Specific laboratory abnormalities of interest assessed included increased AST and ALT levels and 10-hour fasting triglycerides, total cholesterol and low-density lipoprotein (LDL)-cholesterol. Nervous system and psychiatric events were selected based on the type of AEs commonly reported with other antiretrovirals, and were classified based on the Medical Dictionary for Regulatory Activities (MedDRA) system order classes ‘nervous system disorders’

and ‘psychiatric disorders’; any rash-related event was reported as ‘rash’. Lipid- and hepatic-related parameters were recorded as mean changes from baseline over time. The Division of AIDS toxicity grades were used to categorize the severity of AEs. All analyses were Nutlin-3a purchase conducted on the intent-to-treat population (i.e. all participants who received at least one dose of study medication). Fisher’s Alectinib order exact test was

used to compare the proportion of patients in the etravirine and placebo groups with any skin event of interest, rash (including by gender), any neuropsychiatric event of interest, nervous system disorders, psychiatric disorders, any hepatic AE and selected treatment-emergent laboratory abnormalities. In addition, to account for the difference in extent of exposure between the etravirine and placebo groups, the frequency of AEs and laboratory abnormalities per 100 patient-years of exposure was also calculated. Patient-years adjusted relative risk and 95% confidence interval (CI) for the etravirine arm versus the placebo arm were calculated for all AEs and laboratory

abnormalities of interest. Full details of patient disposition in the week 96 analysis have been published previously [4]. Briefly, 599 and 604 patients were randomized to the etravirine Plasmin and placebo groups, respectively. Baseline characteristics were well balanced between the treatment groups [4]. Of 808 patients who completed 48 weeks of treatment, 24 elected not to continue into the optional extension period to week 96 (seven etravirine and 17 placebo patients). Median treatment duration was 96.0 weeks in the etravirine group and 69.6 weeks in the placebo group, and a higher proportion of patients in the placebo group discontinued the trial (60% vs. 32% in the etravirine group), mostly as a result of reaching a virological outcome (40% vs. 16%, respectively). Regardless of severity or causality, neuropsychiatric AEs of interest were reported in 33.7% and 35.9% of patients in the etravirine and placebo groups, respectively; there was no significant difference between the treatment groups in the frequency of these AEs (–2.2%; 95% CI −7.6 to 3.2; P = 0.4319, Fisher’s exact test; predefined analysis).