Trial Outcomes & Findings for A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Caucasian Participants. Part B (P05974) (NCT NCT00552929)

Last Updated: 2019-03-05

Results Overview

Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached \>= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

102 participants

Primary outcome timeframe

Up to 131:40 (min:sec)

Results posted on

2019-03-05

Participant Flow

The trial was conducted in seven centers in Europe: one center in Belgium, one center in Denmark, three centers in France, and two centers in The Netherlands.

Participant milestones

Participant milestones
Measure	Sugammadex 0.5 mg/kg (Rocuronium) Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 1.0 mg/kg (Rocuronium) Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 2.0 mg/kg (Rocuronium) Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 4.0 mg/kg (Rocuronium) Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 8.0 mg/kg (Rocuronium) Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 0.5 mg/kg (Vecuronium) Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.	Sugammadex 1.0 mg/kg (Vecuronium) Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 2.0 mg/kg (Vecuronium) Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 4.0 mg/kg (Vecuronium) Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 8.0 mg/kg (Vecuronium) Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
Overall Study STARTED	9	10	10	11	10	10	10	11	10	11
Overall Study Participants as Treated	9	10	10	11	10	9	10	11	10	11
Overall Study COMPLETED	9	10	10	11	10	9	10	11	9	11
Overall Study NOT COMPLETED	0	0	0	0	0	1	0	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sugammadex 0.5 mg/kg (Rocuronium) Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 1.0 mg/kg (Rocuronium) Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 2.0 mg/kg (Rocuronium) Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 4.0 mg/kg (Rocuronium) Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 8.0 mg/kg (Rocuronium) Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 0.5 mg/kg (Vecuronium) Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.	Sugammadex 1.0 mg/kg (Vecuronium) Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 2.0 mg/kg (Vecuronium) Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 4.0 mg/kg (Vecuronium) Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 8.0 mg/kg (Vecuronium) Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
Overall Study Lost to Follow-up	0	0	0	0	0	0	0	0	1	0
Overall Study Not Eligible	0	0	0	0	0	1	0	0	0	0

Baseline Characteristics

A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Caucasian Participants. Part B (P05974)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugammadex 0.5 mg/kg (Rocuronium) n=9 Participants Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 1.0 mg/kg (Rocuronium) n=10 Participants Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 2.0 mg/kg (Rocuronium) n=10 Participants Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 4.0 mg/kg (Rocuronium) n=11 Participants Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 8.0 mg/kg (Rocuronium) n=10 Participants Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 0.5 mg/kg (Vecuronium) n=9 Participants Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.	Sugammadex 1.0 mg/kg (Vecuronium) n=10 Participants Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 2.0 mg/kg (Vecuronium) n=11 Participants Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 4.0 mg/kg (Vecuronium) n=10 Participants Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 8.0 mg/kg (Vecuronium) n=11 Participants Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Total n=101 Participants Total of all reporting groups
Age, Continuous	49 years STANDARD_DEVIATION 7 • n=99 Participants	42 years STANDARD_DEVIATION 9 • n=107 Participants	49 years STANDARD_DEVIATION 6 • n=206 Participants	51 years STANDARD_DEVIATION 13 • n=7 Participants	52 years STANDARD_DEVIATION 9 • n=31 Participants	44 years STANDARD_DEVIATION 14 • n=30 Participants	50 years STANDARD_DEVIATION 14 • n=3 Participants	54 years STANDARD_DEVIATION 6 • n=6 Participants	40 years STANDARD_DEVIATION 11 • n=114 Participants	50 years STANDARD_DEVIATION 9	48 years STANDARD_DEVIATION 11 • n=19 Participants
Sex: Female, Male Female	4 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants	6 Participants n=7 Participants	5 Participants n=31 Participants	4 Participants n=30 Participants	6 Participants n=3 Participants	4 Participants n=6 Participants	3 Participants n=114 Participants	5 Participants	44 Participants n=19 Participants
Sex: Female, Male Male	5 Participants n=99 Participants	8 Participants n=107 Participants	5 Participants n=206 Participants	5 Participants n=7 Participants	5 Participants n=31 Participants	5 Participants n=30 Participants	4 Participants n=3 Participants	7 Participants n=6 Participants	7 Participants n=114 Participants	6 Participants	57 Participants n=19 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	2 Participants n=19 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=99 Participants	9 Participants n=107 Participants	10 Participants n=206 Participants	11 Participants n=7 Participants	10 Participants n=31 Participants	9 Participants n=30 Participants	9 Participants n=3 Participants	11 Participants n=6 Participants	10 Participants n=114 Participants	11 Participants	99 Participants n=19 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants
American Society of Anaesthesiologists (ASA) Class ASA Class 1	6 Participants n=99 Participants	5 Participants n=107 Participants	2 Participants n=206 Participants	6 Participants n=7 Participants	5 Participants n=31 Participants	7 Participants n=30 Participants	8 Participants n=3 Participants	7 Participants n=6 Participants	9 Participants n=114 Participants	6 Participants	61 Participants n=19 Participants
American Society of Anaesthesiologists (ASA) Class ASA Class 2	3 Participants n=99 Participants	5 Participants n=107 Participants	7 Participants n=206 Participants	5 Participants n=7 Participants	5 Participants n=31 Participants	2 Participants n=30 Participants	2 Participants n=3 Participants	4 Participants n=6 Participants	1 Participants n=114 Participants	5 Participants	39 Participants n=19 Participants
American Society of Anaesthesiologists (ASA) Class ASA Class 3	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	1 Participants n=19 Participants

PRIMARY outcome

Timeframe: Up to 131:40 (min:sec)

Population: The analysis population consisted of all randomized and treated participants who had at least one post-baseline efficacy measurement, without any major or multiple minor protocol violations.

Outcome measures

Outcome measures
Measure	Sugammadex 0.5 mg/kg (Rocuronium) n=8 Participants Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 1.0 mg/kg (Rocuroniium) n=9 Participants Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 2.0 mg/kg (Rocuronium) n=10 Participants Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 4.0 mg/kg (Rocuronium) n=10 Participants Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 8.0 mg/kg (Rocuronium) n=10 Participants Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 0.5 mg/kg (Vecuronium) n=7 Participants Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.	Sugammadex 1.0 mg/kg (Vecuronium) n=9 Participants Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 2.0 mg/kg (Vecuronium) n=11 Participants Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 4.0 mg/kg (Vecuronium) n=8 Participants Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 8.0 mg/kg (Vecuronium) n=10 Participants Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.9 for Train-Of-Four (TOF) Stimulation	79.78 Minutes Standard Deviation 33.02	28.00 Minutes Standard Deviation 43.73	3.17 Minutes Standard Deviation 1.52	1.65 Minutes Standard Deviation 0.65	1.13 Minutes Standard Deviation 0.33	68.40 Minutes Standard Deviation 31.93	25.12 Minutes Standard Deviation 24.87	9.08 Minutes Standard Deviation 20.55	3.30 Minutes Standard Deviation 3.45	1.65 Minutes Standard Deviation 0.75

SECONDARY outcome

Timeframe: Up to 96:24 (min:sec)

Population: The analysis population consisted of all randomized and treated participants who had at least one post-baseline efficacy measurement, without any major protocol violation.

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.

Outcome measures

Outcome measures
Measure	Sugammadex 0.5 mg/kg (Rocuronium) n=8 Participants Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 1.0 mg/kg (Rocuroniium) n=10 Participants Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 2.0 mg/kg (Rocuronium) n=10 Participants Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 4.0 mg/kg (Rocuronium) n=10 Participants Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 8.0 mg/kg (Rocuronium) n=10 Participants Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 0.5 mg/kg (Vecuronium) n=8 Participants Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.	Sugammadex 1.0 mg/kg (Vecuronium) n=9 Participants Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 2.0 mg/kg (Vecuronium) n=11 Participants Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 4.0 mg/kg (Vecuronium) n=9 Participants Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 8.0 mg/kg (Vecuronium) n=10 Participants Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
Time From Start of Sugammadex Administration to a T4/T1 Recovery Ratio of 0.7	47.72 Minutes Standard Deviation 27.62	4.47 Minutes Standard Deviation 1.95	2.17 Minutes Standard Deviation 0.97	1.25 Minutes Standard Deviation 0.52	0.93 Minutes Standard Deviation 0.25	30.22 Minutes Standard Deviation 34.70	4.07 Minutes Standard Deviation 2.02	2.32 Minutes Standard Deviation 1.20	1.65 Minutes Standard Deviation 0.67	1.33 Minutes Standard Deviation 0.57

SECONDARY outcome

Timeframe: Up to 102:25 (min:sec)

Population: The analysis population consisted of all randomized participants who were given at least one administration of sugammadex and had at least one post-baseline efficacy measurement, without any major protocol violation.

Outcome measures

Outcome measures
Measure	Sugammadex 0.5 mg/kg (Rocuronium) n=8 Participants Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 1.0 mg/kg (Rocuroniium) n=10 Participants Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 2.0 mg/kg (Rocuronium) n=10 Participants Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 4.0 mg/kg (Rocuronium) n=10 Participants Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 8.0 mg/kg (Rocuronium) n=10 Participants Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 0.5 mg/kg (Vecuronium) n=7 Participants Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.	Sugammadex 1.0 mg/kg (Vecuronium) n=9 Participants Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 2.0 mg/kg (Vecuronium) n=11 Participants Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 4.0 mg/kg (Vecuronium) n=9 Participants Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 8.0 mg/kg (Vecuronium) n=10 Participants Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
Time From Start of Sugammadex Administration to a T4/T1 Recovery Ratio of 0.8	57.00 Minutes Standard Deviation 32.97	14.22 Minutes Standard Deviation 20.62	2.45 Minutes Standard Deviation 1.12	1.35 Minutes Standard Deviation 0.57	0.98 Minutes Standard Deviation 0.32	45.93 Minutes Standard Deviation 29.55	5.10 Minutes Standard Deviation 2.70	2.92 Minutes Standard Deviation 1.75	2.87 Minutes Standard Deviation 3.25	1.43 Minutes Standard Deviation 0.58

SECONDARY outcome

Timeframe: From Screening to 7 post-operative days

Population: All randomized participants who received at least one dose of study treatment and had follow-up.

The number of participants who had at least one AE during treatment and follow-up was assessed. An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	Sugammadex 0.5 mg/kg (Rocuronium) n=9 Participants Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 1.0 mg/kg (Rocuroniium) n=10 Participants Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 2.0 mg/kg (Rocuronium) n=10 Participants Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 4.0 mg/kg (Rocuronium) n=11 Participants Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 8.0 mg/kg (Rocuronium) n=10 Participants Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 0.5 mg/kg (Vecuronium) n=9 Participants Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.	Sugammadex 1.0 mg/kg (Vecuronium) n=10 Participants Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 2.0 mg/kg (Vecuronium) n=11 Participants Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 4.0 mg/kg (Vecuronium) n=10 Participants Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 8.0 mg/kg (Vecuronium) n=11 Participants Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
Number of Participants With An Adverse Event (AE)	6 Participants	8 Participants	8 Participants	10 Participants	8 Participants	6 Participants	6 Participants	7 Participants	6 Participants	8 Participants

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sugammadex 0.5 mg/kg (Rocuronium) n=9 participants at risk Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 1.0 mg/kg (Rocuronium) n=10 participants at risk Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 2.0 mg/kg (Rocuronium) n=10 participants at risk Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 4.0 mg/kg (Rocuronium) n=11 participants at risk Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 8.0 mg/kg (Rocuronium) n=10 participants at risk Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 0.5 mg/kg (Vecuronium) n=9 participants at risk Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.	Sugammadex 1.0 mg/kg (Vecuronium) n=10 participants at risk Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 2.0 mg/kg (Vecuronium) n=11 participants at risk Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 4.0 mg/kg (Vecuronium) n=10 participants at risk Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 8.0 mg/kg (Vecuronium) n=11 participants at risk Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
Infections and infestations Meningitis	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Nervous system disorders Convulsion	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 2 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Respiratory, thoracic and mediastinal disorders Tracheal stenosis	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Vascular disorders Wound haemorrhage	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.

Other adverse events

Other adverse events
Measure	Sugammadex 0.5 mg/kg (Rocuronium) n=9 participants at risk Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 1.0 mg/kg (Rocuronium) n=10 participants at risk Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 2.0 mg/kg (Rocuronium) n=10 participants at risk Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 4.0 mg/kg (Rocuronium) n=11 participants at risk Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 8.0 mg/kg (Rocuronium) n=10 participants at risk Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary	Sugammadex 0.5 mg/kg (Vecuronium) n=9 participants at risk Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.	Sugammadex 1.0 mg/kg (Vecuronium) n=10 participants at risk Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 2.0 mg/kg (Vecuronium) n=11 participants at risk Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 4.0 mg/kg (Vecuronium) n=10 participants at risk Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary	Sugammadex 8.0 mg/kg (Vecuronium) n=11 participants at risk Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
Blood and lymphatic system disorders Anaemia	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Eye disorders Conjunctival irritation	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Blood and lymphatic system disorders Leukocytosis	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Eye disorders Pupils unequal	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Gastrointestinal disorders Abdominal pain	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Gastrointestinal disorders Colitis	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Gastrointestinal disorders Vomiting	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	20.0% 2/10 • Number of events 2 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	20.0% 2/10 • Number of events 2 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	18.2% 2/11 • Number of events 2 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	30.0% 3/10 • Number of events 3 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 2 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Gastrointestinal disorders Constipation	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Gastrointestinal disorders Nausea	44.4% 4/9 • Number of events 5 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	40.0% 4/10 • Number of events 4 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	30.0% 3/10 • Number of events 3 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	27.3% 3/11 • Number of events 3 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	30.0% 3/10 • Number of events 3 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	30.0% 3/10 • Number of events 4 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	30.0% 3/10 • Number of events 3 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	27.3% 3/11 • Number of events 3 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
General disorders Chills	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
General disorders Fatigue	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
General disorders Malaise	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
General disorders Oedema peripheral	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
General disorders Non-cardiac chest pain	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
General disorders Pain	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	20.0% 2/10 • Number of events 2 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	18.2% 2/11 • Number of events 3 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	20.0% 2/10 • Number of events 2 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	18.2% 2/11 • Number of events 2 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
General disorders Pyrexia	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	22.2% 2/9 • Number of events 2 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Infections and infestations Cystitis	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Infections and infestations Rhinitis	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Injury, poisoning and procedural complications Anaesthetic complication	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 2 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Injury, poisoning and procedural complications Fall	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Injury, poisoning and procedural complications Medication error	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 2 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Injury, poisoning and procedural complications Neuromuscular block prolonged	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Injury, poisoning and procedural complications Operative haemorrhage	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Injury, poisoning and procedural complications Post procedural headache	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Injury, poisoning and procedural complications Post procedural oedema	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Injury, poisoning and procedural complications Postoperative fever	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Injury, poisoning and procedural complications Postoperative thrombosis	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Injury, poisoning and procedural complications Procedural hypertension	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	18.2% 2/11 • Number of events 2 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Injury, poisoning and procedural complications Procedural hypotension	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 2 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	18.2% 2/11 • Number of events 2 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	27.3% 3/11 • Number of events 3 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Injury, poisoning and procedural complications Procedural pain	33.3% 3/9 • Number of events 3 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	40.0% 4/10 • Number of events 5 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	20.0% 2/10 • Number of events 2 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	36.4% 4/11 • Number of events 4 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	30.0% 3/10 • Number of events 4 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	30.0% 3/10 • Number of events 3 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	27.3% 3/11 • Number of events 3 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	30.0% 3/10 • Number of events 4 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	27.3% 3/11 • Number of events 3 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Injury, poisoning and procedural complications Wound complication	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Injury, poisoning and procedural complications Wound secretion	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Investigations Alanine aminotransferase increased	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Investigations Aspartate aminotransferase increased	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Investigations Beta 2 microglobulin increased	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Investigations Gamma-glutamyltransferase increased	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Investigations Urine output decreased	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	18.2% 2/11 • Number of events 2 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Musculoskeletal and connective tissue disorders Shoulder pain	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Nervous system disorders Ageusia	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Nervous system disorders Dizziness	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Nervous system disorders Headache	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Nervous system disorders Nystagmus	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Nervous system disorders Paraesthesia	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Nervous system disorders Somnolence	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Psychiatric disorders Anxiety	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Psychiatric disorders Hallucination	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Psychiatric disorders Insomnia	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	20.0% 2/10 • Number of events 3 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Psychiatric disorders Sleep disorder	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Renal and urinary disorders Urinary retention	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	9.1% 1/11 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Respiratory, thoracic and mediastinal disorders Respiratory depression	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	10.0% 1/10 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Vascular disorders Haemorrhage	11.1% 1/9 • Number of events 1 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 0/11 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any scientific paper, presentation, or other communication concerning the clinical trial described in the protocol will first be submitted to Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
Publication restrictions are in place

Restriction type: OTHER