | 4 | 3 | |
| Intermediate | 14 | 12 | 17 | 13 | |
| Unfavorable | 19 | 17 | 19 | 15 | |
| Characteristic . | GM-CSF Group (N = 114) . | Placebo Group (N = 126) . | P Value . | ||
|---|---|---|---|---|---|
| No. . | % . | No. . | % . | ||
| Median age (yr) | 66 | 66.5 | .30* | ||
| Age group (yr) | |||||
| 55-64 | 50 | 44 | 55 | 44 | .54-151 |
| 65-75 | 64 | 56 | 71 | 56 | |
| Sex (male/female) | 58 | 56 | 69 | 57 | .55-151 |
| Performance status | |||||
| 0-1 | 79 | 69 | 87 | 69 | .84-151 |
| 2-3-4 | 35 | 31 | 39 | 31 | |
| FAB classification | |||||
| M0 | 10 | 9 | 10 | 8 | .80-151 |
| M1 | 30 | 26 | 43 | 34 | |
| M2 | 29 | 25 | 30 | 24 | |
| M3 | 5 | 4 | 2 | 2 | |
| M4 | 20 | 18 | 20 | 16 | |
| M5 | 14 | 12 | 13 | 10 | |
| M6 | 5 | 4 | 5 | 4 | |
| M7 | 0 | 0 | 1 | 1 | |
| Unclassified | 1 | 1 | 2 | 2 | |
| White blood cell count (/μL) | |||||
| <30,000 | 86 | 75 | 93 | 74 | .88-151 |
| >30,000 | 28 | 25 | 33 | 26 | |
| Hemoglobin median value (g/dL) | 9.2 | 9 | .16* | ||
| Median platelet count (×1,000/μL) | 69 | 62 | .27* | ||
| Cytogenetic analysis | |||||
| Missing | |||||
| Not done | 12 | 11 | 14 | 11 | .83-151 |
| Not assessable | 22 | 19 | 28 | 22 | |
| Normal | 41 | 36 | 44 | 35 | |
| Abnormal | |||||
| Favorable | 6 | 5 | 4 | 3 | |
| Intermediate | 14 | 12 | 17 | 13 | |
| Unfavorable | 19 | 17 | 19 | 15 | |
*Student's t test.
Chi-square test or Fisher's exact test when appropriate.