Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients: A Multicentre, Randomized Trial
Table 4
Incidence of infections and adverse events of interest.
RD CsA ()
ST CsA ()
Any adverse event, or infection or serious adverse event
99 (100.0%)
100 (100.0%)
Infection
Any
52 (52.5%)
47 (47.0%)
Bacterial
29 (29.3%)
18 (18.0%)
Fungal
2 (2.0%)
7 (7.0%)
Viral
13 (13.1%)
7 (7.0%)
CMV
7 (7.1%)
3 (3.0%)
Other
5 (5.1%)
9 (9.0%)
Unknown
26 (26.3%)
27 (27.0%)
Anaemia
21 (21.2%)
16 (16.0%)
Thrombocytopenia
5 (5.1%)
6 (6.0%)
Leukopenia
12 (12.1%)
7 (7.0%)
Incision-site related wound healing complications1
10 (9.9%)
8 (8.0%)
Cardiac tamponade2
7 (6.9%)
5 (5.0%)
Effusion-related complications3
5 (5%)
8 (8.0%)
1Wound healing complications associated with a surgical procedure that were reported as serious adverse events. 2Three more cardiac tamponades occurred after iatrogenic myocardial perforation during biopsy procedure (2 ST and 1 RD). 3Pleural and pericardial effusions that were reported as serious adverse events.
