Table 1 Graft biopsies to year 5 post-transplant
Everolimus (n = 154) | CsA (n = 146) | |
|---|---|---|
Number of patients with protocol-specified biopsies, n (%) | ||
Randomization n (%) | 22 (14.3) | 18 (12.3) |
Month 12, n (%) | 17 (11.0) | 17 (11.6) |
Number of patients with investigator-initiated biopsies, n (%) | ||
Before randomization | 61 (39.6) | 64 (43.8) |
After randomization | ||
Core phase (to year 1) | 27 (17.5) | 26 (17.8) |
Extension phase (years 2–5) | 39 (25.3) | 34 (23.3) |
Total | 53 (34.4) | 53 (36.3) |
Total number of investigator-initiated biopsies, n | ||
Before randomization | 111 | 115 |
After randomization | ||
Core phase | 33 | 34 |
Extension phase (years 2–5) | 62 | 49 |
Total | 95 | 83 |
Mean (SD) number of investigator-initiated biopsies per patient, n | ||
Before randomization | 1.8 (1.0) | 1.8 (1.1) |
After randomization | 1.8 (1.2) | 1.6 (1.0) |
Time from transplant to first investigator-initiated biopsy, months | ||
Before randomization | ||
Mean (SD) | 0.9 (0.9) | 0.9 (0.9) |
Median (range) | 0.4 (0.2–3.7) | 0.5 (0.2–4.2) |
After randomization | ||
Mean (SD) | 19.5 (15.8) | 20.2 (16.6) |
Median (range) | 10.5 (4.3–59.5) | 13.3 (30.5–59.6) |