Table 3.
Analyses of the Primary and Key Secondary Outcomes in the Modified Intent-to-Treat Population
| Proportion/Mean Difference Analyses | |||||
|---|---|---|---|---|---|
| Gimsilumab (N = 113) | Placebo (N = 112) | Adjusted Difference | 95% CI | P value | |
| All-cause mortality at Day 43, proportion (n) | 0.283 (32) | 0.232 (26) | 0.05 | (−0.06 to 0.17) | 0.377 |
| Alive and off invasive ventilation at Day 29, proportion (n) | 0.708 (80) | 0.696 (78) | 0.02 | (−0.09 to 0.14) | 0.691 |
| Mechanical ventilator-free days by Day 29, median (first quartile, third quartile) | 29.0 (2, 29) | 29.0 (4, 29) | 0.0 | NA | 0.479 |
| Time-to-Event Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Gimsilumab (N = 113) |
Placebo (N = 112) |
Hazard ratio | 95% CI | Log-rank P value | |||||
| Number of patients with event | Percentage of patients with event | Median number of days to event | Number of patients with event | Percentage of patients with event | Median number of days to event | ||||
| All-cause mortality* | 32 | 28.3 | NR | 31 | 27.7 | NR | 1.1 | (0.7 to 1.8) | 0.777 |
| Hospital discharge† | 78 | 69.0 | 13.0 | 79 | 70.5 | 15.0 | 0.9 | (0.7 to 1.3) | 0.727 |
Definition of abbreviations: CI = confidence interval; NA = not assessed; NR = not reached.
Multiple imputation was used to handle missing data for the binary endpoint analyses.
*
Includes all mortality data through the end of the study at Week 24.
†
Nonsurvivors, along with patients who had not been discharged by the end of the study, were censored at Week 24; patients who withdrew early were censored at the last visit.