Table 3 Safety profiles of grade 1–2 and 3–4 adverse events
AEs | EC | EP | Overall | p value |
|---|---|---|---|---|
(N = 800) | (N = 505) | (N = 1305) | ||
Grade 1–2 AEs | ||||
Neutropaenia | 268 (33.5%) | 141 (27.9%) | 409 (31.3%) | 0.106 |
Anaemia | 167 (20.9%) | 23 (4.6%) | 190 (14.6%) | < 0.001 |
Thrombocytopaenia | 168 (21.0%) | 61 (12.1%) | 229 (17.5%) | < 0.001 |
Hyponatremia | 24 (3.0%) | 4 (0.8%) | 28 (2.1%) | 0.022 |
Hyperthyroidism | 5 (0.6%) | 0 (0%) | 5 (0.4%) | 0.23 |
Hypothyroidism | 22 (2.8%) | 0 (0%) | 22 (1.7%) | < 0.001 |
Vomiting | 162 (20.2%) | 181 (35.8%) | 343 (26.3%) | < 0.001 |
Dyspnoea | 249 (31.1%) | 107 (21.2%) | 356 (27.3%) | < 0.001 |
Infection | 147 (18.4%) | 42 (8.3%) | 189 (14.5%) | < 0.001 |
Pneumonia | 31 (3.9%) | 6 (1.2%) | 37 (2.8%) | 0.013 |
Hearing loss | 2 (0.2%) | 21 (4.2%) | 23 (1.8%) | < 0.001 |
Hypertension | 206 (25.8%) | 20 (4.0%) | 226 (17.3%) | < 0.001 |
Chest pain | 8 (1.0%) | 45 (8.9%) | 53 (4.1%) | < 0.001 |
Arrhythmia | 24 (3.0%) | 0 (0%) | 24 (1.8%) | < 0.001 |
Thrombosis | 18 (2.2%) | 2 (0.4%) | 20 (1.5%) | 0.02 |
Embolism | 4 (0.5%) | 0 (0%) | 4 (0.3%) | 0.288 |
Grade 3–4 AEs | ||||
Neutropaenia | 335 (41.9%) | 161 (31.9%) | 496 (38.0%) | 0.001 |
Anaemia | 98 (12.2%) | 41 (8.1%) | 139 (10.7%) | 0.061 |
Thrombocytopaenia | 89 (11.1%) | 26 (5.1%) | 115 (8.8%) | < 0.001 |
Vomiting | 11 (1.4%) | 19 (3.8%) | 30 (2.3%) | 0.021 |
ECOG PS deterioration | 46 (5.8%) | 46 (9.1%) | 92 (7.0%) | 0.073 |
Hyponatremia | 35 (4.4%) | 9 (1.8%) | 44 (3.4%) | 0.036 |
Infection | 42 (5.2%) | 52 (10.3%) | 94 (7.2%) | 0.003 |
Dyspnoea | 45 (5.6%) | 33 (6.5%) | 78 (6.0%) | 0.788 |
Arrhythmia | 5 (0.6%) | 6 (1.2%) | 11 (0.8%) | 0.559 |
Embolism | 7 (0.9%) | 6 (1.2%) | 13 (1.0%) | 0.839 |