Treatment-related adverse events by cycles of therapy
| Characteristic . | Induction cycle 1, N = 351∗ . | Induction cycle 2, N = 272∗ . | Induction cycle 3, N = 271∗ . | Induction cycle 4, N = 303∗ . | Induction cycle 5, N = 327∗ . | Induction cycle 6, N = 290∗ . | Maintenance cycle 1, N = 99∗ . | Maintenance cycle 2, N = 34∗ . | Maintenance cycle 3, N = 16∗ . | Maintenance cycle 4, N = 9∗ . | Maintenance cycle 5, N = 6∗ . | Maintenance cycle 6, N = 5∗ . | Maintenance cycle 7, N = 5∗ . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AE term | |||||||||||||
| Alanine aminotransferase increased | 11 (3.1%) | 4 (1.5%) | 2 (0.7%) | 1 (0.3%) | 2 (0.6%) | 1 (0.3%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Anemia | 43 (12%) | 45 (17%) | 46 (17%) | 52 (17%) | 58 (18%) | 54 (19%) | 19 (19%) | 2 (5.9%) | 0 (0%) | 1 (11%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Aspartate aminotransferase increased | 10 (2.8%) | 2 (0.7%) | 0 (0%) | 1 (0.3%) | 1 (0.3%) | 0 (0%) | 1 (1.0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (20%) |
| Constipation | 13 (3.7%) | 3 (1.1%) | 3 (1.1%) | 2 (0.7%) | 0 (0%) | 1 (0.3%) | 1 (1.0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (20%) |
| Diarrhea | 3 (0.9%) | 1 (0.4%) | 3 (1.1%) | 2 (0.7%) | 0 (0%) | 4 (1.4%) | 2 (2.0%) | 2 (5.9%) | 0 (0%) | 1 (11%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Dizziness | 0 (0%) | 4 (1.5%) | 3 (1.1%) | 1 (0.3%) | 3 (0.9%) | 2 (0.7%) | 2 (2.0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Dysgeusia | 3 (0.9%) | 2 (0.7%) | 4 (1.5%) | 1 (0.3%) | 3 (0.9%) | 3 (1.0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Fatigue | 7 (2.0%) | 6 (2.2%) | 2 (0.7%) | 3 (1.0%) | 1 (0.3%) | 1 (0.3%) | 4 (4.0%) | 1 (2.9%) | 0 (0%) | 1 (11%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Febrile neutropenia | 4 (1.1%) | 1 (0.4%) | 3 (1.1%) | 0 (0%) | 3 (0.9%) | 3 (1.0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (17%) | 0 (0%) | 0 (0%) |
| Hyperglycemia | 11 (3.1%) | 7 (2.6%) | 6 (2.2%) | 3 (1.0%) | 4 (1.2%) | 8 (2.8%) | 1 (1.0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Hypoalbuminemia | 14 (4.0%) | 12 (4.4%) | 11 (4.1%) | 9 (3.0%) | 13 (4.0%) | 7 (2.4%) | 1 (1.0%) | 0 (0%) | 0 (0%) | 1 (11%) | 0 (0%) | 0 (0%) | 1 (20%) |
| Hypocalcemia | 16 (4.6%) | 9 (3.3%) | 2 (0.7%) | 5 (1.7%) | 8 (2.4%) | 3 (1.0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Hyponatremia | 7 (2.0%) | 0 (0%) | 2 (0.7%) | 2 (0.7%) | 4 (1.2%) | 2 (0.7%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (11%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Lymphocyte count decreased | 75 (21%) | 87 (32%) | 88 (32%) | 90 (30%) | 89 (27%) | 77 (27%) | 26 (26%) | 6 (18%) | 3 (19%) | 2 (22%) | 1 (17%) | 0 (0%) | 1 (20%) |
| Mucositis oral | 3 (0.9%) | 2 (0.7%) | 6 (2.2%) | 6 (2.0%) | 14 (4.3%) | 9 (3.1%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Nausea | 6 (1.7%) | 7 (2.6%) | 2 (0.7%) | 1 (0.3%) | 1 (0.3%) | 2 (0.7%) | 2 (2.0%) | 2 (5.9%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Neutrophil count decreased | 30 (8.5%) | 14 (5.1%) | 14 (5.2%) | 24 (7.9%) | 27 (8.3%) | 27 (9.3%) | 15 (15%) | 6 (18%) | 3 (19%) | 0 (0%) | 0 (0%) | 1 (20%) | 0 (0%) |
| Peripheral motor neuropathy | 0 (0%) | 0 (0%) | 0 (0%) | 2 (0.7%) | 1 (0.3%) | 1 (0.3%) | 1 (1.0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Peripheral sensory neuropathy | 7 (2.0%) | 10 (3.7%) | 7 (2.6%) | 8 (2.6%) | 4 (1.2%) | 2 (0.7%) | 2 (2.0%) | 2 (5.9%) | 2 (13%) | 0 (0%) | 0 (0%) | 1 (20%) | 0 (0%) |
| Platelet count decreased | 45 (13%) | 31 (11%) | 36 (13%) | 51 (17%) | 52 (16%) | 47 (16%) | 5 (5.1%) | 3 (8.8%) | 1 (6.3%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Vomiting | 3 (0.9%) | 1 (0.4%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 3 (3.0%) | 2 (5.9%) | 0 (0%) | 0 (0%) | 1 (17%) | 0 (0%) | 0 (0%) |
| Weight loss | 1 (0.3%) | 4 (1.5%) | 1 (0.4%) | 1 (0.3%) | 1 (0.3%) | 2 (0.7%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (17%) | 0 (0%) | 0 (0%) |
| White blood cell decreased | 39 (11%) | 20 (7.4%) | 30 (11%) | 38 (13%) | 38 (12%) | 34 (12%) | 14 (14%) | 8 (24%) | 7 (44%) | 2 (22%) | 2 (33%) | 3 (60%) | 1 (20%) |
| Characteristic . | Induction cycle 1, N = 351∗ . | Induction cycle 2, N = 272∗ . | Induction cycle 3, N = 271∗ . | Induction cycle 4, N = 303∗ . | Induction cycle 5, N = 327∗ . | Induction cycle 6, N = 290∗ . | Maintenance cycle 1, N = 99∗ . | Maintenance cycle 2, N = 34∗ . | Maintenance cycle 3, N = 16∗ . | Maintenance cycle 4, N = 9∗ . | Maintenance cycle 5, N = 6∗ . | Maintenance cycle 6, N = 5∗ . | Maintenance cycle 7, N = 5∗ . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AE term | |||||||||||||
| Alanine aminotransferase increased | 11 (3.1%) | 4 (1.5%) | 2 (0.7%) | 1 (0.3%) | 2 (0.6%) | 1 (0.3%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Anemia | 43 (12%) | 45 (17%) | 46 (17%) | 52 (17%) | 58 (18%) | 54 (19%) | 19 (19%) | 2 (5.9%) | 0 (0%) | 1 (11%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Aspartate aminotransferase increased | 10 (2.8%) | 2 (0.7%) | 0 (0%) | 1 (0.3%) | 1 (0.3%) | 0 (0%) | 1 (1.0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (20%) |
| Constipation | 13 (3.7%) | 3 (1.1%) | 3 (1.1%) | 2 (0.7%) | 0 (0%) | 1 (0.3%) | 1 (1.0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (20%) |
| Diarrhea | 3 (0.9%) | 1 (0.4%) | 3 (1.1%) | 2 (0.7%) | 0 (0%) | 4 (1.4%) | 2 (2.0%) | 2 (5.9%) | 0 (0%) | 1 (11%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Dizziness | 0 (0%) | 4 (1.5%) | 3 (1.1%) | 1 (0.3%) | 3 (0.9%) | 2 (0.7%) | 2 (2.0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Dysgeusia | 3 (0.9%) | 2 (0.7%) | 4 (1.5%) | 1 (0.3%) | 3 (0.9%) | 3 (1.0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Fatigue | 7 (2.0%) | 6 (2.2%) | 2 (0.7%) | 3 (1.0%) | 1 (0.3%) | 1 (0.3%) | 4 (4.0%) | 1 (2.9%) | 0 (0%) | 1 (11%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Febrile neutropenia | 4 (1.1%) | 1 (0.4%) | 3 (1.1%) | 0 (0%) | 3 (0.9%) | 3 (1.0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (17%) | 0 (0%) | 0 (0%) |
| Hyperglycemia | 11 (3.1%) | 7 (2.6%) | 6 (2.2%) | 3 (1.0%) | 4 (1.2%) | 8 (2.8%) | 1 (1.0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Hypoalbuminemia | 14 (4.0%) | 12 (4.4%) | 11 (4.1%) | 9 (3.0%) | 13 (4.0%) | 7 (2.4%) | 1 (1.0%) | 0 (0%) | 0 (0%) | 1 (11%) | 0 (0%) | 0 (0%) | 1 (20%) |
| Hypocalcemia | 16 (4.6%) | 9 (3.3%) | 2 (0.7%) | 5 (1.7%) | 8 (2.4%) | 3 (1.0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Hyponatremia | 7 (2.0%) | 0 (0%) | 2 (0.7%) | 2 (0.7%) | 4 (1.2%) | 2 (0.7%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (11%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Lymphocyte count decreased | 75 (21%) | 87 (32%) | 88 (32%) | 90 (30%) | 89 (27%) | 77 (27%) | 26 (26%) | 6 (18%) | 3 (19%) | 2 (22%) | 1 (17%) | 0 (0%) | 1 (20%) |
| Mucositis oral | 3 (0.9%) | 2 (0.7%) | 6 (2.2%) | 6 (2.0%) | 14 (4.3%) | 9 (3.1%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Nausea | 6 (1.7%) | 7 (2.6%) | 2 (0.7%) | 1 (0.3%) | 1 (0.3%) | 2 (0.7%) | 2 (2.0%) | 2 (5.9%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Neutrophil count decreased | 30 (8.5%) | 14 (5.1%) | 14 (5.2%) | 24 (7.9%) | 27 (8.3%) | 27 (9.3%) | 15 (15%) | 6 (18%) | 3 (19%) | 0 (0%) | 0 (0%) | 1 (20%) | 0 (0%) |
| Peripheral motor neuropathy | 0 (0%) | 0 (0%) | 0 (0%) | 2 (0.7%) | 1 (0.3%) | 1 (0.3%) | 1 (1.0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Peripheral sensory neuropathy | 7 (2.0%) | 10 (3.7%) | 7 (2.6%) | 8 (2.6%) | 4 (1.2%) | 2 (0.7%) | 2 (2.0%) | 2 (5.9%) | 2 (13%) | 0 (0%) | 0 (0%) | 1 (20%) | 0 (0%) |
| Platelet count decreased | 45 (13%) | 31 (11%) | 36 (13%) | 51 (17%) | 52 (16%) | 47 (16%) | 5 (5.1%) | 3 (8.8%) | 1 (6.3%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Vomiting | 3 (0.9%) | 1 (0.4%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 3 (3.0%) | 2 (5.9%) | 0 (0%) | 0 (0%) | 1 (17%) | 0 (0%) | 0 (0%) |
| Weight loss | 1 (0.3%) | 4 (1.5%) | 1 (0.4%) | 1 (0.3%) | 1 (0.3%) | 2 (0.7%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (17%) | 0 (0%) | 0 (0%) |
| White blood cell decreased | 39 (11%) | 20 (7.4%) | 30 (11%) | 38 (13%) | 38 (12%) | 34 (12%) | 14 (14%) | 8 (24%) | 7 (44%) | 2 (22%) | 2 (33%) | 3 (60%) | 1 (20%) |
AE, adverse event; N, total number of events.
n (%).