Table 4.

Adverse events (safety population)

Adverse EventEverolimus (n=1014)MPA (n=1012)RR (Everolimus versus MPA) (95% CI)
Any adverse event, n (%)993 (97.9)984 (97.2)1.01 (0.99 to 1.02)
Any serious adverse event, n (%)557 (54.9)568 (56.1)0.98 (0.91 to 1.06)
Any adverse event leading to study drug discontinuation, n (%)233 (23.0)120 (11.9)1.94 (1.58 to 2.37)
Adverse events occurring more frequently in the everolimus group, n (%)a
 Hyperlipidemia340 (33.5)188 (18.6)1.86 (1.59 to 2.17)
 Interstitial lung disease11 (1.1)3 (0.3)3.66 (1.02 to 13.08)
 Peripheral edema373 (36.8)262 (25.9)1.42 (1.25 to 1.62)
 Stomatitis and mouth ulceration78 (7.7)21 (2.1)3.71 (2.31 to 5.95)
 Thrombocytopenia82 (8.1)40 (4.0)2.05 (1.42 to 2.96)
 Thrombotic and thromboembolic events119 (11.7)84 (8.3)1.41 (1.08 to 1.84)
 Wound healing events/complications201 (19.8)164 (16.2)1.22 (1.01 to 1.47)
 Hypokalemia144 (14.2)82 (8.1)1.75 (1.36 to 2.27)
 Proteinuria128 (12.6)57 (5.6)2.24 (1.66 to 30.2)
Adverse events occurring more frequently in the MPA group, n (%)a
 Diarrhea219 (21.6)316 (31.2)0.69 (0.60 to 0.80)
 Nausea177 (17.5)214 (21.1)0.83 (0.69 to 0.99)
 Vomiting110 (10.8)141 (13.9)0.78 (0.62 to 0.98)
 Tremor98 (9.7)137 (13.5)0.71 (0.56 to 0.91)
 Leukopenia94 (9.3)192 (19.0)0.49 (0.39 to 0.62)
 Insomnia91 (9.0)130 (12.8)0.70 (0.54 to 0.90)
Infections, n (%)
 Any infection527 (52.0)605 (59.8)0.87 (0.80 to 0.94)
 Any serious infection272 (26.8)305 (30.1)0.89 (0.78 to 1.02)
 Any viral infection174 (17.2)296 (29.2)0.59 (0.50 to 0.69)
  CMV infection36 (3.6)135 (13.3)0.27 (0.19 to 0.38)
  BK virus infection44 (4.3)81 (8.0)0.54 (0.38 to 0.77)
 Any bacterial infection353 (34.8)381 (37.6)0.92 (0.82 to 1.04)
 Any fungal infection69 (6.8)46 (4.5)1.50 (1.04 to 2.15)
  • a Events captured by standard adverse event reporting, or prespecified events of interest, which occurred in ≥10% of patients in either group and for which the 95% CI of the RR did not include 1.0 (excluding prespecified events of interest).