Table 2. Selected Grade 3 or 4 Adverse Events by Treatment Strategy.
| By Week 24 | By Week 48 | |||
|---|---|---|---|---|
| LPV/r QD (n=161) |
LPV/r QD/DOT (n=82) |
LPV/r QD (n=161) |
LPV/r QD/DOT (n=82) |
|
| Any Event | 55 (34%) | 30 (37%) | 62 (39%) | 31 (38%) |
| Any Sign/Symptom | 26 (16%) | 9 (11%) | 27 (17%) | 10 (12%) |
| Diarrhea/loose stools | 3 (2%) | 0 (0%) | 3 (2%) | 0 (0%) |
| Nausea and/or vomiting | 8 (5%) | 0 (0%) | 9 (6%) | 0 (0%) |
| Ache/pain/discomfort | 8 (5%) | 2 (2%) | 9 (6%) | 3 (4%) |
| Fever | 3 (2%) | 1 (1%) | 4 (2%) | 1 (1%) |
| Headache | 3 (2%) | 0 (0%) | 3 (2%) | 0 (0%) |
| Cognition | 3 (2%) | 1 (1%) | 3 (2%) | 1 (1%) |
| Mental status changes | 3 (2%) | 0 (0%) | 3 (2%) | 0 (0%) |
| Any Laboratory Abnormality | 38 (24%) | 22 (27%) | 44 (27%) | 22 (27%) |
| ALT (SGPT) [U/L] | 6 (4%) | 1 (1%) | 9 (6%) | 1 (1%) |
| AST (SGOT) [U/L] | 4 (2%) | 1 (1%) | 7 (4%) | 1 (1%) |
| GGT [U/L] | 0 (0%) | 0 (0%) | 3 (2%) | 0 (0%) |
| Lipase [U/L] | 8 (5%) | 6 (7%) | 8 (5%) | 6 (7%) |
| Neutropenia (ANC) [per mm3] | 4 (2%) | 9 (11%) | 4 (2%) | 9 (11%) |
| Creatine phosphokinase [U/L] | 9 (6%) | 4 (5%) | 11 (7%) | 4 (5%) |
| Glucose (non-fasting) (mg/dL) | 4 (2%) | 1 (1%) | 6 (4%) | 2 (2%) |
| Triglycerides (fasting) (mg/dL) | 4 (2%) | 1 (1%) | 4 (2%) | 1 (1%) |
| Triglycerides (non-fasting) (mg/dL) | 6 (4%) | 4 (5%) | 6 (4%) | 5 (6%) |
Only events present in 2% or more of the participants are listed.
Table numbers give the numbers of participants reporting at least one event at a given grade.
For each event, only the highest grade recorded for each subject that was at least one grade higher than baseline is counted, similarly, for category and overall totals.