Trial Outcomes & Findings for A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Japanese Participants. Part A (P05957) (NCT NCT00591786)

Last Updated: 2019-03-15

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

100 participants

Primary outcome timeframe

Up to 269:45 (min:sec)

Results posted on

2019-03-15

Participant Flow

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 Post-tetanic 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 0.02-0.04 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 0.02-0.04 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 0.02-0.04 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 0.02-0.04 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 0.02-0.04 mg/kg if necessary
Overall Study STARTED	9	9	11	11	10	10	10	10	10	10
Overall Study Treated Participants	9	9	10	11	10	10	10	10	10	10
Overall Study COMPLETED	9	9	10	11	10	10	10	10	10	10
Overall Study NOT COMPLETED	0	0	1	0	0	0	0	0	0	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 Post-tetanic 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 0.02-0.04 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 0.02-0.04 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 0.02-0.04 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 0.02-0.04 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 0.02-0.04 mg/kg if necessary
Overall Study Withdrawal of Informed Consent	0	0	1	0	0	0	0	0	0	0

Baseline Characteristics

A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Japanese Participants. Part A (P05957)

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 Post-tetanic 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=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 (Rcocuronium) 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=10 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 0.02-0.04 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 0.02-0.04 mg/kg if necessary	Sugammadex 2.0 mg/kg (Vecuronium) n=10 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 0.02-0.04 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 0.02-0.04 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 0.02-0.04 mg/kg if necessary	Total n=99 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 13 • n=5 Participants	48 years STANDARD_DEVIATION 13 • n=7 Participants	45 years STANDARD_DEVIATION 13 • n=5 Participants	48 years STANDARD_DEVIATION 13 • n=4 Participants	44 years STANDARD_DEVIATION 13 • n=21 Participants	44 years STANDARD_DEVIATION 14 • n=10 Participants	51 years STANDARD_DEVIATION 10 • n=115 Participants	40 years STANDARD_DEVIATION 13 • n=6 Participants	38 years STANDARD_DEVIATION 11 • n=6 Participants	50 years STANDARD_DEVIATION 12 • n=64 Participants	45 years STANDARD_DEVIATION 13 • n=17 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	8 Participants n=21 Participants	4 Participants n=10 Participants	3 Participants n=115 Participants	5 Participants n=6 Participants	4 Participants n=6 Participants	5 Participants n=64 Participants	45 Participants n=17 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	2 Participants n=21 Participants	6 Participants n=10 Participants	7 Participants n=115 Participants	5 Participants n=6 Participants	6 Participants n=6 Participants	5 Participants n=64 Participants	54 Participants n=17 Participants
Ethnicity (NIH/OMB) Japanese · Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants
Ethnicity (NIH/OMB) Japanese · Not Hispanic or Latino	9 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants	10 Participants n=21 Participants	10 Participants n=10 Participants	10 Participants n=115 Participants	10 Participants n=6 Participants	10 Participants n=6 Participants	10 Participants n=64 Participants	99 Participants n=17 Participants
Ethnicity (NIH/OMB) Japanese · Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants

PRIMARY outcome

Timeframe: Up to 269:45 (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=6 Participants Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 Post-tetanic 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=7 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=5 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 0.02-0.04 mg/kg if necessary	Sugammadex 1.0 mg/kg (Vecuronium) n=7 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 0.02-0.04 mg/kg if necessary	Sugammadex 2.0 mg/kg (Vecuronium) n=10 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 0.02-0.04 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 0.02-0.04 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 0.02-0.04 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	66.90 Minutes Standard Deviation 34.63	4.73 Minutes Standard Deviation 1.73	3.43 Minutes Standard Deviation 2.52	1.58 Minutes Standard Deviation 0.88	1.32 Minutes Standard Deviation 0.57	79.48 Minutes Standard Deviation 46.23	39.82 Minutes Standard Deviation 45.77	16.02 Minutes Standard Deviation 42.20	3.05 Minutes Standard Deviation 2.38	2.93 Minutes Standard Deviation 3.77

SECONDARY outcome

Timeframe: Up to 152:30 (min:sec)

Population: The analysis population was the Per-Protocol (PP) group, which 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.

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=6 Participants Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 Post-tetanic 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=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=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=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 0.02-0.04 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 0.02-0.04 mg/kg if necessary	Sugammadex 2.0 mg/kg (Vecuronium) n=10 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 0.02-0.04 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 0.02-0.04 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 0.02-0.04 mg/kg if necessary
Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.7 for TOF Stimulation	34.45 Minutes Standard Deviation 32.12	4.38 Minutes Standard Deviation 2.32	2.48 Minutes Standard Deviation 2.00	1.07 Minutes Standard Deviation 0.20	1.03 Minutes Standard Deviation 0.32	56.82 Minutes Standard Deviation 35.47	8.30 Minutes Standard Deviation 10.90	3.18 Minutes Standard Deviation 3.72	1.95 Minutes Standard Deviation 1.35	1.33 Minutes Standard Deviation 0.58

SECONDARY outcome

Timeframe: Up to 194:45 (min:sec)

Outcome measures

Outcome measures
Measure	Sugammadex 0.5 mg/kg (Rocuronium) n=6 Participants Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 Post-tetanic 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=8 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=6 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 0.02-0.04 mg/kg if necessary	Sugammadex 1.0 mg/kg (Vecuronium) n=8 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 0.02-0.04 mg/kg if necessary	Sugammadex 2.0 mg/kg (Vecuronium) n=10 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 0.02-0.04 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 0.02-0.04 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 0.02-0.04 mg/kg if necessary
Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.8 for TOF Stimulation	46.78 Minutes Standard Deviation 30.85	4.33 Minutes Standard Deviation 1.85	2.98 Minutes Standard Deviation 2.17	1.33 Minutes Standard Deviation 0.58	1.13 Minutes Standard Deviation 0.40	73.25 Minutes Standard Deviation 45.65	22.60 Minutes Standard Deviation 27.90	6.02 Minutes Standard Deviation 11.83	2.22 Minutes Standard Deviation 1.48	1.42 Minutes Standard Deviation 0.53

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 Post-tetanic 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=9 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=10 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 0.02-0.04 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 0.02-0.04 mg/kg if necessary	Sugammadex 2.0 mg/kg (Vecuronium) n=10 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 0.02-0.04 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 0.02-0.04 mg/kg if necessary	Sugammadex 8.0 mg/kg (Vecuronium) n=10 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 0.02-0.04 mg/kg if necessary
Blood and lymphatic system disorders Disseminated intravascular coagulation	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% 0/9 • 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.	0.00% 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.	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.
Respiratory, thoracic and mediastinal disorders Epistaxis	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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Eye disorders Retinal detachment	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.	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% 0/10 • 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% 0/10 • 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% 0/10 • 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 Post-tetanic 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=9 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=10 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 0.02-0.04 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 0.02-0.04 mg/kg if necessary	Sugammadex 2.0 mg/kg (Vecuronium) n=10 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 0.02-0.04 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 0.02-0.04 mg/kg if necessary	Sugammadex 8.0 mg/kg (Vecuronium) n=10 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 0.02-0.04 mg/kg if necessary
Metabolism and nutrition disorders Decreased appetite	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% 0/9 • 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% 0/10 • 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% 0/10 • 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% 0/10 • 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 Infection	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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Infections and infestations Otitis media acute	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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Injury, poisoning and procedural complications Operative 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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Injury, poisoning and procedural complications Procedural hypotension	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% 0/9 • 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% 0/10 • 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% 0/10 • 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% 0/10 • 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 site reaction	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.	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% 0/10 • 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% 0/10 • 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% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Investigations Blood pressure 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% 0/9 • 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.	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% 0/10 • 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% 0/10 • 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 Oxygen saturation 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% 0/9 • 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% 0/10 • 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% 0/10 • 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% 0/10 • 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 Joint swelling	11.1% 1/9 • 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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Musculoskeletal and connective tissue disorders Joint warmth	11.1% 1/9 • 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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Injury, poisoning and procedural complications Postoperative wound complication	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.	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.	30.0% 3/10 • 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.	27.3% 3/11 • 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.	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.	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.	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.	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.
Musculoskeletal and connective tissue disorders Musculoskeletal 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.	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% 0/10 • 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% 0/10 • 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% 0/10 • 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 Musculoskeltal stiffness	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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Nervous system disorders Dizziness postural	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.	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% 0/10 • 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% 0/10 • 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% 0/10 • 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% 0/9 • 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.	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% 0/10 • 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% 0/10 • 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.
Respiratory, thoracic and mediastinal disorders Haemoptysis	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% 0/9 • 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% 0/10 • 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% 0/10 • 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% 0/10 • 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.	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% 0/10 • 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% 0/10 • 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% 0/10 • 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 Rhinorrhoea	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.	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.	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.	0.00% 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% 0/10 • 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.
Gastrointestinal disorders Constipation	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.	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.	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.	0.00% 0/10 • 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% 0/10 • 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% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Gastrointestinal disorders Diarrhoea	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.	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.	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% 0/10 • 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.	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.
Gastrointestinal disorders Hypoaesthesia oral	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% 0/9 • 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.	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% 0/10 • 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% 0/10 • 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.
Gastrointestinal disorders Mouth 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% 0/9 • 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.	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% 0/10 • 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% 0/10 • 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	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.	55.6% 5/9 • 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.	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.	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.	50.0% 5/10 • Number of events 6 • 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.	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.	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.	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.
Gastrointestinal disorders Palatal 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% 0/9 • 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% 0/10 • 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% 0/10 • 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.	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.
Gastrointestinal disorders Stomach discomfort	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% 0/9 • 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.	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% 0/10 • 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% 0/10 • 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.
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.	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.	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.	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.	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.	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.
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% 0/9 • 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.	0.00% 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% 0/10 • 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.
General disorders Injection site 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.	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% 0/10 • 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% 0/10 • 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% 0/10 • 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% 0/9 • 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% 0/10 • 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.	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% 0/10 • 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.	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.	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.	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.
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.	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.	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% 0/10 • 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% 0/10 • 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.	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.
Infections and infestations Nasopharyngitis	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% 0/9 • 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.	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% 0/10 • 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.
Injury, poisoning and procedural complications Incision site 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.	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.	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.	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% 0/10 • 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.	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.
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% 0/9 • 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% 0/10 • 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 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	0.00% 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% 0/10 • 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 Sputum 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% 0/9 • 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% 0/10 • 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% 0/10 • 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% 0/10 • 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.	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.	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% 0/10 • 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% 0/10 • 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.	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.
Musculoskeletal and connective tissue disorders Neck 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.	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.	0.00% 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% 0/10 • 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.
Injury, poisoning and procedural complications Procedural pain	88.9% 8/9 • Number of events 8 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	88.9% 8/9 • Number of events 9 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	80.0% 8/10 • Number of events 8 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	90.9% 10/11 • Number of events 10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	80.0% 8/10 • Number of events 8 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	70.0% 7/10 • Number of events 7 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	70.0% 7/10 • Number of events 7 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	70.0% 7/10 • Number of events 7 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	60.0% 6/10 • Number of events 7 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.	70.0% 7/10 • Number of events 7 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Investigations Albumin urine present	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% 0/9 • 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% 0/10 • 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% 0/10 • 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% 0/10 • 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 urine 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% 0/9 • 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.	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% 0/10 • 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% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Investigations Blood creatine phosphokinase 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% 0/9 • 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.	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% 0/10 • 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% 0/10 • 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 Back pain	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.	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.	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.	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.	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% 0/10 • 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.
Nervous system disorders Dizziness	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.	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% 0/10 • 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% 0/10 • 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.	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.
Nervous system disorders Headache	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.	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.	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.	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.	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% 0/10 • 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.
Nervous system disorders Hypoaesthesia	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.	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.	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.	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% 0/10 • 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% 0/10 • 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.
Psychiatric disorders Insomnia	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.	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.	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.	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.	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.
Respiratory, thoracic and mediastinal disorders Dysphonia	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% 0/9 • 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% 0/10 • 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.	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.	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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	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.	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.	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.	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% 0/10 • 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.	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.
Respiratory, thoracic and mediastinal disorders Epistaxis	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.	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.	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.	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.	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.
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% 0/9 • 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.	0.00% 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.	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.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal 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.	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.	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.	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.	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% 0/10 • 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.
Skin and subcutaneous tissue disorders Dermatitis contact	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.	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% 0/10 • 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% 0/10 • 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.	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.
Skin and subcutaneous tissue disorders Erythema	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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Skin and subcutaneous tissue disorders Pruritus	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% 0/9 • 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.	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.	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% 0/10 • 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% 0/10 • 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 Swelling face	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.	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% 0/10 • 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% 0/10 • 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% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Eye disorders Corneal 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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Eye disorders Lacrimation 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% 0/9 • 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.	0.00% 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% 0/10 • 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.
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% 0/9 • 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.	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% 0/10 • 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.
Gastrointestinal disorders Abdominal pain upper	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% 0/9 • 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.	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.	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% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Gastrointestinal disorders Aphthous stomatitis	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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Gastrointestinal disorders Proctalgia	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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Gastrointestinal disorders Stomatitis	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% 0/9 • 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.	0.00% 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% 0/10 • 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.
General disorders Catheter site 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% 0/9 • 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.	0.00% 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% 0/10 • 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.
General disorders Feeling hot	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% 0/9 • 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.	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% 0/10 • 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% 0/10 • 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.
General disorders Application site erythema	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% 0/9 • 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.	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% 0/10 • 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% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
General disorders Feeling abnormal	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.	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% 0/10 • 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% 0/10 • 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% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
General disorders Injection site swelling	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% 0/9 • 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.	0.00% 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% 0/10 • 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.
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% 0/9 • 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.	0.00% 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% 0/10 • 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 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% 0/9 • 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.	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% 0/10 • 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% 0/9 • 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.	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% 0/10 • 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 Beta 2 microglobulin 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% 0/9 • 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.	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% 0/10 • 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% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Investigations Blood alkaline phosphatase 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% 0/9 • 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.	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% 0/10 • 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 Blood urine present	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% 0/9 • 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.	0.00% 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% 0/10 • 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.
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% 0/9 • 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.	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% 0/10 • 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 Intraocular pressure 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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Musculoskeletal and connective tissue disorders Tendon 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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Nervous system disorders Dysgeusia	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% 0/9 • 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.	0.00% 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.	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.
Renal and urinary disorders Dysuria	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% 0/9 • 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.	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% 0/10 • 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.
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% 0/9 • 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.	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% 0/10 • 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% 0/10 • 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	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.	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.	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.	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 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.	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.	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.	50.0% 5/10 • 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.	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.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	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% 0/9 • 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.	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% 0/10 • 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% 0/10 • 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 discomfort	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% 0/9 • 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.	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% 0/10 • 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.	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.
Skin and subcutaneous tissue disorders Hyperhidrosis	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% 0/9 • 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.	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% 0/10 • 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.
Skin and subcutaneous tissue disorders Hypoaesthesia facial	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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Skin and subcutaneous tissue disorders Pustular psoriasis	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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	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% 0/9 • 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.	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% 0/10 • 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.
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.	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.	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% 0/10 • 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% 0/10 • 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% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Cardiac disorders Arrhythmia	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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Ear and labyrinth disorders Ear discomfort	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.	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% 0/10 • 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% 0/10 • 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% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Ear and labyrinth disorders Tympanic membrane perforation	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% 0/9 • 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% 0/10 • 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% 0/10 • 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% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Ear and labyrinth disorders Vertigo	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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Gastrointestinal disorders Abdominal distension	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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Gastrointestinal disorders Tooth socket 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% 0/9 • 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% 0/10 • 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% 0/10 • 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% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
General disorders Peripheral coldness	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% 0/9 • 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.	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% 0/10 • 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.
General disorders Thirst	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% 0/9 • 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.	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.	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% 0/10 • 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.	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.
Gastrointestinal disorders Dyspepsia	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% 0/9 • 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% 0/10 • 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% 0/10 • 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% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Gastrointestinal disorders Dysphagia	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% 0/9 • 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.	0.00% 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% 0/10 • 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% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Gastrointestinal disorders Odynophagia	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% 0/9 • 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% 0/10 • 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% 0/10 • 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% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Vascular disorders Deep vein 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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Vascular disorders 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% 0/9 • 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.	0.00% 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% 0/10 • 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.
Reproductive system and breast disorders Pelvic 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% 0/9 • 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% 0/10 • 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% 0/10 • 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% 0/10 • Up to 7 post-operative days All randomized participants who received at least one dose of study treatment and had follow-up.
Reproductive system and breast disorders Pruritus genital	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% 0/9 • 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% 0/10 • 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% 0/10 • 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% 0/10 • 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 Haemorrhage subcutaneous	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.	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.	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.	0.00% 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% 0/10 • 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.
General disorders 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% 0/9 • 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.	0.00% 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.	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.
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% 0/9 • 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% 0/10 • 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% 0/10 • 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% 0/10 • 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