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

Dataset consists of 107 full clinical study reports (CSRs) of published and unpublished randomized, placebo-controlled clinical trials of two neuraminidase inhibitors.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/

该数据集由107份完整的临床试验报告（CSRs）组成，这些报告涉及已发表和未发表的两种神经氨酸酶抑制剂随机、安慰剂对照的临床试验。通过对CSRs及其他监管文件的系统审查，旨在确定奥司他韦（Tamiflu）和扎那米韦（Relenza）的潜在益处与危害。评估指标包括症状首次缓解时间、流感结局、并发症、住院情况以及治疗意向人群中的不良事件。通过基于CONSORT声明清单的提取表格，确定了CSRs相关部分的完整性。作者已向Cochrane协作组织提供了两种药物的全部临床试验报告，这些报告由罗氏公司、葛兰素史克公司和欧洲药品管理局（EMA）提供，用于对神经氨酸酶抑制剂在健康成人及儿童中治疗/预防流感的系统综述。有关该临床试验报告数据集及其产生的Cochrane系统综述的客座文章可在“Dryad新闻与观点”网站查阅：https://blog.datadryad.org/2014/04/17/tamiflu-data/。