Methodologic approach to adverse events applied to bupropion clinical trials.
A strategy for identifying and classifying adverse events and for assessing their relationship to therapy and frequency of occurrence is presented. Data from clinical trials of bupropion (Wellbutrin), a novel antidepressant, are presented as an example. Bupropion was studied in four double-blind, placebo-controlled trials (N = 360) at dosages of 300-750 mg/day. The incidence and frequency of adverse events associated with bupropion were minimal, and correlated well with the known pharmacologic and clinical properties of this new antidepressant.
D017109:Akathisia, Drug-Induced; D000928:Antidepressive Agents / Q000009:adverse effects*; D016642:Bupropion; D002986:Clinical Trials as Topic; D003866:Depressive Disorder / Q000188:drug therapy / Q000523:psychology; D004244:Dizziness / Q000139:chemically induced; D004311:Double-Blind Method; D006801:Humans; D009325:Nausea / Q000139:chemically induced; D010919:Placebos; D011336:Probability; D011427:Propiophenones / Q000009:adverse effects*; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced; D014987:Xerostomia / Q000139:chemically induced
D000928:Antidepressive Agents; D010919:Placebos; D011427:Propiophenones; D016642:Bupropion