Table 3.
Primary efficacy composite endpoint of all-cause mortality and adjudicated cytomegalovirus end-organ disease (full analysis set).
| Parameter, n (%) | ASP0113 (n = 246) | Placebo (n = 255) | Odds ratio⁎ (95% CI) p-value |
|---|---|---|---|
| Total composite | 87 (35.4) | 77 (30.2) | 1.27 (0.87 to 1.85) p = 0.205 |
| All-cause mortality | 78 (31.7) | 72 (28.2) | |
| Known deaths† | 65 (26.4) | 65 (25.5) | |
| Unknown survival status due to withdrawal of consent | 13 (5.3) | 7 (2.7) | |
| Adjudicated CMV EOD | 15 (6.1) | 9 (3.5) |
⁎
ASP0113 vs placebo.
†
Deaths listed here are from transplant through Day 365. Analysis was performed using the Cochran–Mantel–Haenszel test stratified by factors for randomisation (donor–recipient relatedness and donor CMV serostatus). CI=confidence interval; CMV=cytomegalovirus; EOD=end-organ disease.