Table 3.
Adverse events occurring in ≥10% of patients
| Adverse events | Imatinib arm (n=41) |
Placebo arm (n=40) |
P value |
|---|---|---|---|
| Any toxicity | |||
| All grades | 41 (100%) | 39 (98%) | 0·49 |
| Grade 3 or 4 | 20 (49%) | 7 (18%) | 0·004 |
| Neutropenia | |||
| All grades | 12 (29%) | 5 (13%) | 0·10 |
| Grade 3 or 4 | 1 (2%) | 0 | 1·00 |
| Anemia | |||
| All grades | 27 (66%) | 18 (45%) | 0·08 |
| Grade 3 or 4 | 12 (29%) | 3 (8%) | 0·02 |
| Thrombocytopenia | |||
| All grades | 8 (20%) | 3 (8%) | 0·19 |
| Grade 3 or 4 | 0 | 0 | 1·00 |
| Edema | |||
| All grades | 18 (44%) | 5 (13%) | 0·003 |
| Grade 3 or 4 | 0 | 0 | 1·00 |
| Fatigue | |||
| All grades | 15 (37%) | 5 (13%) | 0·02 |
| Grade 3 or 4 | 4 (10%) | 0 | 0·12 |
| Anorexia | |||
| All grades | 14 (34%) | 8 (20%) | 0·21 |
| Grade 3 or 4 | 1 (2%) | 1 (3%) | 1·00 |
| Nausea | |||
| All grades | 13 (32%) | 1 (3%) | 0·0007 |
| Grade 3 or 4 | 0 | 0 | 1·00 |
| Vomiting | |||
| All grades | 13 (32%) | 2 (5%) | 0·003 |
| Grade 3 or 4 | 0 | 0 | 1·00 |
| Constipation | |||
| All grades | 6 (15%) | 4 (10%) | 0·74 |
| Grade 3 or 4 | 0 | 0 | 1·00 |
| Diarrhea | |||
| All grades | 5 (12%) | 4 (10%) | 1·00 |
| Grade 3 or 4 | 0 | 0 | 1·00 |
| Hyperbilirubinemia | |||
| All grades | 10 (24%) | 6 (15%) | 0·40 |
| Grade 3 or 4 | 3 (7%) | 1 (3%) | 0·62 |
| Azotemia | |||
| All grades | 8 (20%) | 4 (10%) | 0·35 |
| Grade 3 or 4 | 0 | 0 | 1·00 |