Secondary End Point There were 101 secondary end-point events (a decline in the estimated GFR or ESRD) in the monotherapy group (14.0%) and 77 events in the combination-therapy group (10.6%) (Table 2 and Fig. 1B). The overall event rate was 7.2 events per 100 person-years of follow-up in the monotherapy group and 5.5 events per 100 person-years of follow-up in the combination-therapy group. There was a lag in the treatment effect, with an effect emerging after about 6 to 12 months, but it was not sustained with longer follow-up (P = 0.02 for the test of nonproportionality). There was no significant between-group difference in mortality
(Table 2 and Fig. 1C) or ESRD (Table 2), though the number of ESRD events was small.