Table 3.
Accumulative adverse events during the 52 weeks of treatment.
| Adverse event | Treatment group (n = 136) |
Control group (n = 135) |
P value |
|---|---|---|---|
| Fatigue | 28 (20.6) | 25 (18.5) | 0.760 |
| Upper abdominal pain | 21 (15.4) | 19 (14.1) | 0.864 |
| Diarrhea | 24 (17.6) | 22 (16.3) | 0.872 |
| Nausea | 21 (15.4) | 22 (16.3) | 0.869 |
| Dyspepsia | 33 (24.3) | 35 (25.9) | 0.781 |
| Dizziness | 12 (8.8) | 15 (11.1) | 0.550 |
| Itching | 24 (17.6) | 29 (21.5) | 0.447 |
| Headache | 20 (14.7) | 16 (11.9) | 0.592 |
| Cough | 8 (5.9) | 9 (6.7) | 0.808 |
| Serious adverse event | 0 (0) | 0 (0) | |
| Discontinuation due to adverse event | 2 (1.4) | 1 (0.7) | 1.000 |
| Death | 0 (0) | 0 (0) |
Values in parentheses are percentages unless indicated otherwise.