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  • Clinical Study Reports (CSR) Used in the Systematic Review of Neuraminidase Inhibitors for Preventing and Treating Influenza in Healthy Adults and Children with Confirmed or Suspected Exposure to Natural Influenza
    UMB Dataset

    Alternate Title(s)
    CSRs used in Cochrane review of neuroaminidase inhibitors for influenza
    Authors
    Peter Doshi
    Description

    Dataset consists of 107 full clinical study reports (CSRs) of published and unpublished randomized, placebo-controlled clinical trials of two neuraminidase inhibitors. A systematic review of the CSRs and other regulatory documents was conducted to determine the potential benefits and harms of oseltamivir (Tamiflu) and zanamivir (Relenza). Outcome measures included time to first alleviation of symptoms, influenza outcomes, complications, admissions to hospital, and adverse events in the intention to treat population. Completeness of relevant parts of the CSRs was determined via an extraction form based on the CONSORT statement checklist. Authors have provided the full set of clinical study reports for both medications provided to the Cochrane collaboration by Roche, GlaxoSmithKline, and the European Medicines Agency (EMA) for use in the systematic review of these neuraminidase inhibitors for treating/preventing influenza in healthy adults and children. A guest post on the "Dryad News and Views" site regarding the dataset of clinical study reports and the resulting Cochrane systematic review is available at: https://blog.datadryad.org/2014/04/17/tamiflu-data/

    Subject
    Influenza, Human
    Access Rights
    Unrestricted access

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