Trial Outcomes & Findings for Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke (NCT NCT00924638)

NCT ID: NCT00924638

Last Updated: 2014-07-28

Results Overview

Percentage of subjects with AF detected within 6 months of follow-up

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 447 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2014-07-28

Participant Flow

A total of 447 subjects were enrolled in 55 study centers from 14 countries in North America and Europe, during the recruitment period of June 2009 to April 2012.

A total of 6 enrolled subjects were exited from the study prior to randomization due to: Eligibility criteria not met (n=4), and Subject withdrew consent (n=2).

Participant milestones

Measure	Continuous Monitoring Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.	Control Arm Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Overall Study STARTED	221	220
Overall Study COMPLETED	209	207
Overall Study NOT COMPLETED	12	13

Reasons for withdrawal

Measure	Continuous Monitoring Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.	Control Arm Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Overall Study Death	3	2
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	5	7
Overall Study Physician Decision	3	3

Baseline Characteristics

Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke

Baseline characteristics by cohort

Measure	Continuous Monitoring n=221 Participants Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.	Control Arm n=220 Participants Follow-up at the same frequency, but with no Insertable Cardiac Monitor	Total n=441 Participants Total of all reporting groups
Age, Continuous	61.6 years STANDARD_DEVIATION 11.4 • n=5 Participants	61.4 years STANDARD_DEVIATION 11.3 • n=7 Participants	61.5 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	79 Participants n=5 Participants	82 Participants n=7 Participants	161 Participants n=5 Participants
Sex: Female, Male Male	142 Participants n=5 Participants	138 Participants n=7 Participants	280 Participants n=5 Participants
Region of Enrollment United States	80 participants n=5 Participants	66 participants n=7 Participants	146 participants n=5 Participants
Region of Enrollment Slovakia	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Greece	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Finland	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Spain	0 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Austria	23 participants n=5 Participants	16 participants n=7 Participants	39 participants n=5 Participants
Region of Enrollment Italy	28 participants n=5 Participants	31 participants n=7 Participants	59 participants n=5 Participants
Region of Enrollment France	17 participants n=5 Participants	17 participants n=7 Participants	34 participants n=5 Participants
Region of Enrollment Canada	3 participants n=5 Participants	6 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment Belgium	14 participants n=5 Participants	27 participants n=7 Participants	41 participants n=5 Participants
Region of Enrollment Denmark	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Germany	39 participants n=5 Participants	32 participants n=7 Participants	71 participants n=5 Participants
Region of Enrollment Netherlands	12 participants n=5 Participants	11 participants n=7 Participants	23 participants n=5 Participants
Region of Enrollment Sweden	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Intention-to-treat (ITT) population (all randomized subjects)

Percentage of subjects with AF detected within 6 months of follow-up

Outcome measures

Measure	Continuous Monitoring n=221 Participants Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.	Control Arm n=220 Participants Follow-up at the same frequency, but with no Insertable Cardiac Monitor
AF Detection Rate Within 6 Months	8.9 percentage of participants	1.4 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intention-to-treat (ITT) population (all randomized subjects)

Percentage of subjects with AF detected within 12 months of follow-up

Outcome measures

Measure	Continuous Monitoring n=221 Participants Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.	Control Arm n=220 Participants Follow-up at the same frequency, but with no Insertable Cardiac Monitor
AF Detection Rate Within 12 Months	12.4 percentage of participants	2.0 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intention-to-treat (ITT) population (all randomized subjects)

Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up

Outcome measures

Measure	Continuous Monitoring n=221 Participants Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.	Control Arm n=220 Participants Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)	7.1 percentage of participants	9.1 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Number of subjects who completed the 12-months follow-up visit

Percentage of subjects who were using OAC drugs at the 12 months follow-up visit

Outcome measures

Measure	Continuous Monitoring n=197 Participants Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.	Control Arm n=185 Participants Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Use of Oral Anticoagulation (OAC) Drugs	14.7 percentage of participants	6.0 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Number of subjects who completed the 12 months follow-up visit

Percentage of subjects who were using antiarrhythmic drugs at the 12 months follow-up visit

Outcome measures

Measure	Continuous Monitoring n=197 Participants Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.	Control Arm n=185 Participants Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Use of Antiarrhythmic Drugs	2.0 percentage of participants	1.6 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Number of subjects who reported EQ-5D VAS score at the 12 months visit

EQ-5D VAS (visual analog scale) quality of life score, which is a continuous measure of quality of life ranging from 0 (worst) to 100 (perfect health).

Outcome measures

Measure	Continuous Monitoring n=191 Participants Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.	Control Arm n=183 Participants Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Health Outcome as Evaluated by EQ-5D Questionnaire	78.9 units on a scale of 0 to 100 Standard Deviation 15.6	76.3 units on a scale of 0 to 100 Standard Deviation 16.2

SECONDARY outcome

Timeframe: 12 months

Population: Intention-to-treat (ITT) population (all randomized subjects)

Incidence of cardiovascular (CV) or stroke/TIA related hospitalizations within 12 months

Outcome measures

Measure	Continuous Monitoring n=221 Participants Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.	Control Arm n=220 Participants Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Clinical Disease Burden and Care Pathway	10.5 percentage of participants	7.2 percentage of participants

SECONDARY outcome

Timeframe: Follow-up closure

Population: Number of subjects in the Continuous Monitoring arm who had AF detected by the Insertable Cardiac Monitor (ICM) during the course of the study

AF detection lag (days from AF occurrence to AF diagnosis) characterized by patient assistant (PA) use frequency

Outcome measures

Measure	Continuous Monitoring n=39 Participants Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.	Control Arm Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Impact of Patient Assistant Use on AF Diagnosis PA used everyday	14.0 days from AF occurrence to AF diagnosis Standard Deviation 35.6	—
Impact of Patient Assistant Use on AF Diagnosis PA used most of the time (5-6 days/week)	25.0 days from AF occurrence to AF diagnosis Standard Deviation 31.4	—
Impact of Patient Assistant Use on AF Diagnosis PA used sometimes (3-4 days/week)	174.8 days from AF occurrence to AF diagnosis Standard Deviation 235.9	—
Impact of Patient Assistant Use on AF Diagnosis PA used rarely (1-2 days/week)	15.3 days from AF occurrence to AF diagnosis Standard Deviation 9.3	—
Impact of Patient Assistant Use on AF Diagnosis PA never used	92.0 days from AF occurrence to AF diagnosis Standard Deviation NA Only one observation was available	—
Impact of Patient Assistant Use on AF Diagnosis PA use frequency not reported	20.0 days from AF occurrence to AF diagnosis Standard Deviation NA Only one observation was available	—

Adverse Events

Continuous Monitoring

Serious events: 68 serious events

Other events: 41 other events

Deaths: 0 deaths

Control Arm

Serious events: 58 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Continuous Monitoring n=221 participants at risk Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.	Control Arm n=220 participants at risk Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Gastrointestinal disorders Abdominal pain	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Reproductive system and breast disorders Adnexa uteri mass	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
General disorders Adverse drug reaction	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Blood and lymphatic system disorders Anaemia	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Cardiac disorders Angina pectoris	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Cardiac disorders Angina unstable	0.90% 2/221 • Number of events 2 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Cardiac disorders Aortic valve stenosis	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Nervous system disorders Aphasia	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
General disorders Asthenia	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Cardiac disorders Atrial fibrillation	2.7% 6/221 • Number of events 6 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	1.4% 3/220 • Number of events 3 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Cardiac disorders Atrial flutter	0.90% 2/221 • Number of events 2 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Congenital, familial and genetic disorders Atrial septal defect	1.4% 3/221 • Number of events 3 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	2.3% 5/220 • Number of events 5 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Cardiac disorders Atrioventricular block second degree	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Cardiac disorders Bradycardia	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Renal and urinary disorders Calculus ureteric	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Cardiac disorders Cardiac arrest	0.90% 2/221 • Number of events 2 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Cardiac disorders Cardiac failure	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Nervous system disorders Carotid artery stenosis	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.91% 2/220 • Number of events 2 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Infections and infestations Cellulitis	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Nervous system disorders Cerebral haemorrhage	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Nervous system disorders Cerebral infarction	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Nervous system disorders Cerebrovascular accident	5.0% 11/221 • Number of events 12 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	2.3% 5/220 • Number of events 5 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Nervous system disorders Cerebrovascular spasm	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
General disorders Chest pain	2.3% 5/221 • Number of events 5 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Hepatobiliary disorders Cholecystitis	0.90% 2/221 • Number of events 2 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Musculoskeletal and connective tissue disorders Chondrolysis	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Musculoskeletal and connective tissue disorders Chondropathy	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.45% 1/221 • Number of events 2 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Infections and infestations Clostridium difficile colitis	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Gastrointestinal disorders Colonic polyp	0.90% 2/221 • Number of events 2 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Cardiac disorders Coronary artery disease	0.90% 2/221 • Number of events 3 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.91% 2/220 • Number of events 2 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Cardiac disorders Coronary artery stenosis	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Musculoskeletal and connective tissue disorders Costochondritis	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Reproductive system and breast disorders Cystocele	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Vascular disorders Deep vein thrombosis	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Metabolism and nutrition disorders Dehydration	1.4% 3/221 • Number of events 3 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Psychiatric disorders Depression	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Gastrointestinal disorders Diverticulum	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Nervous system disorders Dizziness	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Nervous system disorders Dysarthria	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Renal and urinary disorders Dysuria	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Infections and infestations Enteritis infectious	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Nervous system disorders Epilepsy	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.91% 2/220 • Number of events 2 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Injury, poisoning and procedural complications Face injury	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Injury, poisoning and procedural complications Fall	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Vascular disorders Femoral arterial stenosis	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Injury, poisoning and procedural complications Femur fracture	0.90% 2/221 • Number of events 2 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
General disorders Gait disturbance	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Infections and infestations Gastroenteritis	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.90% 2/221 • Number of events 2 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Injury, poisoning and procedural complications Head injury	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Injury, poisoning and procedural complications Humerus fracture	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Immune system disorders Hypersensitivity	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Vascular disorders Hypertension	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Vascular disorders Hypertensive crisis	1.4% 3/221 • Number of events 3 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Metabolism and nutrition disorders Hypoalbuminaemia	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Metabolism and nutrition disorders Hypokalaemia	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Metabolism and nutrition disorders Hypomagnesaemia	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Metabolism and nutrition disorders Hyponatraemia	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Vascular disorders Hypotension	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.91% 2/220 • Number of events 2 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Infections and infestations Implant site infection	1.4% 3/221 • Number of events 3 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Injury, poisoning and procedural complications In-stent arterial restenosis	0.90% 2/221 • Number of events 2 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Injury, poisoning and procedural complications Joint injury	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Infections and infestations Localised infection	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Injury, poisoning and procedural complications Lower limb fracture	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Eye disorders Macular degeneration	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Surgical and medical procedures Medical device removal	0.90% 2/221 • Number of events 2 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Musculoskeletal and connective tissue disorders Meniscal degeneration	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Injury, poisoning and procedural complications Meniscus lesion	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Psychiatric disorders Mental status changes	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Nervous system disorders Migraine	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Renal and urinary disorders Nephrolithiasis	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Renal and urinary disorders Nephropathy	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
General disorders Non-cardiac chest pain	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.45% 1/221 • Number of events 2 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Vascular disorders Peripheral arterial occlusive disease	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Vascular disorders Peripheral vascular disorder	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Infections and infestations Pneumonia	0.90% 2/221 • Number of events 3 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.91% 2/220 • Number of events 2 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Injury, poisoning and procedural complications Pocket erosion	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.91% 2/220 • Number of events 2 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
General disorders Pyrexia	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Gastrointestinal disorders Rectal haemorrhage	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Renal and urinary disorders Renal artery stenosis	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Renal and urinary disorders Renal failure	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Eye disorders Retinal artery embolism	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Eye disorders Retinal artery occlusion	0.90% 2/221 • Number of events 2 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Infections and infestations Sepsis	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Cardiac disorders Sick sinus syndrome	1.4% 3/221 • Number of events 3 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Gastrointestinal disorders Small intestinal obstruction	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Musculoskeletal and connective tissue disorders Soft tissue disorder	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Psychiatric disorders Somatisation disorder	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
General disorders Sudden death	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Cardiac disorders Supraventricular tachycardia	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Nervous system disorders Syncope	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Cardiac disorders Tachyarrhythmia	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Cardiac disorders Tachycardia	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Nervous system disorders Tension headache	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Nervous system disorders Transient ischaemic attack	2.7% 6/221 • Number of events 6 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	4.1% 9/220 • Number of events 9 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Renal and urinary disorders Ureteric obstruction	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Renal and urinary disorders Urethral disorder	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Infections and infestations Urinary tract infection	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Infections and infestations Urosepsis	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Cardiac disorders Ventricular tachycardia	0.45% 1/221 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Ear and labyrinth disorders Vertigo	0.90% 2/221 • Number of events 2 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.00% 0/220 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
Cardiac disorders Wolff-Parkinson-White syndrome	0.00% 0/221 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	0.45% 1/220 • Number of events 1 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.

Other adverse events

Measure	Continuous Monitoring n=221 participants at risk Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.	Control Arm n=220 participants at risk Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Cardiac disorders Atrial fibrillation	18.6% 41/221 • Number of events 60 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.	4.1% 9/220 • Number of events 10 • Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months). Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.

Additional Information

Medtronic CRDM clinical trial manager

Medtronic, Inc.

Phone: 763-505-6000

Email: medtronicCRMtrials@medtronic.com

Results disclosure agreements

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

Restriction type: GT60