Table 3 Listing of the most common adverse events occurring in ≥ 10% patients in either treatment group (safety population)
Most common AE | Pertuzumab group [cases (%)] n = 83 | Control group [cases (%)] n = 80 | ||
|---|---|---|---|---|
Any grade | Grade 3–5 | Any grade | Grade 3–5 | |
Neutropenia | 60 (72.3) | 31 (37.3) | 52 (65.0) | 24 (30.0) |
Leukopenia | 53 (63.9) | 14 (16.9) | 47 (58.8) | 12 (15.0) |
Nausea | 52 (62.7) | 7 (8.4) | 49 (61.3) | 2 (2.5) |
Anemia | 50 (60.2) | 20 (24.1) | 43 (53.8) | 18 (22.5) |
Vomiting | 38 (45.8) | 9 (10.8) | 36 (45.0) | 6 (7.5) |
Decreased appetite | 37 (44.6) | 3 (3.6) | 29 (36.3) | 1 (1.3) |
Diarrhea | 33 (39.8) | 7 (8.4) | 13 (16.3) | 1 (1.3) |
Thrombocytopenia | 31 (37.3) | 5 (6.0) | 28 (35.0) | 7 (8.8) |
Fatigue | 26 (31.3) | 2 (2.4) | 16 (20.0) | 1 (1.3) |
Hypokalemia | 19 (22.9) | 6 (7.2) | 11 (13.8) | 4 (5.0) |
Abdominal distension | 18 (21.7) | 1 (1.2) | 12 (15.0) | 0 |
Palmar-plantar erythrodysesthesia syndrome | 14 (16.9) | 5 (6.0) | 16 (20.0) | 6 (7.5) |
Creatinine renal clearance decreased | 13 (15.7) | 0 | 10 (12.5) | 0 |
Constipation | 11 (13.3) | 0 | 12 (15.0) | 0 |
Weight decreased | 13 (15.7) | 1 (1.2) | 4 (5.0) | 0 |
Stomatitis | 14 (16.9) | 3 (3.6) | 7 (8.8) | 1 (1.3) |
Pyrexia | 9 (10.8) | 0 | 12 (15.0) | 0 |