Safety of Sugammadex for the Reversal of Neuromuscular Bl... | NCT03346057

ID	Type	Description	Link
2017-000187-15	EudraCT Number
MK-8616-145	Other Identifier	Merck Protocol Number

Label	Type	Description	Intervention Names
Sugammadex 2 mg/kg	Experimental	Sugammadex 2 mg/kg administered as a single intravenous (IV) dose	Drug: Sugammadex 2 mg/kg Drug: Rocuronium Drug: Vecuronium
Sugammadex 4 mg/kg	Experimental	Sugammadex 4 mg/kg administered as a single IV dose	Drug: Sugammadex 4 mg/kg Drug: Rocuronium Drug: Vecuronium
Sugammadex 16 mg/kg	Experimental	Sugammadex 16 mg/kg administered as a single IV dose	Drug: Sugammadex 16 mg/kg Drug: Rocuronium
Neostigmine + Glycopyrrolate	Active Comparator	Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose	Drug: Neostigmine + Glycopyrrolate Drug: Rocuronium Drug: Vecuronium

Name	Type	Description	Arm Group Labels	Other Names
Sugammadex 2 mg/kg	Drug	Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex 2 mg/kg for reversal of moderate NMB. Moderate block is a level of NMB in which peripheral nerve stimulation elicits one to four muscle twitches.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events	The percentage of participants experiencing treatment-emergent sinus bradycardia events was identified with continuous electrocardiogram (ECG) monitoring. Treatment-emergent sinus bradycardia were defined as a heart rate <60 bpm that has also decreased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus bradycardia events may or may not have been considered an adverse event (AE), as determined by investigator judgment.	Up to approximately 35 minutes post-administration
Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events	The percentage of participants experiencing treatment-emergent sinus tachycardia events was identified with continuous ECG monitoring. Treatment-emergent sinus tachycardia is defined as a heart rate ≥100 bpm that has also increased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus tachycardia events may or may not have been considered an AE, as determined by investigator judgment.	Up to approximately 35 minutes post-administration
Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events	The percentage of participants experiencing other treatment-emergent cardiac arrhythmia events was identified with continuous ECG monitoring. Other treatment-emergent cardiac arrhythmias were defined as new or worsening arrhythmias (e.g., atrial fibrillation, atrial tachycardia, ventricular fibrillation, or ventricular tachyarrhythmia), sustained for at least 1 minute after administration of study intervention. Worsening arrhythmia events may or may not have been considered an AE, as determined by investigator judgment.	Up to approximately 35 minutes post-administration
Percentage of Participants Experiencing an Adverse Event (AE) Up To 7 Days After Administration of Study Intervention

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has a body mass index (BMI) < 40 kg/m2.
Is categorized as ASA Physical Status Class 3 or 4, as determined by the Investigator.
Has a planned surgical procedure that requires NMB with either rocuronium or vecuronium.
Has a planned surgical procedure (e.g., gastrointestinal, urologic, or laparoscopic) that in the opinion of the investigator does not preclude maintenance of moderate or deep depth of NMB throughout the case.
If female who is not of reproductive potential, is one of the following: (1) postmenopausal; (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; (3) has a congenital or acquired condition that prevents childbearing; or (4) is undergoing surgical sterilization (e.g., hysterectomy or tubal ligation) as the planned surgical procedure associated with participation in this study.
If female who is sexually active and of child-bearing potential, agrees to use a medically accepted method of contraception through seven days after receiving protocol-specified medication. Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and Ethics Review Committees/Institutional Review Boards.
Is able to provide (or the participant's legally authorized representative, in accordance with local requirements), written informed consent for the trial. The participant or legally authorized representative may also provide consent for Future Biomedical Research.

Exclusion Criteria:

Has a pacemaker or automatic implantable cardioverter-defibrillator that precludes the assessment of bradycardia or arrhythmias.
Has a medical condition or surgical procedure that precludes reversal of neuromuscular block at the end of surgery.
Has a neuromuscular disorder(s) that may affect neuromuscular block and/or trial assessments.
Is dialysis-dependent or has severe renal insufficiency, defined as estimated creatinine clearance of <30 mL/min.
Has or is suspected of having a personal history or family history (parents, grandparents, or siblings) of malignant hyperthermia.
Has or is suspected of having an allergy (e.g., hypersensitivity and/or anaphylactic reaction) to study treatments or its/their excipients, to opioids/opiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia.
Has received or is planned to receive toremifene within 24 hours before or within 24 hours after study medication administration.
Has any condition that would contraindicate the administration of study medication.
Is pregnant, is attempting to become pregnant, or is lactating.
Is currently participating in or has participated in an interventional clinical trial (including any other current or ongoing trial with a sugammadex treatment arm) with an investigational compound or device within 30 days of signing the informed consent form of this current trial.

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama - Birmingham ( Site 1046)		Birmingham	Alabama	35233	United States
University Banner Medical Center ( Site 1019)

PubMed Identifier	Type	Citation	Retractions
34711192	Derived	Herring WJ, Mukai Y, Wang A, Lutkiewicz J, Lombard JF, Lin L, Watkins M, Broussard DM, Blobner M. A randomized trial evaluating the safety profile of sugammadex in high surgical risk ASA physical class 3 or 4 participants. BMC Anesthesiol. 2021 Oct 28;21(1):259. doi: 10.1186/s12871-021-01477-5.

ID	Title	Description
FG000	Sugammadex 2 mg/kg	Sugammadex 2 mg/kg administered as a single intravenous (IV) dose
FG001	Sugammadex 4 mg/kg	Sugammadex 4 mg/kg administered as a single IV dose

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 5, 2018

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events

The percentage of participants experiencing treatment-emergent sinus bradycardia events was identified with continuous electrocardiogram (ECG) monitoring. Treatment-emergent sinus bradycardia were defined as a heart rate <60 bpm that has also decreased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus bradycardia events may or may not have been considered an adverse event (AE), as determined by investigator judgment.

All randomized participants who received at least one dose of study intervention

Posted

Number

Percentage of participants

Up to approximately 35 minutes post-administration

ID	Title	Description
OG000	Sugammadex 2 mg/kg	Sugammadex 2 mg/kg administered as a single intravenous (IV) dose
OG001	Sugammadex 4 mg/kg	Sugammadex 4 mg/kg administered as a single IV dose
OG002	Sugammadex 16 mg/kg	Sugammadex 16 mg/kg administered as a single IV dose
OG003	Neostigmine + Glycopyrrolate	Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose

Units	Counts
Participants	OG000105 OG001107 OG00268 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001.0 OG0011.9 OG0027.4 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003	Miettinen & Nurminen method stratified by neuromuscular blocking agent (NMBA) and American Society of Anesthesiologists (ASA) class was used to provide estimated between-treatment difference, 95% confidence interval, and p-value	Stratified Miettinen & Nurminen method		0.026		Estimated Difference in percentage	-6.7			2-Sided	95	-17.5	-0.8					Other
OG001

Primary

Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events

The percentage of participants experiencing treatment-emergent sinus tachycardia events was identified with continuous ECG monitoring. Treatment-emergent sinus tachycardia is defined as a heart rate ≥100 bpm that has also increased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus tachycardia events may or may not have been considered an AE, as determined by investigator judgment.

All randomized participants who received at least one dose of study intervention

Posted

Number

Percentage of participants

Up to approximately 35 minutes post-administration

ID	Title	Description
OG000	Sugammadex 2 mg/kg	Sugammadex 2 mg/kg administered as a single intravenous (IV) dose
OG001	Sugammadex 4 mg/kg	Sugammadex 4 mg/kg administered as a single IV dose
OG002	Sugammadex 16 mg/kg	Sugammadex 16 mg/kg administered as a single IV dose
OG003	Neostigmine + Glycopyrrolate

Primary

Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events

The percentage of participants experiencing other treatment-emergent cardiac arrhythmia events was identified with continuous ECG monitoring. Other treatment-emergent cardiac arrhythmias were defined as new or worsening arrhythmias (e.g., atrial fibrillation, atrial tachycardia, ventricular fibrillation, or ventricular tachyarrhythmia), sustained for at least 1 minute after administration of study intervention. Worsening arrhythmia events may or may not have been considered an AE, as determined by investigator judgment.

All randomized participants who received at least one dose of study intervention

Posted

Number

Percentage of participants

Up to approximately 35 minutes post-administration

ID	Title	Description
OG000	Sugammadex 2 mg/kg	Sugammadex 2 mg/kg administered as a single intravenous (IV) dose
OG001	Sugammadex 4 mg/kg	Sugammadex 4 mg/kg administered as a single IV dose
OG002	Sugammadex 16 mg/kg	Sugammadex 16 mg/kg administered as a single IV dose
OG003

Primary

Percentage of Participants Experiencing an Adverse Event (AE) Up To 7 Days After Administration of Study Intervention

As per the protocol primary analysis, the percentage of participants experiencing an AE up to 7 days after administration of study intervention was reported. An AE was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE.

All randomized participants who received at least one dose of study intervention

Posted

Number

Percentage of participants

Up to 7 days

ID	Title	Description
OG000	Sugammadex 2 mg/kg	Sugammadex 2 mg/kg administered as a single intravenous (IV) dose
OG001	Sugammadex 4 mg/kg	Sugammadex 4 mg/kg administered as a single IV dose
OG002	Sugammadex 16 mg/kg

Primary

Percentage of Participants Experiencing a Serious Adverse Event (SAE) Up To 7 Days After Administration of Study Intervention

As per the protocol primary analysis, the percentage of participants experiencing an SAE up to 7 days after administration of study intervention was reported. An SAE was an adverse event that: resulted in death; was life threatening; resulted in persistent or significant disability or incapacity; resulted in or prolonged an existing inpatient hospitalization; was a congenital anomaly or birth defect; was an other important medical event, was a cancer; or was associated with an overdose.

All randomized participants who received at least one dose of study intervention

Posted

Number

Percentage of Participants

Up to 7 days

ID	Title	Description
OG000	Sugammadex 2 mg/kg	Sugammadex 2 mg/kg administered as a single intravenous (IV) dose
OG001	Sugammadex 4 mg/kg	Sugammadex 4 mg/kg administered as a single IV dose
OG002	Sugammadex 16 mg/kg	Sugammadex 16 mg/kg administered as a single IV dose
OG003	Neostigmine + Glycopyrrolate

Primary

Percentage of Participants Experiencing an Event of Clinical Interest (ECI) Up To 7 Days After Administration of Study Intervention

As per the protocol primary analysis, the percentage of participants experiencing an ECI up to 7 days after administration of study intervention was reported. ECIs were a discrete set of both AEs and SAEs, specifically designated as such for the trial. For the purposes of this investigation, ECIs included 1) drug-induced liver injury; 2) clinically-relevant arrhythmias, inclusive of bradycardia and tachycardia defined as events necessitating intervention, as determined by investigator judgment; and 3) instances of hypersensitivity and/or anaphylaxis adjudicated by an external expert Adjudication Committee. A participant could have experienced more than one type of ECI.

All randomized participants who received at least one dose of study intervention

Posted

Number

Percentage of Participants

Up to 7 days

ID	Title	Description
OG000	Sugammadex 2 mg/kg	Sugammadex 2 mg/kg administered as a single intravenous (IV) dose
OG001	Sugammadex 4 mg/kg	Sugammadex 4 mg/kg administered as a single IV dose
OG002	Sugammadex 16 mg/kg	Sugammadex 16 mg/kg administered as a single IV dose

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0010 events0 affected107 at risk EG0021 events1 affected68 at risk EG0030 events0 affected51 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0010 events0 affected107 at risk EG0021 events1 affected68 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0011 events1 affected107 at risk EG0020 events0 affected68 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected107 at risk EG0021 events1 affected68 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0011 events1 affected107 at risk EG0020 events0 affected68 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0011 events1 affected107 at risk EG0020 events0 affected68 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0011 events1 affected107 at risk EG0020 events0 affected68 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0010 events0 affected107 at risk EG0021 events1 affected68 at risk EG003
Catheter site haemorrhage	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
Dehiscence	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
Hernia	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
Impaired healing	General disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
Bronchitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0010 events0 affected107 at risk EG0021 events1 affected68 at risk EG003
Gallbladder abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0010 events0 affected107 at risk EG0021 events1 affected68 at risk EG003
Post procedural infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
Purulent discharge	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0011 events1 affected107 at risk EG0020 events0 affected68 at risk EG003
Abdominal wound dehiscence	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0011 events1 affected107 at risk EG0020 events0 affected68 at risk EG003
Fascial rupture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
Gastrointestinal stoma necrosis	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
Incision site pain	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0010 events0 affected107 at risk EG0021 events1 affected68 at risk EG003
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0011 events1 affected107 at risk EG0020 events0 affected68 at risk EG003
Postoperative delirium	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected105 at risk EG0011 events1 affected107 at risk EG0020 events0 affected68 at risk EG003
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0011 events1 affected107 at risk EG0020 events0 affected68 at risk EG003
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
C-reactive protein increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0010 events0 affected107 at risk EG0021 events1 affected68 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0010 events0 affected107 at risk EG0021 events1 affected68 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0011 events1 affected107 at risk EG0020 events0 affected68 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0012 events2 affected107 at risk EG0020 events0 affected68 at risk EG003
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0010 events0 affected107 at risk EG0021 events1 affected68 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0011 events1 affected107 at risk EG0020 events0 affected68 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0010 events0 affected107 at risk EG0021 events1 affected68 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0011 events1 affected107 at risk EG0020 events0 affected68 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected105 at risk EG0011 events1 affected107 at risk EG0020 events0 affected68 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0010 events0 affected107 at risk EG0021 events1 affected68 at risk EG003
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
Hypotension	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected107 at risk EG0020 events0 affected68 at risk EG003
Lymphocele	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected105 at risk EG0011 events1 affected107 at risk EG0020 events0 affected68 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bradycardia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected105 at risk EG0014 events4 affected107 at risk EG0021 events1 affected68 at risk EG0033 events3 affected51 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected105 at risk EG0013 events3 affected107 at risk EG0025 events5 affected68 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected105 at risk EG0018 events8 affected107 at risk EG0023 events3 affected68 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0007 events7 affected105 at risk EG0017 events7 affected107 at risk EG0026 events6 affected68 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected105 at risk EG0016 events6 affected107 at risk EG0020 events0 affected68 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG00018 events17 affected105 at risk EG00120 events19 affected107 at risk EG00214 events13 affected68 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected105 at risk EG0016 events6 affected107 at risk EG0023 events3 affected68 at risk EG003
Asthenia	General disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected105 at risk EG0016 events6 affected107 at risk EG0022 events2 affected68 at risk EG003
Incision site pain	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG00026 events25 affected105 at risk EG00131 events31 affected107 at risk EG00219 events19 affected68 at risk EG003
Postoperative hypertension	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected105 at risk EG0013 events3 affected107 at risk EG0024 events4 affected68 at risk EG003
Procedural nausea	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected105 at risk EG0012 events2 affected107 at risk EG0025 events5 affected68 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG00066 events58 affected105 at risk EG00167 events56 affected107 at risk EG00238 events31 affected68 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected105 at risk EG0013 events3 affected107 at risk EG0024 events4 affected68 at risk EG003
Headache	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0004 events3 affected105 at risk EG0015 events5 affected107 at risk EG0022 events2 affected68 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected105 at risk EG0013 events3 affected107 at risk EG0022 events2 affected68 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected105 at risk EG0018 events8 affected107 at risk EG0024 events4 affected68 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected105 at risk EG0012 events2 affected107 at risk EG0020 events0 affected68 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0006 events4 affected105 at risk EG0014 events4 affected107 at risk EG0024 events4 affected68 at risk EG003
Hypertension	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0008 events6 affected105 at risk EG0016 events6 affected107 at risk EG0021 events1 affected68 at risk EG003
Hypotension	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected105 at risk EG0018 events8 affected107 at risk EG0026 events5 affected68 at risk EG003

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D000075224	Cardiac Conduction System Disease

ID	Term
D047408	gamma-Cyclodextrins
D003505	Cyclodextrins
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D003912	Dextrins
D013213	Starch
D005936	Glucans
D011134	Polysaccharides
D002241	Carbohydrates
D050338	Phenylammonium Compounds
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals
D009861	Onium Compounds
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D000732	Androstanols
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds

ID	Title	Description
BG000	Sugammadex 2 mg/kg	Sugammadex 2 mg/kg administered as a single intravenous (IV) dose
BG001	Sugammadex 4 mg/kg	Sugammadex 4 mg/kg administered as a single IV dose
BG002	Sugammadex 16 mg/kg	Sugammadex 16 mg/kg administered as a single IV dose
BG003	Neostigmine + Glycopyrrolate	Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Sugammadex 2 mg/kg	Sugammadex 2 mg/kg administered as a single intravenous (IV) dose	1	111	16	105	89	105
EG001	Sugammadex 4 mg/kg	Sugammadex 4 mg/kg administered as a single IV dose	2	112	12	107	89	107
EG002	Sugammadex 16 mg/kg	Sugammadex 16 mg/kg administered as a single IV dose	0	68	9	68	60	68
EG003	Neostigmine + Glycopyrrolate	Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose	0	53	4	51	41	51

ID	Term
D001145	Arrhythmias, Cardiac
D001919	Bradycardia
D013610	Tachycardia

ID	Term
D000077122	Sugammadex
D009388	Neostigmine
D006024	Glycopyrrolate
D000077123	Rocuronium
D014673	Vecuronium Bromide