Table 2.
Characteristics | Statistics | Meplazumab + SoC | Placebo + SoC (N = 41) | ||
---|---|---|---|---|---|
0.12 mg/kg (N = 41) | 0.2 mg/kg (N = 41) | 0.3 mg/kg (N = 44) | |||
Patients who died by day 29 | n (%) | 1 (2.4) | 6 (14.6) | 4 (9.1) | 6 (14.6) |
Difference in proportionsa | −12.2 | 0 | −5.5 | ||
CMH† | p-value | 0.0150 | 0.9923 | 0.7291 | |
Patients alive and discharged without supplemental oxygen by day 29 | n (%) | 34 (82.9) | 27 (65.9) | 31 (70.5) | 29 (70.7) |
Difference in proportionsa | 12.2 | −4.8 | −0.2 | ||
CMH† | p-value | 0.0337 | 0.4943 | 0.8286 |
Note: Day of death was derived as (Date of death—Date of randomization + 1)
Note: Percentages are based on the number of patients in the analysis set by treatment group
Note: Patients with no data on day 29 are treated as a non-responder
aThe difference in proportions is calculated as: the proportion of dose group—the proportion of control group
†p-value from a CMH test adjusted for age group (age < 65 years versus ≥65 years) and baseline severity grade
Abbreviations: CMH Cochran-Mantel-Haenszel, N number of patients in analysis set, n number of patients, SoC Standard of Care