Table 3 Adverse events reported during the study
Body system | Normal/mild | Moderate/severe | Total |
|---|---|---|---|
Any event | 2 (20%) | 11 (37%)* | 13 (33%) |
Cardiovascular | |||
Any event | 0 | 4 (13%) | 4 (10%) |
Cardiac arrest | 0 | 2 (7%) | 2 (5%) |
Sinus arrest | 0 | 1 (3%) | 1 (3%) |
Ventricular fibrillation | 0 | 1 (3%) | 1 (3%) |
Digestive | |||
Any event | 1 (10%) | 3 (10%) | 4 (10%) |
Diarrhoea | 1 (10%) | 1 (3%) | 2 (5%) |
Ileus | 0 | 2 (7%) | 2 (5%) |
Ischaemic bowel | 0 | 1 (3%) | 1 (3%) |
Body as a whole | |||
Any event | 0 | 3 (10%) | 3 (8%) |
Multiple organ failure | 0 | 2 (7%) | 2 (5%) |
Sepsis | 0 | 1 (3%) | 1 (3%) |
Musculoskeletal | |||
Any event | 0 | 2 (7%) | 2 (5%) |
Muscle rigidity | 0 | 2 (7%) | 2 (5%) |
Nervous | |||
Any event | 1 (10%) | 1 (3%) | 2 (5%) |
Agitation | 1 (10%) | 1 (3%) | 2 (5%) |