Table 3.
Adverse events and laboratory changes.
| IA | PE | Total | |
|---|---|---|---|
| Deep venous thrombosis | 1 (3%) | 1 (3%) | 2 (3%) |
| Mild systemic infections | 0 | 5 (17%) | 5 (8%) |
| Vegetative symptoms (changes of blood pressure or heart rate) | 3 (10%) | 0 | 3 (5%) |
| gastrointestinal symptoms | 4 (13%) | 0 | 4 (7%) |
| Allergic skin reactions | 4 (13%) | 0 | 4 (7%) |
| Anemia | 8 (26%) | 15 (50%) | 23 (38%) |
| Erythropenia | 9 (29%) | 12 (40%) | 21 (34%) |
| Leukopenia | 1 (3%) | 3 (10%) | 4 (7%) |
| Thrombocytopenia | 11 (36%) | 1 (3%) | 12 (20%) |
| Hypokalemia | 4 (13%) | 1 (3%) | 5 (8%) |
Data are n (%). Table presents all adverse events that occurred in 3 (5%) or more patients (across both treatment groups) in the intention-to-treat population during the whole study.