Trial Outcomes & Findings for TRILUMINATE Pivotal Trial (NCT NCT03904147)

NCT ID: NCT03904147

Last Updated: 2024-12-19

Results Overview

Analysis of hierarchical composite of all-cause death or tricuspid valve surgery, heart failure hospitalizations, and KCCQ improvement of at least 15 points was performed in ITT population using Finkelstein-Schoenfeld method. A win ratio was also calculated to descriptively quantify the magnitude of treatment benefits. The win ratio is calculated as the ratio of the number of wins in Device versus Control patients. The primary analysis population consisted of 175 Device patients and 175 Control patients, resulting in 30,625 Device-Control patient pairs (i.e., 175 × 175).

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 572 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2024-12-19

Participant Flow

The last 12-month follow-up visit for the 350 randomized subjects (primary analysis cohort) occurred on November 18, 2022. The last 12-month follow-up visit for the 100 Single-arm subjects (primary analysis cohort) occurred on November 1, 2022. Follow-up through 5years is ongoing for all cohorts.

Participant milestones

Measure	Randomized - Device Group Subjects will undergo TriClipTM implantation and will continue to be managed on medical therapy, per physician discretion	Randomized - Control Group Subjects will continue to be managed on medical therapy, per physician discretion	Single Arm Group Subjects will receive the TriClip TM device and will continue to be managed on medical therapy, per physician discretion.
Overall Study STARTED	175	175	100
Overall Study COMPLETED	152	149	84
Overall Study NOT COMPLETED	23	26	16

Reasons for withdrawal

Measure	Randomized - Device Group Subjects will undergo TriClipTM implantation and will continue to be managed on medical therapy, per physician discretion	Randomized - Control Group Subjects will continue to be managed on medical therapy, per physician discretion	Single Arm Group Subjects will receive the TriClip TM device and will continue to be managed on medical therapy, per physician discretion.
Overall Study Death	15	13	15
Overall Study Withdrawal by Subject	7	12	1
Overall Study 1Y visit completed after 365 days	1	1	0

Baseline Characteristics

TRILUMINATE Pivotal Trial

Baseline characteristics by cohort

Measure	Randomized - Device Group n=175 Participants Subjects will undergo TriClipTM implantation and will continue to be managed on medical therapy, per physician discretion	Randomized - Control Group n=175 Participants Subjects will continue to be managed on medical therapy, per physician discretion	Single Arm Group n=100 Participants Subjects will receive the TriClip TM device and will continue to be managed on medical therapy, per physician discretion.	Total n=450 Participants Total of all reporting groups
Age, Continuous	78.0 years STANDARD_DEVIATION 7.4 • n=5 Participants	77.8 years STANDARD_DEVIATION 7.2 • n=7 Participants	80.4 years STANDARD_DEVIATION 6.2 • n=5 Participants	78.5 years STANDARD_DEVIATION 7.12 • n=4 Participants
Sex: Female, Male Female	98 Participants n=5 Participants	94 Participants n=7 Participants	53 Participants n=5 Participants	245 Participants n=4 Participants
Sex: Female, Male Male	77 Participants n=5 Participants	81 Participants n=7 Participants	47 Participants n=5 Participants	205 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	18 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	163 Participants n=5 Participants	153 Participants n=7 Participants	94 Participants n=5 Participants	410 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	13 Participants n=7 Participants	2 Participants n=5 Participants	22 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	17 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	24 Participants n=4 Participants
Race (NIH/OMB) White	149 Participants n=5 Participants	143 Participants n=7 Participants	87 Participants n=5 Participants	379 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	15 Participants n=7 Participants	3 Participants n=5 Participants	29 Participants n=4 Participants
Prior Aortic or Mitral Valve Intervention	68 Participants n=5 Participants	61 Participants n=7 Participants	44 Participants n=5 Participants	173 Participants n=4 Participants

PRIMARY outcome

Timeframe: 12 Months

Analysis of hierarchical composite of all-cause death or tricuspid valve surgery, heart failure hospitalizations, and KCCQ improvement of at least 15 points was performed in ITT population using Finkelstein-Schoenfeld method.

A win ratio was also calculated to descriptively quantify the magnitude of treatment benefits. The win ratio is calculated as the ratio of the number of wins in Device versus Control patients. The primary analysis population consisted of 175 Device patients and 175 Control patients, resulting in 30,625 Device-Control patient pairs (i.e., 175 × 175).

Outcome measures

Measure	Randomized - Device Group n=175 Participants Subjects received Device treatment.	Randomized - Control Group n=175 Participants Subjects received medical therapy alone.
For Randomized Cohort: Hierarchical Composite of All-cause Death or Tricuspid Valve Surgery, Heart Failure Hospitalizations, and KCCQ Improvement	11,246 wins in the patient pairs	7,791 wins in the patient pairs

PRIMARY outcome

Timeframe: 12 months

Population: Nine (9) subjects were not included in the primary endpoint analysis due to: * KCCQ not available at 12-month visit (n=6) * Subject missed 12-month visit (n=3) * Subject declined to complete KCCQ (n=2) * Subject did not complete a 12-month visit due to COVID-19 (n=1) * Subject experienced hospitalization or death related to COVID-19 prior to 12-month follow-up visit (n=2) * Subject withdrew prior to 12-month visit (n=1)

This outcome will be assessed as the percentage of subjects meeting the definition of the endpoint.

Outcome measures

Measure	Randomized - Device Group n=91 Participants Subjects received Device treatment.	Randomized - Control Group Subjects received medical therapy alone.
For Single-Arm Cohort: Rate of Survival Through 12 Months With a Quality of Life Improvement (Assessed Using KCCQ Overall Score) of at Least 10 Points Compared to Baseline.	46.2 percentage of participants	—

SECONDARY outcome

Timeframe: 30 Days

Freedom from major adverse events (MAE) was assessed in the Attempted Procedure population (n=172). MAEs included cardiovascular mortality, new onset renal failure, endocarditis requiring surgery, and non-elective cardiovascular surgery for TriClip device-related AE post-index procedure.

Outcome measures

Measure	Randomized - Device Group n=172 Participants Subjects received Device treatment.	Randomized - Control Group Subjects received medical therapy alone.
For Randomized Cohort - Device Group Only: Rate of Kaplan-Meier Estimate (SE) of Freedom From Major Adverse Events (MAE) Occurring Within 30 Days Post-procedure	98.3 percentage of participants	—

SECONDARY outcome

Timeframe: 12 months minus baseline

Population: Forty (11%) of the 350 subjects (20 Device, 20 Control) were not included in this endpoint due to missing paired KCCQ values at baseline and 12 months.

The mean change in KCCQ score between 12 months and baseline in the Device and Control groups will be compared, while adjusting for the baseline KCCQ score. The primary analysis for this endpoint imputed a KCCQ score of 0 at 12-month visit for all subjects who experienced a heart failure related cardiovascular death or received tricuspid valve surgery prior to completing 12-month follow-up. All KCCQ scores are scaled from 0 (worst) to 100 (best possible status), where the higher score reflects a better health status.

Outcome measures

Measure	Randomized - Device Group n=155 Participants Subjects received Device treatment.	Randomized - Control Group n=155 Participants Subjects received medical therapy alone.
For Randomized Cohort: Change in Quality of Life as Assessed by KCCQ Score	12.0 scores on a scale Standard Deviation 25.8	1.0 scores on a scale Standard Deviation 21.0

SECONDARY outcome

Timeframe: 30 Days

Population: Forty-one (41, or 12%) of the 350 subjects (13 Device, 28 Control) were not included in the analysis of this endpoint due to TR not available at 30 days.

The percentage of subjects with tricuspid regurgitation reduced to moderate or less at 30-day visit in the Device Group will be compared with that in the Control Group. Tricuspid regurgitation severity will be graded on a 5-point scale: trace/mild, moderate, severe (severe 3), massive (severe 4), and torrential (severe 5), which has frequently been used in recent interventional tricuspid studies to categorize tricuspid regurgitation severity. This grading system follows the 2017 ASE guidelines (Zoghbi WA, Adams D, Bonow RO et al. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr 2017;30:303-371.), and further stratifies the traditional "severe" category into severe (Severe 3), massive (Severe 4), and torrential (Severe 5).

Outcome measures

Measure	Randomized - Device Group n=162 Participants Subjects received Device treatment.	Randomized - Control Group n=147 Participants Subjects received medical therapy alone.
For Randomized Cohort: Tricuspid Regurgitation Reduction to Moderate or Less at 30-Day Visit Mild	39.5 percentage of participants	0.7 percentage of participants
For Randomized Cohort: Tricuspid Regurgitation Reduction to Moderate or Less at 30-Day Visit Severe 3	11.1 percentage of participants	22.4 percentage of participants
For Randomized Cohort: Tricuspid Regurgitation Reduction to Moderate or Less at 30-Day Visit Severe 4	0.6 percentage of participants	21.8 percentage of participants
For Randomized Cohort: Tricuspid Regurgitation Reduction to Moderate or Less at 30-Day Visit Severe 5	1.2 percentage of participants	50.3 percentage of participants
For Randomized Cohort: Tricuspid Regurgitation Reduction to Moderate or Less at 30-Day Visit Trace	10.5 percentage of participants	0.7 percentage of participants
For Randomized Cohort: Tricuspid Regurgitation Reduction to Moderate or Less at 30-Day Visit Moderate	37.0 percentage of participants	4.1 percentage of participants

SECONDARY outcome

Timeframe: 12 Months

Population: Eighty-three (24%) of the 350 subjects (44 Device, 39 Control) were not included in this endpoint due to missing paired 6MWT values at baseline and 12 months.

The primary analysis for this endpoint imputed a 6MWT distance of 0 meters for all subjects who experienced a heart failure related cardiovascular death or received tricuspid valve surgery prior to completing 12-month follow-up. Subjects who were unable to exercise due to cardiac reasons were also assigned a 6MWT distance of 0 meters at 12-month follow-up. Other subjects with missing 6MWT distance at either baseline or 12-month follow-up were excluded from the analysis.

Outcome measures

Measure	Randomized - Device Group n=131 Participants Subjects received Device treatment.	Randomized - Control Group n=136 Participants Subjects received medical therapy alone.
For Randomized Cohort: Change in 6 Minute Walk Test (6MWT) From Baseline to 12 Months	-5.1 meters Standard Deviation 131.4	-28.1 meters Standard Deviation 122.3

SECONDARY outcome

Timeframe: 30 days

Population: Twelve subjects were not included in the analysis of this endpoint due to missing paired TR severity at baseline and 30 days.

Outcome measures

Measure	Randomized - Device Group n=88 Participants Subjects received Device treatment.	Randomized - Control Group Subjects received medical therapy alone.
For Single-Arm Cohort: The Percentage of Subjects With TR Reduction by at Least 1 Grade at 30-Day Follow-up	98.9 percentage of participants	—

SECONDARY outcome

Timeframe: 30 days

Population: One subject (Subject 1300) withdrew from the study prior to 30 days without experiencing any MAE and was therefore excluded from the analysis.

Freedom from MAE occurring after procedure attempt (femoral vein puncture) at 30 days. Components of MAE consist of Cardiovascular Mortality, New Onset Renal Failure, Endocarditis Requiring Surgery, and Non-Elective Cardiovascular Surgery for TriClip device-related AE post-index procedure.

Outcome measures

Measure	Randomized - Device Group n=99 Participants Subjects received Device treatment.	Randomized - Control Group Subjects received medical therapy alone.
For Single-Arm Cohort: Rate of Freedom From MAE Through 30 Days	100.0 percentage of participants	—

SECONDARY outcome

Timeframe: 12 months

Population: Twenty-nine (29%) subjects were not included in the primary analysis due to missing 6MWT values at baseline and/or 12 months.

This analysis imputed a 6MWT distance of 0 meters for all subjects who were unable to exercise due to cardiac reasons. However, there were no subjects unable to exercise due to cardiac reasons and therefore no imputation was performed. Subjects with missing 6MWT distance at either baseline or 12-month follow-up were excluded from the analysis.

Outcome measures

Measure	Randomized - Device Group n=71 Participants Subjects received Device treatment.	Randomized - Control Group Subjects received medical therapy alone.
For Single-Arm Cohort: Change in 6 Minute Walk Test (6MWT) From Baseline to 12 Months	13.7 meter Standard Deviation 92.7	—

SECONDARY outcome

Timeframe: 24 months

H0: HR(24M)>1; H1: HR(24M)≤1

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

H0: Survival curves of the two groups through 24 months are the same. H1: Survival curves of the two groups through 24 months are different.

Outcome measures

Outcome data not reported

Adverse Events

Randomized - Device Group

Serious events: 85 serious events

Other events: 29 other events

Deaths: 15 deaths

Randomized - Control Group

Serious events: 73 serious events

Other events: 28 other events

Deaths: 13 deaths

Randomized - Single Arm Group

Serious events: 62 serious events

Other events: 33 other events

Deaths: 15 deaths

Serious adverse events

Measure	Randomized - Device Group n=175 participants at risk Subjects will undergo TriClipTM implantation and will continue to be managed on medical therapy, per physician discretion	Randomized - Control Group n=175 participants at risk Subjects will continue to be managed on medical therapy, per physician discretion	Randomized - Single Arm Group n=100 participants at risk Subjects will receive the TriClip TM device and will continue to be managed on medical therapy, per physician discretion.
Blood and lymphatic system disorders ANAEMIA	2.9% 5/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.7% 3/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	6.0% 6/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Blood and lymphatic system disorders ANAEMIA MACROCYTIC	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Blood and lymphatic system disorders LEUKOCYTOSIS	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Blood and lymphatic system disorders THROMBOCYTOPENIA	1.7% 3/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders AORTIC VALVE STENOSIS	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders ARRHYTHMIA	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders ATRIAL FIBRILLATION	5.7% 10/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	4.0% 7/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	4.0% 4/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders ATRIAL FLUTTER	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders ATRIOVENTRICULAR BLOCK COMPLETE	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders BRADYCARDIA	1.7% 3/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	2.0% 2/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders CARDIAC ARREST	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders CARDIAC FAILURE	14.9% 26/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	11.4% 20/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	21.0% 21/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders CARDIAC FAILURE ACUTE	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders CARDIAC TAMPONADE	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders CARDIOGENIC SHOCK	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders CARDIOMYOPATHY	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	2.0% 2/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders CHORDAE TENDINAE RUPTURE	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders CORONARY ARTERY DISEASE	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders MITRAL VALVE INCOMPETENCE	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders MYOCARDIAL INFARCTION	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	2.0% 2/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders PERICARDIAL EFFUSION	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders SICK SINUS SYNDROME	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders SINUS ARREST	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders SINUS ARRHYTHMIA	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders TRICUSPID VALVE INCOMPETENCE	3.4% 6/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	4.0% 7/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	11.0% 11/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders VENTRICULAR TACHYCARDIA	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Endocrine disorders ADRENAL MASS	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Endocrine disorders HYPOPARATHYROIDISM	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Gastrointestinal disorders ABDOMINAL PAIN	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Gastrointestinal disorders ASCITES	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Gastrointestinal disorders DIARRHOEA	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Gastrointestinal disorders DYSPHAGIA	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	1.7% 3/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.7% 3/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Gastrointestinal disorders GINGIVAL BLEEDING	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Gastrointestinal disorders ILEUS	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Gastrointestinal disorders TONGUE HAEMATOMA	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
General disorders ASTHENIA	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	2.0% 2/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
General disorders CHEST DISCOMFORT	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
General disorders CHEST PAIN	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
General disorders DEATH	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.7% 3/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	2.0% 2/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
General disorders DEVICE DEPLOYMENT ISSUE	1.7% 3/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
General disorders MULTI-ORGAN FAILURE	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
General disorders OEDEMA PERIPHERAL	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
General disorders OTHERS	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
General disorders PYREXIA	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
General disorders THROMBOSIS IN RIGHT ATRIAL LEAD	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Hepatobiliary disorders CHOLANGITIS	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Immune system disorders AMYLOIDOSIS	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations APPENDICITIS	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations BACTERAEMIA	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations BRONCHITIS	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations CELLULITIS	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	2.3% 4/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	3.0% 3/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations CLOSTRIDIAL INFECTION	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations CORONA VIRUS INFECTION	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations CYSTITIS	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	2.0% 2/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations DIVERTICULITIS	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations ERYSIPELAS	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations INFECTION	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	2.0% 2/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations INFECTIOUS PLEURAL EFFUSION	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations LOCALISED INFECTION	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations MENINGOENCEPHALITIS HERPETIC	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations PNEUMONIA	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	2.0% 2/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations PNEUMONIA PRIMARY ATYPICAL	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations PSEUDOMONAL SEPSIS	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations PULMONARY SEPSIS	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations SEPSIS	2.3% 4/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations SEPTIC SHOCK	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations URINARY TRACT INFECTION	1.7% 3/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	2.0% 2/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Infections and infestations UROSEPSIS	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Injury, poisoning and procedural complications CLAVICLE FRACTURE	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Injury, poisoning and procedural complications CONTUSION	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Injury, poisoning and procedural complications FALL	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	2.9% 5/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	3.0% 3/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Injury, poisoning and procedural complications FEMUR FRACTURE	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Injury, poisoning and procedural complications HIP FRACTURE	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Injury, poisoning and procedural complications INCISION SITE HAEMORRHAGE	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Injury, poisoning and procedural complications RIB FRACTURE	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Injury, poisoning and procedural complications SUBCUTANEOUS HAEMATOMA	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Injury, poisoning and procedural complications SUBDURAL HAEMATOMA	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Injury, poisoning and procedural complications VASCULAR ACCESS COMPLICATION	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Injury, poisoning and procedural complications VASCULAR PROCEDURE COMPLICATION	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Injury, poisoning and procedural complications VASCULAR PSEUDOANEURYSM	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Investigations BLOOD CREATININE INCREASED	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Investigations CATHETERISATION CARDIAC	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Investigations CORONAVIRUS TEST POSITIVE	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Investigations ECHOCARDIOGRAM ABNORMAL	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Investigations ELECTROCARDIOGRAM ABNORMAL	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Investigations INTERNATIONAL NORMALISED RATIO INCREASED	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Investigations LIVER FUNCTION TEST ABNORMAL	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Investigations TROPONIN INCREASED	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Metabolism and nutrition disorders DEHYDRATION	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Metabolism and nutrition disorders FAILURE TO THRIVE	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Metabolism and nutrition disorders FLUID OVERLOAD	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Metabolism and nutrition disorders GOUT	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Metabolism and nutrition disorders HYPERKALAEMIA	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Metabolism and nutrition disorders HYPERVOLAEMIA	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Metabolism and nutrition disorders HYPOKALAEMIA	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	2.0% 2/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Metabolism and nutrition disorders HYPONATRAEMIA	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Musculoskeletal and connective tissue disorders BACK PAIN	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Musculoskeletal and connective tissue disorders CERVICAL SPINAL STENOSIS	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Musculoskeletal and connective tissue disorders INGUINAL MASS	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Musculoskeletal and connective tissue disorders MUSCLE HAEMORRHAGE	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.7% 3/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.7% 3/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Musculoskeletal and connective tissue disorders RHABDOMYOLYSIS	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO CENTRAL NERVOUS SYSTEM	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM MALIGNANT	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OVARIAN CANCER	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN CANCER	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Nervous system disorders CEREBRAL HAEMORRHAGE	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Nervous system disorders CEREBROVASCULAR ACCIDENT	1.7% 3/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Nervous system disorders DIZZINESS	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Nervous system disorders ENCEPHALOPATHY	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Nervous system disorders HEPATIC ENCEPHALOPATHY	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Nervous system disorders METABOLIC ENCEPHALOPATHY	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Nervous system disorders NORMAL PRESSURE HYDROCEPHALUS	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Nervous system disorders PARKINSON'S DISEASE	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Nervous system disorders PERIPHERAL SENSORIMOTOR NEUROPATHY	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Nervous system disorders SUBARACHNOID HAEMORRHAGE	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Nervous system disorders SYNCOPE	2.3% 4/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Nervous system disorders TOXIC ENCEPHALOPATHY	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	2.0% 2/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Nervous system disorders VOCAL CORD PARALYSIS	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Psychiatric disorders CONFUSIONAL STATE	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Renal and urinary disorders HAEMATURIA	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Renal and urinary disorders NEPHROPATHY	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Renal and urinary disorders RENAL FAILURE	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Renal and urinary disorders RENAL FAILURE ACUTE	4.0% 7/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	2.9% 5/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	9.0% 9/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Renal and urinary disorders RENAL FAILURE CHRONIC	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Renal and urinary disorders URINARY RETENTION	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Respiratory, thoracic and mediastinal disorders ASPIRATION	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Respiratory, thoracic and mediastinal disorders HYPOXIA	1.7% 3/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Respiratory, thoracic and mediastinal disorders LUNG INFILTRATION	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	3.0% 3/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Respiratory, thoracic and mediastinal disorders PULMONARY CONGESTION	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	2.0% 2/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Respiratory, thoracic and mediastinal disorders PULMONARY HYPERTENSION	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Respiratory, thoracic and mediastinal disorders RESPIRATORY ARREST	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Skin and subcutaneous tissue disorders DECUBITUS ULCER	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Skin and subcutaneous tissue disorders SKIN ULCER	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Social circumstances EXERCISE LACK OF	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Surgical and medical procedures HIP ARTHROPLASTY	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Surgical and medical procedures MEDICAL DEVICE IMPLANTATION	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Surgical and medical procedures ROTATOR CUFF REPAIR	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Surgical and medical procedures STENT PLACEMENT	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Surgical and medical procedures TRANSURETHRAL PROSTATECTOMY	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Surgical and medical procedures TRICUSPID VALVE REPAIR	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Vascular disorders AORTIC STENOSIS	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Vascular disorders HAEMORRHAGE	8.0% 14/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	4.0% 7/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	8.0% 8/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Vascular disorders HYPERTENSION	1.1% 2/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Vascular disorders HYPOTENSION	2.9% 5/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	4.0% 4/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Vascular disorders PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Vascular disorders PERIPHERAL ISCHAEMIA	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Vascular disorders SHOCK	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.0% 1/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Vascular disorders VENA CAVA THROMBOSIS	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.00% 0/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.

Other adverse events

Measure	Randomized - Device Group n=175 participants at risk Subjects will undergo TriClipTM implantation and will continue to be managed on medical therapy, per physician discretion	Randomized - Control Group n=175 participants at risk Subjects will continue to be managed on medical therapy, per physician discretion	Randomized - Single Arm Group n=100 participants at risk Subjects will receive the TriClip TM device and will continue to be managed on medical therapy, per physician discretion.
Cardiac disorders ATRIAL FIBRILLATION	2.9% 5/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	0.57% 1/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	5.0% 5/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Cardiac disorders CARDIAC FAILURE	3.4% 6/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	5.1% 9/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	9.0% 9/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Renal and urinary disorders RENAL FAILURE ACUTE	3.4% 6/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	1.7% 3/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	10.0% 10/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	1.7% 3/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	5.7% 10/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	4.0% 4/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.
Vascular disorders HAEMORRHAGE	5.1% 9/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	2.9% 5/175 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.	5.0% 5/100 • 12 months The participant flow reports patient status based on visit windows in order to report if a patient completed a visit or not. The AE section including the All-Cause Mortality reports all events through 365 days.

Additional Information

Natalie Richardson, Senior Clinical Project Manager

Abbott

Phone: 651-756-3842

Email: natalie.richardson@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60