Table 3.
Summary of composite end point at week 9 and month 12
| End point | Week 9 (N = 80) | Month 12 (N = 80) | ||
|---|---|---|---|---|
| Treated patients, n (%) | Exact 95% CI, P valuea | Treated patients, n (%) | Exact 95% CI | |
| Central pathology | ||||
| Treatment failure | ||||
| Yes | 7 (8.8) | 3.6‐17.2, <.001 | 15 (18.8) | 10.9‐29.0 |
| No | 73 (91.3) | 65 (81.3) | ||
| Composite end point componenta | ||||
| Biopsy‐proved acute AMRb | 3 (3.8) | 5 (6.3) | ||
| Graft loss | 4 (5.0) | 10 (12.5) | ||
| Death | 1 (1.3) | 2 (2.5) | ||
| Loss to follow‐upb | 0 (0.0) | 0 (0.0) | ||
| Local pathology | ||||
| Treatment failure | ||||
| Yes | 11 (13.8) | 7.1‐23.3, <.01 | 21 (26.3) | 17.0‐37.3 |
| No | 69 (86.3) | 59 (73.8) | ||
| Composite end point componenta | ||||
| Biopsy‐proved acute AMRb | 7 (8.8) | 12 (15.0) | ||
| Graft loss | 4 (5.0) | 10 (12.5) | ||
| Death | 1 (1.3) | 2 (2.5) | ||
| Loss to follow‐upb | 0 (0.0) | 0 (0.0) | ||
AMR, antibody‐mediated rejection; CI, confidence interval.
A patient experiencing multiple events is counted only once for the composite treatment failure rate but is counted for each end point component.
Loss to follow‐up without other events that contributed to the composite end point.
a
P value refers to the comparison between the observed treatment failure rate and the 40% treatment failure rate estimated for patients receiving standard of care from a literature search.
b
Banff 2007 grade II or grade III AMR detected in “for‐cause” biopsies.