Table 3. Safety results—all causality adverse events.
|
Arm A: gemcitabine (n=30) |
Arm B: gemcitabine+200 mg WX-671 (n=30) |
Arm C: gemcitabine+400 mg WX-671 (n=33) |
||||
|---|---|---|---|---|---|---|
| Category/adverse eventa | All (%) | Grade 3/4 (%) | All (%) | Grade 3/4 (%) | All (%) | Grade 3/4 (%) |
| Patients with any grade 3/4 toxicity |
|
43 |
|
57 |
|
67 |
|
Constitutional | ||||||
| Asthenia | 17 | 7 | 37 | 3 | 21 | 6 |
| Back pain | 0 | 0 | 17 | 0 | 9 | 0 |
| Oedema peripheral | 13 | 0 | 13 | 0 | 33 | 0 |
| Fatigue | 13 | 7 | 10 | 0 | 24 | 6 |
| Fever | 27 | 0 | 57 | 7 | 39 | 0 |
| Loss of appetite | 10 | 0 | 10 | 0 | 15 | 6 |
| Weight loss |
33 |
0 |
13 |
0 |
24 |
3 |
|
Gastrointestinal | ||||||
| Abdominal pain | 40 | 14 | 43 | 3 | 58 | 6 |
| Ascites | 3 | 0 | 10 | 3 | 12 | 6 |
| Constipation | 10 | 0 | 10 | 0 | 9 | 0 |
| Diarrhoea | 13 | 3 | 13 | 0 | 12 | 0 |
| Nausea | 20 | 0 | 27 | 0 | 33 | 0 |
| Vomiting |
17 |
0 |
27 |
0 |
21 |
3 |
|
Haematological/laboratory | ||||||
| Alkaline phosphatase high | 3 | 0 | 10 | 3 | 12 | 6 |
| Anaemia | 30 | 0 | 27 | 3 | 33 | 15 |
| Aspartate aminotransferase high | 3 | 3 | 3 | 0 | 12 | 3 |
| Leucopenia | 3 | 3 | 13 | 7 | 15 | 0 |
| Neutropenia | 20 | 13 | 30 | 20 | 24 | 12 |
| Thrombocytopenia |
10 |
7 |
3 |
3 |
18 |
6 |
|
Others | ||||||
| Dyspnoea | 0 | 0 | 0 | 0 | 24 | 0 |
| Hypertension | 0 | 0 | 3 | 0 | 12 | 0 |
| Nasopharyngitis | 0 | 0 | 10 | 0 | 0 | 0 |
| Rash | 3 | 0 | 10 | 0 | 3 | 0 |
a
Reported by at least 10% of patients per arm.