Table 5.
Most relevant suspected AEs by worst NCI-CTC grade
| System organ class preferred term | Safety population (N = 69) |
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| Grade 1, n (%) | Grade 2, n (%) | Grade 3, n (%) | Grade 4, n (%) | Total, n (%) | |
| Anemia | 7 (10.1) | 21 (30.4) | 6 (8.7) | 3 (4.3) | 37 (53.6) |
| Febrile neutropenia | 0 | 0 | 1 (1.4) | 1 (1.4) | 2 (2.9) |
| Leukopenia | 3 (4.3) | 10 (14.5) | 9 (13.0) | 4 (5.8) | 26 (37.7) |
| Neutropenia | 1 (1.4) | 9 (13.0) | 14 (20.3) | 12 (17.4) | 36 (52.2) |
| Thrombocytopenia | 9 (13.0) | 6 (8.7) | 10 (14.5) | 5 (7.2) | 30 (43.5) |
| Constipation | 8 (11.6) | 6 (8.7) | 0 | 0 | 14 (20.3) |
| Diarrhea | 13 (18.8) | 8 (11.6) | 4 (5.8) | 0 | 25 (36.2) |
| Nausea | 25 (36.2) | 22 (31.9) | 1 (1.4) | 0 | 48 (69.6) |
| Vomiting | 25 (36.2) | 9 (13.0) | 2 (2.9) | 0 | 36 (52.2) |
| Abdominal pain upper | 3 (4.3) | 5 (7.2) | 1 (1.4) | 0 | 9 (13) |
| Asthenia | 8 (11.6) | 17 (24.6) | 0 | 0 | 25 (36.2) |
| Fatigue | 10 (14.5) | 3 (4.3) | 0 | 0 | 13 (18.8) |
| Anorexia | 9 (13.0) | 3 (4.3) | 0 | 0 | 12 (17.4) |
| Bone pain | 0 | 0 | 1 (1.4) | 0 | 1 (1.4) |
| Osteonecrosis | 0 | 0 | 0 | 1 (1.4) | 1 (1.4) |
| Epistaxis | 2 (2.9) | 0 | 1 (1.4) | 0 | 3 (4.3) |
| Alopecia | 8 (11.6) | 4 (5.8) | 0 | 0 | 12 (17.4) |
AEs, adverse events; NCI CTC, National Cancer Institute Common—Toxicity Criteria.