Table 3.
Adverse event | 1.0 mg of EVL (N = 51) | 1.5 mg of EVL (N = 56) | P value |
---|---|---|---|
Patients who discontinued everolimus treatment before 12 months | |||
Death | 0 | 2 (3.6) | 0.272 |
Graft loss | 0 | 0 | >0.999 |
Lost to follow-up | 0 | 0 | >0.999 |
Adverse events leading to EVL discontinuation | 12 (23.5) | 19 (33.9) | 0.166 |
Infection | 6 (11.8) | 1 (1.8) | 0.043 |
Edema and/or dyspnoe(total) | 5 (7.8) | 10 (17.9) | 0.105 |
Lingual edema | 0 | 1 (1.8) | 0.523 |
Diarrhea | 0 | 1 (1.8) | 0.523 |
Epitaxis | 1 (2.0) | 2 (3.6) | 0.523 |
Cytopenia | 0 | 4 (7.1) | 0.048 |
Urticaria | 0 | 1 (1.8) | 0.523 |
All patients | 22 (43.1) | 35 (62.5) | 0.054 |
Rejection | 5 (9.8) | 3 (5.4) | 0.307 |
All adverse events | |||
Infection | 10 (19.6) | 2 (3.6) | 0.009 |
Edema and/or dyspnoe (total) | 6 (11.8) | 19 (33.9) | 0.011 |
Lingual edema | 0 | 2 (3.6) | 0.225 |
Diarrhea | 0 | 3 (5.4) | 0.105 |
Epitaxis | 1 (2.0) | 0 | 0.523 |
Cytopenia | 0 | 5 (8.9) | 0.022 |
Urticaria | 0 | 1 (1.8) | 0.523 |
1Data are presented as numbers and percentages.