TEAEs with an incidence of ≥5% in safety analysis set (n = 65)
| AE . | All TEAEs . | Drug-related TEAEs . | ||
|---|---|---|---|---|
| All grade n (%) . | Grade ≥3 n (%) . | All grade n (%) . | Grade ≥3 n (%) . | |
| Hematologic | ||||
| Anemia | 16 (24.6) | 10 (15.4) | 8 (12.3) | 4 (6.2) |
| Thrombocytopenia | 14 (21.5) | 9 (13.8) | 8 (12.3) | 4 (6.2) |
| Neutropenia | 11 (16.9) | 8 (12.3) | 8 (12.3) | 6 (9.2) |
| Leukopenia | 7 (10.8) | 6 (9.2) | 3 (4.6) | 3 (4.6) |
| Lymphopenia | 7 (10.8) | 6 (9.2) | 3 (4.6) | 2 (3.1) |
| Nonhematologic | ||||
| Pyrexia | 27 (41.5) | 2 (3.1) | 10 (15.4) | 1 (1.5) |
| Decreased appetite | 13 (20.0) | 1 (1.5) | 7 (10.8) | 0 |
| Aspartate aminotransferase increased | 12 (18.5) | 2 (3.1) | 11 (16.9) | 2 (3.1) |
| Constipation | 12 (18.5) | 0 | 3 (4.6) | 0 |
| Rash | 10 (15.4) | 2 (3.1) | 3 (4.6) | 1 (1.5) |
| Alanine aminotransferase increased | 10 (15.4) | 0 | 10 (15.4) | 0 |
| Malaise | 9 (13.8) | 0 | 9 (13.8) | 0 |
| Delirium | 8 (12.3) | 2 (3.1) | 6 (9.2) | 2 (3.1) |
| Hypokalemia | 7 (10.8) | 3 (4.6) | 2 (3.1) | 1 (1.5) |
| Hypoalbuminemia | 7 (10.8) | 1 (1.5) | 0 | 0 |
| Vomiting | 7 (10.8) | 0 | 4 (6.2) | 0 |
| Fatigue | 7 (10.8) | 2 (3.1) | 4 (6.2) | 1 (1.5) |
| Pruritus | 7 (10.8) | 1 (1.5) | 0 | 0 |
| Diarrhea | 6 (9.2) | 0 | 3 (4.6) | 0 |
| Upper respiratory tract infection | 6 (9.2) | 0 | 2 (3.1) | 0 |
| Nasopharyngitis | 6 (9.2) | 0 | 0 | 0 |
| Fall | 6 (9.2) | 0 | 0 | 0 |
| Peripheral sensory neuropathy | 5 (7.7) | 0 | 4 (6.2) | 0 |
| Hyponatremia | 5 (7.7) | 3 (4.6) | 1 (1.5) | 0 |
| Dizziness | 5 (7.7) | 0 | 2 (3.1) | 0 |
| Headache | 5 (7.7) | 0 | 1 (1.5) | 0 |
| Nausea | 5 (7.7) | 0 | 3 (4.6) | 0 |
| Hypertension | 4 (6.2) | 4 (6.2) | 0 | 0 |
| Hypophosphatemia | 4 (6.2) | 3 (4.6) | 0 | 0 |
| Pharyngitis | 4 (6.2) | 2 (3.1) | 1 (1.5) | 1 (1.5) |
| Abdominal pain | 4 (6.2) | 2 (3.1) | 1 (1.5) | 0 |
| Hyperkalemia | 4 (6.2) | 2 (3.1) | 2 (3.1) | 0 |
| Dysgeusia | 4 (6.2) | 0 | 4 (6.2) | 0 |
| Insomnia | 4 (6.2) | 0 | 2 (3.1) | 0 |
| Rhinorrhea | 4 (6.2) | 0 | 0 | 0 |
| AE . | All TEAEs . | Drug-related TEAEs . | ||
|---|---|---|---|---|
| All grade n (%) . | Grade ≥3 n (%) . | All grade n (%) . | Grade ≥3 n (%) . | |
| Hematologic | ||||
| Anemia | 16 (24.6) | 10 (15.4) | 8 (12.3) | 4 (6.2) |
| Thrombocytopenia | 14 (21.5) | 9 (13.8) | 8 (12.3) | 4 (6.2) |
| Neutropenia | 11 (16.9) | 8 (12.3) | 8 (12.3) | 6 (9.2) |
| Leukopenia | 7 (10.8) | 6 (9.2) | 3 (4.6) | 3 (4.6) |
| Lymphopenia | 7 (10.8) | 6 (9.2) | 3 (4.6) | 2 (3.1) |
| Nonhematologic | ||||
| Pyrexia | 27 (41.5) | 2 (3.1) | 10 (15.4) | 1 (1.5) |
| Decreased appetite | 13 (20.0) | 1 (1.5) | 7 (10.8) | 0 |
| Aspartate aminotransferase increased | 12 (18.5) | 2 (3.1) | 11 (16.9) | 2 (3.1) |
| Constipation | 12 (18.5) | 0 | 3 (4.6) | 0 |
| Rash | 10 (15.4) | 2 (3.1) | 3 (4.6) | 1 (1.5) |
| Alanine aminotransferase increased | 10 (15.4) | 0 | 10 (15.4) | 0 |
| Malaise | 9 (13.8) | 0 | 9 (13.8) | 0 |
| Delirium | 8 (12.3) | 2 (3.1) | 6 (9.2) | 2 (3.1) |
| Hypokalemia | 7 (10.8) | 3 (4.6) | 2 (3.1) | 1 (1.5) |
| Hypoalbuminemia | 7 (10.8) | 1 (1.5) | 0 | 0 |
| Vomiting | 7 (10.8) | 0 | 4 (6.2) | 0 |
| Fatigue | 7 (10.8) | 2 (3.1) | 4 (6.2) | 1 (1.5) |
| Pruritus | 7 (10.8) | 1 (1.5) | 0 | 0 |
| Diarrhea | 6 (9.2) | 0 | 3 (4.6) | 0 |
| Upper respiratory tract infection | 6 (9.2) | 0 | 2 (3.1) | 0 |
| Nasopharyngitis | 6 (9.2) | 0 | 0 | 0 |
| Fall | 6 (9.2) | 0 | 0 | 0 |
| Peripheral sensory neuropathy | 5 (7.7) | 0 | 4 (6.2) | 0 |
| Hyponatremia | 5 (7.7) | 3 (4.6) | 1 (1.5) | 0 |
| Dizziness | 5 (7.7) | 0 | 2 (3.1) | 0 |
| Headache | 5 (7.7) | 0 | 1 (1.5) | 0 |
| Nausea | 5 (7.7) | 0 | 3 (4.6) | 0 |
| Hypertension | 4 (6.2) | 4 (6.2) | 0 | 0 |
| Hypophosphatemia | 4 (6.2) | 3 (4.6) | 0 | 0 |
| Pharyngitis | 4 (6.2) | 2 (3.1) | 1 (1.5) | 1 (1.5) |
| Abdominal pain | 4 (6.2) | 2 (3.1) | 1 (1.5) | 0 |
| Hyperkalemia | 4 (6.2) | 2 (3.1) | 2 (3.1) | 0 |
| Dysgeusia | 4 (6.2) | 0 | 4 (6.2) | 0 |
| Insomnia | 4 (6.2) | 0 | 2 (3.1) | 0 |
| Rhinorrhea | 4 (6.2) | 0 | 0 | 0 |