Trial Outcomes & Findings for Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com) (NCT NCT01161420)
NCT ID: NCT01161420
Last Updated: 2017-08-25
Results Overview
Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy AHI responder was defined as a subject who experienced at least a 50% reduction in AHI from baseline and had an AHI of less than 20 at the 12-month follow-up.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
929 participants
Primary outcome timeframe
12 months
Results posted on
2017-08-25
Participant Flow
Between 10 Nov 2010 and 15 Feb 2012, 25 clinical sites enrolled 929 subjects into the study. A total of 803 subjects were withdrawn from the study as they were not eligible and did not receive an implant.126 subjects from 22 clinical sites were implanted the UAS system (3 clinical sites enrolled subjects but did not attempt or implant a device).
126 subjects were implanted with the Inspire therapy. At 12 months, the first 46 therapy responders were randomized 1:1 to either therapy ON (maintenance) or therapy OFF (withdrawal) for one week. Those who were in the withdrawal group returned to full therapy after one week of therapy being turned off.
Participant milestones
| Measure |
Inspire Therapy
126 subjects were implanted with Inspire therapy
|
|---|---|
|
Inspire Therapy
STARTED
|
126
|
|
Inspire Therapy
COMPLETED
|
124
|
|
Inspire Therapy
NOT COMPLETED
|
2
|
|
Withdrawal Study - Maintenance
STARTED
|
23
|
|
Withdrawal Study - Maintenance
COMPLETED
|
23
|
|
Withdrawal Study - Maintenance
NOT COMPLETED
|
0
|
|
Withdrawal Study - Withdrawal
STARTED
|
23
|
|
Withdrawal Study - Withdrawal
COMPLETED
|
23
|
|
Withdrawal Study - Withdrawal
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)
Baseline characteristics by cohort
| Measure |
Inspire Therapy
n=126 Participants
Study subjects continue to use Inspire therapy
Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration.
|
|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
110 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
122 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
123 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
87 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsDemonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy AHI responder was defined as a subject who experienced at least a 50% reduction in AHI from baseline and had an AHI of less than 20 at the 12-month follow-up.
Outcome measures
| Measure |
Inspire Therapy
n=126 Participants
Study subjects continue to use Inspire therapy; Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration.
|
Withdrawal
Twenty-three (23) patients were in the therapy withdrawal (OFF) group.
|
|---|---|---|
|
Apnea Hypopnea Index
|
66 percentage of subjects responding
Interval 9.3 to 23.6
|
—
|
PRIMARY outcome
Timeframe: 12 monthsDemonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy ODI responder was defines as a subject who experienced at least a 25% reduction in ODI from baseline.
Outcome measures
| Measure |
Inspire Therapy
n=126 Participants
Study subjects continue to use Inspire therapy; Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration.
|
Withdrawal
Twenty-three (23) patients were in the therapy withdrawal (OFF) group.
|
|---|---|---|
|
Oxygen Desaturation Index
|
75 percentage of subjects responding
Interval 13.9 to 15.7
|
—
|
PRIMARY outcome
Timeframe: 12 monthsThe primary safety objective of this pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment.
Outcome measures
| Measure |
Inspire Therapy
n=126 Participants
Study subjects continue to use Inspire therapy; Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration.
|
Withdrawal
Twenty-three (23) patients were in the therapy withdrawal (OFF) group.
|
|---|---|---|
|
Safety
|
494 Events Reported
|
—
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: The first 46 responders to the Inspire therapy at 12 months were randomized 1:1 to either the Therapy Maintenance Group (ON) or the Therapy Withdrawal Group (OFF). A subsequent sleep study of the two randomized groups was conducted and results were compared between the two groups.
The AHI difference between the 12-month PSG study and the 13-Month PSG study in the therapy maintenance group will be compared to the AHI difference in the therapy withdrawal group. The objective was to demonstrate that AHI increase in the therapy withdrawal group (therapy=OFF) is greater than any AHI change in the active therapy group (therapy=ON). AHI is the number of apneas or hypopneas recorded during a sleep study per hour of sleep; this is calculated by dividing the number of AHI events by the number of hours of sleep.
Outcome measures
| Measure |
Inspire Therapy
n=23 Participants
Study subjects continue to use Inspire therapy; Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration.
|
Withdrawal
n=23 Participants
Twenty-three (23) patients were in the therapy withdrawal (OFF) group.
|
|---|---|---|
|
AHI for the Randomized Controlled Therapy (RCT) Withdrawal Study
|
12.0 events per hour
Interval 9.3 to 23.6
|
16.4 events per hour
Interval 9.3 to 23.6
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Implanted subjects
The intent-to-treat (ITT) analysis for the primary endpoint included all patients who underwent an implant. A modified ITT analysis was conducted to include the subjects who did not completed the 12-month follow-up sleep study also. The ITT analysis was to calculate the AHI responder rate based on the subjects included in the analysis as described below. An Inspire therapy AHI responder was defined as a subject who experienced at least a 50% reduction in AHI from baseline and had an AHI of less than 20 at their last visit. The following subjects were included: * All implanted subjects who had AHI data collected at both baseline and 12-months follow-up. * All implanted subjects who had baseline data but no 12-month data, and had their last data values carried forward, provide they had a least 6-month AHI data. * Any implanted subject who did not have 12-month data available due to therapy failure (e.g., study withdrawal will be included in the analsys as a treatment failure.
Outcome measures
| Measure |
Inspire Therapy
n=126 Participants
Study subjects continue to use Inspire therapy; Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration.
|
Withdrawal
Twenty-three (23) patients were in the therapy withdrawal (OFF) group.
|
|---|---|---|
|
Modified Intent to Treat - AHI Responder Rate for All Implanted Subjects
|
83 Number of subjects responding to therapy
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsThe Functional Outcomes Sleep Questionnaire (FOSQ) is a validated instrument that assesses the effect of a subject's daytime sleepiness on activities of ordinary living. It is a quality of life measure that is commonly used in the clinical evaluation and management of OSA. This self-administered instrument consists of 30 questions divided into 5 domains: activity level, vigilance, intimacy, general productivity and social outcome. Scores range from 5 to 20, with higher scores indicating greater functioning. Change in FOSQ was calculated by subtracting the baseline score from the 12-month score.
Outcome measures
| Measure |
Inspire Therapy
n=123 Participants
Study subjects continue to use Inspire therapy; Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration.
|
Withdrawal
Twenty-three (23) patients were in the therapy withdrawal (OFF) group.
|
|---|---|---|
|
Change in FOSQ From Baseline to 12 Months
|
2.9 units on a scale
Interval 2.4 to 3.5
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsThe Epworth Sleepiness Scale (ESS) is a validated instrument that rates a subject's daytime sleepiness. Like the FOSQ, it is a quality of life measure that is commonly used in clinical evaluation and management of OSA. Scores range from 0 to 24, with lower scores indicating greater functioning. An ESS score of less than 10 is considered to be the cutpoint for normal subjective sleepiness.
Outcome measures
| Measure |
Inspire Therapy
n=123 Participants
Study subjects continue to use Inspire therapy; Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration.
|
Withdrawal
Twenty-three (23) patients were in the therapy withdrawal (OFF) group.
|
|---|---|---|
|
Change Epworth Sleepiness Scale (ESS) From Baseline to 12 Months
|
4.7 units on a scale
Interval 3.8 to 5.5
|
—
|
SECONDARY outcome
Timeframe: 12 monthsThe percentage of time spent with oxygen saturation below 90% has been an increasingly utilized surrogate for morbidity risk in sleep apnea populations. The SaO2 secondary endpoint in this study was determined by the time below an SaO2 level of 90% during the 12-month PSG study compared to that at baseline (average of screening and 1-month PSG studies). The objective was to demonstrate a decrease in the percentage of sleep time with an SaO2 level below 90% at 12 months.
Outcome measures
| Measure |
Inspire Therapy
n=124 Participants
Study subjects continue to use Inspire therapy; Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration.
|
Withdrawal
Twenty-three (23) patients were in the therapy withdrawal (OFF) group.
|
|---|---|---|
|
Percentage Sleep Time at SaO2 < 90%
|
2.5 Percentage of Sleep Time SaO2 <90%
95% Confidence Interval 11.1 • Interval 0.6 to 4.5
|
—
|
Adverse Events
Inspire Therapy
Serious events: 13 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Inspire Therapy
n=126 participants at risk
This pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment.
|
|---|---|
|
Surgical and medical procedures
Device Revision - resuture to secure IPG
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.6%
2/126 • Number of events 2 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Cardiac disorders
Death
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Cardiac disorders
Chest Pressure and/or Pain
|
1.6%
2/126 • Number of events 2 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Surgical and medical procedures
Recurring Syncope
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Injury, poisoning and procedural complications
Rotator Cuff Injury
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Injury, poisoning and procedural complications
Knee Injury
|
0.79%
1/126 • Number of events 2 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Gastrointestinal disorders
Acute Entercolitis
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Injury, poisoning and procedural complications
Motor Vehicle Accident
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Cardiac disorders
Heart Catheter Procedure
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Injury, poisoning and procedural complications
Accident
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Injury, poisoning and procedural complications
Hernia
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Gastrointestinal disorders
Entercolitis
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
Other adverse events
| Measure |
Inspire Therapy
n=126 participants at risk
This pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment.
|
|---|---|
|
Surgical and medical procedures
Events specifically related to an incision
|
25.4%
32/126 • Number of events 45 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Surgical and medical procedures
Post-operative discomfort independent of any surgical incision
|
24.6%
31/126 • Number of events 39 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Surgical and medical procedures
Temporary tongue weakness
|
18.3%
23/126 • Number of events 35 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Surgical and medical procedures
Intubation Effects
|
11.9%
15/126 • Number of events 18 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Nervous system disorders
Post-op Headache
|
6.3%
8/126 • Number of events 8 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Surgical and medical procedures
Other post-op symptoms
|
11.1%
14/126 • Number of events 22 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Infections and infestations
Procedure related Infection (mild or moderate)
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Discomfort due to electrical stimulation
|
33.3%
42/126 • Number of events 66 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Tongue abrasion
|
15.9%
20/126 • Number of events 23 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Mouth dryness
|
7.1%
9/126 • Number of events 9 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Mechanical pain associated with presence of device
|
4.8%
6/126 • Number of events 6 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Investigations
Temporary internal device usability or functionality complaint
|
6.3%
8/126 • Number of events 9 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Investigations
Temporary external device usability or functionality
|
2.4%
3/126 • Number of events 3 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Surgical and medical procedures
Other acute symptoms
|
11.1%
14/126 • Number of events 18 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Infections and infestations
Device related infection
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Abdominal incisional pain
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Gastrointestinal disorders
Abdominal pain/faecal incontinence
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Reproductive system and breast disorders
Abnormal pap smear/HPV
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Abnormal x-ray
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Gastrointestinal disorders
Acid reflux
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Gastrointestinal disorders
Acute gastro-enteritis
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Reproductive system and breast disorders
Acute prostatitis
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Immune system disorders
Allgeric reaction to Diamox
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Immune system disorders
Allergic reaction to post-op antibiotics
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Nervous system disorders
Anxiety
|
2.4%
3/126 • Number of events 3 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Awakening from sleep gasping for air
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back ache
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
5/126 • Number of events 5 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Infections and infestations
Benign fibrous papule and chronic folliculitis
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Bilateral swelling of neck
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Reproductive system and breast disorders
Blood in ejaculate
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Blood in sputum
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Bone spurs
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Reproductive system and breast disorders
BPH
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Broken teeth
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
2.4%
3/126 • Number of events 3 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Burning, pinching, mildly tender at IPG site
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Common cold
|
6.3%
8/126 • Number of events 13 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
4/126 • Number of events 4 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Immune system disorders
Cytomegalovirus
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Immune system disorders
Depression
|
1.6%
2/126 • Number of events 2 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Device stimulation not felt during the night
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Renal and urinary disorders
Difficulty voiding
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dilated cardiomyopathy
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Nervous system disorders
Dizziness
|
1.6%
2/126 • Number of events 2 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Drowsiness after Zolpidem administration
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Immune system disorders
Drug reaction
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Dry throat
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Dysphagia
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Ear pain
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Blood and lymphatic system disorders
Elevated triglycerides & blood sugar
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Immune system disorders
Enlarged lymphnodes
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Fatigue related to B12 deficiency
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Patient fall
|
3.2%
4/126 • Number of events 5 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Flu
|
3.2%
4/126 • Number of events 5 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Gastrointestinal disorders
Grastic pain
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.6%
2/126 • Number of events 2 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Gastrointestinal disorders
Gastrointestinal discomfort with nausea and mild diarrhea
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
General malaise
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Generalized itching
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Nervous system disorders
Generalized neuropathy
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Gastrointestinal disorders
GERD
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Gastrointestinal disorders
GI Upset
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Hangover symptoms with associated nausea and vomiting
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Head cold
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Nervous system disorders
Headache
|
1.6%
2/126 • Number of events 3 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Nervous system disorders
Herpes Zoster (Shingles)
|
1.6%
2/126 • Number of events 2 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Nervous system disorders
Hyperhidrosis
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Vascular disorders
Hypertension
|
2.4%
3/126 • Number of events 3 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Itchy right ear
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Impacted wisdom tooth
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Renal and urinary disorders
Incontinence
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Infections and infestations
Infection of the throat
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Inflammation
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Insomnia
|
2.4%
3/126 • Number of events 3 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Jolting sensation of whole body
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
1.6%
2/126 • Number of events 2 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Left hip/groin pain
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Left middle finger smashed
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Low grade headache
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Lower back muscle pull
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Mould infection (mouth)
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Immune system disorders
Nasal allergies
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Nasal congestion
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Nightmares
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Nervous system disorders
Non-cardiac chest pain
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Obesitas
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Ear and labyrinth disorders
Otitis media with effusion
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Pain after tooth extraction
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Pain below right shoulder
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Pain in esophagus
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Pain in right ear
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Pain in shoulder
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Painful back muscles
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Painful big toe
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Painful hip
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Painful right arm
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Painful right index finger
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Personal and work related problems
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Pharyngitis
|
1.6%
2/126 • Number of events 3 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Problems with jaw joint
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Immune system disorders
Rash
|
1.6%
2/126 • Number of events 2 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Reproductive system and breast disorders
Prostatism
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Nervous system disorders
Restless legs
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Right shoulder arm pain
|
2.4%
3/126 • Number of events 3 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Right thigh hematoma
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Sciatic nerve aggravated
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Sinus infection
|
2.4%
3/126 • Number of events 3 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Sinus/allergy symptoms
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Infections and infestations
Skin infection
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue pain; back/ribs
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Stiff neck pain
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Stress
|
1.6%
2/126 • Number of events 2 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Stuffy nose
|
1.6%
2/126 • Number of events 2 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Nervous system disorders
Submandibular gland pain
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Nervous system disorders
Syncope
|
2.4%
3/126 • Number of events 3 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
TBI with no LOC
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Throat ache
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Throat infection
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Throat pain
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Throat tightness
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Tinnitus
|
1.6%
2/126 • Number of events 2 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Tongue biting
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Tongue hematoma
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Tongue pain
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Tooth ache
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Tooth infection
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Tooth removed
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Trigger fingers
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Endocrine disorders
Type ll Diabetes
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Umbilical hernia
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
3.2%
4/126 • Number of events 5 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Renal and urinary disorders
Urinary tract infection
|
1.6%
2/126 • Number of events 2 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Reproductive system and breast disorders
Vaginal dermititis
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Nervous system disorders
Vertigo
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Cardiac disorders
Worsening arrhythmia - bigeminy
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Worsening occasional difficulty with speech
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Worsening dry mouth
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Renal and urinary disorders
Worsening urinary incontinence
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Nervous system disorders
Worsening RLS
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
Infections and infestations
Worsening sinusitis
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
|
General disorders
Wound on top of thumb
|
0.79%
1/126 • Number of events 1 • For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place