Table 2 Adverse events during neoadjuvant therapy occurring in ≥15% of patients in either group
| Â | Pyrotinib, trastuzumab, and docetaxel (n=178) | Placebo, trastuzumab, and docetaxel (n=177) | ||
|---|---|---|---|---|
Any grade | Grade 3 or 4 | Any grade | Grade 3 or 4 | |
Any adverse events | 178 (100.0%) | 127 (71.3%) | 176 (99.4%) | 66 (37.3%) |
Diarrhea | 178 (100.0%) | 79 (44.4%) | 93 (52.5%) | 9 (5.1%) |
Vomiting | 131 (73.6%) | 23 (12.9%) | 42 (23.7%) | 2 (1.1%) |
Anemia | 118 (66.3%) | 11 (6.2%) | 80 (45.2%) | 2 (1.1%) |
Alopecia | 111 (62.4%) | 0 | 147 (83.1%) | 0 |
Nausea | 85 (47.8%) | 1 (0.6%) | 51 (28.8%) | 0 |
Asthenia | 75 (42.1%) | 0 | 70 (39.5%) | 0 |
ALT increased | 72 (40.4%) | 5 (2.8%) | 65 (36.7%) | 5 (2.8%) |
AST increased | 66 (37.1%) | 2 (1.1%) | 58 (32.8%) | 2 (1.1%) |
WBC decreased | 62 (34.8%) | 29 (16.3%) | 61 (34.5%) | 24 (13.6%) |
Weight decreased | 59 (33.1%) | 0 | 7 (4.0%) | 0 |
Rash | 58 (32.6%) | 2 (1.1%) | 32 (18.1%) | 0 |
Neutropenia | 57 (32.0%) | 33 (18.5%) | 54 (30.5%) | 36 (20.3%) |
Decreased appetite | 55 (30.9%) | 2 (1.1%) | 32 (18.1%) | 0 |
Bone pain | 41 (23.0%) | 0 | 51 (28.8%) | 1 (0.6%) |
Pain | 39 (21.9%) | 0 | 64 (36.2%) | 0 |
Insomnia | 39 (21.9%) | 0 | 35 (19.8%) | 0 |
Pyrexia | 38 (21.3%) | 2 (1.1%) | 37 (20.9%) | 0 |
PPE syndrome | 37 (20.8%) | 1 (0.6%) | 50 (28.2%) | 1 (0.6%) |
Abdominal pain upper | 35 (19.7%) | 1 (0.6%) | 14 (7.9%) | 0 |
Stomatitis | 33 (18.5%) | 4 (2.2%) | 10 (5.6%) | 0 |
Hypokalemia | 28 (15.7%) | 9 (5.1%) | 3 (1.7%) | 0 |
Hypertriglyceridemia | 26 (14.6%) | 1 (0.6%) | 41 (23.2%) | 1 (0.6%) |
Constipation | 22 (12.4%) | 0 | 45 (25.4%) | 0 |
Cough | 17 (9.6%) | 0 | 30 (16.9%) | 0 |