Maximum severity of select grade 3+ adverse events
| Adverse event* . | N (%) . | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Induction (n = 295) . | Postremission consolidation therapy† (n = 237) . | Maintenance (n = 173) . | Overall (n = 295) . | |||||||||
| Grade 3 . | Grade 4 . | Grade 5 . | Grade 3 . | Grade 4 . | Grade 5 . | Grade 3 . | Grade 4 . | Grade 5 . | Grade 3 . | Grade 4 . | Grade 5 . | |
| Allergic reaction/hypersensitivity | 2 (1) | 0 | 0 | 17 (7) | 10 (4) | 0 | 0 | 0 | 0 | 19 (7) | 10 (3) | 0 |
| ALT | 72 (26) | 7 (3) | 0 | 93 (39) | 6 (3) | 0 | 69 (40) | 2 (1) | 0 | 145 (50) | 13 (4) | 0 |
| AST | 31 (11) | 4 (1) | 0 | 55 (23) | 4 (2) | 0 | 26 (15) | 1 (1) | 0 | 89 (31) | 9 (3) | 0 |
| Bilirubin (hyperbilirubinemia) | 34 (12) | 17 (6) | 0 | 19 (8) | 4 (2) | 0 | 16 (9) | 1 (1) | 0 | 56 (19) | 21 (7) | 0 |
| Death NOS | 0 | 0 | 1 (<1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (<1) |
| Fatigue | 14 (5) | 2 (1) | 0 | 29 (12) | 0 | 0 | 6 (3) | 0 | 0 | 38 (13) | 2 (1) | 0 |
| Febrile neutropenia | 53 (19) | 8 (3) | 0 | 93 (39) | 13 (5) | 0 | 25 (15) | 4 (2) | 0 | 128 (44) | 24 (8) | 0 |
| Glucose serum high (hyperglycemia) | 63 (23) | 22 (8) | 0 | 19 (8) | 7 (3) | 0 | 19 (11) | 2 (1) | 0 | 73 (25) | 30 (10) | 0 |
| Hemorrhage CNS | 1 (<1) | 2 (1) | 0 | 0 (0) | 0 | 0 | 1 (1) | 0 | 0 | 2 (1) | 2 (1) | 0 |
| Infection | 36 (13) | 15 (5) | 2 (1) | 53 (22) | 6 (3) | 2 (1) | 24 (14) | 3 (2) | 0 | 60 (21) | 14 (5) | 4 (1) |
| Liver dysfunction/failure | 2 (1) | 1 (<1) | 2 (1) | 0 | 0 | 0 | 0 | 0 | 0 | 2 (1) | 1 (<1) | 2 (1) |
| Mucositis/stomatitis/esophagitis | 4 (1) | 1 (<1) | 0 | 19 (8) | 3 (1) | 0 | 4 (2) | 1 (1) | 0 | 14 (5) | 4 (1) | 0 |
| Neuropathy: motor | 3 (1) | 2 (1) | 0 | 10 (4) | 1 (0) | 0 | 4 (2) | 0 | 0 | 15 (5) | 2 (1) | 0 |
| Neuropathy: sensory | 5 (2) | 2 (1) | 0 | 36 (15) | 1 (0) | 0 | 16 (9) | 0 | 0 | 42 (15) | 3 (1) | 0 |
| Osteonecrosis (avascular necrosis) | 1 (<1) | 0 | 0 | 1 (<1) | 0 | 0 | 10 (6) | 1 (1) | 0 | 11 (4) | 1 (0) | 0 |
| Pancreatitis | 2 (1) | 2 (1) | 0 | 10 (4) | 0 | 0 | 1 (1) | 0 | 0 | 12 (4) | 2 (1) | 0 |
| Thrombosis/thrombus/embolism | 8 (3) | 7 (3) | 0 | 14 (6) | 7 (3) | 0 | 0) | 1 (1) | 0 | 20 (7) | 13 () | 0 |
| Triglyceride serum high (hypertriglyceridemia) | 4 (1) | 4 (1) | 0 | 8 (3) | 21 (9) | 0 | 2 (1) | 1 (1) | 0 | 10 (3) | 23 (8) | 0 |
| Tumor lysis syndrome | 15 (5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 15 (5) | 0 | 0 |
| Ventricular arrhythmia | 0 | 1 (<1) | 1 (<1) | 0 | 0 | 0 | 1 (<1) | 0 | 0 | 1 (0) | 1 (0) | 1 (<1) |
| Adverse event* . | N (%) . | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Induction (n = 295) . | Postremission consolidation therapy† (n = 237) . | Maintenance (n = 173) . | Overall (n = 295) . | |||||||||
| Grade 3 . | Grade 4 . | Grade 5 . | Grade 3 . | Grade 4 . | Grade 5 . | Grade 3 . | Grade 4 . | Grade 5 . | Grade 3 . | Grade 4 . | Grade 5 . | |
| Allergic reaction/hypersensitivity | 2 (1) | 0 | 0 | 17 (7) | 10 (4) | 0 | 0 | 0 | 0 | 19 (7) | 10 (3) | 0 |
| ALT | 72 (26) | 7 (3) | 0 | 93 (39) | 6 (3) | 0 | 69 (40) | 2 (1) | 0 | 145 (50) | 13 (4) | 0 |
| AST | 31 (11) | 4 (1) | 0 | 55 (23) | 4 (2) | 0 | 26 (15) | 1 (1) | 0 | 89 (31) | 9 (3) | 0 |
| Bilirubin (hyperbilirubinemia) | 34 (12) | 17 (6) | 0 | 19 (8) | 4 (2) | 0 | 16 (9) | 1 (1) | 0 | 56 (19) | 21 (7) | 0 |
| Death NOS | 0 | 0 | 1 (<1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (<1) |
| Fatigue | 14 (5) | 2 (1) | 0 | 29 (12) | 0 | 0 | 6 (3) | 0 | 0 | 38 (13) | 2 (1) | 0 |
| Febrile neutropenia | 53 (19) | 8 (3) | 0 | 93 (39) | 13 (5) | 0 | 25 (15) | 4 (2) | 0 | 128 (44) | 24 (8) | 0 |
| Glucose serum high (hyperglycemia) | 63 (23) | 22 (8) | 0 | 19 (8) | 7 (3) | 0 | 19 (11) | 2 (1) | 0 | 73 (25) | 30 (10) | 0 |
| Hemorrhage CNS | 1 (<1) | 2 (1) | 0 | 0 (0) | 0 | 0 | 1 (1) | 0 | 0 | 2 (1) | 2 (1) | 0 |
| Infection | 36 (13) | 15 (5) | 2 (1) | 53 (22) | 6 (3) | 2 (1) | 24 (14) | 3 (2) | 0 | 60 (21) | 14 (5) | 4 (1) |
| Liver dysfunction/failure | 2 (1) | 1 (<1) | 2 (1) | 0 | 0 | 0 | 0 | 0 | 0 | 2 (1) | 1 (<1) | 2 (1) |
| Mucositis/stomatitis/esophagitis | 4 (1) | 1 (<1) | 0 | 19 (8) | 3 (1) | 0 | 4 (2) | 1 (1) | 0 | 14 (5) | 4 (1) | 0 |
| Neuropathy: motor | 3 (1) | 2 (1) | 0 | 10 (4) | 1 (0) | 0 | 4 (2) | 0 | 0 | 15 (5) | 2 (1) | 0 |
| Neuropathy: sensory | 5 (2) | 2 (1) | 0 | 36 (15) | 1 (0) | 0 | 16 (9) | 0 | 0 | 42 (15) | 3 (1) | 0 |
| Osteonecrosis (avascular necrosis) | 1 (<1) | 0 | 0 | 1 (<1) | 0 | 0 | 10 (6) | 1 (1) | 0 | 11 (4) | 1 (0) | 0 |
| Pancreatitis | 2 (1) | 2 (1) | 0 | 10 (4) | 0 | 0 | 1 (1) | 0 | 0 | 12 (4) | 2 (1) | 0 |
| Thrombosis/thrombus/embolism | 8 (3) | 7 (3) | 0 | 14 (6) | 7 (3) | 0 | 0) | 1 (1) | 0 | 20 (7) | 13 () | 0 |
| Triglyceride serum high (hypertriglyceridemia) | 4 (1) | 4 (1) | 0 | 8 (3) | 21 (9) | 0 | 2 (1) | 1 (1) | 0 | 10 (3) | 23 (8) | 0 |
| Tumor lysis syndrome | 15 (5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 15 (5) | 0 | 0 |
| Ventricular arrhythmia | 0 | 1 (<1) | 1 (<1) | 0 | 0 | 0 | 1 (<1) | 0 | 0 | 1 (0) | 1 (0) | 1 (<1) |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; NOS, not otherwise specified.
At least possibly related, per National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0); overall, 289 patients were evaluated for adverse events: 284 during induction, 232 during consolidation, 192 during interim maintenance, 184 during delayed intensification, and 173 during maintenance.
Consolidation, interim maintenance, and delayed intensification.