Summary of adverse events
| Events, n (%) | Low risk (n = 49) | High risk (n = 74) | Total (n = 123) | |||
|---|---|---|---|---|---|---|
| Any grade | Grade 3~4 | Any grade | Grade 3~4 | Any grade | Grade 3~4 | |
| Any adverse event | 49 (100%) | 46 (93.8%) | 74 (100%) | 70 (94.6%) | 123 (100%) | 116 (94.3%) |
| Hematological toxic effects | ||||||
| Anemia | 47 (95.9%) | 21 (42.9%) | 73 (98.6%) | 51 (68.9%) | 120 (97.6%) | 72 (58.5%) |
| Leukopenia | 47 (95.9%) | 43 (87.8%) | 74 (100%) | 70 (94.6%) | 121 (98.4%) | 113 (91.9%) |
| Thrombocytopenia | 38 (77.5%) | 30 (61.2%) | 65 (87.8%) | 60 (81.1%) | 103 (83.7%) | 90 (73.2%) |
| Febrile neutropenia | 19 (38.8%) | 19 (38.8%) | 41 (55.4%) | 41 (55.4%) | 60 (48.8%) | 60 (48.8%) |
| Non-hematological toxic effects | ||||||
| Fatigue | 22 (44.9%) | 0 | 43 (58.1%) | 0 | 65 (52.8%) | 0 |
| Diarrhea | 5 (10.2%) | 0 | 6 (8.1%) | 1 (1.4%) | 11 (8.9%) | 1 (0.8%) |
| Dyspepsia | 22 (44.9%) | 0 | 45 (60.8%) | 0 | 67 (54.5%) | 0 |
| Nausea | 6 (12.2%) | 0 | 21 (28.4%) | 1 (1.4%) | 27 (22.0%) | 1 (0.8%) |
| Emesis | 4 (8.2%) | 0 | 13 (17.6%) | 1 (1.4%) | 17 (13.8%) | 1 (0.8%) |
| Stomatitis | 8 (16.3%) | 1 (2%) | 9 (12.2%) | 1 (1.4%) | 17 (13.8%) | 2 (1.6%) |
| Elevated transaminases | 27 (55.1%) | 1 (2%) | 32 (43.2%) | 1 (1.4%) | 59 (48.0%) | 2 (1.6%) |
| Elevated serum bilirubin | 2 (4.1%) | 0 | 9 (12.2%) | 0 | 11 (8.9%) | 0 |
| Serum creatinine increased | 1 (2%) | 0 | 4 (5.4%) | 0 | 5 (4.1%) | 0 |