TABLE 4.

Treatment-related adverse eventsa

Event, body system, organ classNo. (%) 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)
Total11 (31)6 (19)7 (22)24 (24)
General disorders (headache, edema, rigors)3 (9)2 (6)2 (6)7 (7)
Gastrointestinal system disorder7 (20)2 (6)b6 (19)15 (15)
    Diarrhea3 (3)01 (3)4 (4)
    Nausea4 (11)004 (4)
    Vomiting3 (9)03 (9)6 (6)
Skin and subcutaneous tissue disorders (rash, pruritus, fissures)2 (6)1 (3)03 (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.