Pooled safety and tolerability data from four placebo-controlled teriflunomide studies and extensions
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Safety and tolerability of montelukast in placebo-controlled pediatric studies and their open-label extensions.
BACKGROUND Montelukast is a potent leukotriene-receptor antagonist administered once daily that provides clinical benefit in the treatment of asthma and allergic rhinitis in children and adults. Because of its wide use as a pediatric controller, there is a need for a further review of the safety and tolerability of montelukast in children. OBJECTIVE To summarize safety and tolerability data f...
متن کاملThe safety and tolerability of vortioxetine: Analysis of data from randomized placebo-controlled trials and open-label extension studies
The safety and tolerability of vortioxetine in adults with major depressive disorder was assessed. Tolerability was based on the nature, incidence and severity of treatment-emergent adverse events (TEAEs) during acute (6/8) week treatment in 11 randomized, double-blind placebo-controlled short-term studies in major depressive disorder: six with an active reference. Symptoms following discontinu...
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Cariprazine, a potent dopamine D3 and D2 receptor partial agonist antipsychotic with preferential binding to D3 receptors, is Food and Drug Administration approved for treating schizophrenia and manic or mixed episodes of bipolar I disorder. A post-hoc safety/tolerability analysis of data from the four acute trials in the cariprazine schizophrenia clinical development program (NCT00404573; NCT0...
متن کاملLebrikizumab in moderate-to-severe asthma: pooled data from two randomised placebo-controlled studies
INTRODUCTION In a subset of patients with asthma, standard-of-care treatment does not achieve disease control, highlighting the need for novel therapeutic approaches. Lebrikizumab is a humanised, monoclonal antibody that binds to and blocks interleukin-13 activity. METHODS LUTE and VERSE were replicate, randomised, double-blind, placebo-controlled studies, evaluating multiple doses of lebriki...
متن کاملSafety and tolerability of lacosamide as adjunctive therapy for adults with partial-onset seizures: Analysis of data pooled from three randomized, double-blind, placebo-controlled clinical trials
OBJECTIVE The objective of this study was to describe a priori protocol-defined analyses to evaluate the safety and tolerability of adjunctive oral lacosamide (200-600 mg/day) in adults (ages 16-70 years) with partial-onset seizures (POS) using data pooled from three similarly designed randomized, double-blind, placebo-controlled trials (SP667, SP754 [NCT00136019], SP755 [NCT00220415]). METHO...
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ژورنال
عنوان ژورنال: Multiple Sclerosis and Related Disorders
سال: 2016
ISSN: 2211-0348
DOI: 10.1016/j.msard.2015.11.006