Table 3.
Treatment-related adverse events.
HER2-low (N = 144) | HER2-positive (N = 173) | Overall (N = 317) | ||||
---|---|---|---|---|---|---|
Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | |
Any AE | 117 (81.3%) | 32 (22.2%) | 149 (86.1%) | 35 (20.2%) | 266 (83.9%) | 67 (21.1%) |
SAE | 17 (11.8%) | 17 (11.8%) | 15 (8.7%) | 15 (8.7%) | 32 (10.1%) | 32 (10.1%) |
Leukopenia | 57 (39.6%) | 14 (9.7%) | 51 (29.5%) | 6 (3.5%) | 108 (34.1%) | 20 (6.3%) |
Neutropenia | 51 (35.4%) | 14 (9.7%) | 44 (25.4%) | 12 (6.9%) | 95 (30.0%) | 26 (8.2%) |
Anemia | 51 (35.4%) | 6 (4.2%) | 60 (34.7%) | 4 (2.3%) | 111 (35.0%) | 10 (3.2%) |
Thrombocytopenia | 19 (13.2%) | 5 (3.5%) | 27 (15.6%) | 4 (2.3%) | 46 (14.5%) | 9 (2.8%) |
Nausea | 42 (29.2%) | 2 (1.4%) | 44 (25.4%) | 2 (1.2%) | 86 (27.1%) | 4 (1.3%) |
Dyspepsia | 33 (22.9%) | 1 (0.7%) | 42 (24.3%) | 3 (1.7%) | 75 (23.7%) | 4 (1.3%) |
Vomit | 23 (16.0%) | 3 (2.1%) | 31 (17.9%) | 2 (1.2%) | 54 (17.0%) | 5 (1.6%) |
Fatigue | 18 (12.5%) | 2 (1.4%) | 19 (11.0%) | 4 (2.3%) | 37 (11.7%) | 6 (1.9%) |
Pneumonia | 18 (12.5%) | 6 (4.2%) | 16 (9.2%) | 6 (3.5%) | 34 (10.7%) | 12 (3.8%) |
Interstitial lung disease | 16 (11.1%) | 7 (4.9%) | 13 (7.5%) | 8 (4.6%) | 29 (9.1%) | 15 (4.7%) |
Peripheral sensory neuropathy | 8 (5.6%) | 0 | 20 (11.6%) | 1 (0.6%) | 28 (8.8%) | 1 (0.3%) |
Dizziness | 12 (8.3%) | 0 | 13 (7.5%) | 1 (0.6%) | 25 (7.9%) | 1 (0.3%) |
Headache | 11 (7.6%) | 2 (1.4%) | 10 (5.8%) | 2 (1.2%) | 21 (6.6%) | 4 (1.3%) |
Constipation | 7 (4.9%) | 0 | 9 (5.2%) | 0 | 16 (5.0%) | 0 |
Diarrhea | 8 (5.6%) | 2 (1.4%) | 3 (1.7%) | 0 | 11 (3.5%) | 2 (0.6%) |
Rash | 3 (2.1%) | 0 | 5 (2.9%) | 0 | 8 (2.5%) | 0 |
Oral ulcer | 2 (1.4%) | 0 | 5 (2.9%) | 0 | 7 (2.2%) | 0 |
Pruritus | 2 (1.4%) | 0 | 1 (0.6%) | 0 | 3 (0.9%) | 0 |
AST elevation | 32 (22.2%) | 1 (0.7%) | 53 (30.6%) | 3 (1.7%) | 85 (26.8%) | 4 (1.3%) |
ALT elevation | 21 (14.6%) | 1 (0.7%) | 42 (24.3%) | 0 | 63 (19.9%) | 1 (0.3%) |
Hypoalbuminemia | 28 (19.4%) | 0 | 44 (25.4%) | 0 | 72 (22.7%) | 0 |
Serum total bilirubin elevation | 12 (8.3%) | 1 (0.7%) | 13 (7.5%) | 1 (0.6%) | 25 (7.9%) | 2 (0.6%) |
Serum Creatinine elevation | 8 (5.6%) | 0 | 13 (7.5%) | 0 | 21 (6.6%) | 0 |
Abbreviation: HER2, human epidermal growth factor receptor 2