Bupivacaine Effectiveness and Safety in SABER® Trial | NCT01052012 | Trialant
NCT01052012
Sponsor
Durect
Status
Completed
Last Update Posted
Jun 1, 2021Actual
Enrollment
331Actual
Phase
Phase 3
Conditions
Postoperative Pain
Abdominal Surgery
Interventions
SABER-Bupivacaine
Bupivacaine HCl
SABER-Placebo
Countries
United States
Australia
New Zealand
Protocol Section
Identification Module
NCT ID
NCT01052012
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C803-025
Secondary IDs
Not provided
Brief Title
Bupivacaine Effectiveness and Safety in SABER® Trial
Official Title
Bupivacaine Effectiveness and Safety in SABER Trial (BESST)
Acronym
BESST
Organization
DurectINDUSTRY
Status Module
Record Verification Date
May 2021
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
Dec 2009
Primary Completion Date
Sep 2011Actual
Completion Date
Sep 2011Actual
First Submitted Date
Jan 18, 2010
First Submission Date that Met QC Criteria
Jan 18, 2010
First Posted Date
Jan 20, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 24, 2021
Results First Submitted that Met QC Criteria
May 6, 2021
Results First Posted Date
Jun 1, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Dec 20, 2011
Certification/Extension First Submitted that Passed QC Review
Dec 20, 2011
Certification/Extension First Posted Date
Dec 22, 2011Estimated
Last Update Submitted Date
May 6, 2021
Last Update Posted Date
Jun 1, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
DurectINDUSTRY
Collaborators
Name
Class
Nycomed
INDUSTRY
Hospira, now a wholly owned subsidiary of Pfizer
INDUSTRY
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
This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain.
The purpose of this study is to investigate safety (side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following various kinds of abdominal surgeries.
Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 72 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
0 to 72 hours post-dose
Supplemental Opioid Use
Total morphine-equivalent dose during 0-72 hours post dose. Median values were presented because data was not normally distributed.
0-72 hours post dose
Secondary Outcomes
Measure
Description
Time Frame
Mean Pain Intensity on Movement
Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 48 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patients must be able to read and understand the consent form, provide written consent, complete trial-related procedures, and communicate with the trial staff
Males and females, 18 years of age and older scheduled to undergo elective general abdominal surgery
Patients must be healthy or have only mild systemic disease
BMI < 45
Patients must have ECG wave form within normal limits
Female and male patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial participation is completed
Exclusion Criteria:
Patients who are pregnant or lactating
Patients undergoing emergency surgery (unless full consent is obtained and all screening procedures are completed prior to surgery)
Significant concomitant surgical procedure
History of multiple prior laparotomy procedures
Cancer with known metastases pre-operatively, which are suspected to impact post-operative recovery or pain
Planned formation of stoma during surgery or plans to undergo another laparotomy procedure within 30 days post-operatively
Pre-operative evidence of sepsis or septic shock
Pre-operative evaluation that suggests a surgery may preclude full closure of the incision(s)
Patients with current or regular use of systemic steroids, anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors, who cannot be withdrawn from these medications
Patients with current or regular use of drugs known to significantly prolong the QTc interval
Patients with known hypersensitivity to local anesthetic agents of the amide type (e.g. lidocaine, bupivacaine)
Patients with known hypersensitivity to morphine
Patients with conditions contraindicated for use of opioids
Patients with atrial fibrillation/flutter or other non-sinus rhythm (including paced rhythm); left bundle branch block (LBBB); or the following conditions: right bundle branch block (RBBB) in presence of a cardiac disease, significant cardiomyopathy, and myocardial infarction within last 6 months
Patients with a serum creatinine level two times more than the local laboratory normal limit
Patients who have received greater than 600 mg morphine equivalent daily dose for three or more days per week in the month prior to the surgical procedure
Patients who are currently being treated with methadone, or history of methadone use within the previous 6 months
Patients with known or suspected abuse of opioids or other illicit drugs
Patients with known or suspected alcohol abuse
Participation in another clinical trial at the same time or within 30 days of this trial
Patients who, in the Investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Dmitri Lissin, MD
Durect
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
DURECT Study Site
Birmingham
Alabama
35209
United States
DURECT Study Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
total of 393 patients were screened and 331 patients were randomized. There were 26 patients who were randomized but not treated. The reasons for not treating these patients included: conditions encountered during surgery necessitated procedures that did not meet protocol requirements, peri-operative epidural analgesia was administered, the test drug was not available, or the patient withdrew consent
Recruitment Details
The trial was conducted at 15 sites in the US, 3 sites in Australia, and 1 site in New Zealand. The study was initiated on 21 December 2009 and completed on 30 September 2011.
Pain Intensity at Rest AUC During 0-72 Hours Post Dose
Mean pain intensity at rest AUC during the period 0 to 72 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
0-72 hours post dose
Mean Pain Intensity at Rest AUC During 0-48 Hours Post Dose
Mean pain intensity at rest AUC during the period 0 to 48 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
0-48 hours post dose
Florence
Alabama
35630
United States
DURECT Study Site
Mobile
Alabama
36608
United States
DURECT Study Site
Mobile
Alabama
36617
United States
DURECT Study Site
Montgomery
Alabama
36106
United States
DURECT Study Site
Sheffield
Alabama
35660
United States
DURECT Study Site
Arcadia
California
91007
United States
DURECT Study Site
Fontana
California
92335
United States
DURECT Study Site
Laguna Hills
California
92653
United States
DURECT Study Site
Pasadena
California
91105
United States
DURECT Study Site
Tampa
Florida
33606
United States
DURECT Study Site
Powder Springs
Georgia
30127
United States
DURECT Study Site
Indianapolis
Indiana
46206
United States
DURECT Study Site
Boston
Massachusetts
02135
United States
DURECT Study Site
Troy
Michigan
48085
United States
DURECT Study Site
Duluth
Minnesota
55805
United States
DURECT Study Site
New York
New York
10016
United States
DURECT Study Site
Durham
North Carolina
27710
United States
DURECT Study Site
Columbus
Ohio
43210
United States
DURECT Study Site
Hershey
Pennsylvania
17033
United States
DURECT Study Site
Houston
Texas
77024
United States
DURECT Study Site
Temple
Texas
77375
United States
DURECT Study Site
Woodville South
South Australia
5011
Australia
DURECT Study Site
Box Hill
Victoria
3128
Australia
DURECT Study Site
Ringwood East
Victoria
3135
Australia
DURECT Study Site
Christchurch
8022
New Zealand
FG002
Cohort 2-POSIMIR
Laparoscopic Cholecystectomy
FG003
Cohort 2-Bupivacaine HCl
Laparoscopic Cholecystectomy
FG004
Cohort 3-POSIMIR
Laparoscopic Assisted Colectomy
FG005
Cohort 3-Placebo
Laparoscopic Assisted Colectomy
FG00032 subjects
FG00123 subjects
FG00230 subjects
FG00320 subjects
FG004140 subjects
FG00586 subjects
COMPLETED
FG00028 subjects
FG00117 subjects
FG00230 subjects
FG00319 subjects
FG004124 subjects
FG00576 subjects
NOT COMPLETED
FG0004 subjects
FG0016 subjects
FG0020 subjects
FG0031 subjects
FG00416 subjects
FG00510 subjects
Type
Comment
Reasons
Not treated
FG0002 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG00411 subjects
FG0058 subjects
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety Population
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1-POSIMIR
Open Laparotomy
BG001
Cohort 1-Bupivacaine HCl
Open Laparotomy
BG002
Cohort 2-POSIMIR
Laparoscopic Cholecystectomy
BG003
Cohort 2-Bupivacaine HCl
Laparoscopic Cholecystectomy
BG004
Cohort 3-POSIMIR
Laparoscopic Assisted Colectomy
BG005
Cohort 3-Placebo
Laparoscopic Assisted Colectomy
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00030
BG00118
BG00230
BG00320
BG004129
BG00578
BG006305
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00056.8(28 to 85)
BG00153.8(22 to 87)
BG00244.2(23 to 74)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00018
BG0019
BG002
BMI
Mean
Full Range
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00030.5(17.2 to 52.5)
BG00127.0(20.2 to 36.1)
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
Mean Pain Intensity on Movement
Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 72 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
ITT Population
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
0 to 72 hours post-dose
ID
Title
Description
OG000
Cohort 1-POSIMIR
Open Laparotomy
OG001
Cohort 1-Bupivacaine HCl
Open Laparotomy
OG002
Cohort 2-POSIMIR
Laparoscopic Cholecystectomy
OG003
Cohort 2-Bupivacaine HCl
Laparoscopic Cholecystectomy
OG004
Cohort 3-POSIMIR
Laparoscopic Assisted Colectomy
OG005
Cohort 3-Placebo
Laparoscopic Assisted Colectomy
Units
Counts
Participants
OG00026
OG00117
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG0004.9(4.0 to 5.7)
OG0015.0(4.7 to 6.8)
OG0022.8(2.0 to 3.6)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
With pooled site and treatment group as factors and incision length as a covariate.
0.1473
LS Mean Difference (Final Values)
-0.89
Standard Error of the Mean
0.597
2-Sided
95
-2.11
0.33
Superiority
OG002
OG003
ANCOVA
Primary
Supplemental Opioid Use
Total morphine-equivalent dose during 0-72 hours post dose. Median values were presented because data was not normally distributed.
ITT Population
Posted
Median
Inter-Quartile Range
Milligram equivalents
0-72 hours post dose
ID
Title
Description
OG000
Cohort 1-POSIMIR
Open Laparotomy
OG001
Cohort 1-Bupivacaine HCl
Open Laparotomy
OG002
Cohort 2-POSIMIR
Laparoscopic Cholecystectomy
OG003
Cohort 2-Bupivacaine HCl
Laparoscopic Cholecystectomy
OG004
Cohort 3-POSIMIR
Laparoscopic Assisted Colectomy
OG005
Secondary
Mean Pain Intensity on Movement
Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 48 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
ITT Population
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
0 to 48 hours post-dose
ID
Title
Description
OG000
Cohort 1-POSIMIR
Open Laparotomy
OG001
Cohort 1-Bupivacaine HCl
Open Laparotomy
OG002
Cohort 2-POSIMIR
Laparoscopic Cholecystectomy
OG003
Cohort 2-Bupivacaine HCl
Laparoscopic Cholecystectomy
Secondary
Total Morphine-equivalent Dose
Total morphine-equivalent dose during 0-48 hours post dose.
ITT Population
Posted
Median
Inter-Quartile Range
mg IV Morphine equivalents
0-48 hours post dose
ID
Title
Description
OG000
Cohort 1-POSIMIR
Open Laparotomy
OG001
Cohort 1-Bupivacaine HCl
Open Laparotomy
OG002
Cohort 2-POSIMIR
Laparoscopic Cholecystectomy
OG003
Cohort 2-Bupivacaine HCl
Laparoscopic Cholecystectomy
OG004
Cohort 3-POSIMIR
Laparoscopic Assisted Colectomy
OG005
Cohort 3-Placebo
Secondary
Proportion (Percent) of Patients Who Have Evidence of a Wound Infection
From Surgical Wound Healing and Local Tissue Condition Evaluation
ITT Population
Posted
Count of Participants
Participants
0 to 14 days post-dose (Visits 3 and 4)
ID
Title
Description
OG000
Cohort 1-POSIMIR
Open Laparotomy
OG001
Cohort 1-Bupivacaine HCl
Open Laparotomy
OG002
Cohort 2-POSIMIR
Laparoscopic Cholecystectomy
OG003
Cohort 2-Bupivacaine HCl
Laparoscopic Cholecystectomy
OG004
Cohort 3-POSIMIR
Laparoscopic Assisted Colectomy
OG005
Secondary
Time-to-first Use of Opioid Rescue Medication
ITT Population
Posted
Median
Full Range
Hours
0 to 14 days post-dose (Time from extubation until first opioid use)
ID
Title
Description
OG000
Cohort 1-POSIMIR
Open Laparotomy
OG001
Cohort 1-Bupivacaine HCl
Open Laparotomy
OG002
Cohort 2-POSIMIR
Laparoscopic Cholecystectomy
OG003
Cohort 2-Bupivacaine HCl
Laparoscopic Cholecystectomy
OG004
Cohort 3-POSIMIR
Laparoscopic Assisted Colectomy
OG005
Cohort 3-Placebo
Laparoscopic Assisted Colectomy
Secondary
Number (Incidence) of Participants With Opioid-related Side Effects
Pain Intensity at Rest AUC During 0-72 Hours Post Dose
Mean pain intensity at rest AUC during the period 0 to 72 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
ITT Population
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
0-72 hours post dose
ID
Title
Description
OG000
Cohort 1-POSIMIR
Open Laparotomy
OG001
Cohort 1-Bupivacaine HCl
Open Laparotomy
OG002
Cohort 2-POSIMIR
Laparoscopic Cholecystectomy
OG003
Cohort 2-Bupivacaine HCl
Laparoscopic Cholecystectomy
Secondary
Mean Pain Intensity at Rest AUC During 0-48 Hours Post Dose
Mean pain intensity at rest AUC during the period 0 to 48 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
ITT Population
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
0-48 hours post dose
ID
Title
Description
OG000
Cohort 1-POSIMIR
Open Laparotomy
OG001
Cohort 1-Bupivacaine HCl
Open Laparotomy
OG002
Cohort 2-POSIMIR
Laparoscopic Cholecystectomy
OG003
Cohort 2-Bupivacaine HCl
Laparoscopic Cholecystectomy
Time Frame
Not provided
Description
Not provided
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
Cohort 1-POSIMIR
Open Laparotomy
0
30
9
30
30
30
EG001
Cohort 1-Bupivacaine HCl
Open Laparotomy
0
18
4
18
17
18
EG002
Cohort 2-POSIMIR
Laparoscopic Cholecystectomy
0
30
0
30
28
30
EG003
Cohort 2-Bupivacaine HCl
Laparoscopic Cholecystectomy
0
20
1
20
20
20
EG004
Cohort 3-POSIMIR
Laparoscopic Assisted Colectomy
1
129
16
129
126
129
EG005
Cohort 3-Placebo
Laparoscopic Assisted Colectomy
0
78
9
78
75
78
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ileus
Gastrointestinal disorders
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected18 at risk
EG0020 affected30 at risk
EG0030 affected20 at risk
EG0046 affected129 at risk
EG0051 affected78 at risk
Colitis
Gastrointestinal disorders
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected18 at risk
EG0020 affected30 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Acute abdomen
Gastrointestinal disorders
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Diarrhea
Gastrointestinal disorders
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Abdominal abscess
Infections and infestations
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected18 at risk
EG0020 affected30 at risk
EG003
Perirectal abscess
Infections and infestations
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected18 at risk
EG0020 affected30 at risk
EG003
Clostridium difficile colitis
Infections and infestations
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Peridiverticular abscess
Infections and infestations
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Postoperative wound infection
Infections and infestations
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
Systematic Assessment
EG0002 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Postoperative ileus
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Apnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected18 at risk
EG0020 affected30 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected18 at risk
EG0020 affected30 at risk
EG003
Acute myocardial infarction
Cardiac disorders
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Atrial fibrillation
Cardiac disorders
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Atrial flutter
Cardiac disorders
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected18 at risk
EG0020 affected30 at risk
EG003
Chest pain
General disorders
Systematic Assessment
EG0002 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Application site discolouration
Gastrointestinal disorders
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Anemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Heparin-induced thrombocytopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Deep vein thrombosis
Vascular disorders
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Presyncope
Nervous system disorders
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Urinary retention
Renal and urinary disorders
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected18 at risk
EG0020 affected30 at risk
EG003
Sepsis
Infections and infestations
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected18 at risk
EG0020 affected30 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
Systematic Assessment
EG00018 events16 affected30 at risk
EG00111 events9 affected18 at risk
EG00223 events17 affected30 at risk
EG00320 events14 affected20 at risk
EG00480 events77 affected129 at risk
EG00542 events40 affected78 at risk
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG00012 events9 affected30 at risk
EG0012 events2 affected18 at risk
EG00213 events9 affected30 at risk
EG003
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected18 at risk
EG0028 events8 affected30 at risk
EG003
Abdominal distension
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected30 at risk
EG0012 events2 affected18 at risk
EG0026 events6 affected30 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0005 events4 affected30 at risk
EG0011 events1 affected18 at risk
EG0023 events3 affected30 at risk
EG003
Flatulence
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected30 at risk
EG0012 events2 affected18 at risk
EG0022 events2 affected30 at risk
EG003
Dyspepsia
Gastrointestinal disorders
Systematic Assessment
EG0002 events2 affected30 at risk
EG0012 events2 affected18 at risk
EG0024 events2 affected30 at risk
EG003
Ileus
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected18 at risk
EG0022 events2 affected30 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
Systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected30 at risk
EG003
Haematochezia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Abdominal rigidity
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0023 events2 affected30 at risk
EG003
Colitis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Ascites
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Oesophageal Ulcer
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Application site discolouration
General disorders
Systematic Assessment
EG00017 events14 affected30 at risk
EG0017 events6 affected18 at risk
EG00218 events15 affected30 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG0007 events7 affected30 at risk
EG0013 events3 affected18 at risk
EG0022 events2 affected30 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected18 at risk
EG0025 events5 affected30 at risk
EG003
Chest pain
General disorders
Systematic Assessment
EG0003 events3 affected30 at risk
EG0010 events0 affected18 at risk
EG0026 events3 affected30 at risk
EG003
Oedema peripheral
General disorders
Systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Chills
General disorders
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 affected30 at risk
EG003
Drug intolerance
General disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected30 at risk
EG003
Infusion site pain
General disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Induration
General disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Infusion site pruritus
General disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Non-cardiac chest pain
General disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG0003 events3 affected30 at risk
EG0011 events1 affected18 at risk
EG00215 events11 affected30 at risk
EG003
Dizziness
Nervous system disorders
Systematic Assessment
EG0003 events3 affected30 at risk
EG0011 events1 affected18 at risk
EG0027 events7 affected30 at risk
EG003
Dysgeusia
Nervous system disorders
Systematic Assessment
EG0002 events2 affected30 at risk
EG0011 events1 affected18 at risk
EG0023 events2 affected30 at risk
EG003
Somnolence
Nervous system disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Paraesthesia
Nervous system disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0023 events2 affected30 at risk
EG003
Lethargy
Nervous system disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0022 events2 affected30 at risk
EG003
Hypogeusia
Nervous system disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected30 at risk
EG003
Incision site haemorrhage
Injury, poisoning and procedural complications
Systematic Assessment
EG0004 events4 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Wound secretion
Injury, poisoning and procedural complications
Systematic Assessment
EG0003 events2 affected30 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected30 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
Systematic Assessment
EG0003 events3 affected30 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected30 at risk
EG003
Procedural hypertension
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0024 events4 affected30 at risk
EG003
Postoperative ileus
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Procedural hypotension
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Procedural nausea
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0022 events2 affected30 at risk
EG003
Incision site hypoaesthesia
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Incision site pruritus
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Postoperative wound infection
Infections and infestations
Systematic Assessment
EG0006 events4 affected30 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Urinary tract infection
Infections and infestations
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG0003 events3 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected30 at risk
EG003
Postoperative fever
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Abdominal abscess
Infections and infestations
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Lower respiratory tract infection
Infections and infestations
Systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Oral candidiasis
Infections and infestations
Systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Perirectal abscess
Infections and infestations
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Candidiasis
Infections and infestations
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Lobar pneumonia
Infections and infestations
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Rash pustular
Infections and infestations
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Sepsis
Infections and infestations
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Skin candida
Infections and infestations
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Blood phosphorus decreased
Investigations
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Haemoglobin decreased
Investigations
Systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Blood glucose increased
Investigations
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Blood magnesium decreased
Investigations
Systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Oxygen saturation decreased
Investigations
Systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Liver function test abnormal
Investigations
Systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Breath sounds abnormal
Investigations
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
Systematic Assessment
EG00010 events8 affected30 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected30 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0002 events2 affected30 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected30 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected18 at risk
EG00218 events8 affected30 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected30 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0022 events2 affected30 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0002 events2 affected30 at risk
EG0013 events3 affected18 at risk
EG0023 events2 affected30 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected30 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0003 events3 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0002 events2 affected30 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Apnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0002 events2 affected30 at risk
EG0012 events2 affected18 at risk
EG0021 events1 affected30 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected30 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Tachycardia
Cardiac disorders
Systematic Assessment
EG0003 events3 affected30 at risk
EG0014 events4 affected18 at risk
EG0021 events1 affected30 at risk
EG003
Sinus tachycardia
Cardiac disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Insomnia
Psychiatric disorders
Systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected18 at risk
EG0022 events2 affected30 at risk
EG003
Confusional state
Psychiatric disorders
Systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Hypertension
Vascular disorders
Systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Deep vein thrombosis
Vascular disorders
Systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0004 events4 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
Systematic Assessment
EG0001 events1 affected30 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Haemorrhagic anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
Systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Urinary retention
Renal and urinary disorders
Systematic Assessment
EG0003 events3 affected30 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected30 at risk
EG003
Vision blurred
Eye disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Tinnitus
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Hypotension
Vascular disorders
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Body temperature increased
Investigations
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected30 at risk
EG003
Blood urine present
Investigations
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected30 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Deborah Scott
Durect Corporation
408-777-1417
deborah.scott@durect.com
ID
Term
D010149
Pain, Postoperative
Ancestor Terms
ID
Term
D011183
Postoperative Complications
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
D010146
Pain
D009461
Neurologic Manifestations
D012816
Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D002045
Bupivacaine
Ancestor Terms
ID
Term
D000813
Anilides
D000577
Amides
D009930
Organic Chemicals
D000814
Aniline Compounds
D000588
Amines
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
1 subjects
FG0050 subjects
3 subjects
FG0051 subjects
0 subjects
FG0051 subjects
1 subjects
FG0050 subjects
39.5
(24 to 64)
BG00460.2(24 to 87)
BG00558.2(34 to 84)
BG00656.1(22 to 87)
20
BG00314
BG00470
BG00534
BG006165
Male
BG00012
BG0019
BG00210
BG0036
BG00459
BG00544
BG006140
30.8
(20.7 to 42.2)
BG00331.9(19.2 to 44.8)
BG00429.4(15.9 to 46.8)
BG00527.5(14.4 to 37.9)
BG00629.2(14.1 to 52.5)
20
OG004126
OG00577
3.9
(3.0 to 4.8)
OG0044.8(4.4 to 5.2)
OG0055.1(4.7 to 5.6)
with pooled site and treatment group as factors and incision length as a covariate.
0.0601
LS Mean Difference (Final Values)
-1.06
Standard Error of the Mean
0.547
2-Sided
95
-2.16
0.05
Superiority
OG004
OG005
ANCOVA
with pooled site and treatment group as factors and incision length as a covariate.