TABLE 2.
AEs and laboratory abnormalities
| System organ class or preferred term | TPV/r | TPV/r + EFV | Total |
|---|---|---|---|
| No. of subjects (%) | 34 (100.0) | 31 (100.0) | 34 (100.0) |
| Total no. with adverse events (%) | 29 (85.3) | 25 (80.6) | 32 (94.1) |
| Gastrointestinal disorders | 28 (82.4) | 18 (58.1) | 30 (88.2) |
| Nervous system disorders | 11 (32.4) | 19 (61.3) | 25 (73.5) |
| Psychiatric disorders | 3 (8.8) | 8 (25.8) | 9 (26.5) |
| Skin and subcutaneous tissue disorders | 2 (5.9) | 5 (16.1) | 6 (17.6) |
| General disorders | 7 (20.6) | 12 (38.7) | 18 (52.9) |
| No. with AST increase (%) | 5 (14.7) | 5 (16.1) | |
| No. with AST grade 3 or 4 (%) | 1 (2.9) | 2 (6.5) | |
| No. with ALT increase (%) | 12 (35.3) | 13 (41.9) | |
| No. with ALT grade 3 or 4 (%) | 3 (8.8) | 6 (19.4) | |
| Total no. with cholesterol increase (%) | 0 | 6 (19.4) | |
| Total no. with cholesterol grade 3 or 4 (%) | 0 | 3 (9.7) |