Table 2.
Drug-related adverse events reported by ≥ 5% of subjects
| Event by body system | ABC/EFV/ddI (N = 24) | ABC/EFV/ddI/HU (N = 30) |
| n (%) | n (%) | |
| Ear, nose, and throat | ||
| Nasal signs and symptoms | 2 (8) | 0 |
| Endocrine and metabolic | ||
| Lack of appetite | 1 (4) | 3 (10) |
| Lipid metabolism disorders | 2 (8) | 2 (7) |
| Weight problems | 0 | 2 (7) |
| Gastrointestinal | ||
| Abdominal distension | 1 (4) | 2 (7) |
| Diarrhea | 5 (21) | 6 (20) |
| Gaseous symptoms | 0 | 2 (7) |
| GI discomfort and pain | 0 | 3 (10) |
| Nausea | 3 (13) | 9 (30) |
| Nausea and vomiting | 1 (4) | 6 (20) |
| Musculoskeletal | ||
| Arthralgia | 1 (4) | 2 (7) |
| Neurology | ||
| Abnormal dreams | 5 (21) | 4 (13) |
| Cognitive function | 2 (8) | 1 (3) |
| disorders | 2 (8) | 1 (3) |
| Dizziness | 1 (4) | 4 (13) |
| Headache | 1 (4) | 5 (17) |
| Memory effects | 0 | 2 (7) |
| Neuropathy | 1 (4) | 4 (13) |
| Sleep disorders | 0 | 2 (7) |
| Non-site specific | ||
| ABC hypersensitivity | 1 (4) | 3 (10) |
| Malaise and fatigue | 2 (8) | 6 (20) |
| Psychiatric | ||
| Depressive disorders | 2 (8) | 1 (3) |
| Skin | ||
| Nail disorders | 0 | 2 (7) |
| Skin rashes | 3 (13) | 3 (10) |
Note: ABC, abacavir; ddI, didanosine; EFV, efavirenz; HU, hydroxyurea