Table 5.
Selected AEs of clinical interest up to 7 days post-treatment. All Participants as Treated
| n (%) | Difference in %a (95% CI) | |
|---|---|---|
| With ≥ ECIsb | ||
| Neostigmine/glycopyrrolate, n = 51 | 2 (3.9) | (ref.) |
| Sugammadex 2 mg/kg, n = 105 | 2 (1.9) | −2.1 (− 11.8, 3.8) |
| Sugammadex 4 mg/kg, n = 107 | 6 (5.6) | 1.8 (−8.1, 8.4) |
| Sugammadex 16 mg/kg, n = 68 | 5 (7.4) | 1.1 (−13.5, 11.1) |
| Clinically Relevant Bradycardia | ||
| Neostigmine/glycopyrrolate, n = 51 | 1 (2.0) | (ref.) |
| Sugammadex 2 mg/kg, n = 105 | 0 | −2.0 (−10.5, 1.6) |
| Sugammadex 4 mg/kg, n = 107 | 3 (2.8) | 0.9 (− 7.8, 6.6) |
| Sugammadex 16 mg/kg, n = 68 | 0 | − 3.1 (− 15.9, 2.4) |
| Clinically Relevant Tachycardia | ||
| Neostigmine/glycopyrrolate, n = 51 | 0 | (ref.) |
| Sugammadex 2 mg/kg, n = 105 | 2 (1.9) | 1.9 (−5.3, 6.8) |
| Sugammadex 4 mg/kg, n = 107 | 2 (1.9) | 1.8 (− 5.4, 6.6) |
| Sugammadex 16 mg/kg, n = 68 | 4 (5.9) | 5.9 (− 5.0, 14.3) |
| Other Clinically Relevant Cardiac Arrhythmia | ||
| Neostigmine/glycopyrrolate, n = 51 | 1 (2.0) | (ref.) |
| Sugammadex 2 mg/kg, n = 105 | 0 | −2.0 (−10.5, 1.6) |
| Sugammadex 4 mg/kg, n = 107 | 1 (0.9) | −1.0 (− 9.5, 3.5) |
| Sugammadex 16 mg/kg, n = 68 | 1 (1.5) | −1.7 (− 14.6, 5.4) |
aDifferences are calculated using the stratified Miettinen and Nurminen method with NMBA and ASA Physical Class strata as factors. bNo AEs of adjudicated hypersensitivity, adjudicated anaphylaxis, or drug-induced liver injury were reported up to 7 days post-treatment; ASA American Society of Anesthesiologists, AE Adverse event, CI Confidence interval, ECI Events of clinical interest