TABLE 5.
Summary of most-frequently reported grade 2 to 4 drug-related adverse events from days 1 to 28
| Adverse eventa | No. (%) reporting the event
|
||
|---|---|---|---|
| 908 1,395 mg (n = 26) | 908 1,860 mg (n = 29) | APV 1,200 mg (n = 23) | |
| Any event | 13 (50) | 11 (38) | 9 (39) |
| Diarrhea | 3 (12) | 2 (7) | 4 (17) |
| Sleep disorder | 3 (12) | 1 (3) | 0 |
| Hypersensitivity reaction to abacavir | 2 (8) | 2 (7) | 1 (4) |
| Vomiting | 2 (8) | 1 (3) | 1 (4) |
| Fever | 2 (8) | 1 (3) | 0 |
| Rash | 2 (8) | 1 (3) | 0 |
| Mood disorder | 2 (8) | 0 | 0 |
| Nausea | 1 (4) | 2 (7) | 5 (22) |
| Headache | 1 (4) | 2 (7) | 0 |
| Fatigue | 1 (4) | 1 (3) | 3 (13) |
| Abdominal pain | 1 (4) | 0 | 4 (17) |
| Decreased white cells | 0 | 3 (10) | 0 |
a
Events listed were reported in ≥5% of any group (treatment period 1).