Table 3 All-cause treatment-emergent adverse events occurring in ≥10 % of patients in either arm
Adverse eventa | US commercial cetuximab Arm A (N = 77) n (%) | BI-manufactured cetuximab Arm B (N = 71) n (%) |
|---|---|---|
Patients with ≥1 TEAE | 75 (97.4) | 68 (95.8) |
Nausea | 38 (49.4) | 34 (47.9) |
Fatigue | 35 (45.5) | 36 (50.7) |
Hypomagnesemia | 29 (37.7) | 29 (40.8) |
Diarrhea | 25 (32.5) | 22 (31.0) |
Dermatitis acneiform | 25 (32.5) | 19 (26.8) |
Vomiting | 24 (31.2) | 27 (38.0) |
Anemia | 21 (27.3) | 30 (42.3) |
Hypokalemia | 21 (27.3) | 24 (33.8) |
Neutropenia | 20 (26.0) | 24 (33.8) |
Stomatitis | 20 (26.0) | 21 (29.6) |
Dry skin | 18 (23.4) | 12 (16.9) |
Constipation | 17 (22.1) | 24 (33.8) |
Mucosal inflammation | 16 (20.8) | 16 (22.5) |
Decreased appetite | 15 (19.5) | 18 (25.4) |
Dehydration | 13 (16.9) | 17 (23.9) |
Neutrophil count decreased | 11 (14.3) | 14 (19.7) |
Rash | 10 (13.0) | 19 (26.8) |
Weight decreased | 10 (13.0) | 13 (18.3) |
Platelet count decreased | 10 (13.0) | 11 (15.5) |
Insomnia | 9 (11.7) | 11 (15.5) |
Dyspnea | 8 (10.4) | 12 (16.9) |
Thrombocytopenia | 8 (10.4) | 12 (16.9) |
Dizziness | 8 (10.4) | 11 (15.5) |
Paronychia | 8 (10.4) | 10 (14.1) |
Hyponatremia | 7 (9.1) | 14 (19.7) |
Pyrexia | 7 (9.1) | 8 (11.3) |