Main outcome measures The primary outcome was a composite of time to death or first major cardiovascular event.
A composite of time to the first event of cardiovascular death or nonfatal reinfarction or stroke, adjudicated by an independent committee composed of experienced cardiologists, served as the primary end point (8).
The primary outcome was a composite of time to death or first major cardiovascular event (myocardial infarction, stroke, coronary angioplasty, coronary bypass surgery, carotid endarterectomy, repair of abdominal aortic aneurysm, or peripheral vascular bypass surgery).
The secondary outcome was a composite of time-to-first-event of progression to ESRD or death from any cause.
The primary outcome is the proteinuria in protocol A and the composite endpoint of time to the first occurrence of doubling of serum creatinine, ESRD (the need for chronic dialysis, or renal transplantation) or death in protocol B. The follow-up period is 5 years and the study ends in 2014.
A fourth phase III trial, TENERE, which compared teriflunomide with subcutaneous IFN beta-1a, assessed a composite endpoint of time to disease relapse or treatment discontinuation, rather than evaluating disability as a separate endpoint [ 31].
Using a composite outcome of time to first COPD admission or all cause death, the adjusted hazard ratio for admission in the telemonitoring group was 0.87 (95% confidence interval 0.61 to 1.26) compared with the control group.
However, a recent large long-term double blind study with the ESA, Darbepoetin alpha, did not meet its primary endpoint of reducing the composite endpoint of time to death from any cause or first hospital admission for worsening heart failure in patients with systolic CHF [ 51, 52].
In this randomised, placebo-controlled, multicentre clinical trial named ORIENT (Olmesartan Reducing Incidence of Endstage Renal Disease in Diabetic Nephropathy Trial), we examined the renoprotective benefits of olmesartan medoxomil, an ARB, using the composite endpoint of time to the first occurrence of doubling of serum creatinine (SCr), ESRD and death, mostly in the presence of ACEI therapy.
While a region of interest analysis shows a correlation between a composite measure of time playing video games and grey matter in the hippocampus, Kuhn and Gallinat (2013) did not report whether the hippocampus also correlated negatively to action video games, as did the entorhinal cortex.
