Table 3.
Treatment-emergent adverse events, by relationship to treatment, reported by ≥5 % of patients receiving APF530 SC and palonosetron IV in cycle 1 (safety population)
| AFP530 250 mg SC | APF530 500 mg SC | Palonosetron 0.25 mg IV | ||||
|---|---|---|---|---|---|---|
| N = 464 | N = 468 | N = 463 | ||||
| Related, n (%) | Not related, n (%) | Related, n (%) | Not related, n (%) | Related, n (%) | Not related, n (%) | |
| Preferred terma | ||||||
| Asthenia | 3 (0.6) | 21 (4.5) | 0 | 22 (4.7) | 3 (0.6) | 27 (8) |
| Constipation | 20 (4.3) | 44 (9.5) | 21 (4.5) | 52 (11.1) | 14 (3.0) | 48 (10.4) |
| Diarrhea | 6 (1.3) | 46 (9.9) | 5 (1.1) | 40 (8.5) | 5 (1.1) | 35 (7.6) |
| Fatigue | 6 (1.3) | 59 (12.7) | 5 (1.1) | 61 (13.0) | 3 (0.6) | 52 (11.2) |
| Headache | 13 (2.8) | 19 (4.1) | 13 (2.8) | 36 (7.7) | 9 (1.9) | 38 (8.2) |
| Insomnia | 3 (0.6) | 18 (3.9) | 0 | 25 (5.3) | 0 | 11 (2.4) |
| Nausea | 3 (0.6) | 58 (12.5) | 4 (0.9) | 61 (13.0) | 3 (0.6) | 40 (8.6) |
| Injection-site reactions | ||||||
| Bruising | 60 (12.9) | 18 (3.9) | 73 (15.6) | 20 (4.3) | 30 (6.5) | 12 (2.6) |
| Erythema | 28 (6.0) | 5 (1.1) | 38 (8.1) | 13 (2.8) | 13 (2.8) | 3 (0.6) |
| Nodules | 19 (4.1) | 3 (0.6) | 44 (9.4) | 6 (1.3) | 3 (0.6) | 0 |
| Pain | 14 (3.0) | 3 (0.6) | 27 (5.8) | 6 (1.3) | 6 (1.3) | 2 (0.4) |
IV intravenously, SC subcutaneously
aA patient with more than one event represented by a given preferred term was counted once within each relatedness category that applied within that preferred term