Table 3.
Adverse Events in the Safety Population.*
| Adverse Event | Lapatinib plus Capecitabine (N = 488) | T-DM1 (N = 490) | ||
|---|---|---|---|---|
| Events of Any Grade | Events of Grade 3 or Above | Events of Any Grade | Events of Grade 3 or Above | |
| number of patients (percent) | ||||
| Any event | 477 (97.7) | 278 (57.0) | 470 (95.9) | 200 (40.8) |
| Specific events† | ||||
| Diarrhea | 389 (79.7) | 101 (20.7) | 114 (23.3) | 8 (1.6) |
| Palmar–plantar erythrodysesthesia | 283 (58.0) | 80 (16.4) | 6 (1.2) | 0 |
| Vomiting | 143 (29.3) | 22 (4.5) | 93 (19.0) | 4 (0.8) |
| Neutropenia | 42 (8.6) | 21 (4.3) | 29 (5.9) | 10 (2.0) |
| Hypokalemia | 42 (8.6) | 20 (4.1) | 42 (8.6) | 11 (2.2) |
| Fatigue | 136 (27.9) | 17 (3.5) | 172 (35.1) | 12 (2.4) |
| Nausea | 218 (44.7) | 12 (2.5) | 192 (39.2) | 4 (0.8) |
| Mucosal inflammation | 93 (19.1) | 11 (2.3) | 33 (6.7) | 1 (02) |
| Anemia | 39 (8.0) | 8 (1.6) | 51 (10.4) | 13 (2.7) |
| Elevated ALT | 43 (8.8) | 7 (14) | 83 (16.9) | 14 (2.9) |
| Elevated AST | 46 (9.4) | 4 (0.8) | 110 (22.4) | 21 (4.3) |
| Thrombocytopenia | 12 (2.5) | 1 (02) | 137 (28.0) | 63 (12.9) |
*
The safety population included all patients who received at least one dose of the study treatment. ALT denotes alanine aminotransferase, and AST aspartate aminotransferase.
†
Listed are adverse events of grade 3 or above with an incidence of 2% or higher in either group.