Harms are assessed inconsistently and reported inadequately part 1: systematic adverse events

AbstractObjectivesWe examined systematic adverse events (AEs) in Part 1 (of 2) of a study describing the assessment and reporting of AEs in clinical trials. Study Design and SettingWe examined 52 public and nonpublic data sources about trials of quetiapine for bipolar depression using data from the...

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Veröffentlicht in:	Journal of clinical epidemiology 2019-09, Vol.113, p.20-27
Hauptverfasser:	Mayo-Wilson, Evan, Fusco, Nicole, Li, Tianjing, Hong, Hwanhee, Canner, Joseph K, Dickersin, Kay
Format:	Artikel
Sprache:	eng
Schlagworte:	Adverse events Bipolar disorder Bipolar Disorder - drug therapy Cholesterol Clinical decision making Clinical trials Data Accuracy Data sources Decision making Domains Drug safety Drug-Related Side Effects and Adverse Reactions Epidemiology Extrapyramidal system Gabapentin - adverse effects Gabapentin - therapeutic use Harms Humans Information systems Internal Medicine Laboratories Methods Neuralgia - drug therapy Open science Questionnaires Quetiapine Quetiapine Fumarate - adverse effects Quetiapine Fumarate - therapeutic use Randomized Controlled Trials as Topic - statistics & numerical data Reporting bias Research Report Statistics Studies
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