Friday, July 02, 2021 9:45:26 PM
"Primary Outcome
The study achieved its pre-specified primary endpoint. In the mITT population, the Cox proportional hazard model estimated a 54% relative improvement in the likelihood of subjects treated with lenzilumab achieving SWOV compared to the placebo group (HR: 1.54; 95%CI: 1.02-2.31, p=0.041; Table 2, Figure 2a). Failure to achieve SWOV occurred in 15.6% and 22.1% of subjects treated with lenzilumab or placebo, respectively (Table 2). Separation of the survival curves occurred as early as 3 days following treatment (Figure 2a), continued to increase through approximately Day 10, and then was maintained for the duration of the 28-day observation period. In the ITT population, lenzilumab improved the likelihood of SWOV by 1.90-fold (nominal p=0.043; Table 2).
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