UMB Data Catalog

A project of the Health Sciences and Human Services Library
UMB Dataset

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

Alternate Titles(s): CSRs used in Cochrane review of neuroaminidase inhibitors for influenza
UID: 10
Author(s): Peter Doshi*
* Corresponding Author
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Dataset consists of 107 full clinical study reports (CSRs) of published and unpublished randomized, placebo-controlled clinical trials of two neuraminidase inhibitors.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 of Study
Subject Domain
Influenza, Human
Population Age
Adult (19 years to 64 years)
Child (2 years to 12 years)
Adolescent (13 years to 18 years)
Subject Gender
Female
Male
Keywords
GlaxoSmithKline
Hoffmann-La Roche, Inc.
Influenza Vaccines
Neuraminidase Inhibitors
Oseltamivir/adverse effects
Oseltamivir/therapeutic use
Relenza
Systematic Review
Tamiflu
Zanamivir/adverse effects
Zanamivir/therapeutic use

Access

Restrictions
Unrestricted access
Instructions
Available to download from the Dryad site
Access via Dryad

Full set of clinical study reports and readme files

Associated Publications
Jefferson T, Jones M, Doshi P, Spencer EA, Onakpoya I., Heneghan CJ. (2014). Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments. BMJ 348:g2545 (April 9). DOI: 10.1136/bmj.g2545
Heneghan CJ, Onakpoya I, Thompson M, Spencer EA., Jones M, Jefferson, T. (2014). Zanamivir for Influenza in Adults and Children: Systematic Review of Clinical Study Reports and Summary of Regulatory Comments. BMJ 348;g2547 (April 9). DOI: 10.1136/bmj.g2547
Jefferson T, Jones MA, Doshi P, Del Mar CB, Thompson MJ, Spencer EA, Onakpoya IJ, Mahtani KR, Nunan D, Howick J, Heneghan CJ. (2014). Neuraminidase Inhibitors for Preventing and Treating Influenza in Adults and Children (Review). Cochrane Database of Systematic Reviews, Issue 4, Art. No.: CD008965. DOI: 10.1002/14651858.CD008965.pub4
Heneghan CJ, Onakpoya I, Jones MA, Doshi P, Del Mar CB, Hama R, et al. (2016). Neuraminidase inhibitors for influenza: a systematic review and meta-analysis of regulatory and mortality data. Health Technology Assessessment, 20(42). DOI: 10.3310/hta20420
Data Type
Administrative
Study Type
Observational
Dataset Format(s)
PDF
Dataset Size
741.8 Mb (Tamiflu CSR zip file); 2.84 Kb (README file); 532.2 Mb (Relenza CSR zip file); 8.83 Kb (README file)
Grant Support
#10/80/01/National Institute for Health Research (UK)