Table 4 Summary of adverse events that significantly differed in incidence between arms by maximum CTCAE grade
Event | US commercial cetuximab Arm A (N = 77) n (%) | BI-manufactured cetuximab Arm B (N = 71) n (%) | Arm A vs Arm B p value (95 % CI) |
|---|---|---|---|
Regardless of causality | |||
Bone pain | 2 (2.6) | 9 (12.7) | 0.020 (0.016, 0.186) |
Febrile neutropenia | 1 (1.3) | 11 (15.5) | 0.002 (0.054, 0.230) |
Laryngeal hemorrhage | 0 (0.0) | 6 (8.5) | 0.010 (0.020, 0.149) |
Somnolence | 0 (0.0) | 4 (5.6) | 0.040 (0.003, 0.110) |
Syncope | 0 (0.0) | 5 (7.0) | 0.020 (0.011, 0.130) |
Possibly related to study drug | |||
Dysgeusia | 1 (1.3) | 6 (8.5) | 0.044 (0.002, 0.141) |
Febrile neutropenia | 1 (1.3) | 8 (11.3) | 0.012 (0.022, 0.177) |