Toxicity of Remission Induction Therapy According to Treatment Assignment
| Grade 3, 4, or 5 Toxicity . | Percentage of Patients . | |||
|---|---|---|---|---|
| G-CSF Group (n = 100) . | Placebo Group (n = 93) . | Total (n = 193) . | P . | |
| WBC (<1,000/μL) | 98 | 97 | 97 | .67 |
| Platelets (<25,000/μL) | 97 | 95 | 96 | .71 |
| Hemoglobin (<6.5 g/dL) | 93 | 86 | 90 | .16 |
| Infection | 78 | 87 | 82 | .13 |
| Nausea | 23 | 28 | 26 | .41 |
| Bilirubin (>1.5 × normal) | 44 | 51 | 47 | .39 |
| Transaminases (>5 × normal) | 35 | 35 | 35 | 1.00 |
| Malaise/fatigue (PS > 2) | 16 | 25 | 20 | .15 |
| Motor neuropathy | 18 | 22 | 20 | .59 |
| Pain | 21 | 14 | 18 | .26 |
| Hyperglycemia (>250 mg/dL) | 33 | 35 | 34 | .88 |
| Hypofibrinogenemia (<0.5 × normal) | 26 | 18 | 22 | .16 |
| Grade 3, 4, or 5 Toxicity . | Percentage of Patients . | |||
|---|---|---|---|---|
| G-CSF Group (n = 100) . | Placebo Group (n = 93) . | Total (n = 193) . | P . | |
| WBC (<1,000/μL) | 98 | 97 | 97 | .67 |
| Platelets (<25,000/μL) | 97 | 95 | 96 | .71 |
| Hemoglobin (<6.5 g/dL) | 93 | 86 | 90 | .16 |
| Infection | 78 | 87 | 82 | .13 |
| Nausea | 23 | 28 | 26 | .41 |
| Bilirubin (>1.5 × normal) | 44 | 51 | 47 | .39 |
| Transaminases (>5 × normal) | 35 | 35 | 35 | 1.00 |
| Malaise/fatigue (PS > 2) | 16 | 25 | 20 | .15 |
| Motor neuropathy | 18 | 22 | 20 | .59 |
| Pain | 21 | 14 | 18 | .26 |
| Hyperglycemia (>250 mg/dL) | 33 | 35 | 34 | .88 |
| Hypofibrinogenemia (<0.5 × normal) | 26 | 18 | 22 | .16 |
Only toxic effects with an incidence of >20% in either group are included. Data were incomplete on two patients in the G-CSF group and three patients in the placebo group. The statistical test accounts for missing values.