Table 5.
Adverse events in ≥5% of bortezomib-treated patients with relapsed/refractory multiple myeloma (safety analysis set)
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | |
|---|---|---|---|---|---|
| n (%) | n (%) | n (%) | n (%) | n (%) | |
| Total patients with AEs | 200 (38.8) | 171 (33.2) | 86 (16.7) | 33 (6.4) | 329 (63.9) |
| Thrombocytopeniaa | 18 (3.5) | 31 (6.0) | 31 (6.0) | 6 (1.2) | 74 (14.4) |
| Diarrhea | 37 (7.2) | 27 (5.2) | 7 (1.4) | 0 | 71 (13.8) |
| Peripheral neuropathy | 34 (6.6) | 20 (3.9) | 3 (0.6) | 0 | 55 (10.7) |
| Hypoesthesia | 33 (6.4) | 18 (3.5) | 5 (1.0) | 0 | 52 (10.1) |
| Asthenia | 41 (8.0) | 13 (2.5) | 2 (0.4) | 0 | 51 (9.9) |
| Lung infection | 7 (1.4) | 22 (4.3) | 10 (1.9) | 8 (1.6) | 40 (7.8) |
| Herpes zoster | 14 (2.7) | 12 (2.3) | 3 (0.6) | 0 | 30 (5.8) |
Safety analysis set: included patients who received at least 1 dose of bortezomib (with 1 or more prior treatments)
AE adverse event
aPlatelet count <50 × 109/L