Table 3.
Nonhematological adverse events in >10% of patients, regardless of attribution
| Adverse event* by arm† | n (%) | |||
|---|---|---|---|---|
| Grade 3 | Grade 4 | Grade 5 | Total | |
| Fatigue | ||||
| A | 12 (14.8) | 0 | 0 | 12 (14.8) |
| B | 16 (20) | 0 | 0 | 16 (20) |
| Infections and infestations | ||||
| A | 10 (12.3) | 1 (1.2) | 1 (1.2) | 12 (14.7) |
| B | 10 (12.5) | 0 | 1 (1.3) | 11 (13.8) |
| Sepsis | ||||
| A | 0 | 11 (13.6) | 5 (6.2) | 16 (19.8) |
| B | 0 | 5 (6.3) | 6 (7.5) | 11 (13.8) |
| Lung infection | ||||
| A | 16 (19.8) | 2 (2.5) | 2 (2.5) | 20 (24.8) |
| B | 20 (25) | 0 | 2 (2.5) | 22 (27.5) |
| Hyperglycemia | ||||
| A | 10 (12.3) | 3 (3.7) | 0 | 13 (16) |
| B | 13 (16.3) | 0 | 0 | 13 (16.3) |
| Hypoalbuminemia | ||||
| A | 16 (19.8) | 0 | 0 | 16 (19.8) |
| B | 10 (12.5) | 0 | 0 | 10 (12.5) |
| Hypocalcemia | ||||
| A | 7 (8.6) | 3 (3.7) | 0 | 10 (12.3) |
| B | 3 (3.8) | 1 (1.3) | 0 | 4 (5.1) |
| Hypokalemia | ||||
| A | 10 (12.3) | 3 (3.7) | 0 | 13 (16) |
| B | 12 (15) | 1 (1.3) | 0 | 13 (16.3) |
| Hypophosphatemia | ||||
| A | 9 (11.1) | 0 | 0 | 9 (11.1) |
| B | 6 (7.5) | 0 | 0 | 6 (7.5) |
| Peripheral sensory neuropathy | ||||
| A | 0 | 0 | 0 | 0 |
| B | 8 (10) | 2 (2.5) | 0 | 10 (12.5) |
| Dyspnea | ||||
| A | 9 (11.1) | 0 | 0 | 9 (11.1) |
| B | 10 (12.5) | 1 (1.3) | 0 | 11 (13.8) |
| Hypoxia | ||||
| A | 6 (7.4) | 1 (1.2) | 0 | 7 (8.6) |
| B | 8 (10) | 0 | 1 (1.3) | 9 (11.3) |
| Hypertension | ||||
| A | 6 (7.4) | 0 | 0 | 6 (7.4) |
| B | 14 (17.5) | 0 | 0 | 14 (17.5) |
| Hypotension | ||||
| A | 11 (13.6) | 3 (3.7) | 0 | 14 (17.3) |
| B | 10 (12.5) | 4 (5) | 0 | 14 (17.5) |
Excludes hematological toxicity and febrile neutropenia, which were observed in all patients.
*
Regardless of attribution, per National Cancer Institute Common Toxicity Criteria (version 4.0).
†
161 patients were evaluated for adverse events: arm A (decitabine), n = 81; arm B (decitabine + bortezomib), n = 80.