Efficacy and safety of concentration-controlled everolimus with reduced-dose cyclosporine in Japanese de novo renal transplant patients: 12-month results

Table 3 Summary of efficacy parameters by treatment (intent-to-treat population)

	Everolimus 1.5 mg (n= 61)	MMF 2 g (n= 61)	Comparison of everolimus vs. MMF
Efficacy endpoints
Primary composite endpoint (at 12 months)^a	7 (11.5)	7 (11.5)	Difference in rates 0.0% (9.5%), (−9.49, 9.49) P = 0.012^d
Treated BPAR	3 (4.9)	5 (8.2)
Graft loss	0	0
Death	0	0
Loss to follow-up^b	4 (6.6)	2 (3.3)
Secondary efficacy endpoints
Patients with treated BPAR by Banff grade
IA	2 (3.3)	2 (3.3)
IB	0	1 (1.6)
IIA	1 (1.6)	2 (3.3)
Graft loss or death (month 12)	0	0
Graft loss, death or loss to follow-up^c (month 12)	5 (8.2)	3 (4.9)	3.3% (10.6%), P = 0.015^d

Data presented as n (%). ^aComposite of treated BPAR, graft loss, death, or loss to follow-up. For the individual components of the composite endpoint, patients are counted for the first event to occur. ^bA loss to follow-up in the primary endpoint is a patient who did not experience treated BPAR, graft loss, or death and whose last day of contact was prior to day 316 (that is, prior to the month 12 visit window). ^cA loss to follow-up in the secondary endpoint is a patient who did not experience graft loss or death and whose last day of contact was prior to day 316 (that is, prior to the month 12 visit window). Note that for patients meeting the composite efficacy endpoint, patients are recorded by the individual. ^dZ-test for everolimus – MMF ≥0.13 (non-inferiority test, P value for non-inferiority test is for a one-sided test and should be compared with the 0.05 significance level. BPAR, biopsy-proven acute rejection; MMF, mycophenolate mofetil.