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Serious Adverse Events: What to Expect in Clinical Trials with Participation of Multiple Sclerosis Patients?

Volume 10 - Issue 3

Daniella Bajzath1, Gyorgy Andor2 and Maxim Belotserkovskiy*3

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    • 1Department of Medical Affairs, Germany
    • 2Department of Finance and Accounting, Eotvos Lorand University, Hungary
    • 3Department of Medical Affairs Division, Germany
    • *Corresponding author: Maxim Belotserkovskiy, Department of Medical Affairs Division, Germany

Received: October 11, 2018;   Published: October 24, 2018

DOI: 10.26717/BJSTR.2018.10.001946

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Abstract

Multiple sclerosis is an inflammatory disease attacking the central nervous system, with a slightly reduced life-expectancy, affecting 2.1 million people worldwide, with female prevalence. A retrospective analysis summarizes safety data from 11 completed clinical trials with an aim to give an overview about Serious Adverse Event occurrence in study subjects, also detailing the events according to System Organ Class.

Keywords :SAE: Serious Adverse Event; MedDRA: Medical Dictionary for Regulatory Activities; SOC: System Organ Class; IMP: Investigational Medicinal Product; AEs: Adverse Events

Abstract | Introduction| Conclusion| References|