Table 3. Adverse events occurring in ⩾10% of patients.
|
Total (n=30) |
|||
---|---|---|---|---|
Adverse events | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
Neutropeniaa |
5 (20%) |
2 (7%) |
3 (10%) |
1 (3%) |
Anaemia |
10 (33%) |
4 (13%) |
1 (3%) |
0 (0%) |
Thrombocytopenia |
10 (33%) |
0 (0%) |
1 (3%) |
2 (7%) |
Anorexia |
6 (20%) |
4 (13%) |
0 (0%) |
0 (0%) |
Nausea |
17 (57%) |
1 (3%) |
0 (0%) |
0 (0%) |
Vomiting |
9 (30%) |
2 (7%) |
1 (3%) |
0 (0%) |
Dyspepsia |
5 (17%) |
6 (20%) |
0 (0%) |
0 (0%) |
Stomatitis |
2 (7%) |
5 (17%) |
0 (0%) |
0 (0%) |
Diarrhoea |
14 (47%) |
3 (10%) |
2 (7%) |
0 (0%) |
Asthenia |
9 (30%) |
3 (10%) |
6 (20%) |
0 (0%) |
Skin rash |
7 (23%) |
2 (7%) |
0 (0%) |
0 (0%) |
Elevation of AST |
10 (33%) |
2 (7%) |
0 (0%) |
0 (0%) |
Elevation of ALT |
12 (40%) |
2 (7%) |
1 (3%) |
0 (0%) |
Hyperbilirubinaemia |
2 (7%) |
1 (3%) |
0 (0%) |
0 (0%) |
Increased creatinine |
3 (10%) |
2 (7%) |
0 (0%) |
0 (0%) |
Hypertriglyceridaemia |
4 (13%) |
1 (3%) |
3 (10%) |
0 (0%) |
Hypertension |
7 (23%) |
4 (13%) |
2 (7%) |
0 (0%) |
Proteinuria |
3 (10%) |
6 (20%) |
1 (3%) |
0 (0%) |
Headache |
5 (17%) |
1 (3%) |
0 (0%) |
0 (0%) |
Abdominal pain | 6 (20%) | 6 (20%) | 0 (0%) | 0 (0%) |
Abbreviations: AST=aspartate aminotransferase; ALT=alanine aminotransferase.
No patient had febrile neutropenia.