Trial Outcomes & Findings for Efficacy and Safety of Sugammadex Dosed According to Actual Body Weight (ABW) or Ideal Body Weight (IBW) in Reversal of Neuromuscular Blockade (NMB) in Morbidly Obese Participants (MK-8616-146) (NCT NCT03346070)

NCT ID: NCT03346070

Last Updated: 2021-01-28

Results Overview

The primary efficacy analysis of TTR of TOF ratio to ≥0.9 was performed by estimating event rates within each treatment group using the Kaplan-Meier method. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 207 participants
• Primary outcome timeframe: Up to 76 minutes
• Results posted on: 2021-01-28

Participant Flow

Participant milestones

Measure	Sugammadex 2 mg/kg Actual Body Weight (ABW) Following administration of NMBA, participants received a single intravenous (i.v.) bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg ABW Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex 2 mg/kg Ideal Body Weight (IBW) Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg IBW Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Neostigmine/Glycopyrrolate Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
Overall Study STARTED	41	41	41	42	42
Overall Study Treated	38	38	38	36	38
Overall Study COMPLETED	38	37	37	36	37
Overall Study NOT COMPLETED	3	4	4	6	5

Reasons for withdrawal

Measure	Sugammadex 2 mg/kg Actual Body Weight (ABW) Following administration of NMBA, participants received a single intravenous (i.v.) bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg ABW Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex 2 mg/kg Ideal Body Weight (IBW) Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg IBW Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Neostigmine/Glycopyrrolate Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
Overall Study Death	0	0	0	0	1
Overall Study Lost to Follow-up	0	1	2	0	0
Overall Study Physician Decision	0	0	0	1	1
Overall Study Withdrawal by Subject	1	0	0	1	0
Overall Study Study medication not received as planned	2	3	2	3	2
Overall Study Screen Failure	0	0	0	1	1

Baseline Characteristics

Efficacy and Safety of Sugammadex Dosed According to Actual Body Weight (ABW) or Ideal Body Weight (IBW) in Reversal of Neuromuscular Blockade (NMB) in Morbidly Obese Participants (MK-8616-146)

Baseline characteristics by cohort

Measure	Sugammadex 2 mg/kg ABW n=41 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg ABW n=41 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex 2 mg/kg IBW n=41 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg IBW n=42 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Neostigmine/Glycopyrrolate n=42 Participants Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.	Total n=207 Participants Total of all reporting groups
Age, Continuous	47.7 Years STANDARD_DEVIATION 14.4 • n=5 Participants	46.4 Years STANDARD_DEVIATION 11.2 • n=7 Participants	47.6 Years STANDARD_DEVIATION 14.5 • n=5 Participants	49.2 Years STANDARD_DEVIATION 11.7 • n=4 Participants	47.7 Years STANDARD_DEVIATION 13.3 • n=21 Participants	47.7 Years STANDARD_DEVIATION 13.0 • n=10 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	24 Participants n=7 Participants	30 Participants n=5 Participants	32 Participants n=4 Participants	29 Participants n=21 Participants	149 Participants n=10 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	17 Participants n=7 Participants	11 Participants n=5 Participants	10 Participants n=4 Participants	13 Participants n=21 Participants	58 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	13 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	37 Participants n=7 Participants	40 Participants n=5 Participants	37 Participants n=4 Participants	39 Participants n=21 Participants	191 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	14 Participants n=10 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants	39 Participants n=7 Participants	37 Participants n=5 Participants	38 Participants n=4 Participants	38 Participants n=21 Participants	191 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants

PRIMARY outcome

Timeframe: Up to 76 minutes

Population: All randomized participants dosed with both an NMBA and an NMB reversal agent (study treatment) with ≥1 post-randomization efficacy assessment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.

The primary efficacy analysis of TTR of TOF ratio to ≥0.9 was performed by estimating event rates within each treatment group using the Kaplan-Meier method. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).

Outcome measures

Measure	Sugammadex 2 mg/kg ABW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg ABW n=37 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) n=75 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Sugammadex 2 mg/kg IBW n=37 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg IBW n=36 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) n=73 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Neostigmine/Glycopyrrolate n=38 Participants Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
Time to Recovery (TTR) of Participant Train Of Four (TOF) Ratio to ≥0.9: Primary Kaplan-Meier Analysis	1.7 Minutes Interval 1.5 to 2.1	1.8 Minutes Interval 1.5 to 2.1	1.8 Minutes Interval 1.6 to 2.1	3.4 Minutes Interval 2.2 to 4.4	3.3 Minutes Interval 2.4 to 4.2	3.3 Minutes Interval 2.6 to 4.1	34.5 Minutes Interval 27.0 to 67.4

PRIMARY outcome

Timeframe: Up to 35 minutes

Population: All randomized participants who received at least one dose of study treatment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.

The percentage of participants experiencing treatment-emergent bradycardia events were identified with continuous electrocardiogram (ECG) monitoring. Treatment-emergent sinus bradycardia is defined as a heart rate <60 bpm that has also decreased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus bradycardia events may or may not be considered an adverse event (AE), as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).

Outcome measures

Measure	Sugammadex 2 mg/kg ABW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg ABW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) n=76 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Sugammadex 2 mg/kg IBW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg IBW n=36 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) n=74 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Neostigmine/Glycopyrrolate n=38 Participants Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events	5.3 Percentage of participants	5.3 Percentage of participants	5.3 Percentage of participants	2.6 Percentage of participants	5.6 Percentage of participants	4.1 Percentage of participants	2.6 Percentage of participants

PRIMARY outcome

Timeframe: Up to 35 minutes

Population: All randomized participants who received at least one dose of study treatment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.

The percentage of participants experiencing treatment-emergent sinus tachycardia events were identified with continuous ECG monitoring. Treatment-emergent sinus tachycardia is defined as a heart rate ≥100 bpm that has also increased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus tachycardia events may or may not be considered an AE, as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).

Outcome measures

Measure	Sugammadex 2 mg/kg ABW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg ABW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) n=76 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Sugammadex 2 mg/kg IBW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg IBW n=36 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) n=74 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Neostigmine/Glycopyrrolate n=38 Participants Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events	10.5 Percentage of participants	13.2 Percentage of participants	11.8 Percentage of participants	7.9 Percentage of participants	2.8 Percentage of participants	5.4 Percentage of participants	7.9 Percentage of participants

PRIMARY outcome

Timeframe: Up to 35 minutes

Population: All randomized participants who received at least one dose of study treatment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.

The percentage of participants experiencing other treatment-emergent cardiac arrhythmia events were identified with continuous ECG monitoring. Other treatment-emergent cardiac arrhythmias are defined as new or worsening arrhythmias (e.g., atrial fibrillation, atrial tachyarrhythmia, ventricular fibrillation, or ventricular tachyarrhythmia), sustained for at least 1 minute after administration of study intervention. Worsening arrhythmia events may or may not be considered an AE, as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).

Outcome measures

Measure	Sugammadex 2 mg/kg ABW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg ABW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) n=76 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Sugammadex 2 mg/kg IBW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg IBW n=36 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) n=74 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Neostigmine/Glycopyrrolate n=38 Participants Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	2.6 Percentage of participants	0.0 Percentage of participants	1.4 Percentage of participants	2.6 Percentage of participants

PRIMARY outcome

Timeframe: Up to 7 days

Population: All randomized participants who received at least one dose of study treatment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.

The percentage of participants experiencing an AE following administration of study intervention was monitored. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study treatment is also considered an AE. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).

Outcome measures

Measure	Sugammadex 2 mg/kg ABW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg ABW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) n=76 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Sugammadex 2 mg/kg IBW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg IBW n=36 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) n=74 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Neostigmine/Glycopyrrolate n=38 Participants Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
Percentage of Participants Experiencing an Adverse Event (AE) After Administration of Study Intervention	94.7 Percentage of participants	86.8 Percentage of participants	90.8 Percentage of participants	94.7 Percentage of participants	91.7 Percentage of participants	93.2 Percentage of participants	89.5 Percentage of participants

PRIMARY outcome

Timeframe: Up to 7 days

Population: All randomized participants who received at least one dose of study treatment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.

The percentage of participants experiencing an SAE following administration of study intervention was monitored. An SAE is an adverse event that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially requiring medical or surgical intervention. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).

Outcome measures

Measure	Sugammadex 2 mg/kg ABW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg ABW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) n=76 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Sugammadex 2 mg/kg IBW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg IBW n=36 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) n=74 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Neostigmine/Glycopyrrolate n=38 Participants Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
Percentage of Participants Experiencing a Serious Adverse Event (SAE) After Administration of Study Intervention	2.6 Percentage of participants	0.0 Percentage of participants	1.3 Percentage of participants	5.3 Percentage of participants	8.3 Percentage of participants	6.8 Percentage of participants	7.9 Percentage of participants

PRIMARY outcome

Timeframe: Up to 7 days

Population: All randomized participants who received at least one dose of study treatment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.

The percentage of participants experiencing an ECI following administration of study intervention was monitored. ECIs are a discrete set of both AEs and SAEs, specifically designated as such for the trial. For the purposes of this investigation, ECIs included 1) drug-induced liver injury; 2) clinically-relevant arrhythmias, inclusive of bradycardia and tachycardia defined as events necessitating intervention, as determined by investigator judgment; and 3) instances of hypersensitivity and/or anaphylaxis adjudicated by an external expert Adjudication Committee. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).

Outcome measures

Measure	Sugammadex 2 mg/kg ABW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg ABW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) n=76 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Sugammadex 2 mg/kg IBW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg IBW n=36 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) n=74 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Neostigmine/Glycopyrrolate n=38 Participants Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
Percentage of Participants Experiencing an Event of Clinical Interest (ECI) After Administration of Study Intervention	0.0 Percentage of participants	2.6 Percentage of participants	1.3 Percentage of participants	2.6 Percentage of participants	2.8 Percentage of participants	2.7 Percentage of participants	2.6 Percentage of participants

SECONDARY outcome

Timeframe: Up to 76 minutes

Population: All randomized participants dosed with both an NMBA and an NMB reversal agent (study treatment) with ≥1 post-randomization efficacy assessment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.

Following administration of study intervention, the percentage of participants experiencing prolonged (>10 minutes) recovery to a TOF ratio ≥0.9 was calculated. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).

Outcome measures

Measure	Sugammadex 2 mg/kg ABW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg ABW n=37 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) n=75 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Sugammadex 2 mg/kg IBW n=37 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg IBW n=36 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) n=73 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Neostigmine/Glycopyrrolate n=38 Participants Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
Percentage of Participants With Prolonged (>10 Minutes) Time to Recovery (TTR) of the Train Of Four (TOF) Ratio to ≥0.9	7.9 Percentage of participants	2.7 Percentage of participants	5.3 Percentage of participants	5.4 Percentage of participants	0.0 Percentage of participants	2.7 Percentage of participants	84.2 Percentage of participants

SECONDARY outcome

Timeframe: Up to 76 minutes

Population: All randomized participants dosed with both an NMBA and an NMB reversal agent (study treatment) with ≥1 post-randomization efficacy assessment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.

The secondary efficacy analysis of TTR of participant TOF ratio to ≥0.9 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).

Outcome measures

Measure	Sugammadex 2 mg/kg ABW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg ABW n=37 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) n=75 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Sugammadex 2 mg/kg IBW n=37 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg IBW n=36 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) n=73 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Neostigmine/Glycopyrrolate n=38 Participants Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.9: Secondary Geometric Mean Analysis	2.0 Minutes Interval 1.7 to 2.5	1.9 Minutes Interval 1.5 to 2.3	2.0 Minutes Interval 1.7 to 2.3	3.2 Minutes Interval 2.6 to 3.9	3.5 Minutes Interval 2.9 to 4.3	3.3 Minutes Interval 2.9 to 3.8	23.1 Minutes Interval 18.3 to 29.2

SECONDARY outcome

Timeframe: Up to 69 minutes

Population: All randomized participants dosed with both an NMBA and an NMB reversal agent (study treatment) with ≥1 post-randomization efficacy assessment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.

The efficacy analysis of TTR of participant TOF ratio to ≥0.8 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.8 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).

Outcome measures

Measure	Sugammadex 2 mg/kg ABW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg ABW n=37 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) n=75 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Sugammadex 2 mg/kg IBW n=37 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg IBW n=36 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) n=73 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Neostigmine/Glycopyrrolate n=38 Participants Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.8: Geometric Mean Analysis	1.6 Minutes Interval 1.3 to 1.8	1.5 Minutes Interval 1.2 to 1.7	1.5 Minutes Interval 1.3 to 1.7	2.5 Minutes Interval 2.1 to 2.9	2.6 Minutes Interval 2.1 to 3.1	2.5 Minutes Interval 2.2 to 2.8	16.6 Minutes Interval 12.8 to 21.7

SECONDARY outcome

Timeframe: Up to 61 minutes

Population: All randomized participants dosed with both an NMBA and an NMB reversal agent (study treatment) with ≥1 post-randomization efficacy assessment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.

The efficacy analysis of TTR of participant TOF ratio to ≥0.7 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.7 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).

Outcome measures

Measure	Sugammadex 2 mg/kg ABW n=38 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg ABW n=37 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) n=75 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Sugammadex 2 mg/kg IBW n=37 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg IBW n=36 Participants Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) n=73 Participants Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.	Neostigmine/Glycopyrrolate n=38 Participants Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.7: Geometric Mean Analysis	1.4 Minutes Interval 1.2 to 1.6	1.3 Minutes Interval 1.2 to 1.6	1.4 Minutes Interval 1.2 to 1.5	2.1 Minutes Interval 1.8 to 2.4	2.0 Minutes Interval 1.7 to 2.5	2.1 Minutes Interval 1.8 to 2.3	10.9 Minutes Interval 8.1 to 14.6

Adverse Events

Sugammadex 2 mg/kg ABW

Serious events: 1 serious events

Other events: 36 other events

Deaths: 0 deaths

Sugammadex 4 mg/kg ABW

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Sugammadex 2 mg/kg IBW

Serious events: 3 serious events

Other events: 36 other events

Deaths: 0 deaths

Sugammadex 4 mg/kg IBW

Serious events: 4 serious events

Other events: 32 other events

Deaths: 0 deaths

Neostigmine + Glycopyrrolate

Serious events: 3 serious events

Other events: 32 other events

Deaths: 1 deaths

Serious adverse events

Measure	Sugammadex 2 mg/kg ABW n=38 participants at risk Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg ABW n=38 participants at risk Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex 2 mg/kg IBW n=38 participants at risk Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg IBW n=36 participants at risk Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Neostigmine + Glycopyrrolate n=38 participants at risk Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
Cardiac disorders Cardiovascular insufficiency	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/36 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Cardiac disorders Myocardial infarction	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/36 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Cardiac disorders Tachyarrhythmia	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/36 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/36 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
General disorders Impaired healing	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.8% 1/36 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Infections and infestations Device related infection	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/36 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Infections and infestations Pneumonia	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.8% 1/36 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Infections and infestations Postoperative wound infection	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/36 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Postoperative wound complication	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.8% 1/36 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Borderline ovarian tumour	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.8% 1/36 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/36 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.

Other adverse events

Measure	Sugammadex 2 mg/kg ABW n=38 participants at risk Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg ABW n=38 participants at risk Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Sugammadex 2 mg/kg IBW n=38 participants at risk Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.	Sugammadex 4 mg/kg IBW n=36 participants at risk Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.	Neostigmine + Glycopyrrolate n=38 participants at risk Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
Blood and lymphatic system disorders Anaemia	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.6% 2/36 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.6% 2/36 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Cardiac disorders Bradycardia	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	8.3% 3/36 • Number of events 3 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Cardiac disorders Cardiovascular disorder	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.8% 1/36 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Cardiac disorders Sinus tachycardia	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	7.9% 3/38 • Number of events 3 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.8% 1/36 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Cardiac disorders Tachycardia	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	10.5% 4/38 • Number of events 4 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	7.9% 3/38 • Number of events 3 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.6% 2/36 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Constipation	10.5% 4/38 • Number of events 4 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	13.2% 5/38 • Number of events 5 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	11.1% 4/36 • Number of events 4 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/36 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	15.8% 6/38 • Number of events 6 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	23.7% 9/38 • Number of events 10 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	26.3% 10/38 • Number of events 13 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	16.7% 6/36 • Number of events 6 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	18.4% 7/38 • Number of events 7 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Short-bowel syndrome	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	7.9% 3/38 • Number of events 3 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/36 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.6% 2/36 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
General disorders Oedema peripheral	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/36 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
General disorders Pyrexia	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.6% 2/36 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Anaemia postoperative	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.6% 2/36 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Incision site pain	15.8% 6/38 • Number of events 6 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	10.5% 4/38 • Number of events 4 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.6% 2/36 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	7.9% 3/38 • Number of events 3 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Neuromuscular block prolonged	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/36 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Procedural nausea	23.7% 9/38 • Number of events 10 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	21.1% 8/38 • Number of events 8 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	10.5% 4/38 • Number of events 4 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	11.1% 4/36 • Number of events 4 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	13.2% 5/38 • Number of events 5 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Procedural pain	73.7% 28/38 • Number of events 30 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	60.5% 23/38 • Number of events 23 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	73.7% 28/38 • Number of events 31 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	75.0% 27/36 • Number of events 27 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	63.2% 24/38 • Number of events 25 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Procedural vomiting	5.3% 2/38 • Number of events 3 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/36 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Investigations Blood pressure increased	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.8% 1/36 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Investigations Heart rate increased	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/36 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.3% 2/38 • Number of events 3 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Investigations Oxygen saturation decreased	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/36 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	13.2% 5/38 • Number of events 5 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.8% 1/36 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/36 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.8% 1/36 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Metabolic acidosis	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/36 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Nervous system disorders Dizziness	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	7.9% 3/38 • Number of events 3 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.8% 1/36 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Nervous system disorders Headache	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.6% 2/36 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Nervous system disorders Syncope	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.6% 2/36 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Psychiatric disorders Insomnia	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.6% 2/36 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	7.9% 3/38 • Number of events 3 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Urinary retention	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/36 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	7.9% 3/38 • Number of events 3 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/36 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.6% 2/36 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/36 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/38 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Vascular disorders Hypertension	2.6% 1/38 • Number of events 1 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	7.9% 3/38 • Number of events 3 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.3% 2/38 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	5.6% 2/36 • Number of events 2 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.	7.9% 3/38 • Number of events 4 • Up to 14 days Analysis population consisted of all randomized participants who received at least one dose of study treatment.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
• Publication restrictions are in place

Restriction type: OTHER