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. 2011 Nov 1;73(5):768–775. doi: 10.1111/j.1365-2125.2011.04136.x

Table 4.

Treatment-emergent all-causality adverse events occurring in ≥2 subjects in any treatment group (studies 1 and 2)

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.