Patients (pts) enrolled from NA in study A2310 had a different pattern of induction therapy use; no induction therapy (~50% vs 15% ex-NA); thymoglobulin (17% vs 46% ex-NA). Since this may impact complications post-transplant, we report safety results for NA pts.A 24-month (M), randomized, open-label study of EVR 1.5 or 3mg/d (C0: 3-8 or 6-12ng/mL)+reduced-dose cyclosporine (CsA) vs MMF 3g/d+standard-dose CsA in de novo HTx recipients. All pts received steroids ± induction. The EVR 3mg arm was prematurely terminated due to higher mortality.Compared to the overall population, mortality rates in NA for both EVR (7.7% vs 10.6%) & MMF (7.6% vs 9.2%) were low. The incidence of AEs for NA (EVR/MMF) vs overall was also low: neutropenia (5.3%/8.3% vs 17.9%/40.3%); hyperlipidemia (11.8%/5.8% vs 37.3%/26.9%); peripheral edema (48.7%/47.4% vs 57.7%/57.1%) & CMV infection (5.3%/16.0% vs 7.2%/21.6%). For NA, AE rates were similar at 12 & 24M in EVR & MMF groups (Table).EVR 1.5mg or MMF was better tolerated in NA pts vs the overall population, perhaps due to differences in induction therapy use.Relevant AEs in NA ptsAE, n (%) at month 12/month 24EVR 1.5mg (n=152)MMF (n=156)Thrombocytopenia15 (9.9)/15 (9.9)18 (11.5)/19 (12.2)Leukopenia18 (11.8)/21 (13.8)38 (24.4)/43 (27.6)Neutropenia8 (5.3)/8 (5.3)12 (7.7)/13 (8.3)Hyperlipidemia11 (7.2)/18 (11.8)10 (6.4)/9 (5.8)Diabetes mellitus17 (11.2)/17 (11.2)13 (8.3)/15 (9.6)Any wound event58 (38.2)/65 (42.8)44 (28.2)/47 (30.1)Pericardial effusion67 (44.1)/71 (46.7)40 (25.6)/43 (27.6)Pleural effusion50 (32.9)/52 (34.2)36 (23.1)/39 (25.0)Peripheral edema68 (44.7)/74 (48.7)59 (37.8)/74 (47.4)Proteinuria6 (3.9)/6 (3.9)2 (1.3)/2 (1.3)Any infection98 (64.5)/107 (70.4)96 (61.5)/103 (66.0)Viral infection14 (9.2)/17 (11.2)34 (21.8)/41 (26.3)CMV infection8 (5.3)/8 (5.3)21 (13.5)/25 (16.0)