Comparison of DISCOVER™ Artificial Cervical Disc and ACDF... | NCT00432159 | Trialant
NCT00432159
Sponsor
DePuy Spine
Status
Completed
Last Update Posted
Oct 20, 2017Actual
Enrollment
500Actual
Phase
Not Applicable
Conditions
Cervical Degenerative Disc Disease
Interventions
Cervical TDR
ACDF with plate
Countries
United States
Australia
Netherlands
Protocol Section
Identification Module
NCT ID
NCT00432159
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
06-DISCOVER
Secondary IDs
Not provided
Brief Title
Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)
Official Title
A Multi-Center, Prospective, Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion for the Treatment of Cervical Degenerative Disc Disease
Acronym
Not provided
Organization
DePuy SpineINDUSTRY
Status Module
Record Verification Date
Sep 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
No
Start Date
Jul 1, 2006Actual
Primary Completion Date
May 1, 2013Actual
Completion Date
May 1, 2016Actual
First Submitted Date
Feb 5, 2007
First Submission Date that Met QC Criteria
Feb 5, 2007
First Posted Date
Feb 7, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
May 27, 2014
Results First Submitted that Met QC Criteria
Jul 15, 2014
Results First Posted Date
Aug 7, 2014Estimated
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
Sep 19, 2017
Last Update Posted Date
Oct 20, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
DePuy SpineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
Is FDA Regulated Device
Yes
Is Unapproved Device
Yes
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is intended to treat patients with symptomatic degenerative disc disease at one level of the cervical spine. The patients will be randomized to the DISCOVER Artificial Cervical Disc (total disc replacement) or SLIM-LOC™ (cervical fusion) to determine the safety and efficacy at 2 years post operative. Follow-up on patients treated with total disc replacement will be continued to 5 years post operative.
Detailed Description
This study is designed as a multicenter, prospective, randomized, controlled trial. Subjects will be stratified by the number of levels to be treated then assigned treatment in a randomized 1:1 ratio. Participants in the treatment group will undergo cervical total disc replacement with the DISCOVER Artificial Cervical Disc. Participants in the control group will undergo anterior cervical discectomy and fusion with the SLIM-LOC™ Anterior Cervical Plate System with a cortical or cortico-cancellous allograft spacer. Follow-up visits will occur at 2 weeks, 3 and 6 months and 1, and 2 years for all randomized subjects. Subjects that received the control treatment will complete their required study participation at 2 years post operative and subjects assigned the Discover treatment will complete their participation at 5 years post operative. Follow-up for the Discover treatment group will be via a telephone administered questionnaire at 3, 4 and 5 years post operative.
Conditions Module
Conditions
Cervical Degenerative Disc Disease
Keywords
cervical
spinal
arthroplasty
disc
surgical
ACDF
DDD
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
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
500Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1-level Cervical TDR
Experimental
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Device: Cervical TDR
1-level ACDF with plate
Active Comparator
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
Device: ACDF with plate
2-level Cervical TDR
Experimental
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Device: Cervical TDR
2-level ACDF
Active Comparator
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Device: ACDF with plate
Training: 1 & 2-level Cervical TDR
Experimental
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Cervical TDR
Device
Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
1-level Cervical TDR
2-level Cervical TDR
Training: 1 & 2-level Cervical TDR
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Overall Success
Subject must show 15 point improvement in the Neck Disability Index from baseline to 24 months post operative as well as have no device related SAE, Secondary Surgical Interventions at the index level or any new permanent neurological deterioration.
24 months
Secondary Outcomes
Measure
Description
Time Frame
NDI Success
15 point improvement in NDI. NDI has a max score of 50, which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.
24 months
Neurological Component of Success
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Objective evidence of cervical disc disease in 1 vertebral level between C3-C7 defined as (a) shoulder and/or arm pain in a documented radicular distribution resulting from herniated disc or bony osteophytes or (b)myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement
Unresponsiveness to documented non-surgical management for greater than or equal to 6 weeks and/or presentation with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management
Moderate Neck Disability Index (NDI) score
Able to give informed consent for study participation
Able and willing to return for all follow-up visits
Key Exclusion Criteria:
Significant cervical degenerative disc disease
Prior fusion procedure at any level(s) (C1-T1)
Marked cervical instability on lateral or flexion/extension radiographs
Presence of systemic infection or infection at the surgical site
Diagnosis of a condition, or requires postoperative medication(s), which may interfere with bony/soft tissue healing
History of alcohol and/or drug abuse
Any known allergy to a metal alloy or polyethylene
Morbid obesity
Any significant general illness (e.g., metastatic cancer, HIV)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
21 Years
Maximum Age
70 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Olympia Medical Center
Beverly Hills
California
90211
United States
Sutter Medical Center
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
Not provided
Recruitment Details
First subject was enrolled on July 10, 2006. The final study subjects were enrolled on March 22, 2011 and all study sites were informed that enrollment was closed effective March 31, 2011.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
FG001
1-level ACDF With Plate
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
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
Canada
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
Participant was masked to which treatment they would receive until AFTER the surgery/treatment procedure. At that point, they were unmasked.
Who Masked
Participant
Device: Cervical TDR
cervical arthroplasty
cervical disc
c-TDR
DISCOVER disc
ACDF with plate
Device
Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
1-level ACDF with plate
2-level ACDF
ACDF
Slim-Loc
Anterior cervical discectomy and fusion with plate
no new clinically significant permanent abnormalities in neurological function
24 months
Subsequent Secondary Surgery Component of Success
no subsequent secondary surgical intervention at the index level
24 months
Device-Related SAE Component of Success
no device related serious adverse events
24 months
NDI - Change From Baseline
Change from baseline of the Neck Disability Index. NDI has a minimum score of 0 (no disability) and a maximum score of 50 (complete disability) , which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.
24 months
Neck Pain VAS Scores - Change From Baseline
Change from baseline of the Neck Pain VAS Scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their neck.
24 months
Maximum Arm Pain VAS - Change From Baseline
Change from baseline in maximum value of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.
24 months
Average Arm Pain VAS - Change From Baseline
Change from baseline in average of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.
24 months
Maximum Shoulder Pain VAS - Change From Baseline
Change from baseline in Maximum value of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.
24 months
Average Shoulder Pain VAS - Change From Baseline
Change from baseline in Average of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.
24 months
Dysphagia Disability Index - Change From Baseline
Change from baseline in Dysphagia Disability Index (DDI). The DDI is designed to evaluate dysphagia, difficulty in swallowing, using a 25-item questionnaire. Responses from the questionnaire were scored as "always" 4, "sometimes" 2, or "never" 0, and summed to provide a total score (range 0-100). Higher DDI scores suggest greater subjective signs of dysphagia.
24 months
SF-36 - Physical Composite Scores (PCS) - Change From Baseline
Change from baseline in Quality of Life - Physical Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)
24 months
SF-36 - Mental Composite Scores (MCS) - Change From Baseline
Change from baseline in Quality of Life - Mental Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)
24 months
Work Status Assessment
24 months
Return to Work
Estimated Proportion of Subjects Returning to Work
24 months
Activity
Clinical Assessment of Activity
24 months
Subject Satisfaction
Subject Satisfaction (Would you have this procedure again?)
24 months
Global Cervical Range of Motion - Change From Baseline
24 months
Average Radiographic Disc Height (mm) - Change From Post-op
24 months
Sacramento
California
95816
United States
Rocky Mountain Associates in Orthopedic Medicine, PC
Loveland
Colorado
80538
United States
Yale University
New Haven
Connecticut
06520
United States
Florida Orthopaedic Institute
Tampa
Florida
33607
United States
Emory Orthopaedics and Spine Center
Atlanta
Georgia
30329
United States
Rush University/Midwest Orthopaedics
Chicago
Illinois
60607
United States
Northwestern Medical Faculty Foundation
Chicago
Illinois
60611
United States
Johnson County Spine
Overland Park
Kansas
66210
United States
University of Kentucky
Lexington
Kentucky
40536
United States
Johns Hopkins University
Baltimore
Maryland
21210
United States
Boston Spine Group
Newton
Massachusetts
02458
United States
University of Michigan
Ann Arbor
Michigan
48109
United States
Borgess Medical Center
Kalamazoo
Michigan
49048
United States
William Beaumont Hospital
Royal Oak
Michigan
48073
United States
Twin Cities Spine
Minneapolis
Minnesota
55404
United States
St. John's Regional Medical Center
Springfield
Missouri
65804
United States
St. Patrick Hospital Neurological Associates
Missoula
Montana
59802
United States
Nebraska Spine Center, LLC
Omaha
Nebraska
68154
United States
Center for Diseases and Surgery of the Spine
Las Vegas
Nevada
89106
United States
University of Medicine and Dentistry of New Jersey
Newark
New Jersey
07101
United States
Southern NY Neurosurgical Group
Johnson City
New York
13790
United States
Upstate Medical College/SUNY
Syracuse
New York
13202
United States
Carolina Neurosurgery & Spine Associates
Charlotte
North Carolina
28204
United States
Triangle Orthopaedic Associates
Durham
North Carolina
27704
United States
Neurospine Institute
Eugene
Oregon
97401
United States
North Texas Spine Care at Baylor Health
Dallas
Texas
75246
United States
Texas Back Institute
Plano
Texas
75093
United States
University of Utah
Salt Lake City
Utah
84132
United States
University of Virginia
Charlottesville
Virginia
22903
United States
Pacific Private Clinic
Queensland
4215
Australia
St. Elisabeth Ziekenhuis
Tilburg
5022 GC
Netherlands
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
FG002
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
FG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
FG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
FG000185 subjects
FG001167 subjects
FG00239 subjects
FG00320 subjects
FG00489 subjects
COMPLETED
FG000163 subjectsActual (Complete efficacy)
FG001137 subjectsActual (Complete efficacy)
FG00235 subjectsActual (Complete efficacy)
FG00315 subjectsActual (Complete efficacy)
FG00479 subjectsActual (Complete efficacy)
NOT COMPLETED
FG00022 subjects
FG00130 subjects
FG0024 subjects
FG0035 subjects
FG00410 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Failure
FG0009 subjects
FG0015 subjects
FG0023 subjects
FG0032 subjects
FG004
Missing NDI and/or neuro. assessment
FG00013 subjects
FG00124 subjects
FG0021 subjects
FG0033 subjects
FG004
Intent-to-treat
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
BG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
BG002
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
BG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
BG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000185
BG001167
BG00239
BG00320
BG00489
BG005500
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00044.2± 8.63
BG00142.8± 7.63
BG00244.1± 7.94
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00093
BG00189
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0007
BG0014
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
BMI
Body Mass Index in units of kilogram per meter squared
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00028.3± 4.97
BG00127.6± 4.83
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
Overall Success
Subject must show 15 point improvement in the Neck Disability Index from baseline to 24 months post operative as well as have no device related SAE, Secondary Surgical Interventions at the index level or any new permanent neurological deterioration.
The primary outcome was analyzed with an Intent to Treat (As Randomized) analysis. The difference between the number of treated patients and the number of participants analyzed for each group at the 24 month visit is due to: death of one randomized ACDF patient and patients with no data for NDI and Neurological function (missing data).
Posted
Number
participants who are successes
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG002
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Units
Counts
Participants
OG000169
OG001133
OG00238
OG003
Title
Denominators
Categories
Title
Measurements
OG000137
OG001110
OG00228
OG003
Secondary
NDI Success
15 point improvement in NDI. NDI has a max score of 50, which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Posted
Number
participants who are successes
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG002
2-level Cervical TDR
Secondary
Neurological Component of Success
no new clinically significant permanent abnormalities in neurological function
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Posted
Number
participants who are successes
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG002
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Secondary
Subsequent Secondary Surgery Component of Success
no subsequent secondary surgical intervention at the index level
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Posted
Number
participants who are successes
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG002
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Secondary
Device-Related SAE Component of Success
no device related serious adverse events
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Posted
Number
participants who are successes
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG002
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Secondary
NDI - Change From Baseline
Change from baseline of the Neck Disability Index. NDI has a minimum score of 0 (no disability) and a maximum score of 50 (complete disability) , which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Posted
Mean
Standard Deviation
NDI Score
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG002
Secondary
Neck Pain VAS Scores - Change From Baseline
Change from baseline of the Neck Pain VAS Scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their neck.
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Posted
Mean
Standard Error
Units on a scale
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Secondary
Maximum Arm Pain VAS - Change From Baseline
Change from baseline in maximum value of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Posted
Mean
Standard Deviation
Units on a scale
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Secondary
Average Arm Pain VAS - Change From Baseline
Change from baseline in average of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Posted
Mean
Standard Deviation
Units on a scale
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Secondary
Maximum Shoulder Pain VAS - Change From Baseline
Change from baseline in Maximum value of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Posted
Mean
Standard Deviation
Units on a scale
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Secondary
Average Shoulder Pain VAS - Change From Baseline
Change from baseline in Average of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Posted
Mean
Standard Deviation
Units on a scale
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Secondary
Dysphagia Disability Index - Change From Baseline
Change from baseline in Dysphagia Disability Index (DDI). The DDI is designed to evaluate dysphagia, difficulty in swallowing, using a 25-item questionnaire. Responses from the questionnaire were scored as "always" 4, "sometimes" 2, or "never" 0, and summed to provide a total score (range 0-100). Higher DDI scores suggest greater subjective signs of dysphagia.
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Posted
Mean
Standard Deviation
Units on a scale
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Secondary
SF-36 - Physical Composite Scores (PCS) - Change From Baseline
Change from baseline in Quality of Life - Physical Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Posted
Mean
Standard Deviation
Units on a scale
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG002
Secondary
SF-36 - Mental Composite Scores (MCS) - Change From Baseline
Change from baseline in Quality of Life - Mental Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Posted
Mean
Standard Deviation
Units on a scale
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG002
Secondary
Work Status Assessment
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Posted
Number
participants
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG002
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Secondary
Return to Work
Estimated Proportion of Subjects Returning to Work
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Posted
Number
% of subjects who returned to work
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG002
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Secondary
Activity
Clinical Assessment of Activity
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Posted
Number
participants
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG002
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Secondary
Subject Satisfaction
Subject Satisfaction (Would you have this procedure again?)
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Posted
Number
participants
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG002
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Secondary
Global Cervical Range of Motion - Change From Baseline
As Treated. The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Posted
Mean
Standard Deviation
degrees
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG002
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Secondary
Average Radiographic Disc Height (mm) - Change From Post-op
As Treated. The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Posted
Mean
Standard Deviation
mm
24 months
ID
Title
Description
OG000
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Units
Counts
Participants
Time Frame
24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
Description
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
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
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
59
186
158
186
EG001
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
44
166
135
166
EG002
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
14
39
38
39
EG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
5
20
20
20
EG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
24
89
83
89
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal distension
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected20 at risk
EG0040 events0 affected89 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Adverse drug reaction
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA (14.0)
Systematic Assessment
EG0006 events4 affected186 at risk
EG0011 events1 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0005 events4 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0007 events6 affected186 at risk
EG0014 events3 affected166 at risk
EG0022 events2 affected39 at risk
EG003
Bile duct cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Burns third degree
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0022 events1 affected39 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Catheter related infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Cervicobrachial syndrome
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0011 events1 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Chest pain
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Collapse of lung
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Complication of device removal
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Convulsion
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Cystocele
Reproductive system and breast disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Death
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Delivery
Pregnancy, puerperium and perinatal conditions
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Device malfunction
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Device migration
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Drug toxicity
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Dural tear
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Eustachian tube dysfunction
Ear and labyrinth disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Extraskeletal ossification
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Eye pain
Eye disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Facet joint syndrome
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Foreign body trauma
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Fracture nonunion
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Gun shot wound
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Impaired healing
General disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0013 events3 affected166 at risk
EG0022 events2 affected39 at risk
EG003
Intervertebral disc disorder
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0006 events6 affected186 at risk
EG0012 events2 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Intracranial hypotension
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Local swelling
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Lumbar radiculopathy
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Meniscus lesion
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Multiple fractures
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0022 events1 affected39 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0003 events3 affected186 at risk
EG0017 events6 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Neuroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (14.0)
Systematic Assessment
EG0004 events4 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0003 events3 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Pelvic venous thrombosis
Vascular disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Pharyngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0022 events1 affected39 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0012 events2 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Pneumothorax traumatic
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Procedural hypotension
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Radicular pain
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Radiculitis
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Renal injury
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Spinal X-ray abnormal
Investigations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Spondylitis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0003 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Subcutaneous emphysema
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Surgical failure
General disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Surgical procedure repeated
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Sympathetic posterior cervical syndrome
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Thoracic outlet syndrome
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Thyroid neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Uterine haemorrhage
Reproductive system and breast disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Uterovaginal prolapse
Reproductive system and breast disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Visual disturbance
Eye disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Vulval cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Wound infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected20 at risk
EG004
Abdominal pain
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Adverse drug reaction
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Airway complication of anaesthesia
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Amnesia
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0003 events3 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Areflexia
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0007 events6 affected186 at risk
EG0019 events9 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Asthenia
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Back injury
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG00034 events32 affected186 at risk
EG00122 events21 affected166 at risk
EG0027 events7 affected39 at risk
EG003
Bartholin's cyst
Reproductive system and breast disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Benign breast neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Benign neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Benign neoplasm of thyroid gland
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Bladder disorder
Renal and urinary disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Blood glucose increased
Investigations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0003 events3 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Bradyarrhythmia
Cardiac disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Breast cancer in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Breast cyst
Reproductive system and breast disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Bunion
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0003 events3 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0003 events3 affected186 at risk
EG0015 events5 affected166 at risk
EG0021 events1 affected39 at risk
EG003
CSF pressure increased
Investigations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Carotid arteriosclerosis
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0008 events7 affected186 at risk
EG0016 events5 affected166 at risk
EG0026 events5 affected39 at risk
EG003
Cervical root pain
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0007 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Cervicobrachial syndrome
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG00018 events15 affected186 at risk
EG00111 events10 affected166 at risk
EG0024 events3 affected39 at risk
EG003
Cervicogenic headache
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Cervix carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Chest discomfort
General disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Chest pain
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Choking
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Choking sensation
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Clonus
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Coeliac disease
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Connective tissue disorder
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Contrast media reaction
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0003 events3 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Corneal abrasion
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Cystitis interstitial
Renal and urinary disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Defaecation urgency
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Depression
Psychiatric disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0012 events2 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0012 events2 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0013 events3 affected166 at risk
EG0022 events2 affected39 at risk
EG003
Device breakage
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Device migration
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0003 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Diarrhoea infectious
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Discomfort
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0022 events2 affected39 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Drug intolerance
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Drug withdrawal syndrome
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Dural tear
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Dysfunctional uterine bleeding
Reproductive system and breast disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0012 events2 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG00012 events12 affected186 at risk
EG00119 events19 affected166 at risk
EG0028 events8 affected39 at risk
EG003
Dysphasia
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0013 events3 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0023 events3 affected39 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Endometrial hyperplasia
Reproductive system and breast disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Endometriosis
Reproductive system and breast disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0014 events3 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Eustachian tube dysfunction
Ear and labyrinth disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0004 events4 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Extraskeletal ossification
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Facet joint syndrome
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0006 events5 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0012 events2 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Feeling abnormal
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0012 events2 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Feeling cold
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Fibrocystic breast disease
Reproductive system and breast disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0005 events5 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Folliculitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Foreign body in eye
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Fractured sacrum
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Gait disturbance
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0014 events4 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Gingival disorder
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Glaucoma
Eye disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Granuloma annulare
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Grip strength decreased
Investigations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Headache
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG00013 events13 affected186 at risk
EG00114 events13 affected166 at risk
EG0027 events5 affected39 at risk
EG003
Heart rate irregular
Investigations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Hepatitis C
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0012 events2 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Hoffmann's sign
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Horner's syndrome
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Hyperreflexia
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Hypertension
Vascular disorders
MedDRA (14.0)
Systematic Assessment
EG0004 events4 affected186 at risk
EG0012 events2 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG00026 events22 affected186 at risk
EG00119 events16 affected166 at risk
EG00218 events12 affected39 at risk
EG003
Hypoaesthesia facial
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Hyporeflexia
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Hypotension
Vascular disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Incision site complication
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Incision site erythema
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Incision site haematoma
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0012 events2 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Incision site infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Incision site oedema
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0022 events2 affected39 at risk
EG003
Incision site pain
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Increased upper airway secretion
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Influenza
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Influenza like illness
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Ingrown hair
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0004 events4 affected186 at risk
EG0013 events3 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Intervertebral disc disorder
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0006 events3 affected186 at risk
EG0015 events5 affected166 at risk
EG0023 events2 affected39 at risk
EG003
Intervertebral disc space narrowing
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Intracranial hypotension
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Joint crepitation
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0003 events3 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Kyphosis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Laryngitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Limb traumatic amputation
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Local swelling
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Localised oedema
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Lumbar radiculopathy
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Lung hernia
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Lymphoid tissue hyperplasia
Blood and lymphatic system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Malignant dysphagia
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Meniscus lesion
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0005 events5 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Metatarsalgia
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0023 events2 affected39 at risk
EG003
Migraine
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0003 events3 affected186 at risk
EG0013 events3 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Motor dysfunction
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Multiple sclerosis
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Muscle injury
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG00020 events17 affected186 at risk
EG0016 events6 affected166 at risk
EG0028 events7 affected39 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0005 events5 affected186 at risk
EG0016 events6 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG00010 events7 affected186 at risk
EG0015 events4 affected166 at risk
EG0024 events4 affected39 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0003 events3 affected186 at risk
EG0013 events3 affected166 at risk
EG0024 events4 affected39 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG00071 events54 affected186 at risk
EG00156 events47 affected166 at risk
EG00225 events17 affected39 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0007 events7 affected186 at risk
EG0013 events3 affected166 at risk
EG0023 events3 affected39 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0006 events5 affected186 at risk
EG0013 events3 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Myelopathy
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Myofascial pain syndrome
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0008 events8 affected186 at risk
EG0012 events2 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Myotonia congenita
Congenital, familial and genetic disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0012 events2 affected166 at risk
EG0022 events2 affected39 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0004 events4 affected186 at risk
EG0012 events2 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Neck injury
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0012 events2 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG00081 events66 affected186 at risk
EG00166 events55 affected166 at risk
EG00238 events24 affected39 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0022 events1 affected39 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Nerve injury
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Nerve root compression
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Nerve root lesion
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Nervous system disorder
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Neuritis
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Neurogenic bladder
Renal and urinary disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Neurological symptom
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0012 events2 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0011 events1 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Nuclear magnetic resonance imaging brain abnormal
Investigations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Oedema peripheral
General disorders
MedDRA (14.0)
Systematic Assessment
EG0004 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0012 events2 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Optic neuropathy
Eye disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0012 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Oral disorder
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Pain
General disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG00050 events41 affected186 at risk
EG00153 events44 affected166 at risk
EG00218 events14 affected39 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG00024 events21 affected186 at risk
EG00117 events13 affected166 at risk
EG00213 events7 affected39 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Paresis
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Pharyngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0012 events2 affected166 at risk
EG0023 events3 affected39 at risk
EG003
Pituitary cyst
Endocrine disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Post laminectomy syndrome
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Post lumbar puncture syndrome
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Post procedural haematoma
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Post-traumatic headache
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0012 events2 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Postoperative fever
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Procedural headache
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Procedural nausea
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0007 events4 affected186 at risk
EG0012 events2 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Procedural vomiting
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Pseudarthrosis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0012 events2 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Purulent discharge
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Pyrexia
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Radicular pain
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0013 events3 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Radicular syndrome
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Radiculitis cervical
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Radiculitis lumbosacral
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Radiculopathy
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0014 events4 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0004 events4 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Reflexes abnormal
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0003 events3 affected186 at risk
EG0012 events2 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0009 events9 affected186 at risk
EG0016 events6 affected166 at risk
EG0022 events2 affected39 at risk
EG003
Sacroiliitis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Salivary gland calculus
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Sarcoidosis
Immune system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Scar
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Scoliosis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Sensation of foreign body
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Sensory disturbance
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0006 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Sensory loss
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0022 events2 affected39 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0004 events4 affected186 at risk
EG0012 events2 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Skin burning sensation
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Skin cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Skin graft infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Spinal fusion acquired
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Spinal haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0007 events7 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Spondylitis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Staphylococcal skin infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Stitch abscess
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Stomach discomfort
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Stress urinary incontinence
Renal and urinary disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Suture rupture
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Systemic lupus erythematosus
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Temporomandibular joint syndrome
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Tendon pain
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0012 events2 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0013 events3 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Tenosynovitis stenosans
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Tension headache
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Thoracic outlet syndrome
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0012 events2 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Thyroid neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Tongue disorder
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Tooth loss
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Tremor
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0022 events2 affected39 at risk
EG003
Ulnar neuritis
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0003 events3 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0012 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Urinary retention postoperative
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0012 events2 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Uterine polyp
Reproductive system and breast disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Viral infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Vision blurred
Eye disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Vocal cord disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Vocal cord paralysis
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Vocal cord paresis
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0003 events3 affected186 at risk
EG0012 events2 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Vulval cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0022 events1 affected39 at risk
EG003
Weight decreased
Investigations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Weight increased
Investigations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Whiplash injury
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected186 at risk
EG0011 events1 affected166 at risk
EG0020 events0 affected39 at risk
EG003
Wound infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected186 at risk
EG0010 events0 affected166 at risk
EG0021 events1 affected39 at risk
EG003
Enrollment terminated early, and beginning in March 2013, follow-up visits beyond 24 months were limited to Discover subjects only.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Lynn Wilson
Depuy Synthes
508-880-8109
lwilso45@its.jnj.com
ID
Term
D001860
Bone Plates
Ancestor Terms
ID
Term
D016268
Internal Fixators
D019736
Prostheses and Implants
D004864
Equipment and Supplies
D009984
Orthopedic Fixation Devices
D009983
Orthopedic Equipment
D013523
Surgical Equipment
D053831
Surgical Fixation Devices
Browse Leaves
Not provided
Browse Branches
Not provided
3 subjects
7 subjects
44.4
± 7.74
BG00442.3± 7.49
BG00543.4± 8.0
26
BG00310
BG00442
BG005260
Male
BG00092
BG00178
BG00213
BG00310
BG00447
BG005240
1
BG0031
BG0041
BG00514
Not Hispanic or Latino
BG000172
BG001153
BG00238
BG00319
BG00488
BG005470
Unknown or Not Reported
BG0006
BG00110
BG0020
BG0030
BG0040
BG00516
0
BG0030
BG0041
BG0052
Asian
BG0001
BG0012
BG0021
BG0030
BG0041
BG0055
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Black or African American
BG0008
BG0016
BG0021
BG0032
BG0044
BG00521
White
BG000170
BG001147
BG00236
BG00318
BG00482
BG005453
More than one race
BG0000
BG0010
BG0020
BG0030
BG0041
BG0051
Unknown or Not Reported
BG0006
BG00111
BG0021
BG0030
BG0040
BG00518
28.3
± 4.97
BG00330.0± 3.61
BG00428.9± 5.12
BG00528.3± 4.9
17
OG00482
13
OG00465
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Units
Counts
Participants
OG000161
OG001127
OG00235
OG00315
OG00478
Title
Denominators
Categories
Title
Measurements
OG000139
OG001111
OG00229
OG00313
OG00467
OG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Units
Counts
Participants
OG000162
OG001129
OG00235
OG00315
OG00480
Title
Denominators
Categories
Title
Measurements
OG000161
OG001127
OG00235
OG00315
OG00477
OG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Units
Counts
Participants
OG000185
OG001167
OG00239
OG00320
OG00489
Title
Denominators
Categories
Title
Measurements
OG000176
OG001160
OG00235
OG00318
OG00484
OG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Units
Counts
Participants
OG000185
OG001167
OG00239
OG00320
OG00489
Title
Denominators
Categories
Title
Measurements
OG000184
OG001167
OG00239
OG00320
OG00489
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Units
Counts
Participants
OG000161
OG001127
OG00235
OG00315
OG00478
Title
Denominators
Categories
Title
Measurements
OG000-33.4± 17.97
OG001-33.2± 18.04
OG002-32.8± 20.62
OG003-32.9± 22.10
OG004-34.3± 21.00
OG002
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Units
Counts
Participants
OG000154
OG001124
OG00235
OG00315
OG00478
Title
Denominators
Categories
Title
Measurements
OG000-47.0± 30.43
OG001-41.5± 30.57
OG002-36.1± 33.15
OG003-27.2± 26.14
OG004-46.3± 33.60
OG002
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Units
Counts
Participants
OG000154
OG001123
OG00235
OG00315
OG00478
Title
Denominators
Categories
Title
Measurements
OG000-52.0± 32.69
OG001-49.5± 33.45
OG002-42.4± 37.54
OG003-30.9± 44.62
OG004-44.3± 35.61
OG002
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Units
Counts
Participants
OG000154
OG001123
OG00235
OG00315
OG00478
Title
Denominators
Categories
Title
Measurements
OG000-32.1± 25.62
OG001-28.8± 20.88
OG002-30.5± 25.90
OG003-20.6± 26.33
OG004-26.6± 24.70
OG002
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Units
Counts
Participants
OG000154
OG001123
OG00235
OG00315
OG00478
Title
Denominators
Categories
Title
Measurements
OG000-52.1± 31.96
OG001-47.9± 30.18
OG002-43.0± 34.74
OG003-21.4± 43.84
OG004-45.9± 38.13
OG002
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Units
Counts
Participants
OG000154
OG001123
OG00235
OG00315
OG00478
Title
Denominators
Categories
Title
Measurements
OG000-34.1± 26.45
OG001-31.6± 22.69
OG002-31.7± 30.36
OG003-15.6± 24.85
OG004-31.0± 29.12
OG002
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Units
Counts
Participants
OG000154
OG001117
OG00235
OG00315
OG00477
Title
Denominators
Categories
Title
Measurements
OG000-1.3± 7.91
OG0010.7± 7.22
OG0020.3± 10.19
OG0031.2± 5.89
OG004-0.8± 9.56
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Units
Counts
Participants
OG000160
OG001127
OG00235
OG00315
OG00479
Title
Denominators
Categories
Title
Measurements
OG00014.2± 10.66
OG00113.3± 10.50
OG00215.2± 9.23
OG0036.6± 10.18
OG00415.2± 10.73
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
OG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Units
Counts
Participants
OG000160
OG001127
OG00235
OG00315
OG00479
Title
Denominators
Categories
Title
Measurements
OG0009.2± 11.66
OG0018.8± 12.01
OG0026.3± 12.89
OG00312.2± 13.65
OG0046.3± 13.19
OG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Units
Counts
Participants
OG000167
OG001131
OG00238
OG00316
OG00483
Title
Denominators
Categories
Not Working
Title
Measurements
OG00028
OG00118
OG0026
OG0032
OG00411
Full Time
Title
Measurements
OG000111
OG00191
OG00221
OG003
Part Time
Title
Measurements
OG00012
OG00110
OG0022
OG003
Full or Part Time
Title
Measurements
OG000123
OG001101
OG00223
OG003
Total
Title
Measurements
OG000151
OG001119
OG00229
OG003
Not Applicable
Title
Measurements
OG00016
OG00112
OG0029
OG003
OG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Units
Counts
Participants
OG000172
OG001157
OG00231
OG00320
OG00485
Title
Denominators
Categories
Title
Measurements
OG00087
OG00186
OG00284
OG00390
OG00492
OG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Units
Counts
Participants
OG000162
OG001129
OG00235
OG00315
OG00480
Title
Denominators
Categories
Light
Title
Measurements
OG00039
OG00130
OG00211
OG0035
OG00421
Moderate
Title
Measurements
OG00079
OG00158
OG00217
OG003
Vigorous
Title
Measurements
OG00044
OG00141
OG0027
OG003
OG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Units
Counts
Participants
OG000185
OG001167
OG00239
OG00320
OG00489
Title
Denominators
Categories
Definitely Yes
Title
Measurements
OG000121
OG00186
OG00224
OG0038
OG00462
Probably Yes
Title
Measurements
OG00025
OG00132
OG0025
OG003
Unsure or Too Early to Tell
Title
Measurements
OG00010
OG0016
OG0023
OG003
Probably Not
Title
Measurements
OG0004
OG0013
OG0023
OG003
Definitely Not
Title
Measurements
OG0001
OG0012
OG0022
OG003
OG003
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
OG004
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.