Table 3.
Adverse Events in the Safety Population.*
| Adverse Event | Placebo plus Trastuzumab plus Docetaxel (N = 397) | Pertuzumab plus Trastuzumab plus Docetaxel (N = 407) |
|---|---|---|
| number (percent) | ||
| Most common events, all grades† | ||
|
| ||
| Diarrhea | 184 (46.3) | 272 (66.8) |
|
| ||
| Alopecia | 240 (60.5) | 248 (60.9) |
|
| ||
| Neutropenia | 197 (49.6) | 215 (52.8) |
|
| ||
| Nausea | 165 (41.6) | 172 (42.3) |
|
| ||
| Fatigue | 146 (36.8) | 153 (37.6) |
|
| ||
| Rash | 96 (24.2) | 137 (33.7) |
|
| ||
| Decreased appetite | 105 (26.4) | 119 (29.2) |
|
| ||
| Mucosal inflammation | 79 (19.9) | 113 (27.8) |
|
| ||
| Asthenia | 120 (30.2) | 106 (26.0) |
|
| ||
| Peripheral edema | 119 (30.0) | 94 (23.1) |
|
| ||
| Constipation | 99 (24.9) | 61 (15.0) |
|
| ||
| Febrile neutropenia | 30 (7.6) | 56 (13.8) |
|
| ||
| Dry skin | 17 (4.3) | 43 (10.6) |
|
| ||
| Grade 3 or higher events‡ | ||
|
| ||
| Neutropenia | 182 (45.8) | 199 (48.9) |
|
| ||
| Febrile neutropenia | 30 (7.6) | 56 (13.8) |
|
| ||
| Leukopenia | 58 (14.6) | 50 (12.3) |
|
| ||
| Diarrhea | 20 (5.0) | 32 (7.9) |
|
| ||
| Peripheral neuropathy | 7 (1.8) | 11 (2.7) |
|
| ||
| Anemia | 14 (3.5) | 10 (2.5) |
|
| ||
| Asthenia | 6 (1.5) | 10 (2.5) |
|
| ||
| Fatigue | 13 (3.3) | 9 (2.2) |
|
| ||
| Granulocytopenia | 9 (2.3) | 6 (1.5) |
|
| ||
| Left ventricular systolic dysfunction | 11 (2.8) | 5 (1.2) |
|
| ||
| Dyspnea | 8 (2.0) | 4 (1.0) |
*
The safety population includes all patients who received at least one dose of the study drug.
†
Included are all grades of adverse events with an incidence of 25% or more in either group or at least a 5% difference in incidence between groups.
‡
Included are adverse events of grade 3 or higher with an incidence of at least 2%.