TABLE 1.
Number of subjects with reported adverse effects
| Adverse event or body system affected | No. of subjects from group:
|
||||
|---|---|---|---|---|---|
| 750 mg qda | 750 mg tiwb | 1,000 mg tiwb | Placeboc
|
||
| qd | tiw | ||||
| Any event | 22 | 9 | 7 | 5 | 5 |
| Gastrointestinal | 18 | 5 | 2 | 2 | 3 |
| Nausea | 12 | 1 | 2 | 2 | 1 |
| Diarrhea | 8 | 2 | 1 | 1 | 2 |
| Flatulence | 4 | 0 | 0 | 1 | 0 |
| General | 8 | 3 | 3 | 3 | 2 |
| Fatigue | 4 | 0 | 0 | 0 | 0 |
| Fever | 2 | 1 | 2 | 0 | 1 |
| Central nervous system | 8 | 0 | 2 | 3 | 0 |
| Headache | 7 | 0 | 0 | 3 | 0 |
| Skin | 6 | 2 | 4 | 2 | 2 |
| Pruritus | 2 | 0 | 2 | 1 | 0 |
| Rash | 2 | 1 | 2 | 2 | 1 |
a
Includes patients from groups 1 and 2; n = 23.
b
n = 10.
c
n = 7.