Table 6 Grade 3/4 infusion reactions
Adverse event | Relatedness of adverse event | US commercial cetuximab Arm A (N = 77) n (%) | BI-manufactured cetuximab Arm B (N = 71) n (%) |
|---|---|---|---|
Infusion-related reaction | Regardless of causality | 1 (1.3) | 1 (1.4) |
Possibly related to study drug | 1 (1.3) | 1 (1.4) | |
Anaphylactic shock | Regardless of causality | 3 (3.9) | 0 (0) |
Possibly related to study drug | 3 (3.9) | 0 (0) | |
Hypersensitivity reaction | Regardless of causality | 0 (0) | 1 (1.4) |
Possibly related to study drug | 0 (0) | 1 (1.4) | |
Pyrexia | Regardless of causality | 0 (0) | 0 (0) |
Possibly related to study drug | 0 (0) | 0 (0) |