Table 3 Incidence of toxicities at least possibly related to one or both of the study drugs
Selumetinib related | Cixutumumab related | Common to both drugs | ||||
|---|---|---|---|---|---|---|
Adverse event | All grades | Grade ⩾3 | All grades | Grade ⩾3 | All grades | Grade ⩾3 |
Dermatologica | 23 (77%) | 0 | ||||
GI (all) | 21 (70%) | 1 (3%) | ||||
Abdominal pain | 5 (17%) | 0 | ||||
Nausea/vomiting | 15 (50%) | 1 (3%) | ||||
Constipation | 2 (7%) | 0 | ||||
Diarrhoea | 13 (43%) | 0 | ||||
Mucosal irritationb | 16 (53%) | 0 | ||||
Ophthalmologic symptomsc | 12 (40%) | 2 (7%) | ||||
Poor appetite/weight loss | 11 (37%) | 0 | ||||
Peripheral oedema | 7 (23%) | 0 | ||||
Fatigue | 6 (20%) | 0 | ||||
Hyperglycaemia | 5 (17%) | 4 (13%) | ||||
Neurologic | ||||||
Confusion | 1 (3%) | 0 | ||||
Dizziness | 3 (10%) | 0 | ||||
Headache | 5 (17%) | 0 | ||||
Gait disturbance | 2 (7%) | 0 | ||||
Tinnitus | 1 (3%) | 0 | ||||
Haematologic | ||||||
Anaemia | 4 (13%) | 0 | ||||
Leucopenia/neutropenia | 2 (7%) | 0 | ||||
Bleeding | 1 (3%) | 0 | ||||
Thrombosis (cerebrovascular accident) | 2 (7%) | 1 (3%) | ||||
Myalgias/arthralgias | 3 (10%) | 0 | ||||
Hypertension | 3 (10%) | 2 (7%) | ||||
Cough | 3 (10%) | 0 | ||||
Elevated creatinine | 3 (10%) | 0 | ||||
Thrush | 2 (7%) | 0 | ||||