TABLE 1.
Summary of commonly reported adverse events
| Adverse event | No. (%) of subjects with AE by treatment
|
|||
|---|---|---|---|---|
| BCV (n = 35) | BCV/RTV (n = 30) | Placebo/RTV (n = 26) | Placebo (n = 45) | |
| Overall AEs | ||||
| Any AE | 17 (49) | 18 (60) | 13 (50) | 18 (40) |
| Headache | 5 (14) | 4 (13) | 4 (15) | 9 (20) |
| Dizziness | 1 (3) | 4 (13) | 0 | 1 (2) |
| Diarrhea | 2 (6) | 3 (10) | 0 | 2 (4) |
| Nausea | 3 (9) | 2 (7) | 0 | 0 |
| Flatulence | 3 (9) | 0 | 1 (4) | 0 |
| Constipation | 0 | 2 (7) | 0 | 0 |
| Application site irritation | 1 (3) | 0 | 2 (8) | 0 |
| Back pain | 2 (6) | 1 (3) | 0 | 0 |
| Myalgia | 0 | 0 | 2 (8) | 0 |
| Pharyngolaryngeal pain | 2 (6) | 0 | 0 | 1 (2) |
| Throat irritation | 0 | 0 | 2 (8) | 0 |
| Supraventricular tachycardia | 2 (6) | 0 | 1 (4) | 1 (2) |
| Acne | 1 (3) | 0 | 0 | 2 (4) |
| Drug-related AEs | ||||
| Any drug-related AE | 4 (11) | 4 (13) | 2 (8) | 6 (13) |
| Diarrhea | 2 (6) | 3 (10) | 0 | 2 (4) |
| Flatulence | 3 (9) | 0 | 1 (4) | 0 |