Table 3.
AEs occurring in ≥ 20% of patients at any grade in either arm, by grade
| AEs by preferred term,an (%) | Pertuzumab (n = 40) | Placebo (n = 40) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Any grade | Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | Any grade | Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | |
| Nausea | 29 (72.5) | 23 (57.5) | 6 (15.0) | 0 | 0 | 24 (60.0) | 20 (50.0) | 4 (10.0) | 0 | 0 |
| Diarrhea | 34 (85.0) | 25 (62.5) | 9 (22.5) | 0 | 0 | 15 (37.5) | 13 (32.5) | 2 (5.0) | 0 | 0 |
| Stomatitis | 18 (45.0) | 16 (40.0) | 2 (5.0) | 0 | 0 | 20 (50.0) | 19 (47.5) | 1 (2.5) | 0 | 0 |
| Constipation | 12 (30.0) | 12 (30.0) | 0 | 0 | 0 | 18 (45.0) | 18 (45.0) | 0 | 0 | 0 |
| Vomiting | 14 (35.0) | 13 (32.5) | 1 (2.5) | 0 | 0 | 10 (25.0) | 10 (25.0) | 0 | 0 | 0 |
| Fatigue | 25 (62.5) | 23 (57.5) | 2 (5.0) | 0 | 0 | 14 (35.0) | 13 (32.5) | 1 (2.5) | 0 | 0 |
| Edema | 12 (30.0) | 12 (30.0) | 0 | 0 | 0 | 17 (42.5) | 17 (42.5) | 0 | 0 | 0 |
| Fever | 18 (45.0) | 17 (42.5) | 1 (2.5) | 0 | 0 | 9 (22.5) | 9 (22.5) | 0 | 0 | 0 |
| Malaise | 9 (22.5) | 9 (22.5) | 0 | 0 | 0 | 12 (30.0) | 12 (30.0) | 0 | 0 | 0 |
| Chills | 11 (27.5) | 11 (27.5) | 0 | 0 | 0 | 2 (5.0) | 2 (5.0) | 0 | 0 | 0 |
| Peripheral edema | 2 (5.0) | 2 (5.0) | 0 | 0 | 0 | 8 (20.0) | 8 (20.0) | 0 | 0 | 0 |
| Palmar–plantar erythrodysesthesia | 29 (72.5) | 27 (67.5) | 2 (5.0) | 0 | 0 | 25 (62.5) | 25 (62.5) | 0 | 0 | 0 |
| Dry skin | 9 (22.5) | 9 (22.5) | 0 | 0 | 0 | 8 (20.0) | 8 (20.0) | 0 | 0 | 0 |
| Decreased appetite | 35 (87.5) | 16 (40.0) | 19 (47.5) | 0 | 0 | 33 (82.5) | 22 (55.0) | 11 (27.5) | 0 | 0 |
| Hyponatremia | 5 (12.5) | 1 (2.5) | 4 (10.0) | 0 | 0 | 8 (20.0) | 0 | 8 (20.0) | 0 | 0 |
| Neutropenia | 27 (67.5) | 7 (17.5) | 15 (37.5) | 5 (12.5) | 0 | 21 (52.5) | 9 (22.5) | 8 (20.0) | 4 (10.0) | 0 |
| Nasopharyngitis | 12 (30.0) | 12 (30.0) | 0 | 0 | 0 | 7 (17.5) | 7 (17.5) | 0 | 0 | 0 |
| Taste disorders | 18 (45.0) | 18 (45.0) | 0 | 0 | 0 | 13 (32.5) | 13 (32.5) | 0 | 0 | 0 |
| Peripheral sensory neuropathy | 8 (20.0) | 8 (20.0) | 0 | 0 | 0 | 7 (17.5) | 7 (17.5) | 0 | 0 | 0 |
| Hiccups | 19 (47.5) | 19 (47.5) | 0 | 0 | 0 | 16 (40.0) | 16 (40.0) | 0 | 0 | 0 |
| Creatinine urine decreased | 20 (50.0) | 17 (42.5) | 3 (7.5) | 0 | 0 | 11 (27.5) | 11 (27.5) | 0 | 0 | 0 |
| Injection-related reaction | 9 (22.5) | 9 (22.5) | 0 | 0 | 0 | 4 (10.0) | 4 (10.0) | 0 | 0 | 0 |
| Insomnia | 10 (25.0) | 10 (25.0) | 0 | 0 | 0 | 11 (27.5) | 11 (27.5) | 0 | 0 | 0 |
AE adverse event
aFor frequency counts by preferred term, multiple occurrences of the same AE in an individual are counted only once