A Randomized Trial Evaluating the Safety Profile of Sugammadex in High Surgical Risk ASA Physical Class 3 or 4 Participants

Abbreviations: NMBA Neuromuscular blocking agent, SD Standard deviation, n.a Not applied
^†Creatinine clearance based on Cockcroft-Gault formula

^aDifferences are calculated using the stratified Miettinen and Nurminen method with NMBA and ASA Physical Class strata as factors. ASA American Society of Anesthesiologists, CI Confidence interval, TE Treatment-emergent

^aNumber of participants in ASA Physical Class 3 stratum; ^bnumber of participants in ASA Physical Class 4 stratum; ASA American Society of Anesthesiologists, CI Confidence interval, TE Treatment-emergent

^aNumber of participants in rocuronium stratum; ^bNumber of participants in vecuronium stratum; CI Confidence interval, N/A Not applicable, NMBA Neuromuscular blocking agent, TE Treatment-emergent

^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

^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

Authors and Disclosures

W. Joseph Herring¹*, Yuki Mukai¹, Aobo Wang¹, Jeannine Lutkiewicz¹, John F. Lombard¹, Li Lin¹, Molly Watkins¹, David M. Broussard^2† and Manfred Blobner<sup>3,4†

1</sup>Department of Clinical Research, Merck & Co., Inc., Kenilworth, NJ, USA. ²Ochsner Clinic Foundation, New Orleans, LA, USA. ³Department of Anesthesiology and Intensive Care Medicine, School of Medicine, Technical University of Munich, Munich, Germany. ⁴Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine, University of Ulm, Ulm, Germany.

*Correspondence
william.herring@merck.com

^†David M. Broussard and Manfred Blobner were board-certified anesthesiologists.

Authors' contributions
W.J.H., J.L., J.F.L., and M.W. contributed to the study conception and design. Data collection was performed by Y.M., J.L., L.L., M.W., D.M.B., and M.B. Analysis of data was performed by W.J.H., A.W., and M.B. Interpretation of the results was performed by W.J.H., Y.M., A.W., J.L., M.W., and M.B. The first draft of the manuscript was written by W.J.H., J.F.L., and A.W.; all authors commented on previous versions of the manuscript. All authors critically reviewed, revised, and approved the final manuscript.

Competing interests
W.J.H., Y.M., A.W., J.L., J.F.L., L.L., and M.W. are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD). D.M.B. declares funding research and consulting fees from Merck & Co., Inc., Kenilworth, NJ, USA. M.B. declares grants and personal fees from MSD, Haar, Germany; personal fees from Grünenthal, Aachen, Germany; and personal fees from GE Healthcare, Helsinki, Finland.