Treatment-emergent adverse event | Integrated safety population (n=565),* n (%) | |
Leading to dose modification (treatment interruption and/or dose reduction) | 370 (65.5) | |
Leading to treatment interruption | 340 (60.2) | |
Leading to dose reduction | 260 (46.0) | |
Leading to treatment discontinuation† | 95 (16.8) | |
Leading to death | 26 (4.6) | |
Malignant neoplasm progression | 16 (2.8) | |
Nonprogression event leading to death | 10 (1.8) | |
Individual event occurring in ≥20% of patients | Any grade | Grade ≥3‡ |
Nausea | 439 (77.7) | 29 (5.1) |
Asthenia/fatigue§ | 422 (74.7) | 64 (11.3) |
Vomiting | 259 (45.8) | 25 (4.4) |
Hemoglobin decreased§ | 250 (44.2) | 137 (24.2) |
Alanine/aspartate aminotransferase increased§ | 223 (39.5) | 61 (10.8) |
Decreased appetite | 219 (38.8) | 16 (2.8) |
Constipation | 215 (38.1) | 8 (1.4) |
Dysgeusia | 204 (36.1) | 1 (0.2) |
Abdominal pain | 186 (32.9) | 23 (4.1) |
Diarrhea | 184 (32.6) | 13 (2.3) |
Platelet count decreased§ | 136 (24.1) | 36 (6.4) |
Dyspnea | 127 (22.5) | 5 (0.9) |
Blood creatinine increased | 125 (22.1) | 3 (0.5) |
*All data are from patients with at least one event.
†Excludes patients who discontinued because of disease progression.
‡Other grade ≥3 adverse events occurring in ≥3% of patients were neutrophil count decreased (8.0%, 45/565), malignant neoplasm progression (5.0%, 28/565), and small intestinal obstruction (3.7%, 21/565).
§To ensure full representation of similar treatment-emergent adverse events, certain terms were combined.