A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2... | NCT00552929 | Trialant
NCT00552929
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Mar 5, 2019Actual
Enrollment
102Actual
Phase
Phase 2
Conditions
Anesthesia, General
Interventions
Sugammadex
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00552929
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
P05974
Secondary IDs
ID
Type
Description
Link
2005-001133-15
EudraCT Number
MK-8616-036
Other Identifier
Merck Protocol Number
P05974
Other Identifier
Schering-Plough Protocol Number
19.4.209B
Other Identifier
Organon Protocol Number
Brief Title
A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Caucasian Participants. Part B (P05974)
Official Title
A Multi -Center, Randomized, Open -Label, Prospective Bridging, Parallel Dose-Finding Trial Comparing Efficacy, Safety and Pharmacokinetics of 5 Doses of Org 25969 Administered at 1-2 PTC After Rocuronium or Vecuronium in Japanese and Caucasian Subjects. Part B: Caucasian Subjects.
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Feb 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 4, 2005Actual
Primary Completion Date
Sep 15, 2006Actual
Completion Date
Sep 15, 2006Actual
First Submitted Date
Oct 31, 2007
First Submission Date that Met QC Criteria
Oct 31, 2007
First Posted Date
Nov 2, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 29, 2018
Results First Submitted that Met QC Criteria
Oct 29, 2018
Results First Posted Date
Feb 22, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 21, 2019
Last Update Posted Date
Mar 5, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The objective of the trial was to establish the dose-response relation of sugammadex given as a reversal agent of rocuronium or vecuronium at 1-2 Post-Tetanic Count (PTC) during sevoflurane anesthesia for Caucasian participants
Detailed Description
Not provided
Conditions Module
Conditions
Anesthesia, General
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
102Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Sugammadex 0.5 mg/kg (Rocuronium)
Experimental
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered intravenously (IV), followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the second twitch (T2) response to Train-of-four (TOF) stimulation, a single dose of 0.5 mg/kg sugammadex was administered IV.
Drug: Sugammadex
Sugammadex 1.0 mg/kg (Rocuronium)
Experimental
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 1.0 mg/kg sugammadex was administered IV.
Drug: Sugammadex
Sugammadex 2.0 mg/kg (Rocuronium)
Experimental
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 2.0 mg/kg sugammadex was administered IV.
Drug: Sugammadex
Sugammadex 4.0 mg/kg (Rocuronium)
Experimental
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 4.0 mg/kg sugammadex was administered IV.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Sugammadex
Drug
After induction of anesthesia an intubation dose of a neuromuscular blocking agent (NMBA) was administered IV: either 0.9 mg/kg rocuronium (arms 1-5) or 0.1 mg/kg vecuronium (arms 6-10). Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.
At reappearance of T2 the randomized single dose of sugammadex (0.5 to 8.0 mg/kg) IV was administered.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.9 for Train-Of-Four (TOF) Stimulation
Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.
Up to 131:40 (min:sec)
Secondary Outcomes
Measure
Description
Time Frame
Time From Start of Sugammadex Administration to a T4/T1 Recovery Ratio of 0.7
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants of American Society of Anesthesiologists (ASA) class 1 - 3;
Participants at least 20 years but under 65 years of age;
Caucasian participants ;
Participants scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia, in need of administration of a neuromuscular blocking agent (NMBA), with an anticipated duration of about 1.5- 3 hours;
Participants who had given written informed consent. This was obtained before the investigator or the sub-investigator performed any procedures or assessments for the screening, and after the participant was informed about the nature and purpose of the study, the study procedures, and the risks and restrictions of the study.
Exclusion criteria:
Participants in whom a difficult intubation because of anatomical malformations was expected;
Participants known or suspected to have neuromuscular disorders impairing neuromuscular blockade (NMB) and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic dysfunction.
Participants known or suspected to have a (family) history of malignant hyperthermia;
Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
Participants receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;
Female participants who were pregnant;
Female participants of childbearing potential not using birth control or using only oral contraception as birth control;
Participants who were breast-feeding;
Participants who had already participated in CT 19.4.209B, or in another trial with sugammadex;
Participants who had participated in another clinical trial, not preapproved by Organon, within 6 months of entering into CT 19.4.209B.
Duvaldestin P, Kuizenga K, Saldien V, Claudius C, Servin F, Klein J, Debaene B, Heeringa M. A randomized, dose-response study of sugammadex given for the reversal of deep rocuronium- or vecuronium-induced neuromuscular blockade under sevoflurane anesthesia. Anesth Analg. 2010 Jan 1;110(1):74-82. doi: 10.1213/ANE.0b013e3181c3be3c. Epub 2009 Nov 21.
See Also Links
Label
URL
Click here to access a synopsis of the study results.
The trial was conducted in seven centers in Europe: one center in Belgium, one center in Denmark, three centers in France, and two centers in The Netherlands.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Sugammadex 0.5 mg/kg (Rocuronium)
Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
FG001
Sugammadex 1.0 mg/kg (Rocuronium)
Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
FG002
Sugammadex 2.0 mg/kg (Rocuronium)
Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
FG003
Sugammadex 4.0 mg/kg (Rocuronium)
Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
FG004
Sugammadex 8.0 mg/kg (Rocuronium)
Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
FG005
Sugammadex 0.5 mg/kg (Vecuronium)
Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.
FG006
Sugammadex 1.0 mg/kg (Vecuronium)
Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
FG007
Sugammadex 2.0 mg/kg (Vecuronium)
Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
FG008
Sugammadex 4.0 mg/kg (Vecuronium)
Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
FG009
Sugammadex 8.0 mg/kg (Vecuronium)
Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Randomized Participants
FG0009 subjects
FG00110 subjects
FG00210 subjects
FG00311 subjects
FG004
Participants as Treated
FG0009 subjectsOne participant randomized to sugammadex 0.5 mg/kg received sugammadex 3.7 mg/kg (4.0 mg\\kg group)
FG00110 subjects
FG00210 subjects
FG003
COMPLETED
FG0009 subjects
FG00110 subjects
FG00210 subjects
FG00311 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Overall Number of Participants Receiving Sugammadex + Rocuronium or Sugammadex + Vecuronium as treated
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Sugammadex 0.5 mg/kg (Rocuronium)
Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
BG001
Sugammadex 1.0 mg/kg (Rocuronium)
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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
Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.9 for Train-Of-Four (TOF) Stimulation
Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.
The analysis population consisted of all randomized and treated participants who had at least one post-baseline efficacy measurement, without any major or multiple minor protocol violations.
Posted
Mean
Standard Deviation
Minutes
Up to 131:40 (min:sec)
ID
Title
Description
Adverse Events Module
Frequency Threshold
5
Time Frame
Up to 7 post-operative days
Description
All randomized participants who received at least one dose of study treatment and had follow-up.
All-Cause Mortality Comment
Not provided
Arm/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 0.5 mg/kg (Rocuronium)
Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Meningitis
Infections and infestations
MedDRA 9.1
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukocytosis
Blood and lymphatic system disorders
MedDRA 9.1
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
Jul 10, 2026
Removed Countries
Belgium
Denmark
France
Netherlands
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
MeSH Terms
ID
Term
D000077122
Sugammadex
Ancestor Terms
ID
Term
D047408
gamma-Cyclodextrins
D003505
Cyclodextrins
D047028
Macrocyclic Compounds
D011083
Polycyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Sugammadex
Sugammadex 8.0 mg/kg (Rocuronium)
Experimental
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 8.0 mg/kg sugammadex was administered IV.
Drug: Sugammadex
Sugammadex 0.5 mg/kg (Vecuronium)
Experimental
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 0.5 mg/kg sugammadex was administered IV.
Drug: Sugammadex
Sugammadex 1.0 mg/kg (Vecuronium)
Experimental
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 1.0 mg/kg sugammadex was administered IV.
Drug: Sugammadex
Sugammadex 2.0 mg/kg (Vecuronium)
Experimental
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 2.0 mg/kg sugammadex was administered IV.
Drug: Sugammadex
Sugammadex 4.0 mg/kg (Vecuronium)
Experimental
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 4.0 mg/kg sugammadex was administered IV.
Drug: Sugammadex
Sugammadex 8.0 mg/kg (Vecuronium)
Experimental
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 8.0 mg/kg sugammadex was administered IV.
Drug: Sugammadex
Sugammadex 0.5 mg/kg (Rocuronium)
Sugammadex 0.5 mg/kg (Vecuronium)
Sugammadex 1.0 mg/kg (Rocuronium)
Sugammadex 1.0 mg/kg (Vecuronium)
Sugammadex 2.0 mg/kg (Rocuronium)
Sugammadex 2.0 mg/kg (Vecuronium)
Sugammadex 4.0 mg/kg (Rocuronium)
Sugammadex 4.0 mg/kg (Vecuronium)
Sugammadex 8.0 mg/kg (Rocuronium)
Sugammadex 8.0 mg/kg (Vecuronium)
Org 25969
MK-8616
Bridion^TM
Up to 96:24 (min:sec)
Time From Start of Sugammadex Administration to a T4/T1 Recovery Ratio of 0.8
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.
Up to 102:25 (min:sec)
Number of Participants With An Adverse Event (AE)
The number of participants who had at least one AE during treatment and follow-up was assessed. An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
From Screening to 7 post-operative days
10 subjects
FG00510 subjects
FG00610 subjects
FG00711 subjects
FG00810 subjects
FG00911 subjects
11 subjects
One participant randomized to sugammadex 0.5 mg/kg received sugammadex 3.7 mg/kg (4.0 mg\\kg group)
FG00410 subjects
FG0059 subjects
FG00610 subjects
FG00711 subjects
FG00810 subjects
FG00911 subjects
10 subjects
FG0059 subjects
FG00610 subjects
FG00711 subjects
FG0089 subjects
FG00911 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
Not Eligible
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
BG002
Sugammadex 2.0 mg/kg (Rocuronium)
Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
BG003
Sugammadex 4.0 mg/kg (Rocuronium)
Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
BG004
Sugammadex 8.0 mg/kg (Rocuronium)
Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
BG005
Sugammadex 0.5 mg/kg (Vecuronium)
Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.
BG006
Sugammadex 1.0 mg/kg (Vecuronium)
Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
BG007
Sugammadex 2.0 mg/kg (Vecuronium)
Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
BG008
Sugammadex 4.0 mg/kg (Vecuronium)
Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
BG009
Sugammadex 8.0 mg/kg (Vecuronium)
Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
BG010
Total
Total of all reporting groups
9
BG00110
BG00210
BG00311
BG00410
BG0059
BG00610
BG00711
BG00810
BG00911
BG010101
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00049± 7
BG00142± 9
BG00249± 6
BG00351± 13
BG00452± 9
BG00544± 14
BG00650± 14
BG00754± 6
BG00840± 11
BG00950± 9
BG01048± 11
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0012
BG0025
BG0036
BG0045
BG0054
BG0066
BG0074
BG0083
BG0095
BG01044
Male
BG0005
BG0018
BG0025
BG0035
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0061
BG0070
BG0080
BG0090
BG0102
Not Hispanic or Latino
BG0009
BG0019
BG00210
BG00311
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
American Society of Anaesthesiologists (ASA) Class
ASA class Classification of physical status:
ASA class 1: A normal healthy participant; ASA class 2: A participant with a mild systemic disease; ASA class 3: A participant with a severe systemic disease that limits activity, but is not incapacitating; ASA class 4: A participant with an incapacitating systemic disease that is a constant threat to life; ASA class 5: A moribund participant not expected to survive 24 hours with or without operation
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
ASA Class 1
BG0006
BG0015
BG0022
BG0036
BG0045
BG0057
BG0068
BG0077
BG0089
BG0096
BG01061
ASA Class 2
BG0003
BG0015
BG0027
BG0035
BG004
ASA Class 3
BG0000
BG0010
BG0021
BG0030
BG004
OG000
Sugammadex 0.5 mg/kg (Rocuronium)
Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG001
Sugammadex 1.0 mg/kg (Rocuroniium)
Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG002
Sugammadex 2.0 mg/kg (Rocuronium)
Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG003
Sugammadex 4.0 mg/kg (Rocuronium)
Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG004
Sugammadex 8.0 mg/kg (Rocuronium)
Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG005
Sugammadex 0.5 mg/kg (Vecuronium)
Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.
OG006
Sugammadex 1.0 mg/kg (Vecuronium)
Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
OG007
Sugammadex 2.0 mg/kg (Vecuronium)
Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
OG008
Sugammadex 4.0 mg/kg (Vecuronium)
Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
OG009
Sugammadex 8.0 mg/kg (Vecuronium)
Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
Units
Counts
Participants
OG0008
OG0019
OG00210
OG00310
OG00410
OG0057
OG0069
OG00711
OG0088
OG00910
Title
Denominators
Categories
Title
Measurements
OG00079.78± 33.02
OG00128.00± 43.73
OG0023.17± 1.52
OG0031.65± 0.65
OG0041.13± 0.33
OG00568.40± 31.93
OG00625.12± 24.87
OG0079.08± 20.55
OG0083.30± 3.45
OG0091.65± 0.75
Secondary
Time From Start of Sugammadex Administration to a T4/T1 Recovery Ratio of 0.7
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.
The analysis population consisted of all randomized and treated participants who had at least one post-baseline efficacy measurement, without any major protocol violation.
Posted
Mean
Standard Deviation
Minutes
Up to 96:24 (min:sec)
ID
Title
Description
OG000
Sugammadex 0.5 mg/kg (Rocuronium)
Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG001
Sugammadex 1.0 mg/kg (Rocuroniium)
Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG002
Sugammadex 2.0 mg/kg (Rocuronium)
Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG003
Sugammadex 4.0 mg/kg (Rocuronium)
Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG004
Sugammadex 8.0 mg/kg (Rocuronium)
Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG005
Sugammadex 0.5 mg/kg (Vecuronium)
Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.
OG006
Sugammadex 1.0 mg/kg (Vecuronium)
Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
OG007
Sugammadex 2.0 mg/kg (Vecuronium)
Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
OG008
Sugammadex 4.0 mg/kg (Vecuronium)
Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
OG009
Sugammadex 8.0 mg/kg (Vecuronium)
Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
Units
Counts
Participants
OG0008
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG00047.72± 27.62
OG0014.47± 1.95
OG0022.17± 0.97
OG003
Secondary
Time From Start of Sugammadex Administration to a T4/T1 Recovery Ratio of 0.8
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.
The analysis population consisted of all randomized participants who were given at least one administration of sugammadex and had at least one post-baseline efficacy measurement, without any major protocol violation.
Posted
Mean
Standard Deviation
Minutes
Up to 102:25 (min:sec)
ID
Title
Description
OG000
Sugammadex 0.5 mg/kg (Rocuronium)
Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG001
Sugammadex 1.0 mg/kg (Rocuroniium)
Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG002
Sugammadex 2.0 mg/kg (Rocuronium)
Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG003
Sugammadex 4.0 mg/kg (Rocuronium)
Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG004
Sugammadex 8.0 mg/kg (Rocuronium)
Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG005
Sugammadex 0.5 mg/kg (Vecuronium)
Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.
OG006
Sugammadex 1.0 mg/kg (Vecuronium)
Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
OG007
Sugammadex 2.0 mg/kg (Vecuronium)
Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
OG008
Sugammadex 4.0 mg/kg (Vecuronium)
Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
OG009
Sugammadex 8.0 mg/kg (Vecuronium)
Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
Units
Counts
Participants
OG0008
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG00057.00± 32.97
OG00114.22± 20.62
OG0022.45± 1.12
OG003
Secondary
Number of Participants With An Adverse Event (AE)
The number of participants who had at least one AE during treatment and follow-up was assessed. An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
All randomized participants who received at least one dose of study treatment and had follow-up.
Posted
Count of Participants
Participants
From Screening to 7 post-operative days
ID
Title
Description
OG000
Sugammadex 0.5 mg/kg (Rocuronium)
Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG001
Sugammadex 1.0 mg/kg (Rocuroniium)
Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG002
Sugammadex 2.0 mg/kg (Rocuronium)
Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG003
Sugammadex 4.0 mg/kg (Rocuronium)
Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG004
Sugammadex 8.0 mg/kg (Rocuronium)
Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
OG005
Sugammadex 0.5 mg/kg (Vecuronium)
Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.
OG006
Sugammadex 1.0 mg/kg (Vecuronium)
Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
OG007
Sugammadex 2.0 mg/kg (Vecuronium)
Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
OG008
Sugammadex 4.0 mg/kg (Vecuronium)
Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
OG009
Sugammadex 8.0 mg/kg (Vecuronium)
Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
Units
Counts
Participants
OG0009
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0006
OG0018
OG0028
OG003
0
9
1
9
6
9
EG001
Sugammadex 1.0 mg/kg (Rocuronium)
Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
0
10
0
10
8
10
EG002
Sugammadex 2.0 mg/kg (Rocuronium)
Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
0
10
1
10
8
10
EG003
Sugammadex 4.0 mg/kg (Rocuronium)
Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
0
11
1
11
10
11
EG004
Sugammadex 8.0 mg/kg (Rocuronium)
Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
0
10
0
10
8
10
EG005
Sugammadex 0.5 mg/kg (Vecuronium)
Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.
0
9
0
9
6
9
EG006
Sugammadex 1.0 mg/kg (Vecuronium)
Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
0
10
0
10
6
10
EG007
Sugammadex 2.0 mg/kg (Vecuronium)
Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
0
11
0
11
7
11
EG008
Sugammadex 4.0 mg/kg (Vecuronium)
Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
0
10
0
10
6
10
EG009
Sugammadex 8.0 mg/kg (Vecuronium)
Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
0
11
1
11
8
11
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0031 events1 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0091 events1 affected11 at risk
Convulsion
Nervous system disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0031 events1 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0031 events1 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Laryngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0022 events1 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Tracheal stenosis
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0021 events1 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Wound haemorrhage
Vascular disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
EG0001 events1 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Anaemia
Blood and lymphatic system disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0071 events1 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Conjunctival irritation
Eye disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0021 events1 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Pupils unequal
Eye disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0071 events1 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0021 events1 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Colitis
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0031 events1 affected11 at risk
EG0041 events1 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Vomiting
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0012 events2 affected10 at risk
EG0022 events2 affected10 at risk
EG0032 events2 affected11 at risk
EG0041 events1 affected10 at risk
EG0050 affected9 at risk
EG0063 events3 affected10 at risk
EG0071 events1 affected11 at risk
EG0082 events1 affected10 at risk
EG0090 affected11 at risk
Constipation
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0021 events1 affected10 at risk
EG0031 events1 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0071 events1 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Nausea
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0005 events4 affected9 at risk
EG0014 events4 affected10 at risk
EG0023 events3 affected10 at risk
EG0033 events3 affected11 at risk
EG0043 events3 affected10 at risk
EG0051 events1 affected9 at risk
EG0064 events3 affected10 at risk
EG0071 events1 affected11 at risk
EG0083 events3 affected10 at risk
EG0093 events3 affected11 at risk
Chills
General disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Fatigue
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 events1 affected10 at risk
EG0051 events1 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Malaise
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 events1 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Oedema peripheral
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 events1 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Non-cardiac chest pain
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 events1 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Pain
General disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected10 at risk
EG0033 events2 affected11 at risk
EG0040 affected10 at risk
EG0051 events1 affected9 at risk
EG0062 events2 affected10 at risk
EG0070 affected11 at risk
EG0081 events1 affected10 at risk
EG0092 events2 affected11 at risk
Pyrexia
General disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0052 events2 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0081 events1 affected10 at risk
EG0090 affected11 at risk
Cystitis
Infections and infestations
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 events1 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Rhinitis
Infections and infestations
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0081 events1 affected10 at risk
EG0090 affected11 at risk
Anaesthetic complication
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0062 events1 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0091 events1 affected11 at risk
Medication error
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0032 events1 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Neuromuscular block prolonged
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 events1 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Operative haemorrhage
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0061 events1 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0031 events1 affected11 at risk
EG0041 events1 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0031 events1 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0081 events1 affected10 at risk
EG0090 affected11 at risk
Post procedural headache
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 events1 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 events1 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0071 events1 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Post procedural oedema
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0091 events1 affected11 at risk
Postoperative fever
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0031 events1 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Postoperative thrombosis
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0031 events1 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Procedural complication
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0021 events1 affected10 at risk
EG0030 affected11 at risk
EG0041 events1 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Procedural hypertension
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 events1 affected9 at risk
EG0061 events1 affected10 at risk
EG0072 events2 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Procedural hypotension
Injury, poisoning and procedural complications
MetDRA 9.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 affected10 at risk
EG0022 events1 affected10 at risk
EG0032 events2 affected11 at risk
EG0041 events1 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0071 events1 affected11 at risk
EG0081 events1 affected10 at risk
EG0093 events3 affected11 at risk
Procedural pain
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0003 events3 affected9 at risk
EG0015 events4 affected10 at risk
EG0022 events2 affected10 at risk
EG0034 events4 affected11 at risk
EG0044 events3 affected10 at risk
EG0050 affected9 at risk
EG0063 events3 affected10 at risk
EG0073 events3 affected11 at risk
EG0084 events3 affected10 at risk
EG0093 events3 affected11 at risk
Wound complication
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 events1 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Wound secretion
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 events1 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Alanine aminotransferase increased
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0021 events1 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0021 events1 affected10 at risk
EG0031 events1 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Beta 2 microglobulin increased
Investigations
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0071 events1 affected11 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
Gamma-glutamyltransferase increased
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0021 events1 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Urine output decreased
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0032 events2 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 events1 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0071 events1 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 events1 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Shoulder pain
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0081 events1 affected10 at risk
EG0090 affected11 at risk
Ageusia
Nervous system disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0031 events1 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Dizziness
Nervous system disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0091 events1 affected11 at risk
Headache
Nervous system disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0021 events1 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0071 events1 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Nystagmus
Nervous system disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0061 events1 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Paraesthesia
Nervous system disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 events1 affected10 at risk
EG0051 events1 affected9 at risk
EG0061 events1 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Somnolence
Nervous system disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0091 events1 affected11 at risk
Anxiety
Psychiatric disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0061 events1 affected10 at risk
EG0071 events1 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Hallucination
Psychiatric disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 events1 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Insomnia
Psychiatric disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0013 events2 affected10 at risk
EG0021 events1 affected10 at risk
EG0030 affected11 at risk
EG0041 events1 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Sleep disorder
Psychiatric disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 events1 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Urinary retention
Renal and urinary disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 events1 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0091 events1 affected11 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 events1 affected9 at risk
EG0061 events1 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Hyperventilation
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 events1 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0021 events1 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0081 events1 affected10 at risk
EG0090 affected11 at risk
Respiratory depression
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 events1 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0061 events1 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0081 events1 affected10 at risk
EG0090 affected11 at risk
Haemorrhage
Vascular disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected11 at risk
EG0080 affected10 at risk
EG0090 affected11 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Any scientific paper, presentation, or other communication concerning the clinical trial described in the protocol will first be submitted to Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.