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

Daniella Bajzath; Gyorgy Andor; Maxim Belotserkovskiy

doi:10.26717/BJSTR.2018.10.001946

Mini ReviewOpen Access

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

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

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