Trial Outcomes & Findings for EMRI SureScan™ Clinical Study (NCT NCT00433654)
NCT ID: NCT00433654
Last Updated: 2025-09-15
Results Overview
Subjects with a complication related to the MRI scan. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the MRI scan.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
484 participants
Primary outcome timeframe
MRI scan to one-month post-MRI scan
Results posted on
2025-09-15
Participant Flow
The first implant occurred 5 February 2007. A total of 484 subjects were enrolled, including 113 enrollments at 13 centers in the US and 371 enrollments at 29 centers outside of the US.
Implant procedure included EnRhythm MRI SureScan pacemaker and 2 CapsureFix MRI 5086MRI leads. Pacemaker function and adverse events were assessed. 17 subjects did not have an implant attempt. 3 subjects received a subset of the 3 system components and were followed for safety. All other subjects were randomized after successful implant.
Participant milestones
| Measure |
MRI Group
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
|
|---|---|---|
|
Overall Study
STARTED
|
258
|
206
|
|
Overall Study
COMPLETED
|
243
|
201
|
|
Overall Study
NOT COMPLETED
|
15
|
5
|
Reasons for withdrawal
| Measure |
MRI Group
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
|
|---|---|---|
|
Overall Study
Death
|
4
|
0
|
|
Overall Study
Missed visit
|
6
|
3
|
|
Overall Study
Subject not yet due for visit
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
EMRI SureScan™ Clinical Study
Baseline characteristics by cohort
| Measure |
MRI Group
n=258 Participants
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
n=206 Participants
The control group waited for one hour (did not have an MRI scan) at 9-12 weeks post-implant.
|
Total
n=464 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
183 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
322 Participants
n=5 Participants
|
|
Age, Continuous
|
69.3 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
68.0 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
68.7 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
154 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
289 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
33 participants
n=7 Participants
|
99 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
157 participants
n=5 Participants
|
141 participants
n=7 Participants
|
298 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
34 participants
n=5 Participants
|
32 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Region of Enrollment
Middle East
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: MRI scan to one-month post-MRI scanPopulation: Subjects who underwent an MRI scan following study protocol-specified instructions are included. Of the 243 subjects who completed a one-month post-MRI (4-month) visit, 32 did not complete the MRI scan according to the protocol instructions, and are not included.
Subjects with a complication related to the MRI scan. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the MRI scan.
Outcome measures
| Measure |
MRI Group
n=211 Participants
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
The control group waited for one hour (no MRI) at the 9-12 week follow-up.
|
|---|---|---|
|
Magnetic Resonance Imaging (MRI)-Related Complications
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: 9-12 week visit to 4-month visitPopulation: Subjects were excluded from this analysis if: they did not have atrial pacing capture threshold measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol.
Subjects' atrial pacing capture threshold (the energy sent from the pacemaker needed to make the heart's atrium beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.
Outcome measures
| Measure |
MRI Group
n=165 Participants
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
n=164 Participants
The control group waited for one hour (no MRI) at the 9-12 week follow-up.
|
|---|---|---|
|
Atrial Pacing Capture Threshold Success
|
165 participants
|
164 participants
|
PRIMARY outcome
Timeframe: 9-12 week visit to 4-month visitPopulation: Subjects were excluded from this analysis if: they did not have ventricular pacing capture threshold measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol.
Subjects' ventricular pacing capture threshold (the energy sent from the pacemaker needed to make the heart's ventricle beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.
Outcome measures
| Measure |
MRI Group
n=190 Participants
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
n=184 Participants
The control group waited for one hour (no MRI) at the 9-12 week follow-up.
|
|---|---|---|
|
Ventricular Pacing Capture Threshold Success
|
190 participants
|
183 participants
|
PRIMARY outcome
Timeframe: 9-12 week visit to 4-month visitPopulation: Subjects were excluded from this analysis if: they did not have atrial sensed amplitude measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol; or if their 9-12 week atrial sensed amplitude was less than 1.5 mV.
Subjects' atrial sensed amplitude (the minimum energy produced by the heart's atrium that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 1.5 millivolts (mV).
Outcome measures
| Measure |
MRI Group
n=131 Participants
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
n=139 Participants
The control group waited for one hour (no MRI) at the 9-12 week follow-up.
|
|---|---|---|
|
Atrial Sensed Amplitude Success
|
124 participants
|
129 participants
|
PRIMARY outcome
Timeframe: 9-12 week visit to 4-month visitPopulation: Subjects were excluded from this analysis if: they did not have ventricular sensed amplitude measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol; or if their 9-12 week ventricular sensed amplitude was less than 5.0 mV.
Subjects' ventricular sensed amplitude (the minimum energy produced by the heart's ventricle that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 5.0 millivolts (mV).
Outcome measures
| Measure |
MRI Group
n=134 Participants
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
n=136 Participants
The control group waited for one hour (no MRI) at the 9-12 week follow-up.
|
|---|---|---|
|
Ventricular Sensed Amplitude Success
|
130 participants
|
129 participants
|
SECONDARY outcome
Timeframe: Implant to 4 MonthsPopulation: All implanted subjects with either a 4-month follow-up or a system-related complication within the first 4 months post-implant are included.
Subjects with a complication related to the implanted system, which consisted of the pacemaker, leads to the right chambers of the heart (atrium and ventricle), pacemaker software, and programmer. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.
Outcome measures
| Measure |
MRI Group
n=447 Participants
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
The control group waited for one hour (no MRI) at the 9-12 week follow-up.
|
|---|---|---|
|
Subjects With System-related Complications
|
37 participants
|
—
|
SECONDARY outcome
Timeframe: Implant through 18 months post-implantPopulation: Includes all subjects undergoing an MRI using the instructions in the protocol.
Number of participants with adverse device effects (ADEs) that resulted from insufficiencies or inadequacies in the instructions for use or deployment of the device, or from user error. ADE's were investigator-reported.
Outcome measures
| Measure |
MRI Group
n=211 Participants
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
The control group waited for one hour (no MRI) at the 9-12 week follow-up.
|
|---|---|---|
|
System Related Adverse Device Effects Due to Labeling Instructions
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: During the MRI scanPopulation: Arrhythmia was defined as heart rate \> 150 beats per minute for \> 30 seconds. Asystole was defined as standstill 6 seconds in electrical activity of the heart. Episodes were assessed via pulse oximetry monitoring during MRI scans.
Number of participants with sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan that were considered attributable to the MRI scan
Outcome measures
| Measure |
MRI Group
n=211 Participants
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
The control group waited for one hour (no MRI) at the 9-12 week follow-up.
|
|---|---|---|
|
Occurrence of Arrhythmias
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: 9-12 week visit and 4-month visitPopulation: Subjects with non-missing data are included
Subjects' atrial lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported.
Outcome measures
| Measure |
MRI Group
n=201 Participants
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
n=197 Participants
The control group waited for one hour (no MRI) at the 9-12 week follow-up.
|
|---|---|---|
|
Atrial Lead Impedance Change
|
-0.6 ohms
Standard Deviation 61.8
|
7.3 ohms
Standard Deviation 50.4
|
SECONDARY outcome
Timeframe: 9-12 week visit and 4-month visitPopulation: Subjects with non-missing data are included
Subjects' ventricular lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported.
Outcome measures
| Measure |
MRI Group
n=201 Participants
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
n=196 Participants
The control group waited for one hour (no MRI) at the 9-12 week follow-up.
|
|---|---|---|
|
Ventricular Lead Impedance Change
|
-9.0 ohms
Standard Deviation 48.5
|
-5.7 ohms
Standard Deviation 51.8
|
SECONDARY outcome
Timeframe: During implantPopulation: All surveys completed are included
Physicians' rated atrial lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations.
Outcome measures
| Measure |
MRI Group
n=212 Participants
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
The control group waited for one hour (no MRI) at the 9-12 week follow-up.
|
|---|---|---|
|
Atrial Lead Handling Rating
|
0.53 Units on a scale
Standard Deviation 1.22
|
—
|
SECONDARY outcome
Timeframe: During implantPopulation: All surveys completed are included
Physicians' rated ventricular lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations.
Outcome measures
| Measure |
MRI Group
n=211 Participants
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
The control group waited for one hour (no MRI) at the 9-12 week follow-up.
|
|---|---|---|
|
Ventricular Lead Handling Rating
|
0.58 Units on a scale
Standard Deviation 1.17
|
—
|
SECONDARY outcome
Timeframe: 3 or 4 months post-implantPopulation: Includes all subjects with data.
Average atrial pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.
Outcome measures
| Measure |
MRI Group
n=174 Participants
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
n=175 Participants
The control group waited for one hour (no MRI) at the 9-12 week follow-up.
|
|---|---|---|
|
Atrial Pacing Capture Threshold
|
0.78 Volts
Standard Deviation 0.28
|
0.77 Volts
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: 3 or 4 months post-implantAverage ventricular pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.
Outcome measures
| Measure |
MRI Group
n=197 Participants
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
n=189 Participants
The control group waited for one hour (no MRI) at the 9-12 week follow-up.
|
|---|---|---|
|
Ventricular Pacing Capture Threshold
|
0.82 Volts
Standard Deviation 0.30
|
0.90 Volts
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: 3 or 4 months post-implantAverage atrial sensed amplitude.
Outcome measures
| Measure |
MRI Group
n=166 Participants
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
n=170 Participants
The control group waited for one hour (no MRI) at the 9-12 week follow-up.
|
|---|---|---|
|
Atrial Sensed Amplitude
|
3.0 millivolt (mV)
Standard Deviation 1.3
|
3.1 millivolt (mV)
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 3 or 4 months post-implantAverage ventricular sensed amplitude.
Outcome measures
| Measure |
MRI Group
n=179 Participants
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
n=176 Participants
The control group waited for one hour (no MRI) at the 9-12 week follow-up.
|
|---|---|---|
|
Ventricular Sensed Amplitude
|
10.1 millivolt (mV)
Standard Deviation 5.0
|
10.2 millivolt (mV)
Standard Deviation 5.2
|
Adverse Events
MRI Group
Serious events: 117 serious events
Other events: 24 other events
Deaths: 0 deaths
Control Group
Serious events: 77 serious events
Other events: 19 other events
Deaths: 0 deaths
Non-randomized
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MRI Group
n=260 participants at risk
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
n=207 participants at risk
The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
|
Non-randomized
n=20 participants at risk
Some subjects were enrolled, but either did not receive a system, or received only a partial system, and were not randomized. Their adverse events were collected until they exited the study.
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
13/260 • Number of events 17 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
2.4%
5/207 • Number of events 5 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
5.0%
1/20 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Injury, poisoning and procedural complications
Lead dislodgement
|
4.6%
12/260 • Number of events 12 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
2.9%
6/207 • Number of events 6 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
General disorders
Chest pain
|
3.1%
8/260 • Number of events 8 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
3.4%
7/207 • Number of events 7 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.3%
6/260 • Number of events 6 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
3.4%
7/207 • Number of events 7 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Infections and infestations
Pneumonia
|
1.9%
5/260 • Number of events 5 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
2.4%
5/207 • Number of events 5 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
10.0%
2/20 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Injury, poisoning and procedural complications
Elevated pacing threshold
|
2.3%
6/260 • Number of events 6 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.97%
2/207 • Number of events 3 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Cardiac failure
|
2.3%
6/260 • Number of events 7 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Myocardial infarction
|
1.9%
5/260 • Number of events 5 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
1.4%
3/207 • Number of events 3 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Nervous system disorders
Syncope
|
2.7%
7/260 • Number of events 7 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Respiratory, thoracic and mediastinal disorders
Plural effusion
|
0.38%
1/260 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
1.4%
3/207 • Number of events 4 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
3/260 • Number of events 3 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.97%
2/207 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
3/260 • Number of events 3 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.97%
2/207 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
3/260 • Number of events 4 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
4/260 • Number of events 4 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Psychiatric disorders
Depression
|
1.5%
4/260 • Number of events 4 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Infections and infestations
Implant site infection
|
0.77%
2/260 • Number of events 3 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Pericardial effusion
|
1.2%
3/260 • Number of events 3 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Angina pectoris
|
0.77%
2/260 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Angina unstable
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.97%
2/207 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.2%
3/260 • Number of events 3 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Infections and infestations
Bronchitis
|
1.2%
3/260 • Number of events 3 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Eye disorders
Cataract
|
0.77%
2/260 • Number of events 3 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.77%
2/260 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Coronary artery disease
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.97%
2/207 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Nervous system disorders
Dizziness
|
0.77%
2/260 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Injury, poisoning and procedural complications
Failure to capture
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
1.4%
3/207 • Number of events 3 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Vascular disorders
Hypertensive crisis
|
0.38%
1/260 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.77%
2/260 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Nervous system disorders
Presyncope
|
1.2%
3/260 • Number of events 3 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmoary oedema
|
0.38%
1/260 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Vascular disorders
Thrombosis
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.77%
2/260 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.77%
2/260 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Atrial tachycardia
|
0.77%
2/260 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Infections and infestations
Bronchopneumonia
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Cardiac perforation
|
0.77%
2/260 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Infections and infestations
Endocarditis
|
0.77%
2/260 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Injury, poisoning and procedural complications
Fall
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.77%
2/260 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
General disorders
Implant site haematoma
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.97%
2/207 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Surgical and medical procedures
Knee arthoplasty
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Gastrointestinal disorders
Mesenteric artery stenosis
|
0.38%
1/260 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.77%
2/260 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.97%
2/207 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Palpitations
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.38%
1/260 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Infections and infestations
Sepsis
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.97%
2/207 • Number of events 2 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Vascular disorders
Venous thrombosis
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Infections and infestations
Viral infection
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Infections and infestations
Abscess soft tissue
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Vascular disorders
Aortic aneurysm
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Vascular disorders
Aortic stenosis
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Infections and infestations
Appendicitis
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Eye disorders
Arteriosclerotic retinopathy
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Surgical and medical procedures
Cardiac pacemaker revision
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Nervous system disorders
Cerebral infarction
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
General disorders
Chest discomfort
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Hepatobiliary disorders
Cholecytitis acute
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Nervous system disorders
Cholinergic syndrome
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelomonocytic leukaemia
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Gastrointestinal disorders
Constipation
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Reproductive system and breast disorders
Cytocele
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Vascular disorders
Deep vein thrombosis
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Reproductive system and breast disorders
Endometrial disorder
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Infections and infestations
Enterocoocal bacteraemia
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gliobastoma
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Nervous system disorders
Grand mal convulsion
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Vascular disorders
Haematoma
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Investigations
Haemoglobin decreased
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Vascular disorders
Hypotension
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
General disorders
Implant site pain
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Injury, poisoning and procedural complications
Inappropriate device stimulation of tissue
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Infections and infestations
Influenza
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Nervous system disorders
Ischaemic stroke
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Hepatobiliary disorders
Liver disorder
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Infections and infestations
Lung infection
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Injury, poisoning and procedural complications
Medical device complication
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Renal and urinary disorders
Micturition disorder
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Nodal rhythm
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Pacemaker generated arrhythmia
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
General disorders
Pain
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Pericarditis
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Infections and infestations
Postoperative wound infection
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
General disorders
Pyrexia
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Renal and urinary disorders
Renal failure
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Renal and urinary disorders
Renal failure acute
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Renal and urinary disorders
Renal tubular acidosis
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Nervous system disorders
Sciatica
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Congenital, familial and genetic disorders
Spondylolisthesis
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Renal and urinary disorders
Urinary retention
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/260 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.48%
1/207 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
|
Gastrointestinal disorders
Vomiting
|
0.38%
1/260 • Number of events 1 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/207 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
Other adverse events
| Measure |
MRI Group
n=260 participants at risk
The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
|
Control Group
n=207 participants at risk
The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
|
Non-randomized
n=20 participants at risk
Some subjects were enrolled, but either did not receive a system, or received only a partial system, and were not randomized. Their adverse events were collected until they exited the study.
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
9.2%
24/260 • Number of events 27 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
9.2%
19/207 • Number of events 24 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
0.00%
0/20 • Up to 31 months.
Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical or surgery to prevent permanent impairment to body structure or a body function. 2 more MRI and 1 more control participants here due to a later freeze of adverse event data.
|
Additional Information
EnRhythm MRI Clinical Research Specialist
Medtronic, Inc
Phone: 800-328-2518
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place