TABLE 4.
Treatment-related adverse eventsa
| Event, body system, organ class | No. (%) of patients reporting
|
|||
|---|---|---|---|---|
| Group 1 (200 mg q.i.d./ 400 mg b.i.d.) (n = 35) | Group 2 (400 mg q.i.d./ 600 mg b.i.d.) (n = 31) | Group 3 (800 mg b.i.d./ 800 mg q.d.) (n = 32) | Total (n = 98) | |
| Total | 11 (31) | 6 (19) | 7 (22) | 24 (24) |
| General disorders (headache, edema, rigors) | 3 (9) | 2 (6) | 2 (6) | 7 (7) |
| Gastrointestinal system disorder | 7 (20) | 2 (6)b | 6 (19) | 15 (15) |
| Diarrhea | 3 (3) | 0 | 1 (3) | 4 (4) |
| Nausea | 4 (11) | 0 | 0 | 4 (4) |
| Vomiting | 3 (9) | 0 | 3 (9) | 6 (6) |
| Skin and subcutaneous tissue disorders (rash, pruritus, fissures) | 2 (6) | 1 (3) | 0 | 3 (3) |
a
All randomized patients reporting ≥2 events.
b
Only one of these adverse events (abdominal pain) was considered by the investigator to be severe and possibly related to treatment.