Table 3. Toxicity According to National Cancer Institute Common Toxicity Criteria, Version 4.0.
| Grade 3/4 adverse events (safety population n = 87) | Patients, No. (%) | |
|---|---|---|
| Arm A: pazopanib/gemcitabine (n = 43) | Arm B: pazopanib (n = 44) | |
| All | 34 (79) | 25 (57) |
| Leucopenia | 14 (33) | 1 (2) |
| Febrile neutropenia | 1 (2) | 0 |
| Anemia | 4 (9) | 0 |
| Thrombocytopenia | 17 (40) | 0 |
| Infection | 5 (12) | 2 (5) |
| Fatigue | 3 (7) | 0 |
| Diarrhea | 2 (5) | 1 (2) |
| Stomatitis | 1 (2) | 0 |
| Vomiting | 2 (5) | 0 |
| Transaminase elevation | 4 (9) | 3 (7) |
| Pleural effusion | 3 (7) | 0 |
| Pneumothorax | 1 (2) | 1 (2) |
| Hemoptysis | 1 (2) | 0 |
| Gastrointestinal hemorrhage | 0 | 1 (2) |
| Hypertension | 5 (12) | 2 (5) |
| Events | ||
| Thromboembolic | 2 (5) | 1 (2) |
| Severe adverse | 26 (60) | 22 (50) |
| SAEs | ||
| Treatment related | 22 (51) | 8 (18) |
| Fatal | 3 (7) | 5 (11) |
Abbreviation: SAEs, severe adverse events.