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) |
| 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.