Table 3 All-grade adverse events ≥20% patients and grade 3 and higher adverse events ≥10% patients in either group
Adverse event, n (%) | Study group (n = 188) | Control group (n = 174) | ||
|---|---|---|---|---|
All grade | Grade ≥ 3 | All grade | Grade ≥ 3 | |
Haematological | ||||
Neutropaenia | 148 (78.7) | 99 (52.7) | 65 (37.1) | 11 (6.3) |
Anaemia | 147 (78.2) | 65 (34.6) | 87 (49.7) | 30 (17.1) |
Leucopaenia | 92 (48.9) | 61 (32.4) | 52 (29.7) | 7 (4.0) |
Thrombocytopaenia | 90 (47.9) | 17 (9.0) | 26 (14.9) | 5 (2.9) |
Non-haematological | ||||
Albumin decreased | 46 (24.5) | 6 (3.2) | 23 (13.1) | 2 (1.1) |
Hypokalaemia | 39 (20.7) | 21 (11.2) | 9 (5.1) | 2 (1.1) |
ALT (GPT) increased | 38 (20.2) | 3 (1.6) | 23 (13.1) | 2 (1.1) |
Creatinine increased | 38 (20.2) | 4 (2.1) | 39 (22.3) | 2 (1.1) |
Weight decreased | 38 (20.2) | 5 (2.7) | 10 (5.7) | 1 (0.6) |
Clinical symptoms | ||||
Nausea | 153 (81.4) | 6 (3.2) | 134 (76.6) | 7 (4.0) |
Anorexia | 141 (75.0) | 24 (12.8) | 105 (60.0) | 5 (2.9) |
Fatigue | 109 (58.0) | 20 (10.6) | 79 (45.1) | 3 (1.7) |
Vomiting | 103 (54.8) | 12 (6.4) | 71 (40.6) | 4 (2.3) |
Diarrhoea | 94 (50.0) | 21 (11.2) | 51 (29.1) | 7 (4.0) |
Constipation | 61 (32.4) | 3 (1.6) | 48 (27.4) | 1 (0.6) |
Stomatitis | 59 (31.4) | 7 (3.7) | 16 (9.1) | 0 |
Skin hyperpigmentation | 48 (25.5) | 0 | 2 (1.1) | 0 |
Oedema peripheral | 41 (21.8) | 2 (1.1) | 16 (9.1) | 1 (0.6) |
Peripheral sensory neuropathy | 39 (20.7) | 3 (1.6) | 22 (12.6) | 0 |
Pyrexia | 38 (20.2) | 0 | 20 (11.4) | 1 (0.6) |
