Topcoin,

It is not the entire trial duration or entire enrollment period that you use as the time factor, it is the median drug exposure (1.46 years, ~18 months). Take the event rates at the median drug exposure time point (11.8% and 11.3%) and divide by 1.46 years to get the ~7.8 to 8.1 events per 100 patient years figure. Not all 5380 patients in EXAMINE were enrolled at the same time resulting in varying durations of drug exposure. Recruitment occured between Oct 2009 and March 2013 w/ last patient study visit June 2013. 

BDAZ