TABLE 6.
Summary of AEs reported by ≥5% of patients in any treatment group (safety population)a
| AE (preferred term) | No. (%) of patients with AE |
|||
|---|---|---|---|---|
| 750-mg q12h group (n = 58) | 1,000-mg q12h group (n = 39) | 1,000-mg q8h group (n = 25) | Total (n = 122) | |
| Any event | 41 (71) | 25 (64) | 18 (72) | 84 (69) |
| Nausea | 12 (21) | 9 (23) | 4 (16) | 25 (20) |
| Diarrhea | 5 (9) | 6 (15) | 5 (20) | 16 (13) |
| ALT increased | 4 (7) | 3 (8) | 2 (8) | 9 (7) |
| Vomiting | 3 (5) | 2 (5) | 3 (12) | 8 (7) |
| AST increased | 3 (5) | 3 (8) | 1 (4) | 7 (6) |
| Headache | 6 (10) | 1 (3) | 0 | 7 (6) |
| Flatulence | 3 (5) | 1 (3) | 2 (8) | 6 (5) |
| Gamma-glutamyltransferase increased | 3 (5) | 3 (8) | 0 | 6 (5) |
| Infusion site extravasation | 3 (5) | 1 (3) | 0 | 4 (3) |
| Pruritus, generalized | 1 (2) | 3 (8) | 0 | 4 (3) |
| Gastroesophageal reflux disease | 1 (2) | 0 | 2 (8) | 3 (2) |
a
ALT, alanine aminotransferase; AST, aspartate aminotransferase; q8h, every 8 h; q12h, every 12 h.