Table 2.
Adverse events Grade ≥ 3 |
Arm A (chemo) |
Arm B (chemo + cetux) |
||
---|---|---|---|---|
N = 72 | N = 78 | |||
Leukopenia/neutropenia | 14 | (19%) | 23 | (29%) |
Febrile neutropenia | 0 | (0%) | 2 | (3%) |
Thrombopenia | 2 | (3%) | 4 | (5%) |
Anaemia | 4 | (6%) | 5 | (6%) |
Skin toxicity | 0 | (0%) | 14 | (18%) |
Mucositis | 2 | (3%) | 2 | (3%) |
Diarrhoea | 5 | (7%) | 5 | (6%) |
Nausea/vomiting | 2 | (3%) | 2 | (3%) |
Increased liver enzymes | 2 | (3%) | 1 | (1%) |
Other gastrointestinal events | 3 | (4%) | 6 | (8%) |
Fatigue/decreased performance status | 4 | (6%) | 7 | (9%) |
Thromboembolic events | 4 | (6%) | 4 | (5%) |
Syncope/falls | 0 | (0%) | 2 | (3%) |
Arrhythmia | 0 | (0%) | 2 | (3%) |
Other cardiovascular events | 5 | (7%) | 6 | (8%) |
Polyneuropathy | 3 | (4%) | 4 | (5%) |
Hypersensitivity | 2 | (3%) | 2 | (3%) |
Pain | 12 | (17%) | 13 | (17%) |
Other neurological events | 2 | (3%) | 2 | (3%) |
Hypomagnesaemia | 0 | (0%) | 4 | (5%) |
Renal events | 2 | (3%) | 0 | (0%) |
Other lab events | 3 | (4%) | 2 | (3%) |
Ascites/pleural effusion | 3 | (4%) | 2 | (3%) |
Infections | 3 | (4%) | 5 | (6%) |
Other events | 4 | (6%) | 2 | (3%) |