Trial Outcomes & Findings for Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis (NCT NCT01437098)

NCT ID: NCT01437098

Last Updated: 2019-02-15

Results Overview

The primary endpoint was defined as the proportion of implanted subjects with improvement of at least 1 NYHA class from baseline to 6 months and EOA greater than 1.2 cm² at 6 months.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 55 participants
• Primary outcome timeframe: baseline and 6 months
• Results posted on: 2019-02-15

Participant Flow

Participant milestones

Measure	MDT-2111 TAVI Transcatheter Aortic Valve Implantation (TAVI) with MDT-2111 system.
Overall Study STARTED	55
Overall Study 30 Days	51
Overall Study 6 Months	47
Overall Study 12 Months	45
Overall Study 24 Months	42
Overall Study 36 Months	36
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis

Baseline characteristics by cohort

Measure	MDT-2111 TAVI n=55 Participants Transcatheter Aortic Valve Implantation (TAVI) with MDT-2111 system.
Age, Continuous	82.5 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment Japan	55 participants n=5 Participants
NYHA Class NYHA Class II	0 participants n=5 Participants
NYHA Class NYHA Class III	49 participants n=5 Participants
NYHA Class NYHA Class IV	6 participants n=5 Participants
STS Score	8.0 percent STANDARD_DEVIATION 4.2 • n=5 Participants
Logistic EuroScore	21.5 percent STANDARD_DEVIATION 9.9 • n=5 Participants
Aortic Valve Area (AVA)	0.6 cm² STANDARD_DEVIATION 0.1 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Population: All subjects implanted with the MDT-2111 device.

The primary endpoint was defined as the proportion of implanted subjects with improvement of at least 1 NYHA class from baseline to 6 months and EOA greater than 1.2 cm² at 6 months.

Outcome measures

Measure	All Implanted Subjects n=47 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects n=36 Participants The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Composite Success of Improvement in New York Heart Association (NYHA) Class and a Performance Goal for Effective Orifice Area (EOA).	93.6 percentage of participants	91.7 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: NYHA denominators included deaths (n=2). Taken deaths out, you have n=51 at 30 days.

NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.

Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Outcome measures

Measure	All Implanted Subjects n=53 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
NYHA Classification Over Time NYHA II	30.2 percentage of participants	—
NYHA Classification Over Time NYHA III	5.7 percentage of participants	—
NYHA Classification Over Time NYHA IV	1.9 percentage of participants	—
NYHA Classification Over Time Died prior to visit	3.8 percentage of participants	—
NYHA Classification Over Time NYHA I	58.5 percentage of participants	—

SECONDARY outcome

Timeframe: 6 months

NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.

Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Outcome measures

Measure	All Implanted Subjects n=52 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
NYHA Classification Over Time NYHA I	59.6 percentage of participants	—
NYHA Classification Over Time NYHA II	30.8 percentage of participants	—
NYHA Classification Over Time NYHA III	0.0 percentage of participants	—
NYHA Classification Over Time Died prior to visit	9.6 percentage of participants	—
NYHA Classification Over Time NYHA IV	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: 12 Months

NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.

Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.

Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Outcome measures

Measure	All Implanted Subjects n=53 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
NYHA Classification Over Time NYHA I	60.4 percentage of participants	—
NYHA Classification Over Time NYHA II	24.5 percentage of participants	—
NYHA Classification Over Time NYHA III	0.0 percentage of participants	—
NYHA Classification Over Time NYHA IV	0.0 percentage of participants	—
NYHA Classification Over Time Died prior to visit	15.1 percentage of participants	—

SECONDARY outcome

Timeframe: 24 Months

NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.

Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.

Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Outcome measures

Measure	All Implanted Subjects n=52 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
NYHA Classification Over Time NYHA I	59.6 percentage of participants	—
NYHA Classification Over Time NYHA II	21.2 percentage of participants	—
NYHA Classification Over Time NYHA III	0.0 percentage of participants	—
NYHA Classification Over Time NYHA IV	0.0 percentage of participants	—
NYHA Classification Over Time Died prior to visit	19.2 percentage of participants	—

SECONDARY outcome

Timeframe: 36 Months

NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.

Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.

Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Outcome measures

Measure	All Implanted Subjects n=52 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
NYHA Classification Over Time NYHA I	57.7 percentage of participants	—
NYHA Classification Over Time NYHA II	9.6 percentage of participants	—
NYHA Classification Over Time NYHA III	0 percentage of participants	—
NYHA Classification Over Time NYHA IV	0 percentage of participants	—
NYHA Classification Over Time Died prior to visit	32.7 percentage of participants	—

SECONDARY outcome

Timeframe: 0 day to 30 days

Population: The Kaplan-Meier Method was used to calculate the number.

MACCE is defined as a composite of:

• all-cause death
• myocardial infarction (MI)
• all stroke, and
• reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

Outcome measures

Measure	All Implanted Subjects n=55 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)	89.1 prob of freedom from event @ 30 days	—

SECONDARY outcome

Timeframe: 0 day to 6 months

Population: The Kaplan-Meier Method was used to calculate the number.

MACCE is defined as a composite of:

• all-cause death
• myocardial infarction (MI)
• all stroke, and
• reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

Outcome measures

Measure	All Implanted Subjects n=55 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)	81.6 prob of freedom from event @ 183 days	—

SECONDARY outcome

Timeframe: 0 day to 12 months

Population: The Kaplan-Meier Method was used to calculate the number.

MACCE is defined as a composite of:

• all-cause death
• myocardial infarction (MI)
• all stroke, and
• reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

Outcome measures

Measure	All Implanted Subjects n=55 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)	76.1 prob of freedom from event @ 365 days	—

SECONDARY outcome

Timeframe: 0 day to 24 months

Population: The Kaplan-Meier Method was used to calculate the number.

MACCE is defined as a composite of:

• all-cause death
• myocardial infarction (MI)
• all stroke, and
• reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

Outcome measures

Measure	All Implanted Subjects n=55 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)	68.4 prob of freedom from event at 730 days	—

SECONDARY outcome

Timeframe: 0 day to 36 months

Population: The Kaplan-Meier Method was used to calculate the number.

MACCE is defined as a composite of:

• all-cause death
• myocardial infarction (MI)
• all stroke, and
• reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

Outcome measures

Measure	All Implanted Subjects n=55 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)	57.3 prob of freedom from event at 1095 days	—

SECONDARY outcome

Timeframe: after procedure or discharge

Population: The AT cohort that went through an index procedure were analyzed for Device Success. Also, all components that went into the success measures had to be non-missing. Therefore n=53.

• successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system
• correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function)
• Intended performance of the prosthetic valve (aortic valve area >1.2 cm² (by echocardiography using the continuity equation) and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/sec, without moderate or severe prosthetic valve AR)
• Only one valve implanted in the proper anatomical location

Outcome measures

Measure	All Implanted Subjects n=53 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Device Success as Defined in the Description.	90.6 percentage of participants	—

SECONDARY outcome

Timeframe: after procedure or discharge

Outcome measures

Measure	All Implanted Subjects n=54 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Procedural Success, Defined as Device Success and Absence of In-hospital MACCE.	81.5 percentage of participants	—

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	All Implanted Subjects n=50 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient	9.5 mmHg Standard Deviation 3.4	—

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	All Implanted Subjects n=47 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance- Mean Gradient	8.9 mmHg Standard Deviation 2.3	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	All Implanted Subjects n=45 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient	9.4 mmHg Standard Deviation 3.0	—

SECONDARY outcome

Timeframe: 24 months

Population: The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had mean gradients available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.

Outcome measures

Measure	All Implanted Subjects n=41 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient	8.4 mmHg Standard Deviation 2.6	—

SECONDARY outcome

Timeframe: 36 months

Population: The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.

Outcome measures

Measure	All Implanted Subjects n=33 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient	8.9 mmHg Standard Deviation 3.0	—

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	All Implanted Subjects n=47 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)	1.8 cm² Standard Deviation 0.4	—

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	All Implanted Subjects n=47 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)	1.8 cm² Standard Deviation 0.4	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	All Implanted Subjects n=45 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)	1.7 cm² Standard Deviation 0.4	—

SECONDARY outcome

Timeframe: 24 months

Population: The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had EOA measurement available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.

Outcome measures

Measure	All Implanted Subjects n=38 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)	1.8 cm² Standard Deviation 0.5	—

SECONDARY outcome

Timeframe: 36 months

Population: The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.

Outcome measures

Measure	All Implanted Subjects n=29 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)	1.8 cm² Standard Deviation 0.4	—

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	All Implanted Subjects n=51 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)	63.9 percent Standard Deviation 6.6	—

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	All Implanted Subjects n=47 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)	63.8 percent Standard Deviation 7.7	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	All Implanted Subjects n=45 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)	62.9 percent Standard Deviation 7.0	—

SECONDARY outcome

Timeframe: 24 months

Population: The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.

Outcome measures

Measure	All Implanted Subjects n=42 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)	64.3 percent Standard Deviation 6.3	—

SECONDARY outcome

Timeframe: 36 months

Population: The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.

Outcome measures

Measure	All Implanted Subjects n=35 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)	61.1 percent Standard Deviation 7.8	—

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	All Implanted Subjects n=50 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) None	8.0 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Trace	48.0 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Mild	38.0 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Moderate	6.0 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Severe	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	All Implanted Subjects n=47 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) None	31.9 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Trace	31.9 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Mild	31.9 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Moderate	4.3 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Severe	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	All Implanted Subjects n=45 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) None	24.4 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Trace	26.7 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Mild	44.4 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Moderate	4.4 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Severe	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: 24 months

Population: The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had Total AR available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.

Outcome measures

Measure	All Implanted Subjects n=41 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) None	17.1 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Trace	41.5 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Mild	36.6 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Moderate	4.9 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Severe	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: 36 months

Population: The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.

Outcome measures

Measure	All Implanted Subjects n=35 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) None	25.7 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Trace	31.4 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Mild	37.1 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Moderate	5.7 percentage of participants	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR) Severe	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: 0 day to 30 days

Outcome measures

Measure	All Implanted Subjects n=55 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Repeat Hospitalization	94.3 prob of freedom from event @ 30 days	—

SECONDARY outcome

Timeframe: 0 day to 6 months

Outcome measures

Measure	All Implanted Subjects n=55 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Repeat Hospitalization	61.0 prob of freedom from event @ 183 days	—

SECONDARY outcome

Timeframe: 0 day to 12 months

Outcome measures

Measure	All Implanted Subjects n=55 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Repeat Hospitalization	50.9 prob of freedom from event @ 365 days	—

SECONDARY outcome

Timeframe: 0 day to 24 months

Outcome measures

Measure	All Implanted Subjects n=55 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Repeat Hospitalization	37.4 prob of freedom from event @ 730 days	—

SECONDARY outcome

Timeframe: 0 day to 36 months

Outcome measures

Measure	All Implanted Subjects n=55 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Repeat Hospitalization	35.9 prob of freedom from event @ 1095 days	—

SECONDARY outcome

Timeframe: 0 day to 30 days

Outcome measures

Measure	All Implanted Subjects n=55 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Valve-related Deaths	98.2 prob of freedom from event @ 30 days	—

SECONDARY outcome

Timeframe: 0 day to 6 months

Outcome measures

Measure	All Implanted Subjects n=55 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Valve-related Deaths	98.2 prob of freedom from event @ 183 days	—

SECONDARY outcome

Timeframe: 0 day to 12 months

Outcome measures

Measure	All Implanted Subjects n=55 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Valve-Related Deaths	98.2 prob of freedom from event @ 365 days	—

SECONDARY outcome

Timeframe: 0 day to 24 months

Outcome measures

Measure	All Implanted Subjects n=55 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Valve-related Deaths	98.2 prob of freedom from event @ 730 days	—

SECONDARY outcome

Timeframe: 0 day to 36 months

Outcome measures

Measure	All Implanted Subjects n=55 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Valve-related Deaths	94.5 prob of freedom from event @ 1095 days	—

SECONDARY outcome

Timeframe: Baseline to 30 days

Population: The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had Q of L available at this visit were analyzed. Not everyone followed to this visit had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.

The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.

Outcome measures

Measure	All Implanted Subjects n=50 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)	5.2 Points Interval -8.1 to 18.4	—

SECONDARY outcome

Timeframe: Baseline to 6 months

The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.

Outcome measures

Measure	All Implanted Subjects n=47 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)	11.2 Points Interval 1.4 to 23.8	—

SECONDARY outcome

Timeframe: Baseline to 12 months

The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.

Outcome measures

Measure	All Implanted Subjects n=45 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)	10.8 Points Interval -5.6 to 24.2	—

SECONDARY outcome

Timeframe: Baseline to 24 Months

The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.

Outcome measures

Measure	All Implanted Subjects n=41 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)	9.3 Points Interval -5.3 to 20.1	—

SECONDARY outcome

Timeframe: Baseline to 36 Months

The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.

Outcome measures

Measure	All Implanted Subjects n=34 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)	4.8 Points Interval -6.2 to 16.0	—

Adverse Events

Iliofemoral (As Treated Subjects)

Serious events: 40 serious events

Other events: 44 other events

Deaths: 0 deaths

Subclavian (As Treated Subjects)

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Direct Aortic (As Treated Subjects)

Serious events: 5 serious events

Other events: 6 other events

Deaths: 0 deaths

All Subjects (As Treated Subjects)

Serious events: 49 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Measure	Iliofemoral (As Treated Subjects) n=44 participants at risk The iliofemoral approach is used as the primary access site because there is a large body of clinical data in the past using this approach in patients.	Subclavian (As Treated Subjects) n=5 participants at risk The subclavian access is additionally chosen (as the secondary access site) when physicians may require an alternative to the femoral access site for patients who would benefit from the therapy but have unfavorable peripheral vasculature such as excessive atherosclerosis, calcifications, or tortuosity of common femoral arteries.	Direct Aortic (As Treated Subjects) n=6 participants at risk For patients who would benefit from the therapy but have unfavorable non-aortic vasculature of the transfemoral and subclavian/axillary access sites (i.e. excessive atherosclerosis, calcifications, or tortuosity of arteries), the direct aortic approach is currently being used in oversea(EU and US) in clinical practice with similar outcomes to transfemoral and subclavian/ axillary artery approaches.	All Subjects (As Treated Subjects) n=55 participants at risk This includes subjects from all access approaches, iliofemoral, subclavian and direct aortic.
Vascular disorders Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Vascular Hypotensive Disorders	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Peripheral Embolism And Thrombosis	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Skin and subcutaneous tissue disorders Dermatitis Ascribed To Specific Agent	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Aortic Aneurysms And Dissections	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Circulatory Collapse And Shock	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Blood and lymphatic system disorders Anaemias Nec	4.5% 2/44 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Aortic Valvular Disorders	6.8% 3/44 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.5% 3/55 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Cardiac Conduction Disorders	25.0% 11/44 • Number of events 11 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	40.0% 2/5 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	23.6% 13/55 • Number of events 13 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Cardiac Disorders Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Coronary Artery Disorders Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Heart Failures Nec	13.6% 6/44 • Number of events 15 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	50.0% 3/6 • Number of events 6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	18.2% 10/55 • Number of events 22 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Ischaemic Coronary Artery Disorders	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Myocardial Disorders Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Pericardial Disorders Nec	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Supraventricular Arrhythmias	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Ventricular Arrhythmias And Cardiac Arrest	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Eye disorders Cataract Conditions	6.8% 3/44 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.5% 3/55 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Gastrointestinal disorders Gastrointestinal Ulcers And Perforation, Site Unspecified	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Gastrointestinal disorders Non-Site Specific Gastrointestinal Haemorrhages	9.1% 4/44 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	9.1% 5/55 • Number of events 5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Asthenic Conditions	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Death And Sudden Death	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Device Issues Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Febrile Disorders	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders General Signs And Symptoms Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Pain And Discomfort Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Hepatobiliary disorders Cholecystitis And Cholelithiasis	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Hepatobiliary disorders Hepatic Enzymes And Function Abnormalities	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Hepatobiliary disorders Hepatic Failure And Associated Disorders	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Hepatobiliary disorders Obstructive Bile Duct Disorders (Excl Neoplasms)	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Abdominal And Gastrointestinal Infections	2.3% 1/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Bacterial Infections Nec	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.5% 3/55 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Infections Nec	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Lower Respiratory Tract And Lung Infections	11.4% 5/44 • Number of events 7 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	33.3% 2/6 • Number of events 5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	12.7% 7/55 • Number of events 12 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Sepsis, Bacteraemia, Viraemia And Fungaemia Nec	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Stretococcal Infections	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Cerebral Injuries Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Lower Limb Fractures And Dislocations	6.8% 3/44 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.5% 3/55 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Non-Site Specific Injuries Nec	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Non-Site Specific Procedural Complications	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Pelvic Fractures And Dislocations	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Spinal Fractures And Dislocations	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Physical Examination Procedures	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Metabolism and nutrition disorders Diabetes Mellitus (Incl Subtypes)	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Metabolism and nutrition disorders General Nutritional Disorders Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Musculoskeletal and connective tissue disorders Muscle Weakness Conditions	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Musculoskeletal and connective tissue disorders Musculoskeletal And Connective Tissue Pain And Discomfort	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Musculoskeletal and connective tissue disorders Osteoarthropathies	4.5% 2/44 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.5% 3/55 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast And Nipple Neoplasms Malignant	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Neoplasms Malignant	4.5% 2/44 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatobiliary Neoplasms Malignancy Unspecified	2.3% 1/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphomas Unspecified Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Nervous system disorders Central Nervous System Haemorrhages And Cerebrovascular Accidents	13.6% 6/44 • Number of events 6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	33.3% 2/6 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	14.5% 8/55 • Number of events 8 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Nervous system disorders Central Nervous System Vascular Disorders Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Psychiatric disorders Anxiety Disorders Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Renal and urinary disorders Renal Failure And Impairment	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Renal and urinary disorders Renal Vascular And Ischaemic Conditions	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Reproductive system and breast disorders Pelvic Prolapse Conditions	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Breathing Abnormalities	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Lower Respiratory Tract Inflammatory And Immunologic Conditions	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Mediastinal Disorders	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Nasal Disorders Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Parenchymal Lung Disorders Nec	2.3% 1/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Pneumothorax And Pleural Effusions Nec	2.3% 1/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedemas	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Respiratory Failures (Excl Neonatal)	4.5% 2/44 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Signs And Symptoms	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.

Other adverse events

Measure	Iliofemoral (As Treated Subjects) n=44 participants at risk The iliofemoral approach is used as the primary access site because there is a large body of clinical data in the past using this approach in patients.	Subclavian (As Treated Subjects) n=5 participants at risk The subclavian access is additionally chosen (as the secondary access site) when physicians may require an alternative to the femoral access site for patients who would benefit from the therapy but have unfavorable peripheral vasculature such as excessive atherosclerosis, calcifications, or tortuosity of common femoral arteries.	Direct Aortic (As Treated Subjects) n=6 participants at risk For patients who would benefit from the therapy but have unfavorable non-aortic vasculature of the transfemoral and subclavian/axillary access sites (i.e. excessive atherosclerosis, calcifications, or tortuosity of arteries), the direct aortic approach is currently being used in oversea(EU and US) in clinical practice with similar outcomes to transfemoral and subclavian/ axillary artery approaches.	All Subjects (As Treated Subjects) n=55 participants at risk This includes subjects from all access approaches, iliofemoral, subclavian and direct aortic.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedemas	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	33.3% 2/6 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.5% 3/55 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Respiratory Failures (Excl Neonatal)	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Signs And Symptoms	6.8% 3/44 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.5% 3/55 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Skin and subcutaneous tissue disorders Dermal And Epidermal Conditions Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Skin and subcutaneous tissue disorders Dermatitis And Eczema	6.8% 3/44 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	9.1% 5/55 • Number of events 5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Reproductive system and breast disorders Breast Disorders Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Reproductive system and breast disorders Breast Signs And Symptoms	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Reproductive system and breast disorders Vulvovaginal Disorders Nec	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Breathing Abnormalities	6.8% 3/44 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	7.3% 4/55 • Number of events 5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Coughing And Associated Symptoms	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Nasal Disorders Nec	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Pneumothorax And Pleural Effusions Nec	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	33.3% 2/6 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	7.3% 4/55 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Blood and lymphatic system disorders Anaemias Nec	29.5% 13/44 • Number of events 13 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	33.3% 2/6 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	29.1% 16/55 • Number of events 17 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Blood and lymphatic system disorders Coagulopathies	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Blood and lymphatic system disorders Thrombocytopenias	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Cardiac Conduction Disorders	61.4% 27/44 • Number of events 39 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	80.0% 4/5 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	33.3% 2/6 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	60.0% 33/55 • Number of events 46 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Cardiac Signs And Symptoms Nec	6.8% 3/44 • Number of events 5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	7.3% 4/55 • Number of events 6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Heart Failures Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.5% 3/55 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Ischaemic Coronary Artery Disorders	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Mitral Valvular Disorders	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Pericardial Disorders Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Rate And Rhythm Disorders Nec	9.1% 4/44 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	9.1% 5/55 • Number of events 5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Supraventricular Arrhythmias	20.5% 9/44 • Number of events 11 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	33.3% 2/6 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 11/55 • Number of events 14 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Ventricular Arrhythmias And Cardiac Arrest	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Ear and labyrinth disorders Ear Disorders Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Ear and labyrinth disorders Inner Ear Signs And Symptoms	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Endocrine disorders Adrenal Cortical Hypofunctions	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Endocrine disorders Thyroid Hypofunction Disorders	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Eye disorders Cataract Conditions	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Gastrointestinal disorders Diarrhoea (Excl Infective)	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	40.0% 2/5 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	33.3% 2/6 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.9% 6/55 • Number of events 7 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Gastrointestinal disorders Gastrointestinal Atonic And Hypomotility Disorders Nec	15.9% 7/44 • Number of events 7 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	33.3% 2/6 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	18.2% 10/55 • Number of events 11 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Gastrointestinal disorders Gastrointestinal Inflammatory Disorders Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Gastrointestinal disorders Gastrointestinal Signs And Symptoms Nec	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Gastrointestinal disorders Nausea And Vomiting Symptoms	18.2% 8/44 • Number of events 8 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	18.2% 10/55 • Number of events 11 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Gastrointestinal disorders Non-Site Specific Gastrointestinal Haemorrhages	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Gastrointestinal disorders Oral Soft Tissue Disorders Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Gastrointestinal disorders Tongue Disorders	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Gastrointestinal disorders Tongue Signs And Symptoms	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Administration Site Reactions Nec	9.1% 4/44 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	40.0% 2/5 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	12.7% 7/55 • Number of events 8 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Asthenic Conditions	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Complications Associated With Device Nec	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Febrile Disorders	25.0% 11/44 • Number of events 11 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	40.0% 2/5 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	33.3% 2/6 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	27.3% 15/55 • Number of events 15 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Feelings And Sensations Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Implant And Catheter Site Reactions	6.8% 3/44 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	7.3% 4/55 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Inflammations	6.8% 3/44 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	7.3% 4/55 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Injection Site Reactions	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Oedema Nec	18.2% 8/44 • Number of events 9 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.4% 9/55 • Number of events 10 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Pain And Discomfort Nec	6.8% 3/44 • Number of events 5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.5% 3/55 • Number of events 5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Hepatobiliary disorders Hepatic Enzymes And Function Abnormalities	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.5% 3/55 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Bacterial Infections Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Infections Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Staphylococcal Infections	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Tinea Infections	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Upper Respiratory Tract Infections	11.4% 5/44 • Number of events 9 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.9% 6/55 • Number of events 11 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Urinary Tract Infections	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	33.3% 2/6 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	7.3% 4/55 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Fractures And Dislocations Nec	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Gastrointestinal And Hepatobiliary Procedural Complications	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Non-Site Specific Injuries Nec	22.7% 10/44 • Number of events 10 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	83.3% 5/6 • Number of events 6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	29.1% 16/55 • Number of events 17 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Non-Site Specific Procedural Complications	27.3% 12/44 • Number of events 16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	66.7% 4/6 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	29.1% 16/55 • Number of events 20 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Skin Injuries Nec	9.1% 4/44 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	7.3% 4/55 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Spinal Fractures And Dislocations	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Blood Counts Nec	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Coagulation And Bleeding Analyses	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Faecal Analyses Nec	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Heart Rate And Pulse Investigations	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Lipoprotein And Lipid Tests Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Liver Function Analyses	27.3% 12/44 • Number of events 16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	33.3% 2/6 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	27.3% 15/55 • Number of events 19 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Metabolism Tests Nec	11.4% 5/44 • Number of events 6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	50.0% 3/6 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	14.5% 8/55 • Number of events 10 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Mineral And Electrolyte Analyses	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Physical Examination Procedures	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Platelet Analyses	22.7% 10/44 • Number of events 10 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	21.8% 12/55 • Number of events 12 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Protein Analyses Nec	65.9% 29/44 • Number of events 31 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	60.0% 3/5 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	33.3% 2/6 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	61.8% 34/55 • Number of events 36 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Red Blood Cell Analyses	13.6% 6/44 • Number of events 6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.9% 6/55 • Number of events 6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Renal Function Analyses	6.8% 3/44 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	9.1% 5/55 • Number of events 5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Skeletal And Cardiac Muscle Analyses	27.3% 12/44 • Number of events 15 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	60.0% 3/5 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	100.0% 6/6 • Number of events 7 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	38.2% 21/55 • Number of events 25 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Tissue Enzyme Analyses Nec	15.9% 7/44 • Number of events 10 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	50.0% 3/6 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	18.2% 10/55 • Number of events 13 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Triglyceride Analyses	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Urinary Tract Function Analyses Nec	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Vascular Tests Nec (Incl Blood Pressure)	31.8% 14/44 • Number of events 19 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	40.0% 2/5 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	50.0% 3/6 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	34.5% 19/55 • Number of events 25 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations White Blood Cell Analyses	27.3% 12/44 • Number of events 12 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	60.0% 3/5 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	27.3% 15/55 • Number of events 15 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Metabolism and nutrition disorders Appetite Disorders	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Metabolism and nutrition disorders Diabetes Mellitus (Incl Subtypes)	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	33.3% 2/6 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Metabolism and nutrition disorders Disorders Of Purine Metabolism	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Metabolism and nutrition disorders General Nutritional Disorders Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Metabolism and nutrition disorders Hyperglycaemic Conditions Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Metabolism and nutrition disorders Potassium Imbalance	11.4% 5/44 • Number of events 5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.9% 6/55 • Number of events 6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Metabolism and nutrition disorders Protein Metabolism Disorders Nec	11.4% 5/44 • Number of events 5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	33.3% 2/6 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	12.7% 7/55 • Number of events 7 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Metabolism and nutrition disorders Total Fluid Volume Decreased	6.8% 3/44 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.5% 3/55 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Musculoskeletal and connective tissue disorders Connective Tissue Disorders (Excl Le)	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Musculoskeletal and connective tissue disorders Joint Related Disorders Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Musculoskeletal and connective tissue disorders Musculoskeletal And Connective Tissue Pain And Discomfort	13.6% 6/44 • Number of events 6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	12.7% 7/55 • Number of events 7 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Musculoskeletal and connective tissue disorders Musculoskeletal And Connective Tissue Signs And Symptoms Nec	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Musculoskeletal and connective tissue disorders Osteoarthropathies	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Musculoskeletal and connective tissue disorders Soft Tissue Disorders Nec	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Musculoskeletal and connective tissue disorders Tendon Disorders	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Nervous system disorders Central Nervous System Haemorrhages And Cerebrovascular Accidents	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Nervous system disorders Cortical Dysfunction Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Nervous system disorders Headaches Nec	2.3% 1/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Nervous system disorders Neurological Signs And Symptoms Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Nervous system disorders Paralysis And Paresis (Excl Cranial Nerve)	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Nervous system disorders Sensory Abnormalities Nec	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Nervous system disorders Vagus Nerve Disorders	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Psychiatric disorders Anxiety Disorders Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Psychiatric disorders Anxiety Symptoms	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Psychiatric disorders Depressive Disorders	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Psychiatric disorders Disturbances In Initiating And Maintaining Sleep	6.8% 3/44 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	7.3% 4/55 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Psychiatric disorders Increased Physical Activity Levels	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Renal and urinary disorders Renal Failure And Impairment	11.4% 5/44 • Number of events 5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	33.3% 2/6 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	14.5% 8/55 • Number of events 8 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Renal and urinary disorders Urinary Abnormalities	6.8% 3/44 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.5% 3/55 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Skin and subcutaneous tissue disorders Dermatitis Ascribed To Specific Agent	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Skin and subcutaneous tissue disorders Erythemas	2.3% 1/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Skin and subcutaneous tissue disorders Exfoliative Conditions	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Skin and subcutaneous tissue disorders Hyperkeratoses	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Skin and subcutaneous tissue disorders Ichthyoses	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Skin and subcutaneous tissue disorders Pruritus Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Skin and subcutaneous tissue disorders Purpura And Related Conditions	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Skin and subcutaneous tissue disorders Skin And Subcutaneous Tissue Ulcerations	6.8% 3/44 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.5% 3/55 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Skin and subcutaneous tissue disorders Skin Haemorrhages	4.5% 2/44 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Skin and subcutaneous tissue disorders Skin Injuries And Mechanical Dermatoses	4.5% 2/44 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Aortic Aneurysms And Dissections	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Blood Pressure Disorders Nec	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.5% 3/55 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Haemorrhages Nec	0.00% 0/44 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 1/5 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Non-Site Specific Necrosis And Vascular Insufficiency Nec	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Peripheral Aneurysms And Dissections	4.5% 2/44 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	3.6% 2/55 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Vascular Hypotensive Disorders	6.8% 3/44 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	16.7% 1/6 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	7.3% 4/55 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Vascular Malformations And Acquired Anomalies	2.3% 1/44 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	1.8% 1/55 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.

Additional Information

Hiroko Ookubo

Medtronic

Phone: 81367760811

Email: hiroko.ookubo@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee It is not required per Japan GCP. There is an agreement with the site, but not the individual investigator at the site.
• Publication restrictions are in place

Restriction type: OTHER