Table 2.
Adverse Events During the Study
| Sign/Symptom/ Laboratory Event | Grade |
No. of Subjects | |
|---|---|---|---|
| 3 | 4 | ||
| Any grade 3 or 4 event | 30 (24%) | 20 (16%) | 50 (41%) |
| Phosphorus | 13 | 1 | 14 (11%) |
| Fasting total cholesterol | 11 | 0 | 11 (9%) |
| Fasting total triglycerides | 3 | 7 | 10 (8%) |
| Fasting blood sugar | 3 | 5 | 8 (7%) |
| Fasting LDL | 8 | 0 | 8 (7%) |
| Absolute neutrophil count | 5 | 2 | 7 (6%) |
| Nonfasting glucose | 4 | 2 | 6 (5%) |
| Hemoglobin | 2 | 2 | 4 (3%) |
| Total bilirubin | 3 | 1 | 4 (3%) |
| Diarrhea/loose stools | 3 | 1 | 4 (3%) |
| Cachexia/wasting/weight loss | 4 | 0 | 4 (3%) |
| SGOT | 1 | 2 | 3 (2.4%) |
| SGPT | 1 | 2 | 3 (2.4%) |
| Ache/pain/discomfort | 2 | 1 | 3 (2.4%) |
Table gives number of subjects with at least 1 report of each given event during study follow-up (on lopinavir/ritonavir monotherapy or following intensification). Grade represents the highest reported grade during all follow-up for the subject. Events were graded by site staff according to the Division of AIDS grading scale. Only events reported in ≥3 subjects are shown; total (first) row includes all events.
Abbreviations: LDL, low-density lipoprotein; SGOT, serum glutamic oxaloacetic transaminase; SGPT, serum glutamic pyruvic transaminase.