Efficacy, Safety, and Pharmacokinetics of Sugammadex for... | NCT03351608

NCT03351608

ID	Type	Description	Link
2017-000692-92	EudraCT Number
MK-8616-089	Other Identifier	Merck Protocol Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sugammadex 2 mg/kg (Part A)	Experimental	Single intravenous (i.v.) bolus of sugammadex at 2 mg/kg.	Drug: Sugammadex 2 mg/kg
Sugammadex 4 mg/kg (Part A)	Experimental	Single i.v. bolus of sugammadex at 4 mg/kg.	Drug: Sugammadex 4 mg/kg
Sugammadex 2 mg/kg (Part B)	Experimental	Single i.v. bolus of sugammadex at 2 mg/kg.	Drug: Sugammadex 2 mg/kg
Sugammadex 4 mg/kg (Part B)	Experimental	Single i.v. bolus of sugammadex at 4 mg/kg.	Drug: Sugammadex 4 mg/kg
Neostigmine (Part B)	Active Comparator	Single i.v. bolus containing neostigmine (50 μg/kg; up to 5 mg maximum dose) in combination with either glycopyrrolate (10 μg/kg) or atropine sulfate (20 μg/kg).	Drug: Neostigmine + Glycopyrrolate Drug: Neostigmine + Atropine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sugammadex 2 mg/kg	Drug	For moderate NMB reversal, a single i.v. bolus of sugammadex (2 mg/kg) will be given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Plasma Concentration-Time Curve (AUC) From Dosing to Infinity (AUC0-∞) of Sugammadex [Part A]	The AUCo-∞ for sugammadex, defined as the area under the plasma concentration versus time plot, was determined in each Part A arm.	2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose
Plasma Clearance (CL) of Sugammadex [Part A]	The CL of sugammadex, defined as the rate of elimination relative to plasma concentration, was determined in each Part A arm.	2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose
Apparent Volume of Distribution (Vz) of Sugammadex [Part A]	The Vz of sugammadex, defined as the amount of drug administered relative to plasma concentrations, was determined in each Part A arm.	2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose
Maximum Plasma Concentration (Cmax) of Sugammadex [Part A]	The Cmax of sugammadex, defined as the maximum plasma concentration, was determined in each Part A arm.	2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose
Plasma Half-Life (t½) of Sugammadex [Part A]	The t½ of sugammadex, defined as the time required for the plasma concentration to decrease to 50% of maximum, was determined in each Part A arm.	2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose
Percentage of Participants With ≥1 Adverse Event (AE) [Parts A and B]	The percentage of participants with ≥1 AE(s) for up to 7 days after treatment was determined for each treatment group, pooled according to treatment received. An AE is defined as any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated.

Secondary Outcomes

Measure	Description	Time Frame
Time to Recovery of Participant TOF Ratio to ≥0.7 [Part B]	The time to recovery of TOF ratio to ≥0.7 after administration of study intervention was determined for each Part B arm. The TOF ratio is the ratio of the magnitude of the fourth (T4) and first (T1) thumb twitches elicited by 4 electrical stimulations of the ulnar nerve, indicating the current degree of NMB as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Values closer to 1 indicate less NMB.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be categorized as American Society of Anesthesiologists (ASA) Physical Status Class 1, 2, or 3.
Have a planned non-emergent surgical procedure or clinical situation (e.g., intubation) that requires moderate or deep NMB with either rocuronium or vecuronium.
Have a planned surgical procedure or clinical situation that would allow objective neuromuscular monitoring techniques to be applied with access to the arm for neuromuscular transmission monitoring.
Age between 2 to <17 years at Visit 2.
If female, may participate if she is not pregnant, not breastfeeding, and at least one of the following: 1) Not a woman of childbearing potential (WOCBP); or 2) A WOCBP who agrees to follow the study contraceptive guidance during the treatment period and for at least 7 days after the last dose of study treatment.

Exclusion Criteria:

Has any clinically significant condition or situation (eg, anatomical malformation that complicates intubation) other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.
Has a neuromuscular disorder that may affect NMB and/or trial assessments.
Is dialysis-dependent or has (or is suspected of having) severe renal insufficiency (defined as estimated glomerular filtration rate (eGFR) <30 ml/min).
Has or is suspected of having a family or personal history of malignant hyperthermia.
Has or is suspected of having an allergy 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 and/or fusidic acid via IV administration within 24 hours before or within 24 hours after administration of study treatment.
Has been previously treated with sugammadex or has participated in a sugammadex clinical trial.
Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing the informed consent/assent for this current trial.

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Childrens Hospital Los Angeles ( Site 0030)		Los Angeles	California	90027	United States
Lucille Packard Children's Hospital ( Site 0006)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34878707	Derived	Voss T, Wang A, DeAngelis M, Speek M, Saldien V, Hammer GB, Wrishko R, Herring WJ. Sugammadex for reversal of neuromuscular blockade in pediatric patients: Results from a phase IV randomized study. Paediatr Anaesth. 2022 Mar;32(3):436-445. doi: 10.1111/pan.14370. Epub 2021 Dec 17.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part A: Sugammadex 2 mg/kg	For moderate NMB reversal, a single intravenous (i.v.) bolus of sugammadex (2 mg/kg) was given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to train-of-four (TOF) stimulations.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

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	Aug 18, 2017

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Part A: Sugammadex 2 mg/kg	For moderate NMB reversal, a single intravenous (i.v.) bolus of sugammadex (2 mg/kg) is given after the final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
BG001	Part A: Sugammadex 4 mg	For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) is given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
BG002	Part B: Sugammadex 2 mg/kg	For moderate NMB reversal, a single i.v. bolus of sugammadex (2 mg/kg) is given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
BG003	Part B: Sugammadex 4 mg/kg	For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) is given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
BG004	Part B: Neostigmine + (Glycopyrrolate or Atropine)	For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as either glycopyrrolate (10 μg/kg) or atropine (20 µg/kg) is given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0007.1± 4.7 BG0017.2± 5.0 BG0027.9± 4.4 BG003

Age, Customized

Number

Participants

Title

Denominators

Categories

Children (2-11 years)

Title	Measurements
	BG00015 BG00117 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00011 BG00112 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

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

Area Under the Plasma Concentration-Time Curve (AUC) From Dosing to Infinity (AUC0-∞) of Sugammadex [Part A]

The AUCo-∞ for sugammadex, defined as the area under the plasma concentration versus time plot, was determined in each Part A arm.

All participants with ≥5 post-dosing samples available are included.

Posted

Geometric Mean

Geometric Coefficient of Variation

hr*μg/mL

2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose

ID	Title	Description
OG000	Part A: Sugammadex 2 mg (2 to <6 Years)	Participants in Part A receiving sugammadex 2 mg and who are 2 to <6 years of age are included.
OG001	Part A: Sugammadex 2 mg (6 to <12 Years)	Participants in Part A receiving sugammadex 2 mg and who are 6 to <12 years of age are included.
OG002	Part A: Sugammadex 2 mg (12 to <17 Years)	Participants in Part A receiving sugammadex 2 mg and who are 12 to <17 years of age are included.
OG003	Part A: Sugammadex 4 mg (2 to <6 Years)	Participants in Part A receiving sugammadex 4 mg and who are 2 to <6 years of age are included.
OG004	Part A: Sugammadex 4 mg (6 to <12 Years)	Participants in Part A receiving sugammadex 4 mg and who are 6 to <12 years of age are included.
OG005	Part A: Sugammadex 4 mg (12 to <17 Years)	Participants in Part A receiving sugammadex 4 mg and who are 12 to <17 years of age are included.

Units	Counts
Participants	OG0009 OG0015 OG0024 OG003

Title

Denominators

Categories

Title	Measurements
	OG00014.1± 19.4 OG00118.8± 27.4 OG00227.6± 58.0 OG003

Primary

Plasma Clearance (CL) of Sugammadex [Part A]

The CL of sugammadex, defined as the rate of elimination relative to plasma concentration, was determined in each Part A arm.

All participants with ≥5 post-dosing samples available are included.

Posted

Geometric Mean

Geometric Coefficient of Variation

L/hr

2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose

ID	Title	Description
OG000	Part A: Sugammadex 2 mg (2 to <6 Years)	Participants in Part A receiving sugammadex 2 mg and who are 2 to <6 years of age are included.
OG001	Part A: Sugammadex 2 mg (6 to <12 Years)	Participants in Part A receiving sugammadex 2 mg and who are 6 to <12 years of age are included.
OG002	Part A: Sugammadex 2 mg (12 to <17 Years)	Participants in Part A receiving sugammadex 2 mg and who are 12 to <17 years of age are included.
OG003	Part A: Sugammadex 4 mg (2 to <6 Years)	Participants in Part A receiving sugammadex 4 mg and who are 2 to <6 years of age are included.

Primary

Apparent Volume of Distribution (Vz) of Sugammadex [Part A]

The Vz of sugammadex, defined as the amount of drug administered relative to plasma concentrations, was determined in each Part A arm.

All participants with ≥5 post-dosing samples available are included.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters

2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose

ID	Title	Description
OG000	Part A: Sugammadex 2 mg (2 to <6 Years)	Participants in Part A receiving sugammadex 2 mg and who are 2 to <6 years of age are included.
OG001	Part A: Sugammadex 2 mg (6 to <12 Years)	Participants in Part A receiving sugammadex 2 mg and who are 6 to <12 years of age are included.
OG002	Part A: Sugammadex 2 mg (12 to <17 Years)	Participants in Part A receiving sugammadex 2 mg and who are 12 to <17 years of age are included.
OG003	Part A: Sugammadex 4 mg (2 to <6 Years)	Participants in Part A receiving sugammadex 4 mg and who are 2 to <6 years of age are included.

Primary

Maximum Plasma Concentration (Cmax) of Sugammadex [Part A]

The Cmax of sugammadex, defined as the maximum plasma concentration, was determined in each Part A arm.

All participants with ≥5 post-dosing samples available are included.

Posted

Geometric Mean

Geometric Coefficient of Variation

µg/mL

2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose

ID	Title	Description
OG000	Part A: Sugammadex 2 mg (2 to <6 Years)	Participants in Part A receiving sugammadex 2 mg and who are 2 to <6 years of age are included.
OG001	Part A: Sugammadex 2 mg (6 to <12 Years)	Participants in Part A receiving sugammadex 2 mg and who are 6 to <12 years of age are included.
OG002	Part A: Sugammadex 2 mg (12 to <17 Years)	Participants in Part A receiving sugammadex 2 mg and who are 12 to <17 years of age are included.
OG003	Part A: Sugammadex 4 mg (2 to <6 Years)	Participants in Part A receiving sugammadex 4 mg and who are 2 to <6 years of age are included.

Primary

Plasma Half-Life (t½) of Sugammadex [Part A]

The t½ of sugammadex, defined as the time required for the plasma concentration to decrease to 50% of maximum, was determined in each Part A arm.

All participants with ≥5 post-dosing samples available are included.

Posted

Median

Full Range

Hours

2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose

ID	Title	Description
OG000	Part A: Sugammadex 2 mg (2 to <6 Years)	Participants in Part A receiving sugammadex 2 mg and who are 2 to <6 years of age are included.
OG001	Part A: Sugammadex 2 mg (6 to <12 Years)	Participants in Part A receiving sugammadex 2 mg and who are 6 to <12 years of age are included.
OG002	Part A: Sugammadex 2 mg (12 to <17 Years)	Participants in Part A receiving sugammadex 2 mg and who are 12 to <17 years of age are included.
OG003	Part A: Sugammadex 4 mg (2 to <6 Years)	Participants in Part A receiving sugammadex 4 mg and who are 2 to <6 years of age are included.

Primary

Percentage of Participants With ≥1 Adverse Event (AE) [Parts A and B]

The percentage of participants with ≥1 AE(s) for up to 7 days after treatment was determined for each treatment group, pooled according to treatment received. An AE is defined as any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated.

Each participant who received a dose of study drug is included.

Posted

Number

Percentage of Participants

Up to 7 days

ID	Title	Description
OG000	Part B: Neostigmine + (Glycopyrrolate or Atropine)	For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as either glycopyrrolate (10 μg/kg) or atropine (20 µg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
OG001	Parts A and B: Sugammadex 2 mg	All participants in Parts A and B who received sugammadex 2 mg are included in the analysis.
OG002	Parts A and B: Sugammadex 4 mg	All participants in Parts A and B who received sugammadex 4 mg are included in the analysis.

Primary

Time to Recovery of Participant Train-of-Four (TOF) Ratio to ≥0.9 [Part B]

The time to recovery of TOF ratio to ≥0.9 after administration of study intervention was determined for each Part B arm. The TOF ratio is the ratio of the magnitude of the fourth (T4) and first (T1) thumb twitches elicited by 4 electrical stimulations of the ulnar nerve, indicating the current degree of NMB as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Values closer to 1 indicate less NMB. Per protocol, the efficacy analysis is based on comparison of the Part B: Sugammadex 2 mg arm versus the Part B: Neostigmine + (Glycopyrrolate or Atropine) arm.

All randomized participants in Part B who received ≥1 dose of study drug are included.

Posted

Geometric Mean

95% Confidence Interval

Minutes

Up to 30 minutes post-dose

ID	Title	Description
OG000	Part B: Sugammadex 2 mg/kg	For moderate NMB reversal, a single i.v. bolus of sugammadex (2 mg/kg) was given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
OG001	Part B: Sugammadex 4 mg/kg	For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).

Secondary

Time to Recovery of Participant TOF Ratio to ≥0.7 [Part B]

The time to recovery of TOF ratio to ≥0.7 after administration of study intervention was determined for each Part B arm. The TOF ratio is the ratio of the magnitude of the fourth (T4) and first (T1) thumb twitches elicited by 4 electrical stimulations of the ulnar nerve, indicating the current degree of NMB as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Values closer to 1 indicate less NMB.

All randomized participants in Part B who received ≥1 dose of study drug are included.

Posted

Geometric Mean

95% Confidence Interval

Minutes

Up to 30 minutes post-dose

ID	Title	Description
OG000	Part B: Sugammadex 2 mg/kg	For moderate NMB reversal, a single i.v. bolus of sugammadex (2 mg/kg) was given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
OG001	Part B: Sugammadex 4 mg/kg	For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
OG002	Part B: Neostigmine + (Glycopyrrolate or Atropine)

Secondary

Time to Recovery of Participant TOF Ratio to ≥0.8 [Part B]

The time to recovery of TOF ratio to ≥0.8 after administration of study intervention was determined for each Part B arm. The TOF ratio is the ratio of the magnitude of the fourth (T4) and first (T1) thumb twitches elicited by 4 electrical stimulations of the ulnar nerve, indicating the current degree of NMB as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Values closer to 1 indicate less NMB.

All randomized participants in Part B who received ≥1 dose of study drug are included.

Posted

Geometric Mean

95% Confidence Interval

Minutes

Up to 30 minutes post-dose

ID	Title	Description
OG000	Part B: Sugammadex 2 mg/kg	For moderate NMB reversal, a single i.v. bolus of sugammadex (2 mg/kg) was given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
OG001	Part B: Sugammadex 4 mg/kg	For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
OG002	Part B: Neostigmine + (Glycopyrrolate or Atropine)

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A: Sugammadex 2 mg (2 to <6 Years)	Participants in Part A receiving sugammadex 2 mg and who are 2 to <6 years of age are included.	9	0	9	8	9
EG001	Part A: Sugammadex 2 mg (6 to <12 Years)	Participants in Part A receiving sugammadex 2 mg and who are 6 to <12 years of age are included.	5	0	5	3	5
EG002	Part A: Sugammadex 2 mg (12 to <17 Years)	Participants in Part A receiving sugammadex 2 mg and who are 12 to <17 years of age are included.	4	0	4	2	4
EG003	Part A: Sugammadex 4 mg (2 to <6 Years)	Participants in Part A receiving sugammadex 4 mg and who are 2 to <6 years of age are included.	10	0	10	8	10
EG004	Part A: Sugammadex 4 mg (6 to <12 Years)	Participants in Part A receiving sugammadex 4 mg and who are 6 to <12 years of age are included.	6	0	6	5	6
EG005	Part A: Sugammadex 4 mg (12 to <17 Years)	Participants in Part A receiving sugammadex 4 mg and who are 12 to <17 years of age are included.	6	0	6	6	6
EG006	Part B: Sugammadex 2 mg	For moderate NMB reversal, a single i.v. bolus of sugammadex (2 mg/kg) was given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.	33	3	33	26	33
EG007	Part B: Sugammadex 4 mg	For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).	169	3	169	117	169
EG008	Part B: Neostigmine + (Glycopyrrolate or Atropine)	For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as either glycopyrrolate (10 μg/kg) or atropine (20 µg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.	34	2	34	29	34

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG0030 events0 affected10 at risk EG0040 events0 affected6 at risk EG0050 events0 affected6 at risk EG0060 events0 affected33 at risk EG0071 events1 affected169 at risk EG0080 events0 affected34 at risk
Pyrexia	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Post procedural bile leak	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Laryngospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bradycardia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected9 at risk EG0011 events1 affected5 at risk EG0020 events0 affected4 at risk EG0031 events1 affected10 at risk EG0041 events1 affected6 at risk EG0051 events1 affected6 at risk EG0061 events1 affected33 at risk EG0079 events9 affected169 at risk EG0083 events3 affected34 at risk
Pericardial effusion	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Eye irritation	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected5 at risk EG0020 events0 affected4 at risk EG003
Mouth swelling	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0012 events2 affected5 at risk EG0020 events0 affected4 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Palatal swelling	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0012 events1 affected5 at risk EG0020 events0 affected4 at risk EG003
Pyrexia	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Cystitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Cardiac procedure complication	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Incision site pain	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0021 events1 affected4 at risk EG003
Incision site swelling	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Procedural nausea	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0021 events1 affected4 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected9 at risk EG0013 events3 affected5 at risk EG0021 events1 affected4 at risk EG003
Procedural site reaction	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected5 at risk EG0020 events0 affected4 at risk EG003
Procedural vomiting	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0021 events1 affected4 at risk EG003
Body temperature increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Headache	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Agitation	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected5 at risk EG0020 events0 affected4 at risk EG003

ID	Term
D000077122	Sugammadex
D009388	Neostigmine
D006024	Glycopyrrolate
D001285	Atropine

Ancestor Terms

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
D001286	Atropine Derivatives
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds
D001533	Belladonna Alkaloids
D012991	Solanaceous Alkaloids
D000470	Alkaloids
D019086	Bridged Bicyclo Compounds, Heterocyclic
D006572	Heterocyclic Compounds, Bridged-Ring

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected33 at risk

EG0071 events1 affected169 at risk

EG0080 events0 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0061 events1 affected33 at risk

EG0070 events0 affected169 at risk

EG0080 events0 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected33 at risk

EG0071 events1 affected169 at risk

EG0080 events0 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0061 events1 affected33 at risk

EG0070 events0 affected169 at risk

EG0080 events0 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0061 events1 affected33 at risk

EG0070 events0 affected169 at risk

EG0080 events0 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected33 at risk

EG0070 events0 affected169 at risk

EG0081 events1 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected33 at risk

EG0070 events0 affected169 at risk

EG0081 events1 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected33 at risk

EG0070 events0 affected169 at risk

EG0080 events0 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0061 events1 affected33 at risk

EG0071 events1 affected169 at risk

EG0082 events2 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0062 events2 affected33 at risk

EG0070 events0 affected169 at risk

EG0080 events0 affected34 at risk

EG0040 events0 affected6 at risk

EG0051 events1 affected6 at risk

EG0060 events0 affected33 at risk

EG0071 events1 affected169 at risk

EG0080 events0 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected33 at risk

EG0071 events1 affected169 at risk

EG0080 events0 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected33 at risk

EG0070 events0 affected169 at risk

EG0080 events0 affected34 at risk

EG0040 events0 affected6 at risk

EG0051 events1 affected6 at risk

EG0061 events1 affected33 at risk

EG00710 events10 affected169 at risk

EG0082 events2 affected34 at risk

EG0041 events1 affected6 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected33 at risk

EG0070 events0 affected169 at risk

EG0080 events0 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0063 events3 affected33 at risk

EG00722 events20 affected169 at risk

EG0082 events2 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected33 at risk

EG0071 events1 affected169 at risk

EG0083 events2 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected33 at risk

EG0070 events0 affected169 at risk

EG0080 events0 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected33 at risk

EG0070 events0 affected169 at risk

EG0080 events0 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected33 at risk

EG0070 events0 affected169 at risk

EG0080 events0 affected34 at risk

EG0041 events1 affected6 at risk

EG0050 events0 affected6 at risk

EG0062 events2 affected33 at risk

EG0075 events5 affected169 at risk

EG0081 events1 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected33 at risk

EG0070 events0 affected169 at risk

EG0080 events0 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected33 at risk

EG0070 events0 affected169 at risk

EG0080 events0 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0063 events3 affected33 at risk

EG0079 events9 affected169 at risk

EG0080 events0 affected34 at risk

EG0043 events3 affected6 at risk

EG0053 events3 affected6 at risk

EG00622 events22 affected33 at risk

EG007109 events98 affected169 at risk

EG00825 events24 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected33 at risk

EG0070 events0 affected169 at risk

EG0080 events0 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0062 events2 affected33 at risk

EG0074 events4 affected169 at risk

EG0081 events1 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected33 at risk

EG0071 events1 affected169 at risk

EG0082 events2 affected34 at risk

EG0041 events1 affected6 at risk

EG0051 events1 affected6 at risk

EG0060 events0 affected33 at risk

EG0070 events0 affected169 at risk

EG0080 events0 affected34 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected33 at risk

EG0070 events0 affected169 at risk

EG0082 events2 affected34 at risk

EG0041 events1 affected6 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected33 at risk

EG0070 events0 affected169 at risk