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Psychiatric adverse events in oseltamivir prophylaxis trials: Novel comparative analysis using data obtained from clinical study reports

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Estimating the rate of adverse events (AEs) caused by a treatment in clinical trials typically involves comparing the proportions of patients experiencing AEs in intervention and control groups. However, potentially… Click to show full abstract

Estimating the rate of adverse events (AEs) caused by a treatment in clinical trials typically involves comparing the proportions of patients experiencing AEs in intervention and control groups. However, potentially important information, including duration, recurrence, and intensity of events, is lost. In this study, we illustrate how the additional information can be obtained and incorporated into analyses of AEs.

Keywords: events oseltamivir; study; psychiatric adverse; prophylaxis trials; adverse events; oseltamivir prophylaxis

Journal Title: Pharmacoepidemiology and Drug Safety
Year Published: 2018

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