Table 3.
Grade 3 or 4 toxicity through 8 cycles: Induction, Consolidation, Maintenance 1–6 (Frequency and percent per course, and cumulative incidence)
| Toxicity | Ind. (N=85) |
Cons. (N=82) |
Mnt. 1 (N=76) |
Mnt. 2 (N=73) |
Mnt. 3 (N=70) |
Mnt. 4 (N=68) |
Mnt. 5 (N=65) |
Mnt. 6 (N=65) |
Cum. % |
|---|---|---|---|---|---|---|---|---|---|
| ANC | 20 | 43 | 32 | 34 | 40 | 38 | 35 | 32 | |
| 23.5% | 52.4% | 42.1% | 46.6% | 57.1% | 55.9% | 53.8% | 49.2% | 80% | |
| PLT | 2 | 40 | 24 | 20 | 25 | 31 | 28 | 27 | |
| 2.4% | 48.8% | 31.6% | 27.4% | 35.7% | 45.6% | 43.1% | 41.5% | 68% | |
| HGB | 0 | 35 | 28 | 20 | 21 | 21 | 19 | 16 | |
| 0.0% | 42.7% | 36.8% | 27.4% | 30.0% | 30.9% | 29.2% | 24.6% | 65% | |
| LIVER: SGOT/SGPT/Alk. Phos. | 5 | 7 | 7 | 5 | 4 | 8 | 6 | 8 | |
| 5.9% | 8.5% | 9.2% | 6.8% | 5.7% | 11.8% | 9.2% | 12.3% | 29% | |
| LIVER: Bilirubin | 4 | 8 | 1 | 0 | 0 | 1 | 1 | 0 | |
| 4.7% | 9.8% | 1.3% | 0.0% | 0.0% | 1.5% | 1.5% | 0.0% | 15% | |
| PANCREAS: Amylase, Ultrasound | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 1 | |
| 0.0% | 4.9% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 1.5% | 6% | |
| PANCREAS: Glucose | 4 | 2 | 2 | 2 | 1 | 2 | 3 | 1 | |
| 4.7% | 2.4% | 2.6% | 2.7% | 1.4% | 2.9% | 4.6% | 1.5% | 14% | |
| RENAL: BUN/Creat/CrClr | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | |
| 0.0% | 1.2% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 1.5% | 3% | |
| RENAL: SBP/DBP | 2 | 2 | 0 | 0 | 1 | 2 | 2 | 1 | |
| 2.4% | 2.4% | 0.0% | 0.0% | 1.4% | 2.9% | 3.1% | 1.5% | 8% | |
| GI: Stomatitis | 0 | 5 | 3 | 6 | 2 | 3 | 1 | 4 | |
| 0.0% | 6.1% | 3.9% | 8.2% | 2.9% | 4.4% | 1.5% | 6.2% | 21% | |
| GI: Pain/Constipation/Diarrhea | 1 | 7 | 1 | 1 | 1 | 2 | 1 | 0 | |
| 1.2% | 8.5% | 1.3% | 1.4% | 1.4% | 2.9% | 1.5% | 0.0% | 14% | |
| GI: Nausea/Vomiting | 3 | 4 | 0 | 1 | 2 | 0 | 1 | 0 | |
| 3.5% | 4.9% | 0.0% | 1.4% | 2.9% | 0.0% | 1.5% | 0.0% | 12% | |
| PULMONARY | 1 | 4 | 0 | 1 | 0 | 0 | 0 | 0 | |
| 1.2% | 4.9% | 0.0% | 1.4% | 0.0% | 0.0% | 0.0% | 0.0% | 7% | |
| NERVOUS SYSTEM: Peripheral | 0 | 1 | 2 | 4 | 0 | 0 | 2 | 1 | |
| 0.0% | 1.2% | 2.6% | 5.5% | 0.0% | 0.0% | 3.1% | 1.5% | 8% | |
| NERVOUS SYSTEM: Central | 3 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | |
| 3.5% | 2.4% | 0.0% | 0.0% | 0.0% | 0.0% | 1.5% | 0.0% | 7% | |
| INFECTION | 1 | 5 | 4 | 3 | 6 | 1 | 4 | 5 | |
| 1.2% | 6.1% | 5.3% | 4.1% | 8.6% | 1.5% | 6.2% | 7.7% | 20% |