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%) | ||||
- NCI CTC - National Cancer Institute Common Toxicity Criteria.