Table 2. Adverse events occurring in ⩾5% of the 160 treatment cycles administered, deemed possibly, probably, or definitely related to study treatment.
| Event | Number of patients, any grade | Worst grade, any patient | Number of cycles, grade 3–4 | Number of cycles, any grade |
|---|---|---|---|---|
| Hand-foot syndrome |
11 (50%) |
3 |
4 (2.5%) |
100 (62%) |
| Taste alterations |
5 (22%) |
2 |
0 (0%) |
67 (42%) |
| Hypertension |
3 (14%) |
3 |
29 (18%)a |
64 (40%) |
| Fatigue |
9 (41%) |
3 |
1 (0.6%) |
63 (39%) |
| Diarrhoea |
13 (59%) |
3 |
3 (1.8%) |
52 (32%) |
| Alopecia |
4 (18%) |
2 |
0 (0%) |
50 (31%) |
| Hypophosphatemia |
11 (50%) |
3 |
6 (3.7%) |
42 (26%) |
| Rash |
9 (41%) |
2 |
0 (0%) |
32 (20%) |
| Lymphopenia |
7 (32%) |
2 |
4 (0%) |
31 (19%) |
| Proteinuria |
6 (27%) |
3 |
1 (0.6%) |
29 (18%) |
| Weight loss |
6 (27%) |
2 |
0 (0%) |
28 (18%) |
| Aspartate aminotransferase elevation |
6 (27%) |
3 |
2 (1.2%) |
27 (17%) |
| Nausea |
8 (36%) |
2 |
0 (0%) |
24 (15%) |
| Thrombocytopenia |
3 (14%) |
1 |
0 (0%) |
16 (10%) |
| Lipase elevation |
7 (32%) |
4 |
2 (1.25%) |
12 (7.5%) |
| Peripheral sensory neuropathy |
1 (4.5%) |
1 |
0 (0%) |
11 (7%) |
| Amylase elevation |
6 (27%) |
4 |
2 (1.2%) |
9 (6%) |
| Vomiting |
5 (23%) |
3 |
1 (0.6%) |
8 (5%) |
| Alanine aminotransferase elevation |
3 (14%) |
3 |
1 (0.6%) |
7 (5%) |
| Hypocalcemia | 3 (14%) | 1 | 0 (0%) | 7 (5%) |
a
A single patient accounted for the 29 cycles where grade 3 hypertension was recorded (requiring two drugs for blood pressure control as per CTCAE v.3.0).