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Adverse Events Occurring at an Incidence of 2% or More Among Olanzapine-Treated Patients in Short-Term, Placebo-Controlled Trials Table 1 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred in 2% or more of patients treated with olanzapine (doses 2.5 mg/ day) and with incidence greater than placebo who participated in the acute phase of placebo-controlled trials. 

Commonly Observed Adverse Events in Short-Term Combination Trials In the bipolar mania combination placebo-controlled trials, the most commonly observed adverse events associated with the combination of olanzapine and lithium or valproate (incidence of 5% and at least twice placebo) were: Text Continues Below


Adverse Events Occurring at an Incidence of 2% or More Among Olanzapine-Treated Patients in Short-Term Combination Trials Table 2 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred in 2% or more of patients treated with the combination of olanzapine (doses 5 mg/ day) and lithium or valproate and with incidence greater than lithium or valproate alone who participated in the acute phase of placebo-controlled combination trials.  

For specific information about the adverse reactions observed with lithium or valproate, refer to the ADVERSE REACTIONS section of the package inserts for these other products. Additional Findings Observed in Clinical Trials The following findings are based on clinical trials. Dose Dependency of Adverse Events in Short-Term, Placebo-Controlled Trials Extrapyramidal Symptoms — The following table enumerates the percentage of patients with treatment-emergent extrapyramidal symptoms as assessed by categorical analyses of formal rating scales during acute therapy in a controlled clinical trial comparing olanzapine at 3 fixed doses with placebo in the treatment of schizophrenia. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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