Table 2.
Overview of primary and secondary efficacy endpoints in trimodulin and placebo treatment groups in all patients
| Endpoint | Trimodulin | Placebo | p value | ||
|---|---|---|---|---|---|
| Mean (SD) | Median (IQR) | Mean (SD) | Median (IQR) | ||
| VFDs | n = 81 | n = 79 | |||
| 11.0 (9.5) | 11.0 (0–20) | 9.6 (9.4) | 8.0 (0–19) | 0.173 * | |
| Duration of mechanical ventilation (days)a | n = 81 | n = 79 | |||
| 12.8 (8.5) | 10.0 (6–19) | 13.8 (8.6) | 11.0 (7–21) | Not calculated | |
| VFDs in surviving patients | n = 63 | n = 57 | |||
| 14.2 (8.4) | 18.0 (8–21) | 13.3 (8.5) | 16.0 (4–20) | 0.271† | |
| Vasopressor-free days | n = 81 | n = 79 | |||
| 13.0 (8.9) | 14.0 (6–20) | 13.7 (8.4) | 15.0 (8–20) | 0.639† | |
| Discharge time from ICU (days) | n = 81b | n = 79b | |||
| 13.4 (5.9) | 11.0 (9–17) | 14.4 (5.8) | 13.0 (10–18) | 0.161† | |
| Discharge time from hospital (days) | n = 81 | n = 79 | |||
| 19.5 (5.5) | 20.0 (15–24) | 19.0 (4.9) | 19.0 (15–23) | 0.479 | |
| 28-day all-cause mortality, n (%) | 18/81 (22.2) | 22/79 (27.8) | 0.465‡ | ||
| 28-day pneumonia-related mortality, n (%) | 5/81 (6.2) | 10/79 (12.7) | Not calculated | ||
| Change in SOFA score from day 1 to 7 | −4.8 (7.5) | −7.0 (−10–0) | −5.4 (6.5) | −7.0 (−10 to 3.0) | Not calculated |
aMortality is not considered for duration of mechanical ventilation; b34 patients were missing in the trimodulin group and 38 in the placebo group
ICU intensive care unit, IQR interquartile range, SD standard deviation, SOFA Sequential Organ Failure Assessment, VFD ventilator-free day
Data are n (%), mean (SD) and median (IQR, 25th–75th percentile)
*One-sided Wilcoxon–Mann–Whitney test; †Wilcoxon test; ‡Mantel–Haenszel test