Table 2 Incidence of patients with treatment-emergent, study drug-related adverse events with worst CTC grade (all grades/grade 3)
NCI CTC term | Non-continuous dosing (n = 11) | Continuous dosing (n = 28) | Total (n = 39) | |||
|---|---|---|---|---|---|---|
All Grades | Grade 3 | All Grades | Grade 3 | All Grades | Grade 3 | |
Hypertension | 7 (64%) | 6 (55%) | 7 (25%) | 5 (18%) | 14 (36%) | 11 (28%) |
Diarrhoea (patients with or without colostomy) | 10 (36%) | 6 (21%) | 10 (26%) | 6 (15%) | ||
Anorexia | 1 (9%) | 9 (32%) | 10 (26%) | |||
Nausea | 1 (9%) | 6 (21%) | 7 (18%) | |||
Fatigue (lethargy, malaise, asthenia) | 2 (18%) | 3 (11%) | 1 (4%) | 6 (15%) | 1 (3%) | |
Flatulence | 4 (14%) | 4 (10%) | ||||
Vomiting | 1 (9%) | 3 (10%) | 4 (10%) | |||
Voice changes/stridor/larynx (hoarseness) | 3 (27%) | 1 (4%) | 4 (10%) | |||
Dizziness/lightheadedness | 4 (14%) | 4 (10%) | ||||
Dyspepsia/heartburn | 3 (11%) | 3 (8%) | ||||
Myalgia (muscle pain) | 1 (9%) | 2 (7%) | 3 (8%) | |||
Weight loss | 2 (7%) | 2 (5%) | ||||
Insomnia | 1 (9%) | 1 (4%) | 2 (5%) | |||
Dehydration | 1 (4%) | 1 (4%) | 1 (3%) | 1 (3%) | ||
Hand-foot skin reaction | 1 (4%) | 1 (4%) | 1 (3%) | 1 (3%) | ||
Rash/desquamation | 1 (4%) | 1 (4%) | 1 (3%) | 1 (3%) | ||
Platelets | 1 (4%) | 1 (3%) | ||||
Palpitations | 1 (4%) | 1 (3%) | ||||
Gastritis | 1 (4%) | 1 (3%) | ||||
Stomatitis/pharyngitis (oral/pharyngeal mucositis) | 1 (4%) | 1 (3%) | ||||
Taste disturbance (dysgeusia) | 1 (4%) | 1 (3%) | ||||
Muscle weakness (not due to neuropathy) | 1 (4%) | 1 (3%) | ||||
Neuropathy - sensory | 1 (4%) | 1 (3%) | ||||
Headache | 1 (4%) | 1 (3%) | ||||
Neuropathic pain (jaw, neuro, limb pain) | 1 (4%) | 1 (3%) | ||||
Dry skin | 1 (4%) | 1 (3%) | ||||