Trial Outcomes & Findings for The ARIES HeartMate 3 Pump IDE Study (NCT NCT04069156)

NCT ID: NCT04069156

Last Updated: 2025-03-27

Results Overview

The primary end point was a composite of survival free of non-surgical major hemocompatibility related adverse events (specifically stroke, pump thrombosis, major non-surgical bleeding, and arterial peripheral thromboembolism) at 1-year post implant.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 628 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2025-03-27

Participant Flow

The study enrolled and randomized 628 subjects at 51 sites. Enrollment took place between July 2020 and September 2022, with the last subject follow up concluding in August 2023.

The intent to treat (ITT) population consisted of all subjects randomized including follow up beyond transition to open label (n=314 in each arm).

Participant milestones

Measure	Placebo Arm Patients randomized to the placebo arm were given placebo medication.	Aspirin Arm Patients randomized to the aspirin arm were given aspirin medication (100mg/day).
Modified Intent-to-Treat (mITT) STARTED	314	314
Modified Intent-to-Treat (mITT) COMPLETED	296	293
Modified Intent-to-Treat (mITT) NOT COMPLETED	18	21
Principal Analysis STARTED	296	293
Principal Analysis COMPLETED	271	273
Principal Analysis NOT COMPLETED	25	20

Reasons for withdrawal

Measure	Placebo Arm Patients randomized to the placebo arm were given placebo medication.	Aspirin Arm Patients randomized to the aspirin arm were given aspirin medication (100mg/day).
Modified Intent-to-Treat (mITT) Death	1	2
Modified Intent-to-Treat (mITT) Withdrawal by Subject	9	7
Modified Intent-to-Treat (mITT) Transitioned to open label	8	12
Principal Analysis Withdrawn without primary end point event	25	20

Baseline Characteristics

The ARIES HeartMate 3 Pump IDE Study

Baseline characteristics by cohort

Measure	Placebo Arm n=296 Participants Patients randomized to the placebo arm were given placebo medication.	Aspirin Arm n=293 Participants Patients randomized to the aspirin arm were given aspirin medication (100mg/day).	Total n=589 Participants Total of all reporting groups
Age, Continuous	57.6 years STANDARD_DEVIATION 12.8 • n=5 Participants	56.5 years STANDARD_DEVIATION 14.4 • n=7 Participants	57.1 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	61 Participants n=7 Participants	133 Participants n=5 Participants
Sex: Female, Male Male	224 Participants n=5 Participants	232 Participants n=7 Participants	456 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Black or African American	93 Participants n=5 Participants	84 Participants n=7 Participants	177 Participants n=5 Participants
Race (NIH/OMB) White	179 Participants n=5 Participants	181 Participants n=7 Participants	360 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants
Heart Failure Etiology Ischemic Cardiomyopathy	106 Participants n=5 Participants	101 Participants n=7 Participants	207 Participants n=5 Participants
Heart Failure Etiology Idiopathic Cardiomyopathy	68 Participants n=5 Participants	63 Participants n=7 Participants	131 Participants n=5 Participants
Heart Failure Etiology Dilated Cardiomyopathy	86 Participants n=5 Participants	81 Participants n=7 Participants	167 Participants n=5 Participants
Heart Failure Etiology Other	36 Participants n=5 Participants	48 Participants n=7 Participants	84 Participants n=5 Participants
Intended Use Bridge to Transplantation	56 Participants n=5 Participants	58 Participants n=7 Participants	114 Participants n=5 Participants
Intended Use Bridge to Candidacy for Transplantation	46 Participants n=5 Participants	50 Participants n=7 Participants	96 Participants n=5 Participants
Intended Use Destination Therapy	180 Participants n=5 Participants	174 Participants n=7 Participants	354 Participants n=5 Participants
Intended Use Bridge to Recovery	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
INTERMACS Profile 1	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants
INTERMACS Profile 2	76 Participants n=5 Participants	75 Participants n=7 Participants	151 Participants n=5 Participants
INTERMACS Profile 3	133 Participants n=5 Participants	133 Participants n=7 Participants	266 Participants n=5 Participants
INTERMACS Profile 4	66 Participants n=5 Participants	54 Participants n=7 Participants	120 Participants n=5 Participants
INTERMACS Profile 5	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
INTERMACS Profile 6	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
INTERMACS Profile 7	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
New York Heart Association (NYHA) Class Class II	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
New York Heart Association (NYHA) Class Class IIIA	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
New York Heart Association (NYHA) Class Class IIIB	40 Participants n=5 Participants	38 Participants n=7 Participants	78 Participants n=5 Participants
New York Heart Association (NYHA) Class Class IV	226 Participants n=5 Participants	224 Participants n=7 Participants	450 Participants n=5 Participants
Region of Enrollment North America	251 Participants n=5 Participants	248 Participants n=7 Participants	499 Participants n=5 Participants
Region of Enrollment Other	45 Participants n=5 Participants	45 Participants n=7 Participants	90 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: The primary end point was analyzed in the principal analysis population, which excluded patients with events occurring within 14 days after LVAD implantation to avoid counting surgical complications not attributed to the treatment.

The primary end point was a composite of survival free of non-surgical major hemocompatibility related adverse events (specifically stroke, pump thrombosis, major non-surgical bleeding, and arterial peripheral thromboembolism) at 1-year post implant.

Outcome measures

Measure	Placebo Arm (Principal Analysis Population) n=271 Participants Patients randomized to the placebo arm were given placebo medication.	Aspirin Arm (Principal Analysis Population) n=273 Participants Patients randomized to the aspirin arm were given aspirin medication (100mg/day).
Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events	201 Participants	186 Participants

SECONDARY outcome

Timeframe: Through Study Completion with a Median Follow up of 14 Months

Population: Modified Intention to Treat Population (mITT)

The rate of non-surgical hemorrhagic events were compared between the two arms of the study. Non-surgical Major Hemorrhagic events: Hemorrhagic event rate per patient year was calculated by dividing all non-surgical bleeding events and hemorrhagic stroke events by the cumulative years of study exposure.

Outcome measures

Measure	Placebo Arm (Principal Analysis Population) n=296 Participants Patients randomized to the placebo arm were given placebo medication.	Aspirin Arm (Principal Analysis Population) n=293 Participants Patients randomized to the aspirin arm were given aspirin medication (100mg/day).
Rates of Non-surgical Major Hemorrhagic Events All Non-surgical Major Hemorrhagic events	26.2 Event Per 100 Patient-Year	40.7 Event Per 100 Patient-Year
Rates of Non-surgical Major Hemorrhagic Events Bleeding	25.93 Event Per 100 Patient-Year	39.53 Event Per 100 Patient-Year
Rates of Non-surgical Major Hemorrhagic Events Hemorrhagic Stroke	0.27 Event Per 100 Patient-Year	0.85 Event Per 100 Patient-Year
Rates of Non-surgical Major Hemorrhagic Events Ischemic Stroke with Hemorrhagic Conversion	0.00 Event Per 100 Patient-Year	0.28 Event Per 100 Patient-Year

SECONDARY outcome

Timeframe: Through Study Completion with a Median Follow up of 14 Months

Population: Modified Intention to Treat Population (mITT)

The bleeding rate was calculated by dividing the number of bleeding events by the cumulative duration of study exposure (years of support).

Outcome measures

Measure	Placebo Arm (Principal Analysis Population) n=296 Participants Patients randomized to the placebo arm were given placebo medication.	Aspirin Arm (Principal Analysis Population) n=293 Participants Patients randomized to the aspirin arm were given aspirin medication (100mg/day).
Rates of Bleeding Events GI Bleeding	13.10 Event Per 100 Patient-Year	21.61 Event Per 100 Patient-Year
Rates of Bleeding Events All Bleeding Events	25.92 Event Per 100 Patient-Year	39.53 Event Per 100 Patient-Year
Rates of Bleeding Events Moderate Bleeding	8.46 Event Per 100 Patient-Year	13.65 Event Per 100 Patient-Year
Rates of Bleeding Events Severe Bleeding	17.47 Event Per 100 Patient-Year	25.88 Event Per 100 Patient-Year
Rates of Bleeding Events Fatal Bleeding	0.55 Event Per 100 Patient-Year	0.85 Event Per 100 Patient-Year

SECONDARY outcome

Timeframe: Through Study Completion with a Median Follow up of 14 Months

Population: Modified Intention to Treat Population (mITT)

The rates of non-surgical major thrombotic events was compared between the two arms of the study. The thrombotic event rate per patient year was calculated by dividing the number of non-surgical ischemic strokes, pump thrombosis and arterial peripheral thromboembolic events by the cumulative years of study exposure

Outcome measures

Measure	Placebo Arm (Principal Analysis Population) n=296 Participants Patients randomized to the placebo arm were given placebo medication.	Aspirin Arm (Principal Analysis Population) n=293 Participants Patients randomized to the aspirin arm were given aspirin medication (100mg/day).
Rates of Non-surgical Major Thrombotic Events All Major Thrombotic events	1.64 Event Per 100 Patient-Year	2.84 Event Per 100 Patient-Year
Rates of Non-surgical Major Thrombotic Events Ischemic Stroke without Hemorrhagic Conversion	1.64 Event Per 100 Patient-Year	2.56 Event Per 100 Patient-Year
Rates of Non-surgical Major Thrombotic Events Device Thrombosis	0.00 Event Per 100 Patient-Year	0.00 Event Per 100 Patient-Year
Rates of Non-surgical Major Thrombotic Events Arterial Peripheral Thromboembolism	0.00 Event Per 100 Patient-Year	0.00 Event Per 100 Patient-Year

SECONDARY outcome

Timeframe: Through Study Completion with a Median Follow up of 14 Months

Population: Modified Intention to Treat Population (mITT)

The stroke rate was calculated based on the number of strokes experienced by subjects, 14 days or more after device implant, and while on their treatment assignment, divided by the cumulative duration of study exposure (years of support).

Outcome measures

Measure	Placebo Arm (Principal Analysis Population) n=296 Participants Patients randomized to the placebo arm were given placebo medication.	Aspirin Arm (Principal Analysis Population) n=293 Participants Patients randomized to the aspirin arm were given aspirin medication (100mg/day).
Rates of Stroke All Stroke	1.91 Event Per 100 Patient-Year	3.70 Event Per 100 Patient-Year
Rates of Stroke Debilitating Stroke (MRS>3)	0.82 Event Per 100 Patient-Year	0.57 Event Per 100 Patient-Year
Rates of Stroke Non-Debilitating Stroke (MRS<=3)	1.09 Event Per 100 Patient-Year	3.13 Event Per 100 Patient-Year

SECONDARY outcome

Timeframe: 24 Months

Population: Modified Intention to Treat Population (mITT)

The overall survival rate was analyzed using a Kaplan-Meier analysis and the treatment groups were compared using log-rank test. Survival was calculated starting at 14 days post implant.

Outcome measures

Measure	Placebo Arm (Principal Analysis Population) n=296 Participants Patients randomized to the placebo arm were given placebo medication.	Aspirin Arm (Principal Analysis Population) n=293 Participants Patients randomized to the aspirin arm were given aspirin medication (100mg/day).
Survival Rates	93 Percentage of Participants	89.7 Percentage of Participants

SECONDARY outcome

Timeframe: 24 Months

Population: Modified Intention to Treat Population

Risk of non-surgical bleeding events was analyzed using a Kaplan-Meier analysis. The treatment groups were compared using a log-rank test.

Outcome measures

Measure	Placebo Arm (Principal Analysis Population) n=296 Participants Patients randomized to the placebo arm were given placebo medication.	Aspirin Arm (Principal Analysis Population) n=293 Participants Patients randomized to the aspirin arm were given aspirin medication (100mg/day).
Risk of Non-Surgical Bleeding Events	30.0 Percentage of Participants	42.4 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through Study Completion with a Median Follow up of 14 Months

Population: Modified Intention to Treat Population

This study assessed changes in the rehospitalization as a result of removal of antiplatelet therapy from the antithrombotic regimen.

Outcome measures

Measure	Placebo Arm (Principal Analysis Population) n=296 Participants Patients randomized to the placebo arm were given placebo medication.	Aspirin Arm (Principal Analysis Population) n=293 Participants Patients randomized to the aspirin arm were given aspirin medication (100mg/day).
Rate of Rehospitalization Hemocompatibility Related	0.15 Event Per 100 Patient-Year	0.28 Event Per 100 Patient-Year
Rate of Rehospitalization Major Infection	0.34 Event Per 100 Patient-Year	0.36 Event Per 100 Patient-Year
Rate of Rehospitalization Hypertension	0.03 Event Per 100 Patient-Year	0.02 Event Per 100 Patient-Year
Rate of Rehospitalization Cardiovascular Related	0.33 Event Per 100 Patient-Year	0.33 Event Per 100 Patient-Year
Rate of Rehospitalization Non-cardiovascular organ dysfunction	0.06 Event Per 100 Patient-Year	0.05 Event Per 100 Patient-Year
Rate of Rehospitalization Neurologic dysfunction (excluding stroke, TIA)	0.01 Event Per 100 Patient-Year	0.02 Event Per 100 Patient-Year
Rate of Rehospitalization Other	0.41 Event Per 100 Patient-Year	0.42 Event Per 100 Patient-Year

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Only US subjects were included in this analysis

Cost of bleeding episodes was calculated based on a previously published economic model, adjusted for inflation using the US Bureau of Labor Statistics Medical Consumer Price Index. To ensure uniformity in care practices and relevance of the previously published model, only US subjects were included.

Outcome measures

Measure	Placebo Arm (Principal Analysis Population) n=247 Participants Patients randomized to the placebo arm were given placebo medication.	Aspirin Arm (Principal Analysis Population) n=244 Participants Patients randomized to the aspirin arm were given aspirin medication (100mg/day).
Economic Cost Implications - Total Estimated Cost for Bleeding Events (CMS Cost Basis)	546,947 USD	927,040 USD

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Only US subjects were included in this analysis

These values were derived by dividing the total estimated cost for bleeding events by the number of events to determine the average cost per bleeding event. Consequently, a measure of dispersion is not available for these outcomes.

Outcome measures

Measure	Placebo Arm (Principal Analysis Population) n=247 Participants Patients randomized to the placebo arm were given placebo medication.	Aspirin Arm (Principal Analysis Population) n=244 Participants Patients randomized to the aspirin arm were given aspirin medication (100mg/day).
Economic Cost Implications - Average Cost Per Bleeding Event	13,674 USD	13,836 USD

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Only US subjects were included in this analysis

These values were derived by dividing the total estimated cost for bleeding events by the number of patients to obtain the average cost per study patient. Consequently, a measure of dispersion is not available for these outcomes.

Outcome measures

Measure	Placebo Arm (Principal Analysis Population) n=247 Participants Patients randomized to the placebo arm were given placebo medication.	Aspirin Arm (Principal Analysis Population) n=244 Participants Patients randomized to the aspirin arm were given aspirin medication (100mg/day).
Economic Cost Implications - Average Cost Per Study Patient Over the First-year Post-implant	2,214 USD	3,799 USD

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Only US subjects were included in this analysis

Cost of bleeding episodes was calculated based on a previously published economic model, adjusted for inflation using the US Bureau of Labor Statistics Medical Consumer Price Index. To ensure uniformity in care practices and relevance of the previously published model, only US subjects were included.

Outcome measures

Measure	Placebo Arm (Principal Analysis Population) n=247 Participants Patients randomized to the placebo arm were given placebo medication.	Aspirin Arm (Principal Analysis Population) n=244 Participants Patients randomized to the aspirin arm were given aspirin medication (100mg/day).
Economic Cost Implications - Cost of Bleeding Hospitalization for 1000 LVAD Implants Over the First-year Post-implant	2,214,362 USD/1000 implants/1 year	3,799,344 USD/1000 implants/1 year

Adverse Events

Placebo Arm (Modified Intent-to-treat Population)

Serious events: 208 serious events

Other events: 200 other events

Deaths: 21 deaths

Aspirin Arm (Modified Intent-to-treat Population)

Serious events: 223 serious events

Other events: 181 other events

Deaths: 22 deaths

Serious adverse events

Measure	Placebo Arm (Modified Intent-to-treat Population) n=296 participants at risk Patients randomized to the placebo arm were given placebo medication.	Aspirin Arm (Modified Intent-to-treat Population) n=293 participants at risk Patients randomized to the aspirin arm were given aspirin medication (100mg/day).
Blood and lymphatic system disorders Bleeding	23.0% 68/296 • Number of events 92 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	34.1% 100/293 • Number of events 138 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Hemolysis	0.34% 1/296 • Number of events 1 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.34% 1/293 • Number of events 1 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Cardiac disorders Cardiac Arrhythmia	14.9% 44/296 • Number of events 59 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	14.0% 41/293 • Number of events 73 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Cardiac disorders Right Heart Failure	4.1% 12/296 • Number of events 14 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	2.0% 6/293 • Number of events 8 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Hepatobiliary disorders Hepatic Dysfunction	2.0% 6/296 • Number of events 6 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	1.4% 4/293 • Number of events 4 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Infections and infestations Major Infection	33.4% 99/296 • Number of events 201 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	39.6% 116/293 • Number of events 197 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Neurologic Dysfunction	8.4% 25/296 • Number of events 25 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	7.2% 21/293 • Number of events 29 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	5.1% 15/296 • Number of events 16 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	4.8% 14/293 • Number of events 19 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Renal and urinary disorders Renal Dysfunction	5.1% 15/296 • Number of events 18 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.68% 2/293 • Number of events 3 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Vascular disorders Venous Thromboembolism	0.68% 2/296 • Number of events 2 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	1.0% 3/293 • Number of events 3 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Vascular disorders Hypertension	3.0% 9/296 • Number of events 12 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	2.4% 7/293 • Number of events 7 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Blood And Lymphatic System Disorders	1.0% 3/296 • Number of events 3 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	1.4% 4/293 • Number of events 7 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Cardiac disorders Cardiac Disorders	11.1% 33/296 • Number of events 64 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	11.9% 35/293 • Number of events 51 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Ear and labyrinth disorders Ear And Labyrinth Disorders	0.34% 1/296 • Number of events 1 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/293 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Endocrine disorders Endocrine Disorders	1.0% 3/296 • Number of events 3 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.68% 2/293 • Number of events 2 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Eye disorders Eye Disorders	0.34% 1/296 • Number of events 1 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.34% 1/293 • Number of events 1 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Gastrointestinal Disorders	8.1% 24/296 • Number of events 26 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	4.4% 13/293 • Number of events 17 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders General Disorders And Administration Site Conditions	10.5% 31/296 • Number of events 39 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	8.2% 24/293 • Number of events 34 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Hepatobiliary disorders Hepatobiliary Disorders	0.34% 1/296 • Number of events 1 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/293 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Immune system disorders Immune System Disorders	0.00% 0/296 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.34% 1/293 • Number of events 1 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Infections and infestations Infections And Infestations	0.68% 2/296 • Number of events 2 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	1.0% 3/293 • Number of events 3 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Injury, poisoning and procedural complications Injury, Poisoning And Procedural Complications	5.1% 15/296 • Number of events 16 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	5.8% 17/293 • Number of events 20 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Investigations Investigations	4.7% 14/296 • Number of events 18 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	5.8% 17/293 • Number of events 20 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Metabolism and nutrition disorders Metabolism And Nutrition Disorders	10.8% 32/296 • Number of events 40 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	11.3% 33/293 • Number of events 44 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Musculoskeletal And Connective Tissue Disorders	1.4% 4/296 • Number of events 5 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	1.4% 4/293 • Number of events 6 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)	0.68% 2/296 • Number of events 2 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	1.4% 4/293 • Number of events 4 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Nervous System Disorders	7.4% 22/296 • Number of events 26 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	8.9% 26/293 • Number of events 34 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Pregnancy, puerperium and perinatal conditions Pregnancy, Puerperium And Perinatal Conditions	0.34% 1/296 • Number of events 1 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/293 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Psychiatric disorders Psychiatric Disorders	1.7% 5/296 • Number of events 6 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.68% 2/293 • Number of events 2 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Renal and urinary disorders Renal And Urinary Disorders	3.7% 11/296 • Number of events 13 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	2.7% 8/293 • Number of events 10 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic And Mediastinal Disorders	8.4% 25/296 • Number of events 35 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	8.2% 24/293 • Number of events 31 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Skin And Subcutaneous Tissue Disorders	0.68% 2/296 • Number of events 2 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.34% 1/293 • Number of events 1 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Social circumstances Social Circumstances	0.00% 0/296 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.34% 1/293 • Number of events 1 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Surgical and medical procedures Surgical And Medical Procedures	0.34% 1/296 • Number of events 1 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.34% 1/293 • Number of events 1 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Vascular disorders Vascular Disorders	7.4% 22/296 • Number of events 31 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	6.8% 20/293 • Number of events 24 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

Other adverse events

Measure	Placebo Arm (Modified Intent-to-treat Population) n=296 participants at risk Patients randomized to the placebo arm were given placebo medication.	Aspirin Arm (Modified Intent-to-treat Population) n=293 participants at risk Patients randomized to the aspirin arm were given aspirin medication (100mg/day).
Infections and infestations Major Infection	31.8% 94/296 • Number of events 129 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	31.4% 92/293 • Number of events 118 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Cardiac disorders Cardiac Arrhythmia	2.7% 8/296 • Number of events 9 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	3.8% 11/293 • Number of events 12 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Hepatobiliary disorders Hepatic Dysfunction	1.7% 5/296 • Number of events 5 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	2.0% 6/293 • Number of events 6 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Vascular disorders Venous Thromboembolism	1.4% 4/296 • Number of events 4 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	1.4% 4/293 • Number of events 4 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Bleeding	1.0% 3/296 • Number of events 4 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.34% 1/293 • Number of events 1 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Renal and urinary disorders Renal Dysfunction	1.0% 3/296 • Number of events 3 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/293 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Blood And Lymphatic System Disorders	4.7% 14/296 • Number of events 15 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	3.4% 10/293 • Number of events 11 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Cardiac disorders Cardiac Disorders	14.2% 42/296 • Number of events 52 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	7.8% 23/293 • Number of events 33 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Eye disorders Eye Disorders	4.7% 14/296 • Number of events 14 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.68% 2/293 • Number of events 2 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Gastrointestinal Disorders	7.1% 21/296 • Number of events 27 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	6.1% 18/293 • Number of events 22 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders General Disorders And Administration Site Conditions	11.5% 34/296 • Number of events 43 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	7.2% 21/293 • Number of events 26 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Hepatobiliary disorders Hepatobiliary Disorders	2.0% 6/296 • Number of events 7 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.34% 1/293 • Number of events 1 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Infections and infestations Infections And Infestations	1.7% 5/296 • Number of events 5 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	1.0% 3/293 • Number of events 3 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Injury, poisoning and procedural complications Injury, Poisoning And Procedural Complications	6.8% 20/296 • Number of events 25 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	8.2% 24/293 • Number of events 31 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Investigations Investigations	8.4% 25/296 • Number of events 51 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	9.9% 29/293 • Number of events 54 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Metabolism and nutrition disorders Metabolism And Nutrition Disorders	14.5% 43/296 • Number of events 61 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	11.3% 33/293 • Number of events 36 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Musculoskeletal And Connective Tissue Disorders	6.4% 19/296 • Number of events 21 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	5.1% 15/293 • Number of events 15 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Nervous System Disorders	13.5% 40/296 • Number of events 45 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	8.9% 26/293 • Number of events 29 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Psychiatric disorders Psychiatric Disorders	5.4% 16/296 • Number of events 21 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	3.1% 9/293 • Number of events 11 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Renal and urinary disorders Renal And Urinary Disorders	6.4% 19/296 • Number of events 29 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	2.7% 8/293 • Number of events 12 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Reproductive system and breast disorders Reproductive System And Breast Disorders	1.7% 5/296 • Number of events 5 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.34% 1/293 • Number of events 1 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic And Mediastinal Disorders	8.4% 25/296 • Number of events 31 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	9.2% 27/293 • Number of events 31 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Skin And Subcutaneous Tissue Disorders	5.1% 15/296 • Number of events 15 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	3.1% 9/293 • Number of events 9 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Vascular disorders Vascular Disorders	12.2% 36/296 • Number of events 44 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	13.3% 39/293 • Number of events 49 • All adverse events occurring through study completion (median follow up of 14 months) were collected. An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

Additional Information

Nourdine Chakouri, PhD

Abbott

Phone: (925) 989-5982

Email: nourdine.chakouri@abbott.com

Results disclosure agreements

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