Table 5.
Summary of adverse events (AEs) - Safety Analysis Set.
| Adamgammadex | Sugammadex | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2 mg/kg ( n = 6) | 4 mg/kg ( n = 5) | 6 mg/kg ( n = 6) | 8 mg/kg ( n = 6) | 10 mg/kg ( n = 6) | Summation ( N = 29) | 4 mg/kg ( n = 6) | ||||||||
| Events | Subjects with at least one adverse event (%) | Events | Subjects with at least one adverse event (%) | Events | Subjects with at least one adverse event (%) | Events | Subjects with at least one adverse event (%) | Events | Subjects with at least one adverse event (%) | Events | Subjects with at least one adverse event (%) | Events | Subjects with at least one adverse event (%) | |
| Total adverse events | 8 | 4 (66.7%) | 10 | 5 (100.0%) | 9 | 5 (83.3%) | 12 | 5 (83.3%) | 19 | 6 (100.0%) | 58 | 25 (86.2%) | 12 | 6 (100.0%) |
| Various laboratory examinations | 8 | 4 (66.7%) | 9 | 5 (100.0%) | 8 | 5 (83.3%) | 12 | 5 (83.3%) | 16 | 5 (83.3%) | 53 | 24 (82.8%) | 10 | 6 (100.0%) |
| Urinary tract infection | 0 | 0 | 0 | 0 | 1 | 1 (16.7%) | 0 | 0 | 2 | 2 (33.3%) | 3 | 3 (10.3%) | 0 | 0 |
| Abdominal discomfort | 0 | 0 | 1 | 1 (20.0%) | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 (3.4%) | 0 | 0 |
| Sinus bradycardia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 (16.7%) | 1 | 1 (3.4%) | 0 | 0 |
| Recurrence of neuromuscular block | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 (16.7%) |
| Shiver | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 (16.7%) |
According to the frequency, the adverse events related to various examinations were as follows: elevated serum creatine phosphokinase, urine ketone body positive, elevated blood ketone body, urine red blood cells positive, etc.