Trial Outcomes & Findings for Baroreflex Activation Therapy for Heart Failure (NCT NCT02627196)
NCT ID: NCT02627196
Last Updated: 2026-03-10
Results Overview
To demonstrate that treatment with the BAROSTIM NEO® System, relative to medical management, reduces the rate of cardiovascular mortality or worsening heart failure that leads to hospitalization, cardiac assist device or heart transplant. Event rates were calculated using negative binomial to account for varying follow-up times. Rates are expressed as events per patient-year, with 95% confidence intervals reflecting dispersion.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1090 participants
Primary outcome timeframe
From randomization until data-cut date for the endpoint analysis. Median follow-up was 3.6 years per patient.
Results posted on
2026-03-10
Participant Flow
The protocol indicates a subject is considered enrolled upon signing the informed consent form. A total of 1090 subjects provided informed consent and were enrolled. Following completion of screening procedures and application of eligibility criteria per protocol, 467 subjects met randomization criteria and were assigned to study arms. The remaining enrolled subjects were considered screen failures and did not proceed to randomization.
Participant milestones
| Measure |
Device and Medical Management
Subjects will be implanted with the BAROSTIM NEO System and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
BAROSTIM NEO® System
Medical Management
|
Medical Management
Subjects will receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
Medical Management
|
|---|---|---|
|
Overall Study
STARTED
|
232
|
235
|
|
Overall Study
COMPLETED
|
159
|
160
|
|
Overall Study
NOT COMPLETED
|
73
|
75
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baroreflex Activation Therapy for Heart Failure
Baseline characteristics by cohort
| Measure |
Device and Medical Management
n=163 Participants
Subjects will be implanted with the BAROSTIM NEO System and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
BAROSTIM NEO® System
Medical Management
|
Medical Management
n=160 Participants
Subjects will receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
Medical Management
|
Total
n=323 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
28 Participants
n=68 Participants
|
35 Participants
n=69 Participants
|
63 Participants
n=137 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 11 • n=68 Participants
|
63 years
STANDARD_DEVIATION 10 • n=69 Participants
|
63 years
STANDARD_DEVIATION 11 • n=137 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=68 Participants
|
125 Participants
n=69 Participants
|
260 Participants
n=137 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
2 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=68 Participants
|
2 Participants
n=69 Participants
|
5 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
3 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=68 Participants
|
24 Participants
n=69 Participants
|
53 Participants
n=137 Participants
|
|
Race (NIH/OMB)
White
|
120 Participants
n=68 Participants
|
116 Participants
n=69 Participants
|
236 Participants
n=137 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=68 Participants
|
4 Participants
n=69 Participants
|
6 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=68 Participants
|
12 Participants
n=69 Participants
|
18 Participants
n=137 Participants
|
|
Region of Enrollment
United States
|
162 participants
n=68 Participants
|
160 participants
n=69 Participants
|
322 participants
n=137 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=68 Participants
|
0 participants
n=69 Participants
|
1 participants
n=137 Participants
|
|
New York Heart Association Class
Class III
|
155 participants
n=68 Participants
|
151 participants
n=69 Participants
|
306 participants
n=137 Participants
|
|
New York Heart Association Class
Class II
|
8 participants
n=68 Participants
|
9 participants
n=69 Participants
|
17 participants
n=137 Participants
|
|
Left Ventricular Ejection Fraction
|
27 %
STANDARD_DEVIATION 6 • n=68 Participants
|
28 %
STANDARD_DEVIATION 6 • n=69 Participants
|
27 %
STANDARD_DEVIATION 6 • n=137 Participants
|
|
NT-proBNP
|
736 pg/mL
n=68 Participants
|
704 pg/mL
n=69 Participants
|
716 pg/mL
n=137 Participants
|
|
Minnesota Living with Heart Failure Questionnaire
|
53 score
STANDARD_DEVIATION 24 • n=68 Participants
|
51 score
STANDARD_DEVIATION 24 • n=69 Participants
|
52 score
STANDARD_DEVIATION 24 • n=137 Participants
|
|
6 Minute Hall Walk
|
314 meters
STANDARD_DEVIATION 66 • n=68 Participants
|
300 meters
STANDARD_DEVIATION 71 • n=69 Participants
|
307 meters
STANDARD_DEVIATION 69 • n=137 Participants
|
PRIMARY outcome
Timeframe: From randomization until data-cut date for the endpoint analysis. Median follow-up was 3.6 years per patient.To demonstrate that treatment with the BAROSTIM NEO® System, relative to medical management, reduces the rate of cardiovascular mortality or worsening heart failure that leads to hospitalization, cardiac assist device or heart transplant. Event rates were calculated using negative binomial to account for varying follow-up times. Rates are expressed as events per patient-year, with 95% confidence intervals reflecting dispersion.
Outcome measures
| Measure |
Device and Medical Management
n=159 Participants
Subjects will be implanted with the BAROSTIM NEO System and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
BAROSTIM NEO® System
Medical Management
|
Medical Management
n=160 Participants
Subjects will receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
Medical Management
|
|---|---|---|
|
Rate of Cardiovascular Mortality and Heart Failure Morbidity
|
.46 Rate of Events Per Patient-Year
Interval 0.32 to 0.65
|
.48 Rate of Events Per Patient-Year
Interval 0.33 to 0.7
|
PRIMARY outcome
Timeframe: 6 months post implantPopulation: Analysis includes all BAT + Medical Management Arm subjects who had an implant attempted. The protocol specifies only this singular arm will be evaluated for this endpoint.
To demonstrate the safety of the Barostim NEO® System via the event-free rate of all system- and procedure-related Major Adverse Neurological and Cardiovascular Events (MANCE) occurring within 6 months post implant in the device arm.
Outcome measures
| Measure |
Device and Medical Management
n=125 Participants
Subjects will be implanted with the BAROSTIM NEO System and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
BAROSTIM NEO® System
Medical Management
|
Medical Management
Subjects will receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
Medical Management
|
|---|---|---|
|
Major Adverse Neurological and Cardiovascular Events (MANCE)
|
121 MANCE Event-Free Rate
Interval 121.0 to 125.0
|
—
|
PRIMARY outcome
Timeframe: 6 months post-implantTo demonstrate that treatment with the BAROSTIM NEO® system results in a larger reduction in NT-proBNP from baseline to 6 months post-implant than medical management.
Outcome measures
| Measure |
Device and Medical Management
n=120 Participants
Subjects will be implanted with the BAROSTIM NEO System and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
BAROSTIM NEO® System
Medical Management
|
Medical Management
n=123 Participants
Subjects will receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
Medical Management
|
|---|---|---|
|
Percent Change in Log 10 Amino-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) From Baseline to 6 Months Post-implant
|
-21.1 Percent change
Standard Deviation 0.4
|
3.3 Percent change
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: Baseline and 6 months post-implantTo demonstrate that treatment with the BAROSTIM NEO® system results in a larger improvement in 6MHW at 6 months than medical management. The 6 Minute Hall Walk is an assessment of a patient's functional exercise capacity by recording the maximum distance walked in 6 minutes on a flat course in meters (m). A higher score (more distance) indicates better functional capacity.
Outcome measures
| Measure |
Device and Medical Management
n=118 Participants
Subjects will be implanted with the BAROSTIM NEO System and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
BAROSTIM NEO® System
Medical Management
|
Medical Management
n=120 Participants
Subjects will receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
Medical Management
|
|---|---|---|
|
Change to Six Minute Hall Walk (6MHW)
|
48.6 Change in Walk Distance-Meters
Standard Deviation 66.3
|
-7.9 Change in Walk Distance-Meters
Standard Deviation 88.4
|
PRIMARY outcome
Timeframe: Baseline and 6 months post-implantTo demonstrate that treatment with the BAROSTIM NEO® System results in a larger improvement in MLWHF QOL score at 6 months than medical management. The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a validated patient-reported outcome measure assessing the impact of heart failure on quality of life. It includes 21 items rated from 0 to 5 (0 = no impact, 5 = very much impact). The Total Score is the sum of all items and ranges from 0 to 105, with higher scores indicating worse quality of life.
Outcome measures
| Measure |
Device and Medical Management
n=120 Participants
Subjects will be implanted with the BAROSTIM NEO System and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
BAROSTIM NEO® System
Medical Management
|
Medical Management
n=125 Participants
Subjects will receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
Medical Management
|
|---|---|---|
|
Change in Minnesota Living With Heart Failure Quality of Life (MLWHF QOL) Score
|
-20.7 Change in QoL Score
Standard Deviation 25.4
|
-6.2 Change in QoL Score
Standard Deviation 20.1
|
Adverse Events
Device and Medical Management
Serious events: 121 serious events
Other events: 134 other events
Deaths: 33 deaths
Medical Management
Serious events: 121 serious events
Other events: 128 other events
Deaths: 42 deaths
Serious adverse events
| Measure |
Device and Medical Management
n=163 participants at risk
Subjects will be implanted with the BAROSTIM NEO System and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
BAROSTIM NEO® System
Medical Management
|
Medical Management
n=160 participants at risk
Subjects will receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
Medical Management
|
|---|---|---|
|
Blood and lymphatic system disorders
Hematology (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Blood and lymphatic system disorders
Other (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Blood and lymphatic system disorders
Severe Complications of Heart Failure Treatment (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Blood and lymphatic system disorders
Thromboembolism - Pulmonary (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Acute Myocardial Infarction (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Acute Myocardial Infarction - Non-STEMI (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
3.1%
5/160 • Number of events 6 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Acute Myocardial Infarction - STEMI (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Angina - Unstable (unrelated)
|
2.5%
4/163 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Cardiac Arrest (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Cardiac Arrhythmias - Atrial Flutter / AF (unrelated)
|
4.9%
8/163 • Number of events 9 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
5.6%
9/160 • Number of events 10 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Cardiac Arrhythmias - Other Arrhythmia (unrelated)
|
1.8%
3/163 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Cardiac Arrhythmias - Ventricular Tachycardia/VF (unrelated)
|
8.0%
13/163 • Number of events 16 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
9.4%
15/160 • Number of events 24 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Chest Pain - Cardiac (unrelated)
|
6.7%
11/163 • Number of events 13 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
2.5%
4/160 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Chest Pain - Non-Cardiac (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Death, Cardiovascular-Related (unrelated)
|
8.6%
14/163 • Number of events 14 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
10.0%
16/160 • Number of events 16 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Death, Non-Cardiac (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Gastroenterology (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Heart Failure - Acute Decompensated Heart Failure (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Heart Failure - Acute Decompensated Heart Failure (unrelated)
|
31.3%
51/163 • Number of events 118 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
31.2%
50/160 • Number of events 117 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Heart Failure - Worsening of HF (unrelated)
|
3.1%
5/163 • Number of events 5 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
5.6%
9/160 • Number of events 10 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Hypotension (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Hypotension - Worsening of Condition (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Infection (Other than Surgical) - Systemic (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Liver (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Other (unrelated)
|
3.1%
5/163 • Number of events 5 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
6.2%
10/160 • Number of events 10 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Other Cardiac (unrelated)
|
6.1%
10/163 • Number of events 12 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
8.8%
14/160 • Number of events 14 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Other Vascular (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Pain, General (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Peripheral Vascular/Artery Disease (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Respiratory - Other Respiratory (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Severe Complications of Heart Failure Treatment (unrelated)
|
2.5%
4/163 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.9%
3/160 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Stroke (CVA) - Ischemic (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Syncope (unrelated)
|
2.5%
4/163 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
2.5%
4/160 • Number of events 6 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Thromboembolism - Pulmonary (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Transient Ischemic Attack (TIA) (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Ear and labyrinth disorders
Other (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Endocrine disorders
Chest Pain - Cardiac (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Endocrine disorders
Endocrinology - New Onset of Diabetes (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Endocrine disorders
Endocrinology - Other Endocrine (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Endocrine disorders
Endocrinology - Worsen of Diabetes (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Endocrine disorders
Heart Failure - Acute Decompensated Heart Failure (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Endocrine disorders
Other (unrelated)
|
1.2%
2/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Endocrine disorders
Renal - Acute Kidney Injury (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Endocrine disorders
Respiratory - Pneumonia (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Eye disorders
Other (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Chest Pain - Cardiac (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Death, Non-Cardiac (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Gastroenterology (unrelated)
|
5.5%
9/163 • Number of events 12 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
7.5%
12/160 • Number of events 15 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Heart Failure - Acute Decompensated Heart Failure (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Infection (Other than Surgical) - Localized (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Infection (Other than Surgical) - Systemic (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Liver (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Muscle and Bone (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Other (unrelated)
|
1.8%
3/163 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Pain, General (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Cardiac Arrhythmias - Atrial Flutter / AF (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Cardiac Arrhythmias - Other Arrhythmia (unrelated)
|
0.61%
1/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Chest Pain - Cardiac (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Death, Cardiovascular-Related (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Death, Non-Cardiac (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Gastroenterology (unrelated)
|
1.8%
3/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Genitourinary System (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Heart Failure - Acute Decompensated Heart Failure (unrelated)
|
3.1%
5/163 • Number of events 8 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Heart Failure - Worsening of HF (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Hypertension - Hypertensive Crisis / Emergency (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Infection (Other than Surgical) (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Infection (Other than Surgical) - Other Infection (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Liver (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Muscle and Bone (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Nerve Damage/Stimulation - Neuropathy (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Other (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Other (unrelated)
|
1.8%
3/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
3.1%
5/160 • Number of events 5 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Other Vascular (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Renal - Acute Kidney Injury (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Respiratory - COPD Exacerbation (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Respiratory - Pneumonia (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Severe Complications of Heart Failure Treatment (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Surgical or Anesthetic Complications - Other Surgical Complication (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Syncope (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.9%
3/160 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Thromboembolism - Pulmonary (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Transient Ischemic Attack (TIA) (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Hepatobiliary disorders
Liver (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Hepatobiliary disorders
Other (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Immune system disorders
Severe Complications of Heart Failure Treatment (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Immune system disorders
Surgical or Anesthetic Complications - Allergic Reaction (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Death, Non-Cardiac (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Endocrinology - Worsen of Diabetes (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Heart Failure - Acute Decompensated Heart Failure (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Infection (Other than Surgical) - Cellulitis (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
2.5%
4/160 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Infection (Other than Surgical) - Localized (unrelated)
|
2.5%
4/163 • Number of events 5 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
2.5%
4/160 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Infection (Other than Surgical) - Other Infection (unrelated)
|
3.1%
5/163 • Number of events 5 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
2.5%
4/160 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Infection (Other than Surgical) - Systemic (unrelated)
|
1.8%
3/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
2.5%
4/160 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Muscle and Bone (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Other (unrelated)
|
1.8%
3/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
2.5%
4/160 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Respiratory - Other Respiratory (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Respiratory - Pneumonia (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Respiratory - Pneumonia (unrelated)
|
1.8%
3/163 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Respiratory - Upper Respiratory Infection (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Surgical or Anesthetic Complications-Infection at Implant Site (No Explant) (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Death, Non-Cardiac (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Muscle and Bone (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Other (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Other Vascular (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Trauma (unrelated)
|
2.5%
4/163 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Investigations
Heart Failure - Acute Decompensated Heart Failure (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Metabolism and nutrition disorders
Other (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Metabolism and nutrition disorders
Severe Complications of Heart Failure Treatment (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Metabolism and nutrition disorders
Syncope (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Angina - Unstable (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Chest Pain - Cardiac (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Chest Pain - Non-Cardiac (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Infection (Other than Surgical) - Localized (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Muscle and Bone (unrelated)
|
4.3%
7/163 • Number of events 8 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
3.8%
6/160 • Number of events 9 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Nerve Damage/Stimulation - Cranial Nerve Stimulation (system only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Other (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Pain, General (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Severe Complications of Heart Failure Treatment (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Trauma (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Surgical and medical procedures
Other Nerve (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death, Non-Cardiac (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastroenterology (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Genitourinary System (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Reproductive System (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Respiratory - Other Respiratory (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Death, Cardiovascular-Related (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Nerve Damage/Stimulation - Other Nerve Damage (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Nerve Damage/Stimulation - Other Nerve Damage (system only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Other (system only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Other (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Other Nerve (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Pain, General (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Stroke (CVA) - Ischemic (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Syncope (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Transient Ischemic Attack (TIA) (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Psychiatric disorders
Other (unrelated)
|
1.8%
3/163 • Number of events 5 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Genitourinary System (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.9%
3/160 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Heart Failure - Acute Decompensated Heart Failure (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Infection (Other than Surgical) - Systemic (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Other (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Other Cardiac (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Renal (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Renal - Acute Kidney Injury (unrelated)
|
3.1%
5/163 • Number of events 7 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.9%
3/160 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Renal - End Stage Renal Disease (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Renal - Other Renal (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Septic Shock (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Severe Complications of Heart Failure Treatment (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Syncope (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Death, Non-Cardiac (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Heart Failure - Acute Decompensated Heart Failure (unrelated)
|
4.9%
8/163 • Number of events 8 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
3.8%
6/160 • Number of events 6 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Infection (Other than Surgical) - Other Infection (unrelated)
|
1.8%
3/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Other (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory - COPD Exacerbation (unrelated)
|
4.3%
7/163 • Number of events 9 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
2.5%
4/160 • Number of events 6 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory - Other Respiratory (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory - Pneumonia (unrelated)
|
4.3%
7/163 • Number of events 7 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
3.1%
5/160 • Number of events 7 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory - Upper Respiratory Infection (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Surgical or Anesthetic Complications - Other Surgical Complication (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Thromboembolism (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Thromboembolism - Pulmonary (unrelated)
|
0.61%
1/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Dermatology (unrelated)
|
1.8%
3/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Endocrinology - Worsen of Diabetes (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Infection (Other than Surgical) (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Infection (Other than Surgical) - Localized (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Infection (Other than Surgical) - Other Infection (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Other Vascular (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Trauma (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Surgical and medical procedures
Endocrinology - Other Endocrine (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Surgical and medical procedures
Endocrinology - Worsen of Diabetes (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Surgical and medical procedures
Fibrosis (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Surgical and medical procedures
Muscle and Bone (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Surgical and medical procedures
Other (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Surgical and medical procedures
Other Vascular (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Surgical and medical procedures
Surgical or Anesthetic Complications - Infection Requiring Explant (system and procedure related)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Angina - Unstable (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Gastroenterology (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Other (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.9%
3/160 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Other Cardiac (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.9%
3/160 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Other Vascular (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
3.1%
5/160 • Number of events 5 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Peripheral Vascular/Artery Disease (unrelated)
|
2.5%
4/163 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
5.0%
8/160 • Number of events 17 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Stroke (CVA) (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Stroke (CVA) - Hemorrhagic (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Stroke (CVA) - Ischemic (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Stroke (CVA) - Ischemic (unrelated)
|
3.7%
6/163 • Number of events 6 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
2.5%
4/160 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Thromboembolism - Pulmonary (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Thromboembolism - Systemic (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Transient Ischemic Attack (TIA) (unrelated)
|
3.1%
5/163 • Number of events 5 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
Other adverse events
| Measure |
Device and Medical Management
n=163 participants at risk
Subjects will be implanted with the BAROSTIM NEO System and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
BAROSTIM NEO® System
Medical Management
|
Medical Management
n=160 participants at risk
Subjects will receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
Medical Management
|
|---|---|---|
|
Cardiac disorders
Aflutter (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Anasarca (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Angina - Stable (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Angina Pectoris (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Asymptomatic hypotension (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Atrial Fibrillation (unrelated)
|
3.1%
5/163 • Number of events 6 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.9%
3/160 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Atrial Fibrillation - paroxysmal (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Atrial Fibrillation with RVR (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Atrial fibrillation (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Atypical Chest Pain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
C/o imbalance & SOB on higher amiodarone dose (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
CHF (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
CHF Exacerbation (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
CHF and cough (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Other (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
3.8%
6/160 • Number of events 6 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Cardiac Arrhythmias - Atrial Flutter / AF (unrelated)
|
4.3%
7/163 • Number of events 9 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
3.1%
5/160 • Number of events 6 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Cardiac Arrhythmias - Other Arrhythmia (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Cardiac Arrhythmias - Sinus Bradycardia (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Cardiac Arrhythmias - Ventricular Tachycardia/VF (unrelated)
|
2.5%
4/163 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
3.8%
6/160 • Number of events 8 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Cardiac Arrythmia (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Chest Pain (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Chest Pain - Cardiac (unrelated)
|
4.3%
7/163 • Number of events 7 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
2.5%
4/160 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Chest Pain - Non-Cardiac (unrelated)
|
1.8%
3/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Chest Pain - Unknown (suspected ischemic) (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Other Cardiac (system only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Chest pain (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
3.1%
5/160 • Number of events 5 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Chest pain, elevated BNP (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Chest pains (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Chronic combined systolic and diastolic heart failure (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Class III chronic systolic congestive heart failure, chronic venous insufficiency (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Other Cardiac (unrelated)
|
3.7%
6/163 • Number of events 6 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
5.0%
8/160 • Number of events 8 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Congestive heart failure worsening (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Severe pain on ICD site (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Shock from ICD (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
DYSPNEA ON EXERTION NYHA 2, NOISE IN THE ATRIAL LEAD, HEART RATE IN 40S (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Decompensated Heart Failure (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Decrease EF (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Dizziness (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Dizzy, syncopal episode (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Dyspnea (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Extra cardiac stimulation - CCM device (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Fluid Build-up (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Fluid weight gain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Blood and lymphatic system disorders
Other Vascular (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Blood and lymphatic system disorders
Polycythemia (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Headache r/t HTN (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Blood and lymphatic system disorders
T-cell lymphoma (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Blood and lymphatic system disorders
Worsening nosebleed, RECURRING (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
1 episode of sustained VT 07/04/2022 one shock qave (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Abnormal EKG, Leukemia, chronic, Hypertension, (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Acute Exacerbation of CHF (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Hypotension (unrelated)
|
3.7%
6/163 • Number of events 6 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
2.5%
4/160 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Acute on chronic combined systolic and diastolic CHF (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Acute on chronic systolic heart failure (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Low blood pressure (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Acute systolic heart failure (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Blood and lymphatic system disorders
Anemia, chronic disease (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Blood and lymphatic system disorders
Bleeding gums (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Blood and lymphatic system disorders
Blood transfusion (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Blood and lymphatic system disorders
Bruising of lower leg (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Blood and lymphatic system disorders
Hematology (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.9%
3/160 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Blood and lymphatic system disorders
Hypermagnesemia and Hypokalemia (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anemia (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Blood and lymphatic system disorders
Other (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Heart Failure - Acute Decompensated Heart Failure (unrelated)
|
8.6%
14/163 • Number of events 19 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
4.4%
7/160 • Number of events 9 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Heart Failure - Worsening of HF (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Heart Failure - Worsening of HF (unrelated)
|
18.4%
30/163 • Number of events 35 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
13.8%
22/160 • Number of events 26 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Heart failure (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Heart palpitations (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
High BP (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Hypertension - Hypertensive Crisis / Emergency (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Hypertension - Worsening of Condition (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Hypervolemia (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Hypotension - New Onset (system only related)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Hypotension - New Onset (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Hypotension - Orthostatic (unrelated)
|
1.8%
3/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Hypotension - Other (system only related)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Hypotension - Worsening of Condition (unrelated)
|
1.8%
3/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Hypotension, lightheadedness (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
ICD Shock (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
INAPPROPRIATE ICD SHOCK FOR AF (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Increased fatigue (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Increased fatigue and shortness of breath with activity (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Increased water retention (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Increased water weight (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Increased weight gain and abdominal distention; CHF Exacerbation (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Increasing Intermittent Atrial Fibrillation (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Ischemic Cardio Myopathy (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
LV Thrombus (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Left neck and left arm pain transciently (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Left-sided chest pain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Loss of Consciousness (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Low blood pressure and medication changes (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Low blood pressure, dizziness, fatigue (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Mitral regurgitation (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Moderate Pulmonary Hypertension (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Moderate mitral valve regurgitation (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Moderate to severe Mitral Valve Regurgitation (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
NSVT (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Near syncope, fatique (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Non sustained VT events (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Paroxysmal atrial fibrillation (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Persistent A Fib (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Persistent Atrial Fibrillation (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Persistent Chest pain of unknown ideology (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Pre-syncope (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Recurrent atrial fibrillation (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Respiratory - COPD Exacerbation (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Respiratory - Shortness of Breath (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Right sided Chest pain (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Ruled out for acute coronary sydrome with negative enzymes (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
SOB (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
SOB and cardiomyopathy (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
SUBSTERNAL CHEST HEAVINESS,DYSPNEA ON EXERTION NYHA 2-3 (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Severe Complications of Heart Failure Treatment (system only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Severe Complications of Heart Failure Treatment (unrelated)
|
3.1%
5/163 • Number of events 5 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.9%
3/160 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Severe Group 2 Pulmonary Hypertension (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Severe Pulmonary Hypertension (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Severe Three-Vessel Coronary Artery Disease (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Shortness of Breath (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Shortness of breath (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.9%
3/160 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Syncope (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Syncope and collapse; intravascular volume depletion (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Syncope, CHF, dehydration (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Thrombocytopenia (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Thrombus (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Tiredness, sob (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Unstable Angina (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Unstable Angina with mild to moderate CAD (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Unsteadiness on feet; poor balance (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
V-TACH; V-FIB (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
VT/VF (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Ventricular Fibrillation (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Ventricular Tachycardia (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Ventricular fibrillation / ventricular tachycardia (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Ventricular tachycardia and syncope (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Ventricular tachycardia per ICD interrogation that occurred in April, 2019 (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Ventricular tachycardia with unsuccessful pacing resulting in successful ICD shock (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Wide QRS complex (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Worsened Heart Failure (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Worsening CHF (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Worsening Heart Failure (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Worsening Heart Failure Symptoms (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Worsening Shortness of Breath (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Worsening congestive heart failure (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Cardiac disorders
Worsening of Atrial fibrilation (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Ear and labyrinth disorders
Dizziness (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Ear and labyrinth disorders
Impacted Cerumen Right Ear (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Ear and labyrinth disorders
Infection (Other than Surgical) - Localized (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Ear and labyrinth disorders
Other (system only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Ear and labyrinth disorders
Other (unrelated)
|
1.8%
3/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Ear and labyrinth disorders
Popping in right ear (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Ear and labyrinth disorders
Vertigo (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Endocrine disorders
Endocrinology - New Onset of Diabetes (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Endocrine disorders
Endocrinology - Other Endocrine (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
2.5%
4/160 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Endocrine disorders
Endocrinology - Worsen of Diabetes (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
2.5%
4/160 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Endocrine disorders
Hematology (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Endocrine disorders
Hyperglycemia (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Endocrine disorders
Hyperthyroidism (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Endocrine disorders
Hypokalemia per labwork (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Endocrine disorders
Worsening Neuropathy (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Endocrine disorders
Worsening Type 2 Diabetes Mellitus (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Eye disorders
Age-related macular degeneration right eye (early stage) (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Eye disorders
Cataract of both eye (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Eye disorders
Cataract of the left eye (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Eye disorders
Cataract surgery (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Eye disorders
Episodes of bright light flashes (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Eye disorders
Eye irritation (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Eye disorders
Hypopyon (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Eye disorders
Left eye cataract (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Eye disorders
Nonproliferative diabetic retinopathy with macular edema (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Eye disorders
Other (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Eye disorders
Senile ectropion to left lower eyelid (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Eye disorders
Senile nuclear sclerosis, bilateral (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Abdominal Pain and Diarrhea (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Abdominal Pain, Colitis (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Abdominal pain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Abdominal pain - Emesis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Abdominal pain, nausea / vomiting (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Ascites, kidney stone, hemateria (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Bright red blood per rectum (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
C-Diff Colitis (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Calculus of gallbladder with Acute cholecystitis without obstruction (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Chest Pain (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Chest Pain - Non-Cardiac (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Colitis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Constipation (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Diarrhea (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Diverticulosis in the sigmoid colon (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Diverticulosis of large intestine without perforation or abscess, without bleeding. (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Dysphagia, Candida esophagitis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Emesis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Epigastric and right upper quadrant abdominal pain (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Esophagitis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
GI Bleed (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
GI upset (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Gastroenterology (unrelated)
|
4.9%
8/163 • Number of events 8 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
10.6%
17/160 • Number of events 20 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Infection (Other than Surgical) - Localized (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Internal Hemorrhoids (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
LLQ Abdominal Pain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Liver (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Mild Abdominal Discomfort (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Mild Pancreatitis (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Nausea (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Other Cardiac (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Pain, General (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Polyps Descending Colon (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Positive fecal immunochemical test; anemia (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Respiratory - Upper Respiratory Infection (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Right inguinal hernia (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Right lower quadrant pain- abdominal (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Right upper quadrant abdominal pain and pleural effusion (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Chronic Cough (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Stomach ache (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Suspicious colon polyps during colonoscopy (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Symptomatic mixed hemorrhoids with grade 3 internal prolapse (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Tongue Laceration (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Transverse Colon Polyps (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Gastrointestinal disorders
Upset stomach with diarrhea (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Abdominal pain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Ace Inhibitor Cough (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Acute Cystitis w/o hematuria, dysuria, Acute viral syndrome (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Acute Pyelonephritis; Acute febrile illness (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Acute cystitis w/o hematuria (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Acute mild adverse reaction to covid pfizer vaccine (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Acute non-recurrent sinusitis, Cough, Diarrhea, Bacterial Sinusitis, Viral UR (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Allergic Reaction (Other than Procedural) (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Altered mental status (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Amnesia (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Angina - Unstable (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Apical thrombus in left Ventricle (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Epiploic appendagitis (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Brain Fog, Tingling Sensation Right side of head (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Bronchitis (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
C. Difficile diarrhea, mild dehydration (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
COVID19 screening (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Chest Pain - Cardiac (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Chest Pain - Non-Cardiac (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Chest pain (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Chest pain- non cardiac (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Chondrocostal Junction Syndrome (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Chronic pain B knees, Eczema B ears, IBS, constipation, GERD s esophagitis, Food allerg (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Common cold (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Cough, Sinus Congestion, Viral URI, Bacterial Sinusitis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Cough, sore throat (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Dehydration episode (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Dehydration, symptomatic hypotension, a-fib,CP due to hypotension,cardiomyopathy, anemia (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Dizziness (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Elevated serum creatinine (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Endocrinology - Worsen of Diabetes (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Epistaxis (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Extravascular stimulation (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Extreme Fatigue (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Fall (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Fall down stairs (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Fatigue (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Fingernail abnormalities (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Food Poisoning (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Gastroenterology (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
General disorder (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Gout (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Gouty arthritis, cellulitis of forearm, right (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Ground level fall, right forehead abrasion (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Head Cold (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Headache (unrelated)
|
0.61%
1/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Headaches (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Heart Failure - Acute Decompensated Heart Failure (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Heart Failure - Worsening of HF (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Hyperkalemia (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Hypertension (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Hypokalemia (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Infection (Other than Surgical) - Localized (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Infection (Other than Surgical) - Other Infection (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Injured back of head, neck and left hip after mechanical fall (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Insomnia (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Left Index Finger Laceration (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Left Inguinal hernia (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Left shoulder and arm pain (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Left thyroid nodule (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Left-sided inguinal hernia (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Mechanical Fall (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Medication reaction (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Migraine (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Muscle and Bone (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Muscle spasm (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Nausea/Vomiting, Intractability of vomiting, abd pain, Anemia, Hypomagnesemia (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Near Syncope (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Non- Specific throat tightness (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Obstructive sleep apea (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Orthostatic hypotension (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Other (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Other (unrelated)
|
4.3%
7/163 • Number of events 8 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.9%
3/160 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Other Cardiac (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Other Nerve (system only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Other Nerve (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Pacemaker pocket hematoma (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Pain in neck and jaw area of lead after mammogram (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Pain, General (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Pain, General (unrelated)
|
1.8%
3/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Psychogenic, depression, and left ankle pain (acute) (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Rash all over body (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Respiratory - Other Respiratory (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Respiratory - Upper Respiratory Infection (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Severe Complications of Heart Failure Treatment (unrelated)
|
1.8%
3/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Shortness of Breath (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Shoulder pain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Sinus Infection (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Sinusitis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Sleep disturbance (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Surgical or Anesthetic Complications - Other Surgical Complication (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Syncope (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Tooch ache (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Tooth decay (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Trauma (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.9%
3/160 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Trichomonas, Jock Itch (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Uncontrolled OSA (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Urinary Tract Infection s Hematuria, dysuria (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Viral URI with cough (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Vision Changes (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Worms in stool, R ear pulsatile tinnitus, R ear hearing loss (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
General disorders
Worsening Diabetic Neuropathy (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Hepatobiliary disorders
Acute Cholecystitis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Hepatobiliary disorders
Cholelithiasis (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Hepatobiliary disorders
Pain, General (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Immune system disorders
Allergic Reaction (Other than Procedural) (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Immune system disorders
Dermatology (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Immune system disorders
Flu Like Symptoms (Self Reported) (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Abscess of right middle finger (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Abscess on back of neck (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Abscess to right chest wall - nipple area (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Acute right foot insect bite infection, and rt foot Cellulitis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Bacteremia (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Bronchitis (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
COVID -19 (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
COVID 19 (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
COVID 19 Infection (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
COVID-19 (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Cellulitis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Chronic sinusitis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Clinical sinusitis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Community accquired pneumonia (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Covid-19 (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Dental abscess (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Diarrhea (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Fever with cough (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Flu (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Genitourinary System (unrelated)
|
1.8%
3/163 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Head Cold (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Heart Failure - Acute Decompensated Heart Failure (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Infection (Other than Surgical) - Cellulitis (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Infection (Other than Surgical) - Localized (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.9%
3/160 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Infection (Other than Surgical) - Other Infection (unrelated)
|
1.8%
3/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Infection (Other than Surgical) - Systemic (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Other (unrelated)
|
1.8%
3/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.9%
3/160 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Paronychia of great toe on left (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Pneumonia (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Recurrent UTI (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Respiratory - Pneumonia (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Respiratory - Upper Respiratory Infection (unrelated)
|
4.9%
8/163 • Number of events 9 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
2.5%
4/160 • Number of events 7 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
SARS-CoV-2 infection (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Shingles (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Sinus infection (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Sinusitis (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Strep Throat (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Surgical or Anesthetic Complications - Infection at Implant Site-No Explant (procedure only related)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
UTI (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Upper Respiratory Infection (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Venustatis ulcer to left extremity (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Infections and infestations
Yeast infection (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Acute left posterior scalp hematoma, fall from stairs (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Effusion of left knee (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Fall with Leg and Hand Injury (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Fall/concussion (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Laceration of right forearm (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Laceration to right hand (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Mechanical fall after dizziness (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Muscle and Bone (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Nerve Damage/Stimulation - Cranial Nerve Damage, Temporary (procedure only related)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Nerve Damage/Stimulation - Cranial Nerve Stimulation (system only related)
|
0.61%
1/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Other (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Other Nerve (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Pain, General (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Post-operative wound hematoma s/p ICD implant 11/07/2017 (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Right Knees pain (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Surgical or Anesthetic Complications - Other Surgical Complication (system only related)
|
0.61%
1/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Surgical or Anesthetic Complications - Pain (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Surgical or Anesthetic Complications - Wound Complication (procedure only related)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Injury, poisoning and procedural complications
Trauma (unrelated)
|
4.3%
7/163 • Number of events 9 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
2.5%
4/160 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Metabolism and nutrition disorders
Diabetes (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Metabolism and nutrition disorders
GOUT (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Metabolism and nutrition disorders
Hyperkalemia (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Metabolism and nutrition disorders
Hypomagnesemia (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Metabolism and nutrition disorders
Muscle and Bone (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Metabolism and nutrition disorders
Other (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Metabolism and nutrition disorders
Thromboembolism - Systemic (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Abrasion (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Accidental Mechanical Fall, Left radial head Fracture (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Acute Exacerbation of chronic low back pain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Acute cervical sprain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Acute left periscapular somatic dysfunction and muscle spasm (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Acute muscle spasms of unclear cause (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Angina - Unstable (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Back Pain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Back pain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.9%
3/160 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Bilat hip pain (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Bilateral foot pain (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Bilateral sciatica (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Bursitis of the left retrocalcaneal Bursa (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Cellulitis of right knee (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Cervical Stenosis (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Chest Pain - Non-Cardiac (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.9%
3/160 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Chest Pain after being punched (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain after fall (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Chronic low back pain (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Degenerative joint disease (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Effusion of right knee (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Exacerbation of osteoarthritis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Fall (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.9%
3/160 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Fall -not a syncopal episide (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Fall without injury (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Fall-right arm pain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Frequent falls (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Gout (Flare Up) / Right Hand Pain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Gout (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Gout Flare (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Gout Flare Up (L) Foot (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Gout Flare Up (R) Knee Pain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Gout to left wrist, right elbow (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Heart Failure - Worsening of HF (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Left Foot Pain (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Left Hip Pain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Left hand fracture (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Left knee arthritis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Left knee pain (contusion) (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Left sided sciatica and lumbar radiculopathy (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Limited ROM in right shoulder and pain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Radiculopathy (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Lumbar strain (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Motor vehicle crash (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasm (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Muscle and Bone (unrelated)
|
9.8%
16/163 • Number of events 20 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
11.2%
18/160 • Number of events 21 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm of back (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Nasal bone fracture (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Neck pain (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Nerve Damage/Stimulation - Cranial Nerve Stimulation (system only related)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Nerve Damage/Stimulation - Cranial Nerve Stimulation (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Nondisplaced Fracture Over Fifth Metatarsal - Left Foot (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Oligoarthritic gout flare up (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Pain - Localized (system only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Pain, General (system only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Pain, General (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.9%
3/160 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Pain, neck and shoulder (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Plantar faciitis with chronic sprain of right foot (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Rib cage pain secondary to fall (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Right Arm Radial Head and Neck Fracture (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Right Hip Bursitis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Right Leg Pain (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Right Shoulder Pain (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Right Wrist Pain due to Gout (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Right calf pain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
R foot navicular avulsion fracture, proximal 4th metatarsal fracture both nondisplaced (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Right knee sprain (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Right lower back pain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Right shoulder impingement with partial rotator cuff tear (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Right shoulder pain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Right side rib pain/cough (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Right wrist pain status post motor vehicle accident. (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Should and wrist pain from a fall (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Shoulder impingement syndrome - right (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis of Lumbar Region (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Sprained Right Ankle (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Sprained ankle (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Surgical consult about superficial PM Lead. (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Syncope (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis of the left achilles tendon (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Torn Rotator Cuff (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Trauma (unrelated)
|
3.1%
5/163 • Number of events 5 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Ulnar fracture (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Worsening of Peripheral Diabetic Neuropathy (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Wrist fracture and crushed hand (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Wrist pain (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anterior urethral stricture (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hx of bladder cancer,Stricture of Bulbous urethra,stricture of anterior urethra unspec. (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipomatous mass on neck (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urethral Stricture ,history of bladder cancer (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urethral stricture history of bladder cancer (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Acute nonintractable headache and nausea (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Allergic Reaction (Other than Procedural) (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Burning and tingling in hands (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Concussion (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Dizziness (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Dizziness worsening (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Dysphagia (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Fall/laceration (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Flank pain on left side (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Gait instability, dizziness (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Headaches (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Headaches (worsening after 2nd COVID-19 Vaccine) (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Heart Failure - Acute Decompensated Heart Failure (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Insomnia (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Intractable chronic migrane without aura and without status migranosus (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Memory Loss (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Migraine Exacerbation (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Nerve Damage/Stimulation - Cranial Nerve Damage, Temporary (system only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Nerve Damage/Stimulation - Cranial Nerve Stimulation (system only related)
|
10.4%
17/163 • Number of events 20 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Other (unrelated)
|
1.8%
3/163 • Number of events 5 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Other Cardiac (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Other Nerve (unrelated)
|
3.1%
5/163 • Number of events 7 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Pain, General (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Restless Leg Syndrome (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Sciatica (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Tension type headache (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Nervous system disorders
Worsening hand tremors (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Psychiatric disorders
Other (unrelated)
|
1.8%
3/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
2.5%
4/160 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
AKI (Acute Kidney injury) on CKD (Chronic kidney disease) (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
AKI (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Acute Cystitis s Hematuria, Acute suprapubic pain, Cystitis, R ovarian cyst (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Acute Cystitis without hematuria (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Acute Kidney Injury (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Acute Kidney Injury on CKD vs progressive CKD w/ metabolic acidosis (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Acute cystitis with hematuria (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Acute cystitis without hematuria, Dysuria (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Acute cystitis without hematuria, urinary tract infection (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Acute urinary retention (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
BPH (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Benign Prostatic Hyperplasia (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Benign prostatic hyperplasia (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Bilateral Renal cyst (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Bloody urine (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Cardiac Arrhythmias - Ventricular Tachycardia/VF (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Chronic kidney disease (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Dysuria (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Gastroenterology (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Genitourinary System (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Genitourinary System (unrelated)
|
2.5%
4/163 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
5.0%
8/160 • Number of events 8 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Kidney Stone (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Liver mass (suspected) (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
N/v intractability of vomiting, UTIs hematuria, urine mslodor, dysuria, urgency (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Nephrolithiasis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Painful Urination, Dysuria (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Recurrent Urinary Tract Infection (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Renal - Acute Kidney Injury (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Renal - Other Renal (unrelated)
|
2.5%
4/163 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
3.1%
5/160 • Number of events 5 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Severe Complications of Heart Failure Treatment (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
UTI (unrelated)
|
1.2%
2/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Urinary Tract Infection (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Urinary stress incontinence (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Urinary tract infection (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Worsening Kidney Function (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Renal and urinary disorders
Worsening chronic kidney disease stage 3 (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Reproductive system and breast disorders
Epididymitis (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Reproductive system and breast disorders
Erectile Dysfunction (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Reproductive system and breast disorders
Genitourinary System (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Reproductive system and breast disorders
Gynecomastia (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Reproductive system and breast disorders
Hypotestosteronism (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Reproductive system and breast disorders
Reproductive System (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Bronchitis (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Recurrent Sinusitis (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Arm pain and cough (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Bacterial Upper Respiratory Infection (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis and cough (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
COPD (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
COPD EXACERBATION (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
COVID (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19 (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain - Non-Cardiac (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain on left side (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease (COPD) (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Cold (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Common Cold (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Cough (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Cough with Viral URI (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Covid-19 (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Dermatology (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea with exertion (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Exertional dyspnea, possibly anginal equivalent (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Extreme shortnes of breath associted with extreme fatigue (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
F/U congestion, nasal drainage, achiness, low-grade temp 100.3-100.5. (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Heart Failure - Acute Decompensated Heart Failure (unrelated)
|
1.8%
3/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Heart Failure - Worsening of HF (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Influenza (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Influenza B (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Muscle and Bone (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Nerve Damage/Stimulation - Cranial Nerve Stimulation (system only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Nocturnal hypoxia (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnea (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Other (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia of right lung due to infectious organism, myalgia, cough, shortness of breath (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Possible Worsened Heart Failure (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Potential COVID-19 Infection (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory - COPD Exacerbation (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory - COPD Exacerbation (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.9%
3/160 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory - Other Respiratory (unrelated)
|
8.0%
13/163 • Number of events 14 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
6.9%
11/160 • Number of events 14 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory - Pneumonia (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
2.5%
4/160 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory - Shortness of Breath (unrelated)
|
0.61%
1/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory - Upper Respiratory Infection (unrelated)
|
7.4%
12/163 • Number of events 15 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
7.5%
12/160 • Number of events 14 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
SOB (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath, Moderate Pleural Effusion Right Side (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat, runny nose and slightly productive cough with clear sputum (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Stroke (CVA) - Hemorrhagic (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Suspicion Of Pneumonia (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Throat nodules (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
URI (unrelated)
|
0.61%
1/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Worsening COPD (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Worsening Heart Failure (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Abscess to right axilla (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Acute wound dehiscence, s/p derma bond clousure (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Basal cell Carcinoma on right side of face (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Bruised elbow (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
CELLULITIS LOWER EXTREMITY (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Cellulitis Right Lower Extremity (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Cellulitis of Abdominal Wall (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Cellulitis of right index finger (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Cellulitis/Venous ulcer (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Dermatitis of gluteal region (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Dermatology (unrelated)
|
3.7%
6/163 • Number of events 6 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
3.1%
5/160 • Number of events 5 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Eczema (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Endocrinology - Worsen of Diabetes (unrelated)
|
0.61%
1/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Facial Contusion (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Folliculitis (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Head laceration (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Hematoma (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Hematoma right foot (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Infected Sebaceous Cyst (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Infected sebaceous cyst on back (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Infected sebaceous cyst- Right lateral chest (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Infection (Other than Surgical) - Cellulitis (unrelated)
|
1.8%
3/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Infection (Other than Surgical) - Localized (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Ingrown nail of great toe of right foot, ingrown nail of great toe of left foot (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Insect bite (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Laceration third digit left hand (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Left index finger injury (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Left shin laceration (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Muscle and Bone (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Nerve Damage/Stimulation - Cranial Nerve Stimulation (system only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Non-healing sacral wound (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Olecranon bursitis of right elbow (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Other (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Other Nerve (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Pain, General (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Poison ivy (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Pruritic rash (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Rash (unrelated)
|
1.2%
2/163 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Rash - Contact Dermatitis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Right Eyebrow Laceration, Pain Right Wrist (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Right Medial Ankle Acute Dermatitis (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Right upper extremity dependent edema and resolving skin rash/excoriations (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Ring worm of bilateral upper extremeties (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer of toe of left foot with fat layer exposed (left hallux lateral wound) (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Squamous cell carcinoma in situ, involving the base (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Surgical or Anesthetic Complications - Wound Complication (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Surgical or Anesthetic Complications - Wound Complication (system and procedure related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Swelling of Breast (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Swollen left hand (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Tinea Corpis (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
Trauma (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Skin and subcutaneous tissue disorders
YEAST DERMATITIS (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Surgical and medical procedures
Bilateral hernia groin repair (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Surgical and medical procedures
Diaphragm paralysis (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Surgical and medical procedures
Nerve Damage/Stimulation - Cranial Nerve Stimulation (system only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Surgical and medical procedures
Other Nerve (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Surgical and medical procedures
Surgical or Anesthetic Complications - Infection at Implant Site-No Explant (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Surgical and medical procedures
Surgical or Anesthetic Complications - Other Surgical Complication (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Surgical and medical procedures
Surgical or Anesthetic Complications - Wound Complication (procedure only related)
|
2.5%
4/163 • Number of events 4 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
DVT (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Endocrinology - Worsen of Diabetes (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Foot pain (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Groin hematoma (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
LGSV thrombus (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Lumps in left leg (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Other Cardiac (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Other Vascular (unrelated)
|
1.8%
3/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
1.2%
2/160 • Number of events 2 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Peripheral Vascular/Artery Disease (unrelated)
|
1.2%
2/163 • Number of events 3 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Right Thigh Hematoma (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Superficial venous thrombosis in lower bilateral extremeties (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Tarsal Tunnel syndrome (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Thromboembolism (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Thromboembolism - Systemic (procedure only related)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Thromboembolism - Systemic (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Transient Ischemic Attack (TIA) (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Transient ischemic attack (TIA) (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Worsening PVD (unrelated)
|
0.00%
0/163 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.62%
1/160 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
|
Vascular disorders
Worsening Stenosis of Right Internal Carotid Artery (unrelated)
|
0.61%
1/163 • Number of events 1 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
0.00%
0/160 • Median follow-up of 3.6 years per patient.
The total number of participants assessed for All-Cause Mortality was assessed for participants that completed the study. This number is consistent with the 'complete' category of the participant flow.
|
Additional Information
Seth Wilks, PhD, Senior Director, Clinical Science
CVRx, Inc.
Phone: 763-416-2840
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place