Table 3. Toxicity.
| |
|
|
|
Total (n=19) |
|
|||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| |
Dose level 1 (n=3) |
Dose level 2 (n=6) |
Dose level 2.A (n=6) |
Dose level 3 (n=4) |
All grades |
Grade 3–4 |
||||||
| Toxicity | All grades | Grade 3–4 | All grades | Grade 3–4 | All grades | Grade 3–4 | All grades | Grade 3–4 | n | % | n | % |
| Anorexia |
2 |
|
2 |
|
3 |
|
2 |
|
9 |
47 |
|
|
| Mucositis |
2 |
|
2 |
|
3 |
|
1 |
|
8 |
42 |
|
|
| Fever |
|
|
3 |
|
3 |
|
1 |
|
7 |
37 |
|
|
| Nausea/vomiting |
1 |
|
3 |
|
2 |
|
1 |
|
7 |
37 |
|
|
| Fatigue |
|
|
3 |
|
3 |
|
|
|
6 |
32 |
|
|
| Rash |
2 |
|
3 |
|
|
|
1 |
|
6 |
32 |
|
|
| Diarrhoea |
|
|
|
|
1 |
|
2 |
|
3 |
16 |
|
|
| Anaemia |
2 |
|
4 |
|
6 |
1 |
4 |
|
16 |
84 |
1 |
5 |
| Neutropenia |
2 |
1 |
3 |
1 |
5 |
3 |
3 |
1 |
13 |
68 |
6 |
32 |
| Thrombocytopenia |
1 |
1 |
4 |
|
5 |
|
3 |
2 |
13 |
68 |
3 |
16 |
| Leukopenia |
1 |
|
1 |
|
3 |
|
3 |
|
8 |
42 |
|
|
| Raised AST |
1 |
|
4 |
1 |
4 |
|
2 |
|
11 |
58 |
1 |
5 |
| Raised GGT |
3 |
1 |
2 |
1 |
4 |
|
|
|
9 |
47 |
2 |
11 |
| Hypercholesterolaemia |
1 |
|
4 |
1 |
3 |
|
1 |
|
9 |
47 |
1 |
5 |
| Raised ALT |
1 |
|
3 |
2 |
2 |
|
1 |
|
7 |
37 |
2 |
11 |
| Hyperglycaemia |
|
|
1 |
|
2 |
|
2 |
|
5 |
26 |
|
|
| Raised creatinine | 1 | 1 | 5 | |||||||||
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotranferase; GGT=gamma-glutamyl transferase. Toxicities reported at any time from first treatment administration to 30 days of last treatment administration are included.