Table 3 Final clinical diagnosis following a post-randomization investigator-initiated biopsy in response to suspected rejectiona
No. events | % based on number of patients with ≥1 suspected rejection | % based on number of ITT patients | ||||||
|---|---|---|---|---|---|---|---|---|
Everolimus | CsA | Everolimus N = 52 | CsA N = 50 | P valueb | Everolimus N = 154 | CsA N = 146 | P valueb | |
Acute cellular rejectionc | 17 | 26 | 32.7 | 52.0 | 0.071 | 11.0 | 17.8 | 0.102 |
Acute & chronic rejection | 1 | 2 | 1.9 | 4.0 | 0.614 | 0.6 | 1.4 | 0.614 |
Borderline lesions | 17 | 17 | 32.7 | 34.0 | 1.000 | 11.0 | 11.6 | 1.000 |
CNI-induced toxicity | 14 | 14 | 26.9 | 28.0 | 1.000 | 9.1 | 9.6 | 1.000 |
Acute tubular necrosis | 4 | 6 | 7.7 | 12.0 | 0.521 | 2.6 | 4.1 | 0.533 |
Chronic allograft nephropathy | 9 | 9 | 17.3 | 18.0 | 1.000 | 5.8 | 6.2 | 1.000 |
Infection | 0 | 3 | 0 | 6.0 | 0.114 | 0 | 2.1 | 0.114 |
Normal | 13 | 10 | 25.0 | 20.0 | 0.638 | 8.4 | 6.8 | 0.668 |
Other | 23 | 20 | 44.2 | 40.0 | 0.692 | 14.9 | 13.7 | 0.869 |