There were 152 primary end-point events in the monotherapy group (21.0%) and 132 in the combination-therapy group (18.2%) (Table 2 and Fig.1A). The overall event rate was 10.8 events per 100 person-years of follow-up in the monotherapy group and 9.5 events per 100 person-years offollow-up in the combination-therapy group. The composition of first events was as follows: in themonotherapy group, 78 patients had a change in the estimated GFR (31 patients with a decline of ≥30 ml per minute per 1.73 m2 and 47 patients with a decline of ≥50%), 23 had ESRD, and 51
died; in the combination-therapy group, 59 patients had a change in the estimated GFR (23 patients with a decline of ≥30 ml per minute per 1.73 m2 and 36 patients with a decline of ≥50%), 18 had ESRD, and 55 died. The risk of the primary end point did not differ significantly between the two groups. There was also no significant difference in the hazard ratios among prespecified subgroups (P>0.10 for all interactions) (Fig. S3 in the Supplementary Appendix).