A randomized trial evaluating the safety profile of sugammadex in high surgical risk ASA physical class 3 or 4 participants

Table 6 Overall AE summary up to 7 days post-treatment. All Participants as Treated

	n (%)	Difference in %^a (95% CI)
Patients with ≥1 AEs
Neostigmine/glycopyrrolate, n = 51	45 (88.2)	(ref.)
Sugammadex 2 mg/kg, n = 105	99 (94.3)	6.2 (−2.6, 18.5)
Sugammadex 4 mg/kg, n = 107	95 (88.8)	0.5 (− 9.3, 13.1)
Sugammadex 16 mg/kg, n = 68	63 (92.6)	2.0 (− 8.4, 17.7)
Patients with ≥1 drug-related^b AEs
Neostigmine/glycopyrrolate, n = 51	4 (7.8)	(ref.)
Sugammadex 2 mg/kg, n = 105	4 (3.8)	−4.1 (− 15.3, 3.3)
Sugammadex 4 mg/kg, n = 107	5 (4.7)	− 3.1 (− 14.3, 4.3)
Sugammadex 16 mg/kg, n = 68	2 (2.9)	−6.4 (−21.7, 2.6)
Patients with ≥1 serious AEs^c
Neostigmine/glycopyrrolate, n = 51	3 (5.9)	(ref.)
Sugammadex 2 mg/kg, n = 105	12 (11.4)	5.6 (−5.5, 14.3)
Sugammadex 4 mg/kg, n = 107	8 (7.5)	1.5 (−9.2, 9.3)
Sugammadex 16 mg/kg, n = 68	7 (10.3)	0.9 (−15.1, 12.7)
Patients with ≥1 serious drug-related^b AEs
Neostigmine/glycopyrrolate, n = 51	0 (0.0)	(ref.)
Sugammadex 2 mg/kg, n = 105	0	0.0 (−7.2, 3.6)
Sugammadex 4 mg/kg, n = 107	0	0.0 (− 7.2, 3.6)
Sugammadex 16 mg/kg, n = 68	1 (1.5)	1.5 (−9.5, 8.0)

^aDifferences are calculated using the stratified Miettinen and Nurminen method with NMBA and ASA Physical Class strata as factors. ^bRated as possibly, probably or definitely related to study medication by the study investigator
^cIncluding 1 death in the 2 mg/kg and 4 mg/kg sugammadex groups each. AE Adverse event, ASA American Anesthesiology Association, CI Confidence interval, NMBA Neuromuscular binding agent

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