Table 2.
Pertuzumab plus trastuzumab plus docetaxel (n = 122) | Placebo plus trastuzumab plus docetaxel (n = 120) | |
---|---|---|
Diarrhea | 56 (45.9) | 28 (23.3) |
Grade ≥ 3 | 5 (4.1) | 2 (1.7) |
Rash | 36 (29.5) | 22 (18.3) |
Grade ≥ 3 | 2 (1.6) | 3 (2.5) |
Leukopenia | 96 (78.7) | 89 (74.2) |
Grade ≥ 3 | 74 (60.7) | 73 (60.8) |
Leukopenia infection | 6 (4.9) | 3 (2.5) |
Grade ≥ 3 | 1 (0.8) | 0 |
Febrile neutropenia | 5 (4.1) | 5 (4.2) |
Grade ≥ 3 | 5 (4.1) | 5 (4.2) |
Febrile neutropenia infection | 0 | 0 |
Grade ≥ 3 | 0 | 0 |
Anaphylaxis and hypersensitivity | 2 (1.6) | 1 (0.8) |
Grade ≥ 3 | 0 | 1 (0.8) |
Infusion-related reactions | 41 (33.6) | 29 (24.2) |
Grade ≥ 3 | 4 (3.3) | 3 (2.5) |
Mucositis | 32 (26.2) | 12 (10.0) |
Grade ≥ 3 | 4 (3.3) | 0 |
Interstitial lung disease | 2 (1.6) | 4 (3.3) |
Grade ≥ 3 | 0 | 0 |
Data are number of patients, n (%)
AEs to monitor, i.e., AEs that the health authorities requested to be monitored closely (usually potential risks or missing information)
AE adverse event