Table 5. Safety profile.
| Selected AEs† | Lapatinib + capecitabine (n=49), n (%) | T-DM1 (n=151), n (%) | |||
|---|---|---|---|---|---|
| All-grade | Grade ≥3 | All-grade | Grade ≥3 | ||
| Any selected AE | 44 (89.8) | 4 (8.2) | 139 (92.1) | 65 (43.0) | |
| Hepatoxicity | 41 (83.7) | 1 (2.0) | 119 (78.8) | 13 (8.6) | |
| Thrombocytopenia | 10 (20.4) | 2 (4.1) | 115 (76.2) | 61 (40.4) | |
| Infusion-related reaction/hypersensitivity | 0 | 0 | 12 (7.9) | 1 (0.7) | |
| Pneumonitis | 0 | 0 | 1 (0.7) | 0 | |
| Cardiac dysfunction | 0 | 0 | 3 (2.0) | 1 (0.7) | |
| Peripheral neuropathy | 3 (6.1) | 1 (2.0) | 12 (7.9) | 0 | |
| Hemorrhage | 2 (4.1) | 0 | 49 (32.5) | 0 | |
†, AEs selected based on the known safety profile of T-DM1 and defined by related preferred terms for each AE category. AE, adverse event; T-DM1 trastuzumab emtansine.