Table 3.
Adverse events of Japanese patients with relapsed or refractory multiple myeloma during the induction phase of treatment with bortezomib + dexamethasone (BD) or thalidomide + dexamethasone (TD)
| Event, n (%) | BD (n = 22) | TD (n = 22) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade | Grade | |||||||||||
| 1 | 2 | 3 | 4 | Total % | G3/4% | 1 | 2 | 3 | 4 | Total % | G3/4% | |
| Hematologic toxicity | ||||||||||||
| Leukopenia | 2 | 10 | 3 | 1 | 72.7 | 18.2 | 2 | 6 | 3 | 0 | 50.0 | 13.6 |
| Neutropenia | 5 | 11 | 2 | 1 | 86.4 | 13.6 | 4 | 11 | 3 | 0 | 81.8 | 13.6 |
| Anemia | 9 | 10 | 0 | 2 | 95.5 | 9.1 | 11 | 9 | 1 | 0 | 95.5 | 4.5 |
| Thrombocytopenia | 6 | 4 | 9 | 3 | 100.0 | 54.5 | 15 | 2 | 0 | 0 | 77.3 | 0.0 |
| Non‐hematologic toxicity | ||||||||||||
| Hypoalbuminemia | 14 | 7 | 0 | ‐ | 95.5 | 0.0 | 15 | 6 | 1 | ‐ | 100.0 | 4.5 |
| ALP increased | 7 | 2 | 0 | 0 | 40.9 | 0.0 | 8 | 0 | 0 | 0 | 36.4 | 0.0 |
| AST increased | 8 | 2 | 3 | 0 | 59.1 | 13.6 | 8 | 1 | 0 | 0 | 40.9 | 0.0 |
| ALT increased | 9 | 4 | 3 | 0 | 72.7 | 13.6 | 10 | 3 | 1 | 0 | 63.6 | 4.5 |
| Cr increased | 9 | 1 | 0 | 0 | 45.5 | 0.0 | 11 | 2 | 0 | 0 | 59.1 | 0.0 |
| Hypernatremia | 3 | 0 | 0 | 0 | 13.6 | 0.0 | 2 | 0 | 0 | 0 | 9.1 | 0.0 |
| Hyponatremia | 13 | ‐ | 1 | 1 | 68.2 | 9.1 | 21 | ‐ | 0 | 0 | 95.5 | 0.0 |
| Hyperkalemia | 7 | 1 | 1 | 0 | 40.9 | 4.5 | 13 | 1 | 0 | 0 | 63.6 | 0.0 |
| Hypokalemia | 7 | ‐ | 2 | 0 | 40.9 | 9.1 | 5 | ‐ | 1 | 0 | 27.3 | 4.5 |
| Hypercalcemia | 2 | 0 | 0 | 0 | 9.1 | 0.0 | 7 | 1 | 0 | 0 | 36.4 | 0.0 |
| Hypocalcemia | 12 | 1 | 0 | 0 | 59.1 | 0.0 | 10 | 3 | 0 | 0 | 59.1 | 0.0 |
| Hyperglycemia | 10 | 6 | 1 | 0 | 77.3 | 4.5 | 10 | 8 | 3 | 0 | 95.5 | 13.6 |
| Fever | 3 | 3 | 0 | 0 | 27.3 | 0.0 | 2 | 2 | 0 | 0 | 18.2 | 0.0 |
| Fatigue | 3 | 4 | 1 | 0 | 36.4 | 4.5 | 5 | 2 | 3 | 0 | 45.5 | 13.6 |
| Rash | 1 | 2 | 1 | 0 | 18.2 | 4.5 | 1 | 2 | 1 | 0 | 18.2 | 4.5 |
| Nausea | 4 | 2 | 1 | 0 | 31.8 | 4.5 | 2 | 0 | 1 | 0 | 13.6 | 4.5 |
| Anorexia | 4 | 3 | 1 | 0 | 36.4 | 4.5 | 1 | 0 | 1 | 0 | 9.1 | 4.5 |
| Vomiting | 3 | 2 | 0 | 0 | 22.7 | 0.0 | 0 | 0 | 0 | 0 | 0.0 | 0.0 |
| Diarrhea | 5 | 2 | 0 | 0 | 31.8 | 0.0 | 0 | 0 | 0 | 0 | 0.0 | 0.0 |
| Constipation | 5 | 7 | 3 | 0 | 68.2 | 13.6 | 5 | 7 | 0 | 1 | 59.1 | 4.5 |
| Paralytic ileus | 0 | 1 | 1 | 0 | 9.1 | 4.5 | 0 | 0 | 1 | 0 | 4.5 | 4.5 |
| Mucositis | 1 | 0 | 0 | 0 | 4.5 | 0.0 | 2 | 0 | 0 | 0 | 9.1 | 0 |
| Herpes zoster | 0 | 0 | 0 | 0 | 0.0 | 0.0 | 0 | 0 | 1 | 0 | 4.5 | 4.5 |
| Somnolence | ‐ | 3 | 0 | 0 | 13.6 | 0.0 | ‐ | 1 | 1 | 0 | 9.1 | 4.5 |
| Peripheral neuropathy, motor | 0 | 1 | 2 | 0 | 13.6 | 9.1 | 0 | 1 | 1 | 0 | 9.1 | 4.5 |
| Peripheral neuropathy, sensory | 5 | 9 | 5 | 0 | 86.4 | 22.7 | 9 | 1 | 2 | 0 | 54.5 | 9.1 |
| Hypoxia | ‐ | 0 | 0 | 0 | 0.0 | 0.0 | ‐ | 0 | 1 | 0 | 4.5 | 4.5 |
| Pneumonitis | 0 | 1 | 0 | 0 | 4.5 | 0.0 | 0 | 0 | 1 | 0 | 4.5 | 4.5 |
| Thrombosis | ‐ | 0 | 0 | 0 | 0.0 | 0.0 | ‐ | 1 | 0 | 0 | 4.5 | 0.0 |
Adverse events categorized according to according to the NCI's Common Terminology Criteria for Adverse Events version 3.0. ‐, not defined. ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; Cr, creatinine.