11.07.2015 Views

Clinical Trials

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❘❙❚■ Chapter 35 | Use of TablesFigure 2. Kaplan–Meier plot of cumulative mortality [3].25Proportion with event (%)2015105PlaceboMagnesium00 30 60 90Follow-up (days)Number at riskPlacebo 119810521013998Magnesium11881021983960Reproduced with permission from Elsevier (Lancet 2004;363:439–45).This IMAGES paper included a:• trial profile• baseline table• figure/table reporting primary and secondary endpoints (our Figure 1)• figure showing the primary endpoint in detail (our Figure 2)• table reporting cause of death (our Table 1)• figure/table reporting subgroup analyses (similar format to our Figure 1)• table of adverse events (similar format to our Table 1)This gives a comprehensive guide to the pertinent results that are needed.When should table construction begin in a trial?‘Ghost’, ‘dummy’, or ‘template’ tables are often drafted by a trial statisticianaccording to the statistical analysis plan, and approved or amended by the principalinvestigators. Such tables provide layout, headings, and footnotes, but the fieldsremain empty of any data. Often, the appropriate time to construct such tables is398

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