Active | Control | |
---|---|---|
Serious adverse events | ||
Death | 2 (100%) | 4 (50%) |
Serious cardiac events | 0 | 3 (37.5%) |
Respiratory failure requiring reintubation | 0 | 1 (12.5%) |
Total | 2 | 8 |
Non-serious adverse events, n (%) | ||
Hospital-acquired infection | 4 (50%) | 6 (42.9%) |
Tracheostomy | 1 (12.5%) | 1 (7.1%) |
Blocked intracranial pressure drain | 1 (12.5%) | 0 |
Headache | 1 (12.5%) | 0 |
Pneumonia | 1 (12.5%) | 0 |
Diarrhoea | 0 | 1 (7.1%) |
Gout | 0 | 1 (7.1%) |
High respiratory rate | 0 | 1 (7.1%) |
Laparotomy | 0 | 1 (7.1%) |
Cardiac event | 0 | 1 (7.1%) |
Poorly healing surgical wound | 0 | 1 (7.1%) |
Violence to staff | 0 | 1 (7.1%) |
Total | 8 | 14 |