Table 3. Patients With Adverse Events .
| Variable | No. (%) | |
|---|---|---|
| Dabigatran Etexilate (n = 60) | Warfarin (n = 60) | |
| Any adverse event | 47 (78.3) | 42 (70.0) |
| Serious adverse event | 8 (13.3) | 6 (10.0) |
| Adverse event leading to trial drug discontinuation | 7 (11.7) | 0 |
| Worsening of the index CVT | 1 (1.7) | NA |
| Intestinal hematoma, major bleeding event | 1 (1.7) | NA |
| Epigastric/abdominal discomfort | 2 (3.3) | NA |
| Urticaria | 1 (1.7) | NA |
| Thrombocytopenia | 1 (1.7) | NA |
| Elevated liver enzymes | 1 (1.7) | NA |
| Adverse event occurring in ≥5 patients, system organ class/preferred terma | ||
| Headache | 10 (16.7) | 8 (13.3) |
| Depression | 2 (3.3) | 4 (6.7) |
| Abdominal pain/epigastric discomfort | 4 (6.7) | 2 (3.3) |
| Diarrhea | 4 (6.7) | 2 (3.3) |
| Cough | 5 (8.3) | 0 |
Abbreviations: CVT, cerebral venous thrombosis; NA, not applicable.
a
Bleeding not listed (see Table 2).