Trial Outcomes & Findings for Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017) (NCT NCT00475215)

Last Updated: 2019-04-12

Results Overview

The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.9 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four \[TOF\] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

86 participants

Primary outcome timeframe

Up to 90 minutes

Results posted on

2019-04-12

Participant Flow

Participants were enrolled at 9 study sites in the United States.

Participant milestones

Participant milestones
Measure	Rocuronium + Sugammadex 2.0 mg/kg After the intravenous (IV) intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg.	Rocuronium + Sugammadex 4.0 mg/kg After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
Overall Study STARTED	44	42
Overall Study Treated	39	38
Overall Study COMPLETED	39	38
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rocuronium + Sugammadex 2.0 mg/kg n=39 Participants After the intravenous (IV) intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg.	Rocuronium + Sugammadex 4.0 mg/kg n=38 Participants After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.	Total n=77 Participants Total of all reporting groups
Age, Continuous	49 Years STANDARD_DEVIATION 17 • n=5 Participants	46 Years STANDARD_DEVIATION 14 • n=7 Participants	47 Years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	27 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 90 minutes

Population: All randomized participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure. For 11 participants (2.0 mg/kg n=6 and 4.0 mg/kg n=5), data were missing due to watch malfunction (n=2), the data that was obtained was considered unreliable (n=6), or the watch was removed prior to recovery to 0.9 (n=3).

Outcome measures

Outcome measures
Measure	Rocuronium + Sugammadex 2.0 mg/kg n=33 Participants After the intravenous (IV) intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg.	Rocuronium + Sugammadex 4.0 mg/kg n=33 Participants After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.9 in Participants With or Having a Past History of Pulmonary Disease	2.42 Minutes Standard Deviation 1.93	2.1 Minutes Standard Deviation 1.8

PRIMARY outcome

Timeframe: Up to 7 days

Population: All randomized participants who received sugammadex are included.

The percentage of participants experiencing ≥1 AE(s) was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Outcome measures

Outcome measures
Measure	Rocuronium + Sugammadex 2.0 mg/kg n=39 Participants After the intravenous (IV) intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg.	Rocuronium + Sugammadex 4.0 mg/kg n=38 Participants After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
Percentage of Participants Experiencing ≥1 Adverse Event(s) (AE)	97.4 Percentage of Participants	94.7 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 7 days

Population: All randomized participants who received sugammadex are included.

The percentage of participants discontinuing from study treatment due to an AE was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Outcome measures

Outcome measures
Measure	Rocuronium + Sugammadex 2.0 mg/kg n=39 Participants After the intravenous (IV) intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg.	Rocuronium + Sugammadex 4.0 mg/kg n=38 Participants After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event (AE)	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 90 minutes

Population: All randomized participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure. For 6 participants (2.0 mg/kg n=3 and 4.0 mg/kg n=3), data were unavailable due to TOF-Watch® malfunction (n=2), or the data that was obtained was considered unreliable (n=4).

The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.7 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four \[TOF\] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.

Outcome measures

Outcome measures
Measure	Rocuronium + Sugammadex 2.0 mg/kg n=36 Participants After the intravenous (IV) intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg.	Rocuronium + Sugammadex 4.0 mg/kg n=35 Participants After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.7 in Participants With or Having a Past History of Pulmonary Disease	1.5 Minutes Standard Deviation 0.55	1.35 Minutes Standard Deviation 0.45

SECONDARY outcome

Timeframe: Up to 90 minutes

Population: All randomized participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure. For 7 participants (2.0 mg/kg n=4 and 4.0 mg/kg n=3), data were unavailable due to TOF-Watch® malfunction (n=2), or the data that was obtained was considered unreliable (n=5).

The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.8 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four \[TOF\] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.

Outcome measures

Outcome measures
Measure	Rocuronium + Sugammadex 2.0 mg/kg n=35 Participants After the intravenous (IV) intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg.	Rocuronium + Sugammadex 4.0 mg/kg n=35 Participants After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.8 in Participants With or Having a Past History of Pulmonary Disease	1.8 Minutes Standard Deviation 0.82	1.62 Minutes Standard Deviation 0.65

SECONDARY outcome

Timeframe: Up to 6 hours (prior to transfer to the recovery room after extubation)

Population: All randomized participants who received sugammadex and had ≥1 post-baseline assessment for the outcome measure. One participant in the 4.0 mg/kg group had missing data.

The level of consciousness prior to transfer to the recovery room was determined by the clinician for each participant. Each participants was assigned 1 of 3 potential levels of consciousness: 1) awake and oriented; 2) arousable with minimal stimulation; or 3) responsive only to tactile stimulation.

Outcome measures

Outcome measures
Measure	Rocuronium + Sugammadex 2.0 mg/kg n=39 Participants After the intravenous (IV) intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg.	Rocuronium + Sugammadex 4.0 mg/kg n=38 Participants After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation Awake and oriented	17 Participants	22 Participants
Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation Arousable with minimal stimulation	16 Participants	13 Participants
Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation Responsive only to tactile stimulation	6 Participants	2 Participants
Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation Missing data	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 6 hours (prior to discharge from the recovery room)

Population: All randomized participants who received sugammadex and had ≥1 post-baseline assessment for the outcome measure.

The level of consciousness prior to discharge from the recovery room was determined by the clinician for each participant. Each participants was assigned 1 of 3 potential levels of consciousness: 1) awake and oriented; 2) arousable with minimal stimulation; or 3) responsive only to tactile stimulation.

Outcome measures

Outcome measures
Measure	Rocuronium + Sugammadex 2.0 mg/kg n=39 Participants After the intravenous (IV) intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg.	Rocuronium + Sugammadex 4.0 mg/kg n=38 Participants After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room Awake and oriented	38 Participants	38 Participants
Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room Arousable with minimal stimulation	1 Participants	0 Participants
Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room Responsive only to tactile stimulation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 6 hours (prior to transfer to the recovery room after extubation)

Population: All randomized and cooperative participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure.

The ability of each cooperative (based on clinician determination) participant to perform a 5-second head lift was determined by the clinician. Participants were rated as either able or not able to complete the head lift task.

Outcome measures

Outcome measures
Measure	Rocuronium + Sugammadex 2.0 mg/kg n=28 Participants After the intravenous (IV) intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg.	Rocuronium + Sugammadex 4.0 mg/kg n=34 Participants After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
Five-Second Head Lift Assessment 1: Prior to Transfer to the Recovery Room Following Extubation Able to perform	23 Participants	29 Participants
Five-Second Head Lift Assessment 1: Prior to Transfer to the Recovery Room Following Extubation Not able to perform	5 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 6 hours (prior to discharge from the recovery room)

Population: All randomized and cooperative participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure.

Outcome measures

Outcome measures
Measure	Rocuronium + Sugammadex 2.0 mg/kg n=39 Participants After the intravenous (IV) intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg.	Rocuronium + Sugammadex 4.0 mg/kg n=38 Participants After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
Five-Second Head Lift Assessment 2: Prior to Discharge From the Recovery Room Able to perform	39 Participants	37 Participants
Five-Second Head Lift Assessment 2: Prior to Discharge From the Recovery Room Not able to perform	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 6 hours (prior to transfer to the recovery room after extubation)

Population: All randomized and cooperative participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure.

Each cooperative (based on clinician determination) participant was assessed by a clinician to determine if there was muscle weakness. Participants were rated as having or not having muscle weakness by the clinician.

Outcome measures

Outcome measures
Measure	Rocuronium + Sugammadex 2.0 mg/kg n=28 Participants After the intravenous (IV) intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg.	Rocuronium + Sugammadex 4.0 mg/kg n=34 Participants After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
General Muscle Weakness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation Muscle Weakness	3 Participants	4 Participants
General Muscle Weakness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation No Muscle Weakness	25 Participants	30 Participants

SECONDARY outcome

Timeframe: Up to 6 hours (prior to discharge from the recovery room)

Population: All randomized and cooperative participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure.

Outcome measures

Outcome measures
Measure	Rocuronium + Sugammadex 2.0 mg/kg n=39 Participants After the intravenous (IV) intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg.	Rocuronium + Sugammadex 4.0 mg/kg n=38 Participants After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
General Muscle Weakness Assessment 2: Prior to Discharge From the Recovery Room Muscle Weakness	4 Participants	6 Participants
General Muscle Weakness Assessment 2: Prior to Discharge From the Recovery Room No Muscle Weakness	35 Participants	32 Participants

Adverse Events

Rocuronium + Sugammadex 2.0 mg

Serious events: 4 serious events

Other events: 38 other events

Deaths: 0 deaths

Rocuronium + Sugammadex 4.0 mg

Serious events: 3 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rocuronium + Sugammadex 2.0 mg n=39 participants at risk After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg.	Rocuronium + Sugammadex 4.0 mg n=38 participants at risk After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
Cardiac disorders Coronary artery disease	2.6% 1/39 • Number of events 1 • Up to 7 days All randomized participants who received sugammadex are included.	0.00% 0/38 • Up to 7 days All randomized participants who received sugammadex are included.
Gastrointestinal disorders Constipation	2.6% 1/39 • Number of events 1 • Up to 7 days All randomized participants who received sugammadex are included.	0.00% 0/38 • Up to 7 days All randomized participants who received sugammadex are included.
Injury, poisoning and procedural complications Operative haemorrhage	2.6% 1/39 • Number of events 1 • Up to 7 days All randomized participants who received sugammadex are included.	0.00% 0/38 • Up to 7 days All randomized participants who received sugammadex are included.
Injury, poisoning and procedural complications Seroma	0.00% 0/39 • Up to 7 days All randomized participants who received sugammadex are included.	2.6% 1/38 • Number of events 1 • Up to 7 days All randomized participants who received sugammadex are included.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/39 • Up to 7 days All randomized participants who received sugammadex are included.	5.3% 2/38 • Number of events 2 • Up to 7 days All randomized participants who received sugammadex are included.
Vascular disorders Poor peripheral circulation	2.6% 1/39 • Number of events 1 • Up to 7 days All randomized participants who received sugammadex are included.	0.00% 0/38 • Up to 7 days All randomized participants who received sugammadex are included.

Other adverse events

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 such scientific paper, presentation, or other communication concerning the clinical trial described in this protocol will first be submitted to the 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

Measure	Rocuronium + Sugammadex 2.0 mg n=39 participants at risk After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg.	Rocuronium + Sugammadex 4.0 mg n=38 participants at risk After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
Gastrointestinal disorders Constipation	7.7% 3/39 • Number of events 3 • Up to 7 days All randomized participants who received sugammadex are included.	7.9% 3/38 • Number of events 3 • Up to 7 days All randomized participants who received sugammadex are included.
Gastrointestinal disorders Flatulence	10.3% 4/39 • Number of events 5 • Up to 7 days All randomized participants who received sugammadex are included.	5.3% 2/38 • Number of events 2 • Up to 7 days All randomized participants who received sugammadex are included.
Gastrointestinal disorders Nausea	33.3% 13/39 • Number of events 19 • Up to 7 days All randomized participants who received sugammadex are included.	23.7% 9/38 • Number of events 10 • Up to 7 days All randomized participants who received sugammadex are included.
Gastrointestinal disorders Vomiting	17.9% 7/39 • Number of events 7 • Up to 7 days All randomized participants who received sugammadex are included.	13.2% 5/38 • Number of events 5 • Up to 7 days All randomized participants who received sugammadex are included.
General disorders Chills	2.6% 1/39 • Number of events 1 • Up to 7 days All randomized participants who received sugammadex are included.	5.3% 2/38 • Number of events 2 • Up to 7 days All randomized participants who received sugammadex are included.
General disorders Pyrexia	7.7% 3/39 • Number of events 3 • Up to 7 days All randomized participants who received sugammadex are included.	5.3% 2/38 • Number of events 2 • Up to 7 days All randomized participants who received sugammadex are included.
Infections and infestations Wound infection	5.1% 2/39 • Number of events 2 • Up to 7 days All randomized participants who received sugammadex are included.	0.00% 0/38 • Up to 7 days All randomized participants who received sugammadex are included.
Injury, poisoning and procedural complications Anaemia postoperative	5.1% 2/39 • Number of events 2 • Up to 7 days All randomized participants who received sugammadex are included.	0.00% 0/38 • Up to 7 days All randomized participants who received sugammadex are included.
Injury, poisoning and procedural complications Incision site complication	20.5% 8/39 • Number of events 16 • Up to 7 days All randomized participants who received sugammadex are included.	18.4% 7/38 • Number of events 8 • Up to 7 days All randomized participants who received sugammadex are included.
Injury, poisoning and procedural complications Incision site haematoma	5.1% 2/39 • Number of events 2 • Up to 7 days All randomized participants who received sugammadex are included.	0.00% 0/38 • Up to 7 days All randomized participants who received sugammadex are included.
Injury, poisoning and procedural complications Post procedural complication	10.3% 4/39 • Number of events 4 • Up to 7 days All randomized participants who received sugammadex are included.	0.00% 0/38 • Up to 7 days All randomized participants who received sugammadex are included.
Injury, poisoning and procedural complications Post procedural nausea	7.7% 3/39 • Number of events 3 • Up to 7 days All randomized participants who received sugammadex are included.	10.5% 4/38 • Number of events 6 • Up to 7 days All randomized participants who received sugammadex are included.
Injury, poisoning and procedural complications Procedural complication	2.6% 1/39 • Number of events 1 • Up to 7 days All randomized participants who received sugammadex are included.	5.3% 2/38 • Number of events 2 • Up to 7 days All randomized participants who received sugammadex are included.
Injury, poisoning and procedural complications Procedural hypertension	7.7% 3/39 • Number of events 3 • Up to 7 days All randomized participants who received sugammadex are included.	7.9% 3/38 • Number of events 3 • Up to 7 days All randomized participants who received sugammadex are included.
Injury, poisoning and procedural complications Procedural hypotension	7.7% 3/39 • Number of events 3 • Up to 7 days All randomized participants who received sugammadex are included.	2.6% 1/38 • Number of events 1 • Up to 7 days All randomized participants who received sugammadex are included.
Injury, poisoning and procedural complications Procedural pain	69.2% 27/39 • Number of events 28 • Up to 7 days All randomized participants who received sugammadex are included.	71.1% 27/38 • Number of events 30 • Up to 7 days All randomized participants who received sugammadex are included.
Investigations Beta 2 microglobulin increased	5.1% 2/39 • Number of events 2 • Up to 7 days All randomized participants who received sugammadex are included.	0.00% 0/38 • Up to 7 days All randomized participants who received sugammadex are included.
Investigations Haemoglobin decreased	12.8% 5/39 • Number of events 5 • Up to 7 days All randomized participants who received sugammadex are included.	2.6% 1/38 • Number of events 1 • Up to 7 days All randomized participants who received sugammadex are included.
Investigations Urine output decreased	5.1% 2/39 • Number of events 2 • Up to 7 days All randomized participants who received sugammadex are included.	0.00% 0/38 • Up to 7 days All randomized participants who received sugammadex are included.
Metabolism and nutrition disorders Hypokalaemia	5.1% 2/39 • Number of events 2 • Up to 7 days All randomized participants who received sugammadex are included.	2.6% 1/38 • Number of events 1 • Up to 7 days All randomized participants who received sugammadex are included.
Musculoskeletal and connective tissue disorders Back pain	7.7% 3/39 • Number of events 3 • Up to 7 days All randomized participants who received sugammadex are included.	0.00% 0/38 • Up to 7 days All randomized participants who received sugammadex are included.
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 3/39 • Number of events 3 • Up to 7 days All randomized participants who received sugammadex are included.	0.00% 0/38 • Up to 7 days All randomized participants who received sugammadex are included.
Nervous system disorders Dizziness	10.3% 4/39 • Number of events 4 • Up to 7 days All randomized participants who received sugammadex are included.	0.00% 0/38 • Up to 7 days All randomized participants who received sugammadex are included.
Nervous system disorders Headache	5.1% 2/39 • Number of events 2 • Up to 7 days All randomized participants who received sugammadex are included.	2.6% 1/38 • Number of events 1 • Up to 7 days All randomized participants who received sugammadex are included.
Psychiatric disorders Insomnia	5.1% 2/39 • Number of events 2 • Up to 7 days All randomized participants who received sugammadex are included.	2.6% 1/38 • Number of events 1 • Up to 7 days All randomized participants who received sugammadex are included.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.7% 3/39 • Number of events 4 • Up to 7 days All randomized participants who received sugammadex are included.	5.3% 2/38 • Number of events 2 • Up to 7 days All randomized participants who received sugammadex are included.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	2.6% 1/39 • Number of events 1 • Up to 7 days All randomized participants who received sugammadex are included.	7.9% 3/38 • Number of events 3 • Up to 7 days All randomized participants who received sugammadex are included.
Skin and subcutaneous tissue disorders Pruritus	12.8% 5/39 • Number of events 5 • Up to 7 days All randomized participants who received sugammadex are included.	5.3% 2/38 • Number of events 2 • Up to 7 days All randomized participants who received sugammadex are included.