In addition, statistically significant increases in non-fatal serious adverse events (SAE) were observed in patients on Tredaptive plus statin therapy compared to placebo plus statin therapy...Adverse events were consistent with those already known for eplerenone, primarily hyperkalemia

Adverse event (AE) profiles were similar between the two treatment groups and consistent with known AEs associated with progesterone

The adverse event profile was consistent with that known for Lyrica, with the most common adverse events including headache, dizziness, insomnia, somnolence, nausea and fatigue

There was also a statistically significant increase in some nonfatal serious adverse events in the group receiving extended-release niacin/laropiprant

The study enrolled 2,051 subjects at 127 sites in 13 countries, and was designed to evaluate safety and efficacy, with a primary endpoint of mortality or death over two years, and a secondary endpoint of treatment emergent adverse events

UCB SA, of Brussels, Belgium, said a subgroup analysis of pooled data from three long-term open-label extension trials showed a consistent safety profile with epilepsy drug Vimpat (lacosamide), with the most commonly reported treatment-emergent adverse events being dizziness, headache and nasopharyngitis

Single doses up to 7.5 mg were generally well tolerated, with no significant adverse events

The most common adverse events included fatigue, rash, diarrhea, nausea, cough, joint pain, fever and itching, with seven MK-3475-related Grade 3/4 adverse events potentially immune related

The overall incidence of adverse events (AEs) was generally similar across all treatment arms

primary safety measures include serious adverse events, adverse events and major bleeding events

Serious adverse events included six cases of pelvic inflammatory disease (PID, two with LNG-IUS12 and four with LNG-IUS16

Doses of 0.5 mg and 1 mg laquinimod also were well tolerated, with adverse events similar to placebo

The study showed that the adverse event profile was as expected based on similar long-term safety studies with other extended-release opioid formulations, with the most common adverse events being nausea, constipation, vomiting and headache

The study will investigate two doses of Alpha-1 HC aerosol, an inhaled formulation of Grifols' alpha-1-proteinase inhibitor, and investigators will measure adverse events and other endpoints during the three-week study period

Started in March, the Eslicarbazepine acetate in Partial-Onset Seizures study is intended to enroll about 800 patients, with a primary endpoint of six-month retention rate and other assessments, including seizure frequency, adverse events and quality of life

Inc., of Whitehouse Station, N.J., reported data from the two-month discontinuation phase of its 12-month study showing that patients who stopped taking insomnia drug suvorexant, following daily use for one year, experienced a return of their sleeping difficulties similar to those who received placebo, while adverse events were generally consistent with those reported during the 12-month study

At all specified time points, the regimen containing Isentress had fewer drug-related adverse events vs

Sleepiness and headache were the most common adverse events

The profile of adverse events was comparable and evenly distributed across all three treatment groups, and most adverse events were mild to moderate