Table 4.
Study 1 | ||
---|---|---|
Lersivirine (250 mg once daily) + ketoconazole (400 mg once daily) (n = 14) | Lersivirine (250 mg once daily) + placebo (n = 14) | |
MedDRA preferred term, n (%) | ||
Abdominal pain | 2 (14) | 0 |
Diarrhoea | 5 (36) | 2 (14) |
Dyspepsia | 3 (21) | 0 |
Nausea | 5 (36) | 0 |
Headache | 5 (36) | 1 (7) |
Pharyngolaryngeal pain | 2 (14) | 3 (21) |
Study 2 | ||
---|---|---|
Lersivirine (500 mg once daily) + valproic acid (1000 mg once daily) (n = 14) | Lersivirine (500 mg once daily) + placebo (n = 14) | |
MedDRA preferred term, n (%) | ||
Nausea | 1 (7) | 2 (14) |
Vessel puncture site haematoma | 2 (14) | 0 |
Upper respiratory tract infection | 0 | 2 (14) |
Headache | 2 (14) | 0 |
MedDRA, medical dictionary for regulatory activities.