At 24 months, overall safety data were similar, including incidence of adverse events (92.8 percent for abatacept plus MTX vs. 91.5 percent for adalimumab plus MTX), serious adverse events (13.8 percent vs. 16.5 percent, respectively) and malignancies (2.2 percent vs. 2.1 percent, respectively...According to cumulative safety data assessed at week 268, common adverse events in the three studies included upper respiratory tract infection, bronchitis or sinusitis and nasopharyngitis
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
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
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
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 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 24 months, overall safety data were similar, including incidence of adverse events (92.8 percent for abatacept plus MTX vs. 91.5 percent for adalimumab plus MTX), serious adverse events (13.8 percent vs. 16.5 percent, respectively) and malignancies (2.2 percent vs. 2.1 percent, respectively...According to cumulative safety data assessed at week 268, common adverse events in the three studies included upper respiratory tract infection, bronchitis or sinusitis and nasopharyngitis