Table 3. Related haematological and biochemical adverse events of all grades and those grade 3 or highera.
| Dose level | 1 | 2 | 3 | 4 | 5 | 5.5 | 6 | 7 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of patients | 3 | 6 | 6 | 4 | 4 | 7 | 6 | 2 | ||||||||
| Dose | 10 mgb | 10 mg | 20 mg | 30 mg | 50 mg | 60 mg | 70 mg | 90 mg | ||||||||
| Grades | All grades | Grades 3/4 | All grade | Grades 3/4 | All grades | Grades 3/4 | All grades | Grades 3/4 | All grades | Grades 3/4 | All grades | Grades 3/4 | All grades | Grades 3/4 | All grades | Grades 3/4 | 
| General | ||||||||||||||||
| Fatigue | 0 | 0 | 2 | 0 | 2 | 0 | 1 | 0 | 3 | 0 | 6 | 1 | 4 | 2 | 2c | 1 | 
| GI | ||||||||||||||||
| Anorexia | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 4 | 0 | 3 | 0 | 1 | 0 | 
| Altered taste | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 
| Mucositis | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 
| Nausea | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 0 | 5 | 0 | 4 | 0 | 2 | 0 | 
| Vomiting | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 4 | 0 | 2 | 0 | 2c | 1 | 
| Diarrhoea | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 4 | 1 | 0 | 0 | 0 | 0 | 
| Constipation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 
| Abdominal pain | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 
| Cardiac | ||||||||||||||||
| QT prolongation | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 
| Ventricular bigemini | 0 | 0 | 1c | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 
| Ventricular arrythmias (PVCs) | 0 | 0 | 1c | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 
| Cardiac dysfunction | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 
| Supra ventricular arrythmia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 
| Cardiac ischaemia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 
| Cardiac arrythmia other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 
| Metabolic | ||||||||||||||||
| Creatinine (raised) | 0 | 0 | 1 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 
| Alkaline phophatase (raised) | 1 | 0 | 5 | 1 | 4 | 1 | 2 | 0 | 2 | 0 | 6 | 0 | 3 | 0 | 1 | 0 | 
| ALT (raised) | 0 | 0 | 1 | 0 | 2 | 0 | 2 | 0 | 0 | 0 | 4 | 2 | 1 | 0 | 2 | 0 | 
| AST (raised) | 1 | 0 | 3 | 0 | 3 | 0 | 1 | 0 | 2 | 0 | 5 | 0 | 2 | 0 | 2 | 0 | 
| Bilirubin (raised) | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 
| CPK | NA | NA | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 
| Hematologic | ||||||||||||||||
| Anaemia | 2 | 0 | 6 | 0 | 5 | 1 | 4 | 0 | 4 | 0 | 7 | 0 | 6 | 0 | 2 | 0 | 
| Leukopenia | 1 | 0 | 2 | 0 | 1 | 0 | 2 | 0 | 1 | 0 | 5 | 1 | 3 | 1 | 1 | 0 | 
| Neutropenia | 1 | 1 | 1 | 0 | 1 | 0 | 2 | 0 | 1 | 0 | 5 | 0 | 3 | 1 | 1 | 0 | 
| Lymphopenia | 0 | 0 | 5 | 2 | 2 | 0 | 2 | 0 | 4 | 2 | 6 | 3 | 4 | 3 | 2 | 0 | 
| Thrombocytopenia | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 6 | 1 | 2 | 0 | 
| Others | ||||||||||||||||
| Myositis | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 
| Syncope | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 
Abbreviations: ALT=alanine transaminase, AST=aspartate transaminase, CPK=creatine phosphokinase; PVCs=premature ventricular contraction.
Graded according to CTCAE version 3.0.
3 days every 2 weeks.
One or more SAE.