TABLE 4.
Secondary end-points
| Intention-to-treat analysis | Per-protocol analysis | |||||
| MP (n=337) | DM (n=340) | p-value# | MP (n=279) | DM (n=286) | p-value# | |
| Mechanical ventilation-free days at 28 days | 23.0 (14.0) | 24.0 (16.0) | 0.49 | 24.0 (10.0) | 26.0 (8.0) | 0.09 |
| Invasive mechanical ventilation-free days at 28 days | 28.0 (0.0) | 28.0 (0.0) | 0.92 | 28.0 (0.0) | 28.0 (0.0) | 0.93 |
| Days of hospitalisation among survivors | 15.0 (11.0) | 14.0 (11.0) | 0.005 | 15 (10.0) | 13 (10.0) | 0.001 |
| Tracheostomy, n (%) | 8.0 (2.4) | 9.0 (2.6) | 0.82 | 3.0 (1.1) | 6.0 (2.1) | 0.33 |
| CRP (mg·L−1) | ||||||
| Day 3 | 32.0 (57.5) | 37.7 (56.6) | 0.16 | |||
| Day 7 | 8.6 (21.9) | 12.4 (28.9) | 0.006 | |||
| Day 14 | 5.0 (21.8) | 11.5 (36.2) | 0.0001 | |||
| PaO2/FIO2 (mmHg) | ||||||
| Day 3 | 187.0 (132.0) | 192.0 (138.0) | 0.40 | |||
| Day 7 | 213.0 (146.0) | 227.4 (151.0) | 0.20 | |||
| Day 14 | 253.2 (159.0) | 264.4 (165.5) | 0.67 | |||
| ICU referral, n (%) | 41.0 (12.2) | 45.0 (13.2) | 0.68 | 7.0 (2.1) | 19.0 (5.6) | 0.02 |
Data are presented as median (interquartile range), unless otherwise stated. MP: methylprednisolone; DM: dexamethasone; CRP: C-reactive protein; PaO2/FIO2: ratio of arterial oxygen tension (mmHg) to inspiratory oxygen fraction; ICU: intensive care unit. #: p-value of the Mann–Whitney test for numerical variables, or the Chi-squared test or Fisher's exact test for dichotomous variable, as appropriate.