TABLE III.
Secondary Clinical Outcomes and Adverse Events
| Parameter | Sargramostim arm (n = 78) | SOC arm (n = 44) | P-value |
|---|---|---|---|
| 28-day mortality, n (%) | 9 (11.5) | 6 (13.6) | |
| Hazard ratio (95% CI) | 0.85 (0.30 to 2.39) | .76 | |
| 90-day mortality, n (%) | 11 (14.1) | 8 (18.2) | |
| Hazard ratio (95% CI) | 0.77 (0.31 to 1.92) | .58 | |
| Duration of hospitalization, na,b | 78 | 44 | |
| Mean (SD), days | 12.1 (9.4) | 11.8 (8.6) | – |
| Median (IQR), days | 9.0 (6.0, 15.0) | 9.0 (5.5, 14.5) | – |
| Discharged home | 58 (74.4) | 31 (70.5) | .64 |
| Duration of ICU stay, nb | 13 | 9 | |
| Mean (SD), days | 10.9 (11.9) | 14.4 (12.7) | – |
| Median (IQR), days | 6.0 (3.0, 12.0) | 9.0 (4.0, 19.0) | – |
| Duration of invasive ventilation (ventilator or EMCO), nb | 12 | 9 | |
| Mean (SD), days | 16.4 (14.4) | 22.7 (23.8) | .46 |
| Median (IQR), days | 12.5 (9.5, 17.5) | 19.0 (6.0, 26.0) | – |
| Ordinal score | |||
| Baseline, n | 78 | 44 | |
| Mean (SD) | 4.5 (0.50) | 4.5 (0.51) | – |
| Day 6 change from baseline, n | 58 | 33 | |
| LS, mean (SE) | −0.1 (0.10) | −0.2 (0.14) | .46 |
| Day 28 change from baseline, n | 61 | 25 | |
| LS, mean (SE) | −2.7 (0.15) | −2.7 (0.22) | .93 |
| Day 90 change from baseline, n | 61 | 30 | |
| LS, mean (SE) | −3.3 (0.16) | −3.4 (0.23) | .81 |
| Treatment-emergent adverse events, n (%) | 53 (67.9) | 31 (70.5) | – |
| Treatment-emergent serious adverse events, n (%) | 15 (19.2) | 14 (31.8) | – |
Abbreviations: ECMO = extracorporeal membrane oxygenation; ICU = intensive care unit; IQR = interquartile range; LS = least squares; P(A–a)O2 = alveolar–arterial oxygen gradient; SE = standard error; SOC = standard of care.
Patients evaluated at both baseline and post-baseline time points are included in the table. A number of patients evaluated are noted for each outcome.
a
Duration of hospitalization includes ICU days.
b
All durations were assessed up to 90 (±30) days of follow-up.