Table 2. Adverse Events During the Overall Study Period by Body-Weight Quartilea.
| Adverse Event | Patients, No. (%) | |
|---|---|---|
| Subcutaneous Trastuzumab (n = 297) | Intravenous Trastuzumab (n = 298) | |
| Any | 290 (97.6) | 282 (94.6) |
| Grade ≥3 | 158 (53.2) | 160 (53.7) |
| Serious | 65 (21.9) | 45 (15.1) |
| Cardiac, kg | 44 (14.8) | 42 (14.1) |
| <59 | 6 (8.5) | 9 (11.7) |
| ≥59 to <68 | 8 (11.4) | 9 (10.7) |
| ≥68 to <79 | 15 (21.1) | 7 (10.0) |
| ≥79 kg | 15 (17.6) | 17 (25.4) |
| LVEF decline (≥10% points from baseline to <50%)b | 11 (3.8) | 12 (4.2) |
Abbreviation: LVEF, left ventricular ejection fraction.
a
Data on body-weight quartiles are based on the subcutaneous trastuzumab group (<59 kg, n = 71; ≥59 to <68 kg, n = 70; ≥68 to <79 kg, n = 71; ≥79 kg, n = 85) and the intravenous trastuzumab group (<59 kg, n = 77; ≥59 to <68 kg, n = 84; ≥68 to <79 kg, n = 70; ≥79 kg, n = 67).
b
Data on LVEF decline are based on 291 patients in the subcutaneous trastuzumab group and 288 patients in the intravenous trastuzumab group with LVEF values at baseline and at least 1 postbaseline time point.