Table 2.
Secondary clinical outcomes and serious adverse events
| Randomization | |||
|---|---|---|---|
| Methylprednisolone, N = 68 | Placebo, N = 69 | p value | |
| Secondary outcomes | |||
| Mortality, hospital discharge, n (%) | 16 (24%) | 24 (35%) | 0.15 |
| Mortality, 180 days, n (%) | 17 (25%) | 25 (36%) | 0.15 |
| CPCa score at discharge from hospital among patients alive at discharge, n (%) | 0.17 | ||
| 1 | 30 (58%) | 34 (76%) | |
| 2 | 15 (29%) | 7 (16%) | |
| 3 | 7 (13%) | 4 (8.9%) | |
| mRSb score at discharge from hospital among patients alive at discharge, n (%) | 0.65 | ||
| 0 | 14 (27%) | 13 (29%) | |
| 1 | 14 (27%) | 13 (29%) | |
| 2 | 10 (20%) | 11 (24%) | |
| 3 | 8 (16%) | 6 (13%) | |
| 4 | 5 (9.8%) | 1 (2.2%) | |
| 5 | 0 (0%) | 1 (2.2%) | |
| Serious adverse eventsc | |||
| Patients with ≥ 1 SAE, n (%) | 35 (51%) | 37 (54%) | 0.80 |
| Infection, n (%) | 5 (7.4%) | 4 (5.8%) | 0.74 |
| Bleeding, n (%) | 0 (0%) | 4 (5.8%) | 0.12 |
| Dialysis, n (%) | 2 (2.9%) | 1 (1.4%) | 0.62 |
| Electrolyte, n (%) | 2 (2.9%) | 1 (1.4%) | 0.62 |
| Metabolic, n (%) | 1 (1.5%) | 0 (0%) | 0.50 |
| Arrhytmia, n (%) | 7 (10%) | 10 (14%) | 0.46 |
| Seizures, n (%) | 12 (18%) | 13 (19%) | 0.86 |
CPC cerebral performance categories, mRS modified Rankin Score, SAE serious adverse event
aRange from 1 to 5 with higher scores indicating greater disability with 3 or 4 being severe disability, coma or vegetative state and 5 being death
bRange from 0 to 6 with higher scores indicating greater degree of disability or dependence in daily activities with 0 being no symptoms and 6 being death
cAdverse event leading to prolonged hospitalization or a life-threatening condition requiring re-hospitalization or death