Table 3. Summary of treatment-related AE by dose level.
| |
No. of patients with AEs of any grade by dose level |
|
|
|||
|---|---|---|---|---|---|---|
| 14.4 mg m−2 (n=5) | 21.6 mg m−2 (n=7) | 27.0 mg m−2 (n=15) | 32.4 mg m−2 (n=5) | Any grade AE No. of patients (%) | Grade 3/4 AE No. of patients (%) | |
| Fatigue |
0 |
4 |
10 |
3 |
17 (53.1) |
3 (9.4) |
| Mucositis |
0 |
3 |
11 |
3 |
17 (53.1) |
3 (9.4) |
| Nausea |
1 |
2 |
6 |
4 |
13 (31.7) |
0 |
| Vomiting |
1 |
1 |
4 |
5 |
11 (34.4) |
0 |
| Infection without neutropenia |
0 |
1 |
3 |
2 |
6 (18.8) |
1 (3.1) |
| Diarrhoea |
0 |
2 |
3 |
0 |
5 (15.6) |
0 |
| Anorexia |
0 |
1 |
2 |
1 |
4 (12.5) |
0 |
| Anaemia |
5 |
6 |
12 |
5 |
28 (87.5) |
1 (3.1) |
| Lymphopenia |
4 |
5 |
13 |
5 |
27 (84.4) |
12 (37.5) |
| Neutropenia |
0 |
0 |
4 |
1 |
5 (15.6) |
1 (3.1) |
| Thrombocytopenia |
0 |
1 |
6 |
2 |
9 (28.1) |
0 |
| AST elevation |
2 |
2 |
9 |
3 |
16 (50.0) |
3 (9.4) |
| ALP elevation |
3 |
5 |
7 |
5 |
20 (62.5) |
5 (15.6) |
| Creatinine elevation |
1 |
1 |
1 |
2 |
5 (15.6) |
1 (3.1) |
| Hyperglycaemia (random) | 0 | 1 | 9 | 2 | 12 (37.5) | 2 (6.3) |
Abbreviations: AST=aspartate aminotransferase; ALP= alkaline phosphatase; AV=adverse events.