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 |
Reported by at least 10% of patients per arm.