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) |
