A Follow-On Trial to Assess the Long Term Safety and Effi... | NCT00235443 | Trialant
NCT00235443
Sponsor
UCB Pharma
Status
Completed
Last Update Posted
Jul 17, 2018Actual
Enrollment
451Actual
Phase
Phase 2Phase 3
Conditions
Diabetic Neuropathy
Interventions
lacosamide
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00235443
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
SP0745
Secondary IDs
Not provided
Brief Title
A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy
Official Title
A Multi-Center, Open-Label, Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy
Acronym
Not provided
Organization
UCB PharmaINDUSTRY
Status Module
Record Verification Date
Jul 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT03559673No longer available
Start Date
Sep 2004
Primary Completion Date
Jul 2008Actual
Completion Date
Jul 2008Actual
First Submitted Date
Oct 6, 2005
First Submission Date that Met QC Criteria
Oct 6, 2005
First Posted Date
Oct 10, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 31, 2009
Results First Submitted that Met QC Criteria
Aug 31, 2009
Results First Posted Date
Oct 5, 2009Estimated
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
Jun 20, 2018
Last Update Posted Date
Jul 17, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
UCB PharmaINDUSTRY
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
Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated.
Detailed Description
This phase 2/3 open-label trial is being conducted at approximately 100 sites in the US to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. Approximately 525 subjects will be enrolled. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have completed trials SP665, SP742, or SP768 and, in the investigator's opinion, may benefit from long-term administration of lacosamide. Subjects will be titrated to their optimal dose of lacosamide (up to 600mg/day). The safety and tolerability of the different doses of lacosamide will be investigated throughout the trial. In addition, to determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity and pain interference with sleep and activity. Subjects' quality of life will also be investigated.
Conditions Module
Conditions
Diabetic Neuropathy
Keywords
Painful Distal Diabetic Neuropathy
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 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
451Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Experimental
Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Drug: lacosamide
Interventions
Name
Type
Description
Arm Group Labels
Other Names
lacosamide
Drug
Open-label treatment (two times per day) with film-coated tablets include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, and 600mg/day throughout individual study period.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.
Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).
Throughout the study up to a maximum study period of 2.8 years
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).
Change from Baseline in average daily pain score using an 11-point Likert scale (0-10). On Likert scale, 0=no pain and 10=worst possible pain.
Baseline to end of entire treatment phase (maximum study period of 2.8 years).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects who completed Study SP665, SP742, or SP768 and, in the investigators opinion, might benefit from long-term administration of SPM 927. Exception: subjects who prematurely discontinued Study SP742 or SP768 due to lack of efficacy or due to intolerability to trial medication may be eligible to participate in Study SP745, after consultation with the medical monitor.
Exclusion Criteria:
Subject has clinically relevant electrocardiogram (ECG) abnormalities, or QT-corrected (QTc) interval >=500 milliseconds (ms), and/or a QTc interval increase of >=60ms from the mean pre-dose QTc value at Visit 2 of Studies SP665, SP742 or SP768.
Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >=3 times the upper limit of the normal range (ULN) with total bilirubin >=2 times ULN or transaminases (AST and/or ALT) >=5 times ULN.
Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial.
Trial SP745 (NCT00235443) was conducted in 93 sites in the US and 89 of these sites screened at least 1 subject. The first subject was enrolled on 13Sep2004 and the last subject completed on 25Jul2008.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
FG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
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
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group 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
1
SPM927
Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS).
Change from Baseline in average pain score as measured by a 100mm Visual Analogue Scale (VAS). On VAS 0mm=no pain and 100mm=worst possible pain.
Baseline to end of entire treatment phase (maximum study period of 2.8 years).
Patient's Global Impression of Change (PGIC) From Baseline in Pain.
Patient's Global Impression of Change (PGIC) from Baseline in Pain. Original categorical responses are much worse, moderately worse, mildly worst, no change, mildly better, moderately better, and much better. Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse).
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity.
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for intensity of pain where 0=no pain and 10=most intense pain sensation imaginable.
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for sharpness of pain where 0=not sharp and 10=most sharp sensation imaginable ("like a knife").
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with heat sensation where 0=not hot and 10=the most hot sensation imaginable ("on fire").
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with dullness of pain where 0=not dull and 10=most dull sensation imaginable.
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with cold sensation where 0=not cold and 10=most cold sensation imaginable ("freezing").
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with sensitivity of pain where 0=not sensitive and 10=most sensitive sensation imaginable ("raw skin").
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with itchiness where 0=not itchy and 10=most itchy sensation imaginable ("like poison oak").
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with unpleasantness where 0=not pleasant and 10=most unpleasant sensation imaginable ("intolerable").
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with deep pain where 0=no deep pain and 10=most intense deep pain sensation imaginable.
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with surface pain where 0=no surface pain and 10=most intense surface pain imaginable.
Baseline to Termination Visit
Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale)
Change from Baseline in average pain interference with sleep (11-point Likert scale) where 0=no interference with sleep and 10=worst possible interference with sleep.
Baseline to end of entire treatment phase visit
Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale)
Change from Baseline in average pain interference with activity (11-point Likert scale) where 0=no interfence with activity and 10=worst possible interference with activity.
Baseline to end of entire treatment phase visit
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS)
Change from Baseline in quality of life using the SF-36 Health Survey - Physical Component Summary (PCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.
Baseline to Termination Visit
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS)
Change from Baseline in quality of life using the SF-36 Health Survey - Mental Component Summary (MCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.
Baseline to Termination Visit
Hoover
Alabama
United States
Huntsville
Alabama
United States
Northport
Alabama
United States
Tuscaloosa
Alabama
United States
Peoria
Arizona
United States
Phoenix
Arizona
United States
Tucson
Arizona
United States
Hot Springs
Arkansas
United States
Jonesboro
Arkansas
United States
Little Rock
Arkansas
United States
Irvine
California
United States
Los Angeles
California
United States
San Diego
California
United States
Santa Monica
California
United States
Spring Valley
California
United States
Tustin
California
United States
Walnut Creek
California
United States
Denver
Colorado
United States
Stratford
Connecticut
United States
Newark
Delaware
United States
Wilmington
Delaware
United States
Bradenton
Florida
United States
Clearwater
Florida
United States
Fort Myers
Florida
United States
New Port Richey
Florida
United States
Ocala
Florida
United States
Pembroke Pines
Florida
United States
Pinellas Park
Florida
United States
South Miami
Florida
United States
St. Petersburg
Florida
United States
Sunrise
Florida
United States
Tallahassee
Florida
United States
Marietta
Georgia
United States
Chicago
Illinois
United States
Elk Grove Village
Illinois
United States
North Chicago
Illinois
United States
Evansville
Indiana
United States
West Des Moines
Iowa
United States
Crestview Hills
Kentucky
United States
Louisville
Kentucky
United States
Madisonville
Kentucky
United States
Paducah
Kentucky
United States
Owings Mills
Maryland
United States
Towson
Maryland
United States
Brockton
Massachusetts
United States
Ann Arbor
Michigan
United States
St Louis
Missouri
United States
Great Falls
Montana
United States
Omaha
Nebraska
United States
Las Vegas
Nevada
United States
Lawrenceville
New Jersey
United States
Voorhees Township
New Jersey
United States
Albany
New York
United States
Mineola
New York
United States
White Plains
New York
United States
Charlotte
North Carolina
United States
Greensboro
North Carolina
United States
Greenville
North Carolina
United States
Raleigh
North Carolina
United States
Winston-Salem
North Carolina
United States
Cincinnati
Ohio
United States
Toledo
Ohio
United States
Oklahoma City
Oklahoma
United States
Tulsa
Oklahoma
United States
Medford
Oregon
United States
Portland
Oregon
United States
Upland
Pennsylvania
United States
Greer
South Carolina
United States
Bristol
Tennessee
United States
Nashville
Tennessee
United States
Amarillo
Texas
United States
Dallas
Texas
United States
Fort Worth
Texas
United States
Houston
Texas
United States
Richardson
Texas
United States
San Antonio
Texas
United States
Bennington
Vermont
United States
Richmond
Virginia
United States
Salem
Virginia
United States
Virginia Beach
Virginia
United States
Spokane
Washington
United States
Tacoma
Washington
United States
Wenatchee
Washington
United States
FG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
FG003
Lacosamide 400mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
FG004
Lacosamide 500mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
FG005
Lacosamide 600mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
FG00011 subjects
FG00157 subjects
FG00285 subjects
FG003205 subjects
FG00439 subjects
FG00554 subjects
COMPLETED
FG0003 subjects
FG00119 subjects
FG00223 subjects
FG003108 subjects
FG0049 subjects
FG0059 subjects
NOT COMPLETED
FG0008 subjects
FG00138 subjects
FG00262 subjects
FG00397 subjects
FG00430 subjects
FG00545 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG00112 subjects
FG00217 subjects
FG00344 subjects
FG00410 subjects
FG00515 subjects
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0025 subjects
FG00312 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0019 subjects
FG00225 subjects
FG00324 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0018 subjects
FG0026 subjects
FG0036 subjects
FG004
Unsatisfactory compliance
FG0000 subjects
FG0012 subjects
FG0023 subjects
FG0034 subjects
FG004
Other reasons for premature termination
FG0001 subjects
FG0016 subjects
FG0026 subjects
FG0037 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
BG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
BG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
BG003
Lacosamide 400mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
BG004
Lacosamide 500mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
BG005
Lacosamide 600mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00011
BG00157
BG00285
BG003205
BG00439
BG00554
BG006451
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00064.0± 8.16
BG00159.3± 10.53
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG00133
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00011
BG00157
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
Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.
Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).
Safety population are subjects who took at least one dose of lacosamide (LCM).
Posted
Number
Participants
Throughout the study up to a maximum study period of 2.8 years
ID
Title
Description
OG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG003
Lacosamide 400mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG004
Lacosamide 500mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG005
Lacosamide 600mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG006
Total
All modal dose groups combined
Units
Counts
Participants
OG00011
OG00157
OG00285
OG003
Title
Denominators
Categories
Title
Measurements
OG00011
OG00152
OG00274
OG003
Secondary
Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).
Change from Baseline in average daily pain score using an 11-point Likert scale (0-10). On Likert scale, 0=no pain and 10=worst possible pain.
Safety population are subjects who took at least one dose of lacosamide (LCM).
Posted
Mean
Standard Deviation
Units on a scale
Baseline to end of entire treatment phase (maximum study period of 2.8 years).
ID
Title
Description
OG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG003
Lacosamide 400mg/Day
Secondary
Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS).
Change from Baseline in average pain score as measured by a 100mm Visual Analogue Scale (VAS). On VAS 0mm=no pain and 100mm=worst possible pain.
Safety population are subjects who took at least one dose of lacosamide (LCM).
Posted
Mean
Standard Deviation
Units on a scale
Baseline to end of entire treatment phase (maximum study period of 2.8 years).
ID
Title
Description
OG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG003
Lacosamide 400mg/Day
Secondary
Patient's Global Impression of Change (PGIC) From Baseline in Pain.
Patient's Global Impression of Change (PGIC) from Baseline in Pain. Original categorical responses are much worse, moderately worse, mildly worst, no change, mildly better, moderately better, and much better. Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse).
Safety population are subjects who took at least one dose of lacosamide (LCM).
Posted
Number
Participants
Baseline to Termination Visit
ID
Title
Description
OG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG003
Secondary
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity.
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for intensity of pain where 0=no pain and 10=most intense pain sensation imaginable.
Safety population are subjects who took at least one dose of lacosamide (LCM).
Posted
Mean
Standard Deviation
Units on a scale
Baseline to Termination Visit
ID
Title
Description
OG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG003
Lacosamide 400mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Secondary
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for sharpness of pain where 0=not sharp and 10=most sharp sensation imaginable ("like a knife").
Safety population are subjects who took at least one dose of lacosamide (LCM).
Posted
Mean
Standard Deviation
Units on a scale
Baseline to Termination Visit
ID
Title
Description
OG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG003
Lacosamide 400mg/Day
Secondary
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with heat sensation where 0=not hot and 10=the most hot sensation imaginable ("on fire").
Safety population are subjects who took at least one dose of lacosamide (LCM).
Posted
Mean
Standard Deviation
Units on a scale
Baseline to Termination Visit
ID
Title
Description
OG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG003
Lacosamide 400mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Secondary
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with dullness of pain where 0=not dull and 10=most dull sensation imaginable.
Safety population are subjects who took at least one dose of lacosamide (LCM).
Posted
Mean
Standard Deviation
Units on a scale
Baseline to Termination Visit
ID
Title
Description
OG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG003
Lacosamide 400mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Secondary
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with cold sensation where 0=not cold and 10=most cold sensation imaginable ("freezing").
Safety population are subjects who took at least one dose of lacosamide (LCM).
Posted
Mean
Standard Deviation
Units on a scale
Baseline to Termination Visit
ID
Title
Description
OG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG003
Lacosamide 400mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Secondary
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with sensitivity of pain where 0=not sensitive and 10=most sensitive sensation imaginable ("raw skin").
Safety population are subjects who took at least one dose of lacosamide (LCM).
Posted
Mean
Standard Deviation
Units on a scale
Baseline to Termination Visit
ID
Title
Description
OG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG003
Lacosamide 400mg/Day
Secondary
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with itchiness where 0=not itchy and 10=most itchy sensation imaginable ("like poison oak").
Safety population are subjects who took at least one dose of lacosamide (LCM).
Posted
Mean
Standard Deviation
Units on a scale
Baseline to Termination Visit
ID
Title
Description
OG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG003
Lacosamide 400mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Secondary
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with unpleasantness where 0=not pleasant and 10=most unpleasant sensation imaginable ("intolerable").
Safety population are subjects who took at least one dose of lacosamide (LCM).
Posted
Mean
Standard Deviation
Units on a scale
Baseline to Termination Visit
ID
Title
Description
OG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG003
Lacosamide 400mg/Day
Secondary
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with deep pain where 0=no deep pain and 10=most intense deep pain sensation imaginable.
Safety population are subjects who took at least one dose of lacosamide (LCM).
Posted
Mean
Standard Deviation
Units on a scale
Baseline to Termination Visit
ID
Title
Description
OG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG003
Lacosamide 400mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Secondary
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with surface pain where 0=no surface pain and 10=most intense surface pain imaginable.
Safety population are subjects who took at least one dose of lacosamide (LCM).
Posted
Mean
Standard Deviation
Units on a scale
Baseline to Termination Visit
ID
Title
Description
OG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG003
Lacosamide 400mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Secondary
Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale)
Change from Baseline in average pain interference with sleep (11-point Likert scale) where 0=no interference with sleep and 10=worst possible interference with sleep.
Safety population are subjects who took at least one dose of lacosamide (LCM).
Posted
Mean
Standard Deviation
Units on a scale
Baseline to end of entire treatment phase visit
ID
Title
Description
OG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG003
Lacosamide 400mg/Day
Secondary
Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale)
Change from Baseline in average pain interference with activity (11-point Likert scale) where 0=no interfence with activity and 10=worst possible interference with activity.
Safety population are subjects who took at least one dose of lacosamide (LCM).
Posted
Mean
Standard Deviation
Units on a scale
Baseline to end of entire treatment phase visit
ID
Title
Description
OG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG003
Lacosamide 400mg/Day
Secondary
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS)
Change from Baseline in quality of life using the SF-36 Health Survey - Physical Component Summary (PCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.
Safety population are subjects who took at least one dose of lacosamide (LCM).
Posted
Mean
Standard Deviation
Units on a scale
Baseline to Termination Visit
ID
Title
Description
OG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG003
Lacosamide 400mg/Day
Secondary
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS)
Change from Baseline in quality of life using the SF-36 Health Survey - Mental Component Summary (MCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.
Safety population are subjects who took at least one dose of lacosamide (LCM).
Posted
Mean
Standard Deviation
Units on a scale
Baseline to Termination Visit
ID
Title
Description
OG000
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
OG003
Lacosamide 400mg/Day
Time Frame
3 years, 10 months
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
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1
11
10
11
EG001
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
13
57
47
57
EG002
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
17
85
68
85
EG003
Lacosamide 400mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
52
205
183
205
EG004
Lacosamide 500mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10
39
28
39
EG005
Lacosamide 600mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
7
54
43
54
EG006
Total
All modal dose groups combined
100
451
379
451
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG0031 events1 affected205 at risk
EG004
Haemorrhagic anaemia
Blood and lymphatic system disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0023 events3 affected85 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0022 events2 affected85 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Sick sinus syndrome
Cardiac disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Artioventricular block second degree
Cardiac disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Cardiac valve disease
Cardiac disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Gastrointestinal angiodysplasia haemorrhagic
Congenital, familial and genetic disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Vision blurred
Eye disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Chest pain
General disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0022 events1 affected85 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Abdominal wall abscess
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Haemothorax
Injury, poisoning and procedural complications
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Hepatitis C antibody positive
Investigations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Electrocardiogram PR prolongation
Investigations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Diabetic foot
Metabolism and nutrition disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Pituitary tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Hepatic neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Inflammatory carcinoma of the breast
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Syncope
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Depression
Psychiatric disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Depression suicidal
Psychiatric disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Cystocele
Reproductive system and breast disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Knee arthroplasty
Surgical and medical procedures
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Toe amputation
Surgical and medical procedures
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Shoulder operation
Surgical and medical procedures
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Peripheral vascular disorder
Vascular disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Aortic dilatation
Vascular disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected57 at risk
EG0024 events4 affected85 at risk
EG00310 events10 affected205 at risk
EG0041 events1 affected39 at risk
EG0051 events1 affected54 at risk
EG00618 events18 affected451 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0013 events3 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0013 events3 affected57 at risk
EG0025 events2 affected85 at risk
EG003
Vision blurred
Eye disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0023 events3 affected85 at risk
EG003
Cataract
Eye disorders
MedDRA 9.1
Non-systematic Assessment
EG0002 events1 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Visual disturbance
Eye disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG00110 events8 affected57 at risk
EG00221 events13 affected85 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0016 events5 affected57 at risk
EG0025 events5 affected85 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0015 events5 affected57 at risk
EG0024 events4 affected85 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0002 events1 affected11 at risk
EG0012 events2 affected57 at risk
EG0024 events3 affected85 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0012 events1 affected57 at risk
EG0022 events2 affected85 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0023 events3 affected85 at risk
EG003
Stomach discomfort
Gastrointestinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0002 events1 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Gastrointestinal motility disorder
Gastrointestinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Oedema peripheral
General disorders
MedDRA 9.1
Non-systematic Assessment
EG0002 events1 affected11 at risk
EG00111 events9 affected57 at risk
EG0029 events8 affected85 at risk
EG003
Fatigue
General disorders
MedDRA 9.1
Non-systematic Assessment
EG0003 events3 affected11 at risk
EG0016 events6 affected57 at risk
EG0029 events8 affected85 at risk
EG003
Chest pain
General disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0012 events2 affected57 at risk
EG0025 events3 affected85 at risk
EG003
Pyrexia
General disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0013 events3 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Gait disturbance
General disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Chest discomfort
General disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Asthenia
General disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Irritability
General disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG00111 events10 affected57 at risk
EG00218 events14 affected85 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0003 events2 affected11 at risk
EG0014 events3 affected57 at risk
EG0024 events3 affected85 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0017 events3 affected57 at risk
EG0027 events6 affected85 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0003 events1 affected11 at risk
EG0016 events5 affected57 at risk
EG0028 events7 affected85 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0003 events3 affected11 at risk
EG0012 events2 affected57 at risk
EG0028 events7 affected85 at risk
EG003
Influenza
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0015 events5 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Ear infection
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0014 events3 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Skin infection
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 9.1
Non-systematic Assessment
EG0002 events2 affected11 at risk
EG0014 events4 affected57 at risk
EG0026 events4 affected85 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0014 events2 affected57 at risk
EG00212 events8 affected85 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0022 events2 affected85 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 9.1
Non-systematic Assessment
EG0002 events1 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Blood glucose increased
Investigations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0014 events3 affected57 at risk
EG0024 events3 affected85 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected57 at risk
EG0026 events6 affected85 at risk
EG003
Weight increased
Investigations
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0022 events2 affected85 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0013 events3 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0014 events4 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0014 events2 affected57 at risk
EG00210 events8 affected85 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0015 events5 affected57 at risk
EG0027 events6 affected85 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Non-systematic Assessment
EG0003 events1 affected11 at risk
EG0013 events2 affected57 at risk
EG0028 events7 affected85 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Non-systematic Assessment
EG0003 events1 affected11 at risk
EG0016 events6 affected57 at risk
EG0024 events3 affected85 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0023 events3 affected85 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0012 events2 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected57 at risk
EG0023 events3 affected85 at risk
EG003
Benign neoplasm of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0002 events2 affected11 at risk
EG00115 events11 affected57 at risk
EG00231 events23 affected85 at risk
EG003
Headache
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG00110 events10 affected57 at risk
EG00215 events8 affected85 at risk
EG003
Tremor
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0015 events4 affected57 at risk
EG0028 events7 affected85 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected57 at risk
EG0027 events7 affected85 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0013 events3 affected57 at risk
EG0024 events3 affected85 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0014 events4 affected57 at risk
EG0026 events6 affected85 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0002 events2 affected11 at risk
EG0011 events1 affected57 at risk
EG0024 events4 affected85 at risk
EG003
Pallanaesthesia
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0014 events4 affected57 at risk
EG0022 events1 affected85 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0002 events2 affected11 at risk
EG0012 events1 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Hyporeflexia
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0016 events1 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Coordination abnormal
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0014 events3 affected57 at risk
EG0023 events3 affected85 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Depression
Psychiatric disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0017 events7 affected57 at risk
EG0023 events3 affected85 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected57 at risk
EG0023 events3 affected85 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0022 events2 affected85 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected57 at risk
EG0028 events5 affected85 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0019 events6 affected57 at risk
EG0021 events1 affected85 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected57 at risk
EG0025 events4 affected85 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 9.1
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0014 events2 affected57 at risk
EG0022 events2 affected85 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Wound treatment
Surgical and medical procedures
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Peripheral nerve transposition
Surgical and medical procedures
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected57 at risk
EG0020 events0 affected85 at risk
EG003
Hypertension
Vascular disorders
MedDRA 9.1
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0012 events2 affected57 at risk
EG0027 events4 affected85 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.