Table 3.
Letermovir (n = 325) | Placebo (n = 170) | |||||
---|---|---|---|---|---|---|
n/N (%) | HRa (95% CI) | P Value | n/N (%) | HRa (95% CI) | P Value | |
CS-CMVi (time dependent) | 9/57 (15.8) | 1.15 (0.56–2.37) | .71 | 22/71 (31.0) | 2.34 (1.17–4.67) | .02 |
No CS-CMVi (time dependent) | 52/268 (19.4) | … | 18/99 (18.2) | … |
Graft-versus-host disease and baseline risk of CMV reactivation were not adjusted for in the model due to multicollinearity (both variables were highly correlated with CS-CMVi). CS-CMVi is treated as a time-dependent variable in the model because the time of onset of CS-CMVi varies for each subject. Death includes all-cause mortality through week 48 post-HCT. Clinically significant CMV infection is defined through week 24 post-HCT. Denominator in the first row only includes subjects with clinically significant CMV infection and does not include subjects who discontinued early and had missing data. Every subject is counted a single time for each applicable row and column.
Abbreviations: CI, confidence interval; CMV, cytomegalovirus; CS-CMVi, clinically significant cytomegalovirus infection; HCT, hematopoietic cell transplantation; HR, hazard ratio.
aHR is adjusted for baseline age.