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Metabolic and Nutritional Disorders Weight gain 2% 0%
Skin and Appendages Rash 4% 3%
Respiratory System Rhinitis 3% 1%
Special Senses Ear pain 1% 0% 1 Events for which the SEROQUEL incidence was equal to or less than placebo are not listed in the table, but included the following: pain, infection, chest pain, hostility, accidental injury, hypertension, hypotension, nausea, vomiting, diarrhea, myalgia, agitation, insomnia, anxiety, nervousness, akathisia, hypertonia, tremor, depression, paresthesia, pharyngitis, dry skin, amblyopia and urinary tract infection. Explorations for interactions on the basis of gender, age, and race did not reveal any clinically meaningful differences in the adverse event occurrence on the basis of these demographic factors. Text Continues Below
Dose Dependency of Adverse Events in Short-Term, Placebo-Controlled Trials Dose-related Adverse Events: Spontaneously elicited adverse event data from a study comparing five fixed doses of SEROQUEL (75 mg, 150 mg, 300 mg, 600 mg, and 750 mg/ day) to placebo were explored for dose-relatedness of adverse events. Logistic regression analyses revealed a positive dose response (p< 0.05) for the following adverse events: dyspepsia, abdominal pain, and weight gain. Extrapyramidal Symptoms Data from one 6-week clinical trial comparing five fixed doses of SEROQUEL (75, 150, 300, 600, 750 mg/ day) provided evidence for the lack of treatment-emergent extrapyramidal symptoms (EPS) and dose-relatedness for EPS associated with SEROQUEL treatment. Three methods were used to measure EPS: (1) Simpson-Angus total score (mean change from baseline) which evaluates parkinsonism and akathisia, (2) incidence of spontaneous complaints of EPS (akathisia, akinesia, cogwheel rigidity, extrapyramidal syndrome, hypertonia, hypokinesia, neck rigidity, and tremor), and Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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