Table 3.
Summary of adverse events (safety set population).
| QL1209 (n = 257) | Reference pertuzumab (n = 259) | |
|---|---|---|
| TEAEs, n (%) | ||
| Any grade | 245 (95.3) | 249 (96.1) |
| Grade ≥3 | 94 (36.6) | 97 (37.5) |
| Serious TEAEs | 23 (8.9) | 25 (9.7) |
| TRAEs, n (%) | ||
| Any grade | 235 (91.4) | 239 (92.3) |
| Grade ≥3 | 70 (27.2) | 73 (28.2) |
| TRSAEs | 13 (5.1) | 12 (4.6) |
| TRAEs leading to discontinuation | 1 (0.4) | 2 (0.8) |
| Infusion-related reaction | 25 (9.7) | 15 (5.8) |
| Death | 1 (0.4) | 1 (0.4) |
| TEAEs occurred in ≥10% patients in either group | ||
| Alopecia | 106 (41.2) | 107 (41.3) |
| Decreased white blood cell | 96 (37.4) | 86 (33.2) |
| Diarrhea | 91 (35.4) | 89 (34.4) |
| Decreased neutrophil count | 90 (35.0) | 82 (31.7) |
| Anemia | 82 (31.9) | 93 (35.9) |
| Nausea | 81 (31.5) | 72 (27.8) |
| ALT increased | 76 (29.6) | 68 (26.3) |
| Infections | 70 (27.2) | 59 (22.8) |
| AST increased | 57 (22.2) | 49 (18.9) |
| Vomiting | 53 (20.6) | 48 (18.5) |
| Fatigue | 52 (20.2) | 55 (21.2) |
| Fever | 34 (13.2) | 29 (11.2) |
| Anorexia | 34 (13.2) | 41 (15.8) |
| Cough | 28 (10.9) | 23 (8.9) |
| Pain | 26 (10.1) | 18 (6.9) |
| Hypertriglyceridemia | 23 (8.9) | 29 (11.2) |
TEAE treatment-emergent adverse event, TRAE, treatment-related adverse event, TRSAEs, treatment-related serious adverse events, ALT elevated alanine aminotransferase, AST elevated aspartate aminotransferase.