Table 2.
TEAEs in patients who continued on monotherapy (≥ 5% in Either Treatment Group)
TEAEs, n (%) | Patients, n (%) | |||
---|---|---|---|---|
Trastuzumab-dkst (N = 179) | Trastuzumab (N = 164) | |||
All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | |
Any TEAE | 124 (69.3) | 23 (12.8) | 119 (72.6) | 31 (18.9) |
Headache | 19 (10.6) | 0 | 23 (14.0) | 4 (2.4) |
Hypertension | 12 (6.7) | 2 (1.1) | 9 (5.5) | 1 (0.6) |
Increased ALT | 11 (6.1) | 2 (1.1) | 7 (4.3) | 3 (1.8) |
Vomiting | 10 (5.6) | 0 | 7 (4.3) | 0 |
Decreased ejection fraction | 10 (5.6) | 0 | 6 (3.7) | 1 (0.6) |
Upper respiratory tract infection | 10 (5.6) | 0 | 4 (2.4) | 0 |
Increased AST | 9 (5.0) | 1 (0.6) | 7 (4.3) | 3 (1.8) |
Fatigue | 9 (5.0) | 0 | 7 (4.3) | 0 |
Arthralgia | 9 (5.0) | 0 | 3 (1.8) | 0 |
Cough | 9 (5.0) | 0 | 3 (1.8) | 0 |
Anemia | 6 (3.4) | 0 | 17 (10.4) | 2 (1.2) |
Peripheral neuropathy | 5 (2.8) | 0 | 9 (5.5) | 0 |
ALT alanine aminotransferase, AST aspartate aminotransferase