Table 3 Treatment-emergent adverse events (> 5 %) in any group in cycle 1
Adverse Eventsa | APF530 250 mg SC | APF530 500 mg SC | Palonosetron 0.25 mg IV | |||
|---|---|---|---|---|---|---|
n = 219 | n = 464 | n = 211 | n = 468 | n = 199 | n = 463 | |
Breast Cancer | Overall | Breast Cancer | Overall | Breast Cancer | Overall | |
At least one adverse event | 166 (75.8) | 315 (67.9) | 161 (76.3) | 317 (67.7) | 147 (73.9) | 313 (67.6) |
Preferred term,b n (%) | ||||||
Asthenia | 11 (5.0) | 23 (5.0) | 10 (4.7) | 22 (4.7) | 15 (7.5) | 30 (6.5) |
Constipation | 30 (13.7) | 62 (13.4) | 38 (18.0) | 72 (15.4) | 25 (12.6) | 62 (13.4) |
Diarrhea | 24 (11.0) | 49 (10.6) | 25 (11.8) | 44 (9.4) | 20 (10.1) | 39 (8.4) |
Fatigue | 42 (19.2) | 62 (13.4) | 37 (17.5) | 62 (13.2) | 32 (16.1) | 52 (11.2) |
Headache | 24 (11.0) | 31 (6.7) | 33 (15.6) | 47 (10.0) | 28 (14.1) | 45 (9.7) |
Insomnia | 12 (5.5) | 20 (4.3) | 10 (4.7) | 25 (5.3) | 3 (1.5) | 11 (2.4) |
Injection-site reactions,b n (%) | ||||||
Bruising | 41 (18.7) | 78 (16.8) | 54 (25.6) | 93 (19.9) | 21 (10.6) | 41 (8.9) |
Erythema | 14 (6.4) | 33 (7.1) | 26 (12.3) | 51 (10.9) | 9 (4.5) | 14 (3.0) |
Nodule | 12 (5.5) | 22 (4.7) | 32 (15.2) | 50 (10.7) | 1 (0.5) | 3 (0.6) |
Pain | 11 (5.0) | 16 (3.4) | 25 (11.4) | 33 (7.1) | 3 (1.5) | 5 (1.1) |