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. 2011 Feb 1;104(5):756–762. doi: 10.1038/bjc.2011.13

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.

a

Graded according to CTCAE version 3.0.

b

3 days every 2 weeks.

c

One or more SAE.