Trial Outcomes & Findings for Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (NCT NCT03241459)

NCT ID: NCT03241459

Last Updated: 2025-03-25

Results Overview

Composite of freedom from clinically-driven target lesion revascularization (TLR) and binary restenosis (restenosis defined as duplex ultrasound \[DUS\] peak systolic velocity ratio \[PSVR\] ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs) through 12 months post-index procedure.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 446 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-03-25

Participant Flow

Subjects with symptomatic PAD presenting for percutaneous revascularization of stenosed femoral and/or popliteal arteries (either de novo lesions or non-stented restenotic lesions >90 days from prior POBA angioplasty or >180 days from prior DCB treatment) will be screened according to the protocol inclusion and exclusion criteria. Enrolled subjects who have met all the clinical inclusion criteria and none of the clinical exclusion criteria will then be screened for angiographic criteria.

Subjects screened via angiographic assessment to confirm remaining study eligibility prior to randomization. Subjects not meeting criteria were considered screen failures and exited from the study.

Participant milestones

Measure	Surmodics SurVeil DCB Surmodics SurVeil Drug-Coated Balloon is an investigational device coated with paclitaxel. Surmodics SurVeil DCB: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.	Medtronic IN.PACT Admiral DCB Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter. Medtronic IN.PACT Admiral DCB: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Randomization STARTED	222	224
Randomization COMPLETED	222	224
Randomization NOT COMPLETED	0	0
1-Month Visit (30 Days, - 2 to +15 Days) STARTED	222	224
1-Month Visit (30 Days, - 2 to +15 Days) COMPLETED	215	224
1-Month Visit (30 Days, - 2 to +15 Days) NOT COMPLETED	7	0
6-Month Visit (180 Days +/- 30 Days) STARTED	215	224
6-Month Visit (180 Days +/- 30 Days) COMPLETED	209	223
6-Month Visit (180 Days +/- 30 Days) NOT COMPLETED	6	1
12-Month Visit (365 Days +/- 30 Days) STARTED	209	223
12-Month Visit (365 Days +/- 30 Days) COMPLETED	198	214
12-Month Visit (365 Days +/- 30 Days) NOT COMPLETED	11	9
24-Month Visit (730 Days +/- 60 Days) STARTED	198	214
24-Month Visit (730 Days +/- 60 Days) COMPLETED	184	200
24-Month Visit (730 Days +/- 60 Days) NOT COMPLETED	14	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of the SurVeil™ Drug-Coated Balloon

Baseline characteristics by cohort

Measure	Surmodics SurVeil DCB n=222 Participants Surmodics SurVeil Drug-Coated Balloon is an investigational device coated with paclitaxel. Surmodics SurVeil DCB: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.	Medtronic IN.PACT Admiral DCB n=224 Participants Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter. Medtronic IN.PACT Admiral DCB: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.	Total n=446 Participants Total of all reporting groups
Age, Continuous	68.7 years STANDARD_DEVIATION 9.4 • n=5 Participants	67.4 years STANDARD_DEVIATION 9.3 • n=7 Participants	68.0 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants	82 Participants n=7 Participants	165 Participants n=5 Participants
Sex: Female, Male Male	139 Participants n=5 Participants	142 Participants n=7 Participants	281 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	212 Participants n=5 Participants	216 Participants n=7 Participants	428 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) White	191 Participants n=5 Participants	199 Participants n=7 Participants	390 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The primary analysis of the primary effectiveness endpoint was carried out on all randomized participants. For participants missing primary effectiveness endpoint status (48 for SurVeil DCB and 31 for IN.PACT Admiral DCB), a logistic regression model was used for multiple imputation with pre-specified baseline variables as model predictors.

Composite of freedom from clinically-driven target lesion revascularization (TLR) and binary restenosis (restenosis defined as duplex ultrasound [DUS] peak systolic velocity ratio [PSVR] ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs) through 12 months post-index procedure.

Outcome measures

Measure	SurVeil DCB n=222 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=224 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Primary Lesion Patency Though 12 Months	82.2 percentage of participants Interval 76.4 to 87.9	85.9 percentage of participants Interval 80.8 to 91.0

PRIMARY outcome

Timeframe: 12 months

Population: Multiple Imputation was carried out on Intention-to-Treat (ITT) subjects. For subjects missing primary safety endpoint status, a logistic regression model was used for multiple imputation with pre-specified baseline variables as model predictors.

Composite of freedom from device- and procedure-related death through 30 days post-index procedure and freedom from major target limb amputation (above the ankle) and clinically-driven TVR through 12 months post-index procedure.

Outcome measures

Measure	SurVeil DCB n=222 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=224 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Safety Composite of Freedom From Death, Amputation, and Target Vessel Revascularization (TVR)	91.8 percentage of participants Interval 88.0 to 95.6	89.8 percentage of participants Interval 85.8 to 93.8

SECONDARY outcome

Timeframe: Day 0

Population: Intention-to-Treat (ITT) Analysis Population with quantitative angiography completed by an angiography core lab.

Defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure, and achievement of <50% residual stenosis of the target lesion (by core lab-assessed quantitative angiography [QA]) without flow-limiting arterial dissection (≥ 50% residual stenosis or dissection grade E or F) using only the study device.

Outcome measures

Measure	SurVeil DCB n=216 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=222 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Proportion of Participants With Device Success	199 Participants	208 Participants

SECONDARY outcome

Timeframe: Day 0

Population: Intention-to-Treat (ITT) Analysis Population with quantitative angiography completed by an angiography core lab.

Defined as achievement of a final residual diameter stenosis of <50% (by core lab-assessed QA) without flow-limiting arterial dissection at the end of the procedure.

Outcome measures

Measure	SurVeil DCB n=217 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=223 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Proportion of Participants With Technical Success	217 Participants	223 Participants

SECONDARY outcome

Timeframe: 72 hours

Population: Intention-to-Treat (ITT) Analysis Population

Defined as evidence of both acute technical success and absence of Peripheral Academic Research Consortium major adverse events (PARC MAEs; e.g., death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and or need for urgent/emergent vascular surgery) within 72 hours of the index procedure.

Outcome measures

Measure	SurVeil DCB n=218 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=223 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Proportion of Participants With Procedure Success	217 Participants	222 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Intent-to-Treat Analysis Population with assessments/follow-up completed through 30 days and/or subjects who experienced the endpoint (or any of its components) were included in the analysis (i.e., counted in the denominator).

Proportion of participation free of all-cause death, major target limb amputation and TVR through 30 days. All clinical endpoints adjudications by independent, blinded CEC.

Outcome measures

Measure	SurVeil DCB n=218 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=223 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Freedom From All-cause Death, Major Target Limb Amputation and TVR Through 30 Days	217 Participants	223 Participants

SECONDARY outcome

Timeframe: 24 months

Population: The analysis was carried out on ITT subjects with available data (i.e., subjects who experienced CD-TLR through 790 days and/or binary restenosis through 24 months, or had at least 670 days of follow-up).

Primary patency through 24 months (only if both the primary safety and efficacy hypotheses of noninferiority are met).

Outcome measures

Measure	SurVeil DCB n=154 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=181 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Proportion of Participants With Primary Lesion Patency	100 Participants	121 Participants

SECONDARY outcome

Timeframe: 12 months, 24 months

Population: Intention-to-Treat (ITT) analysis population with available data (i.e., subjects who experienced CD-TLR through 790 days and/or binary restenosis through 24 months, or had at least 670 days of follow-up).

Defined as freedom from clinically-driven target vessel revascularization (TVR) and binary restenosis (restenosis defined as DUS PSVR ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs) within 12 and 24 months.

Outcome measures

Measure	SurVeil DCB n=180 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=203 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Proportion of Participants With Target Vessel Patency Target Vessel Patency at 12-Months	143 Participants	165 Participants
Proportion of Participants With Target Vessel Patency Target Vessel Patency at 24-Months	102 Participants	118 Participants

SECONDARY outcome

Timeframe: 6 months, 12 months, 24 months

Population: Intent-to-Treat analysis population consisting of participants either experiencing the event within the period or who have adequate follow-up.

Defined as freedom from major target limb amputation, TVR and worsening target limb Rutherford class, within 6, 12, and 24 months.

Outcome measures

Measure	SurVeil DCB n=195 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=208 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Proportion of Participants With Sustained Clinical Improvement 6-Months	158 Participants	172 Participants
Proportion of Participants With Sustained Clinical Improvement 12-Months	121 Participants	142 Participants
Proportion of Participants With Sustained Clinical Improvement 24-Months	93 Participants	111 Participants

SECONDARY outcome

Timeframe: 6 months, 12 months, 24 months

Population: Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 30 days for 1-month time point, 180 days for 6-month time point, 365 days for 12-month time point, 730 days for 24-month time point) or who have adequate follow-up.

Includes participants experiencing a clinically-driven target lesion revascularization event as reported by sites and adjudicated by an independent CEC.

Outcome measures

Measure	SurVeil DCB n=209 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=222 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR) Clinically-driven TLR at 6-Months	3 Participants	3 Participants
Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR) Clinically-driven TLR at 12-Months	11 Participants	10 Participants
Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR) Clinically-driven TLR at 24-Months	27 Participants	24 Participants

SECONDARY outcome

Timeframe: 6 months, 12 months, 24 months

Population: Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 30 days for 1-month time point, 180 days for 6-month time point, 365 days for 12-month time point, 730 days for 24-month time point) or who have adequate follow-up.

MAEs defined as composite of all-cause death, clinically-driven TLR, major target limb amputation, or thrombosis at the target lesion, within 6, 12, 24 months.

Outcome measures

Measure	SurVeil DCB n=212 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=223 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Proportion of Participants With a Historical Major Adverse Events (MAEs) Historical MAEs at 6-Months	6 Participants	4 Participants
Proportion of Participants With a Historical Major Adverse Events (MAEs) Historical MAEs at 12-Months	17 Participants	17 Participants
Proportion of Participants With a Historical Major Adverse Events (MAEs) Historical MAEs at 24-Months	43 Participants	39 Participants

SECONDARY outcome

Timeframe: 6 months, 12 months, 24 months

Population: Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 30 days for 1-month time point, 180 days for 6-month time point, 365 days for 12-month time point, 730 days for 24-month time point) or who have adequate follow-up.

Major target limb amputation within 6, 12, 24 months as reported by site and adjudicated by CEC.

Outcome measures

Measure	SurVeil DCB n=208 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=222 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Proportion of Participants With a Major Target Limb Amputation Major Target Limb Amputation at 6-Months	0 Participants	0 Participants
Proportion of Participants With a Major Target Limb Amputation Major Target Limb Amputation at 12-Months	0 Participants	0 Participants
Proportion of Participants With a Major Target Limb Amputation Major Target Limb Amputation at 24-Months	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months, 12 months, 24 months

Population: Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 30 days for 1-month time point, 180 days for 6-month time point, 365 days for 12-month time point, 760 days for 24-month time point) or who have adequate follow-up.

Thrombosis at target lesion within 6, 12, 24 months as reported by the site and adjudicated by the CEC.

Outcome measures

Measure	SurVeil DCB n=208 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=222 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Proportion of Participants With a Thrombosis at the Target Lesion. Thrombosis at Target Lesion at 24-Months	1 Participants	0 Participants
Proportion of Participants With a Thrombosis at the Target Lesion. Thrombosis at Target Lesion at 6-Months	0 Participants	0 Participants
Proportion of Participants With a Thrombosis at the Target Lesion. Thrombosis at Target Lesion at 12-Months	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, 1 month, 6 months, 12 months, and 24 months

Population: Analysis of the secondary endpoint includes the Intention-to-Treat analysis population for whom Rutherford classification was available at the respective timepoint.

Change in target limb Rutherford class from Baseline (BL) to 1, 6, 12, and 24 months.

Rutherford classification criteria categorize the severity of chronic limb ischemia based on a clinical description of symptoms and pre-defined objective criteria.

Possible scores range from 0 to 6 (with lower scores representing a better outcome) with scores defined as follows:

0 - Asymptomatic - no hemodynamically significant occlusive disease

1. - Mild claudication

2. - Moderate claudication

3. - Severe claudication

4. - Ischemic rest pain

5. - Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia

6. - Major tissue loss, extending above transmetatarsal) with all scores defined as follows:

Change = 1-Month scores - BL scores; 6-Month scores - BL scores; 12-Month scores - BL scores; 24-Month scores - BL scores

Outcome measures

Measure	SurVeil DCB n=210 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=220 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 24-Months · No change	17 Participants	14 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 1-Month · Grade ≥+3 Markedly improved	101 Participants	90 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 1-Month · Grade +2 Moderately improved	63 Participants	78 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 1-Month · Grade +1 Mildly improved	28 Participants	29 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 1-Month · No change	16 Participants	20 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 1-Month · Grade -1 Mildly worsening	1 Participants	2 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 1-Month · Grade -2 Moderately worsening	0 Participants	0 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 1-Month · Grade ≤-3 Markedly worsening	1 Participants	1 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 6-Months · Grade ≥+3 Markedly improved	101 Participants	95 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 6-Months · Grade +2 Moderately improved	65 Participants	70 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 6-Months · Grade +1 Mildly improved	15 Participants	30 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 6-Months · No change	11 Participants	12 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 6-Months · Grade -1 Mildly worsening	1 Participants	2 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 6-Months · Grade -2 Moderately worsening	1 Participants	0 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 6-Months · Grade ≤-3 Markedly worsening	1 Participants	0 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 12-Months · Grade ≥+3 Markedly improved	82 Participants	74 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 12-Months · Grade +2 Moderately improved	50 Participants	76 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 12-Months · Grade +1 Mildly improved	28 Participants	33 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 12-Months · No change	18 Participants	16 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 12-Months · Grade -1 Mildly worsening	5 Participants	3 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 12-Months · Grade -2 Moderately worsening	0 Participants	2 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 12-Months · Grade ≤-3 Markedly worsening	0 Participants	0 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 24-Months · Grade ≥+3 Markedly improved	77 Participants	65 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 24-Months · Grade +2 Moderately improved	36 Participants	60 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 24-Months · Grade +1 Mildly improved	26 Participants	34 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 24-Months · Grade -1 Mildly worsening	1 Participants	4 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 24-Months · Grade -2 Moderately worsening	0 Participants	1 Participants
Change in Target Limb Rutherford Class Change in Rutherford Classification from Baseline to 24-Months · Grade ≤-3 Markedly worsening	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Screening, 1 month, 6 months, 12 months, and 24 months

Population: Analysis of the secondary endpoint includes the Intention-to-Treat analysis population for whom PARC clinical classification was available at the respective timepoint.

Change in target limb PARC class from baseline to 1, 6, 12, and 24 months.

PARC definitions of clinical symptom classification were used to classify subject claudication at baseline and subsequent follow-up visits. PARC clinical symptom classification is used to capture information regarding lower extremity symptoms and broadly define functional limitations of patients with lower extremity peripheral artery disease (PAD).

Possible classifications (asymptomatic=best outcome to ischemic gangrene=worst outcome) include the following:

Asymptomatic Mild claudication/limb symptoms (no limitation in walking) Moderate claudication/limb symptoms (able to walk without stopping > 2 blocks or 200 meters or 4 minutes) Severe claudication/limb symptoms (only able to walk without stopping < 2 blocks or 200 meters or 4 minutes) Ischemic rest pain (pain in the distal limb at rest, felt to be due to limited arterial perfusion) Ischemic ulcers on distal leg Ischemic gangrene

Change =

Outcome measures

Measure	SurVeil DCB n=210 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=221 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Class from BL to 12-Months: Grade +2 Moderately improved	53 Participants	80 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC class from BL to 1-Month: Grade ≥+3 Markedly improved	99 Participants	89 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC class from BL to 1-Month: Grade +2 Moderately improved	59 Participants	78 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC class from BL to 1-Month: Grade +1 Mildly improved	31 Participants	31 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC class from BL to 1-Month: Grade 0 No change	18 Participants	18 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC class from BL to 1-Month: Grade -1 Mildly worsening	2 Participants	4 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC class from BL to 1-Month: Grade -2 Moderately worsening	0 Participants	0 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC class from BL to 1-Month: Grade ≤-3 Markedly worsening	1 Participants	1 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Class from BL to 6-Months: Grade ≥+3 Markedly improved	99 Participants	92 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Class from BL to 6-Months: Grade +2 Moderately improved	65 Participants	70 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Class from BL to 6-Months: Grade +1 Mildly improved	16 Participants	30 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Class from BL to 6-Months: Grade 0 No change	12 Participants	14 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Class from BL to 6-Months: Grade -1 Mildly worsening	1 Participants	2 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Class from BL to 6-Months: Grade -2 Moderately worsening	1 Participants	0 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Class from BL to 6-Months: Grade ≤-3 Markedly worsening	1 Participants	0 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Class from BL to 12-Months: Grade ≥+3 Markedly improved	80 Participants	69 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Class from BL to 12-Months: Grade +1 Mildly improved	27 Participants	31 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Class from BL to 12-Months: Grade 0 No change	17 Participants	17 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Class from BL to 12-Months: Grade -1 Mildly worsening	6 Participants	4 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Class from BL to 12-Months: Grade -2 Moderately worsening	0 Participants	1 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Class from BL to 12-Months: Grade ≤-3 Markedly worsening	0 Participants	1 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Classification from BL to 24-Months: Grade ≥+3 Markedly improved	73 Participants	63 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Classification from BL to 24-Months: Grade +2 Moderately improved	37 Participants	62 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Classification from BL to 24-Months: Grade +1 Mildly improved	25 Participants	33 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Classification from BL to 24-Months: Grade 0 No change	19 Participants	14 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Classification from BL to 24-Months: Grade -1 Mildly worsening	2 Participants	5 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Classification from BL to 24-Months: Grade -2 Moderately worsening	0 Participants	1 Participants
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class Change in PARC Classification from BL to 24-Months: Grade ≤-3 Markedly worsening	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Screening, 6 months, 12 months, and 24 months

Population: Analysis of the secondary endpoint includes the Intention-to-Treat analysis population for whom the ABI or TBI was available at the respective timepoint. Worsening of ABI was defined as a decrease in ABI ≥0.15 from baseline.

Decrease in target limb resting ABI or TBI ≥0.15 from baseline to 6, 12, and 24 months.

Ankle-brachial index (ABI) is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial artery.

Toe brachial index (TBI) is the ratio of SBP measured at the toe to that measured at the brachial artery.

if ABI could not be assessed, TBI could be used.

Outcome measures

Measure	SurVeil DCB n=183 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=199 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) BL to 6-Months: Decrease in Resting Target Limb ABI ≥0.15	6 Participants	8 Participants
Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) BL to 6-Months: Decrease in Resting Target Limb TBI ≥0.15	0 Participants	0 Participants
Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) BL to 12-Months: Decrease in Resting Target Limb ABI ≥0.15	15 Participants	6 Participants
Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) BL to 12-Months: Decrease in Resting Target Limb TBI ≥0.15	2 Participants	1 Participants
Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) BL to 24-Months: Decrease in Resting Target Limb ABI ≥0.15	9 Participants	15 Participants
Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) BL to 24-Months: Decrease in Resting Target Limb TBI ≥0.15	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Screening, 1 month, 12 months, and 24 months

Population: Intention-to-Treat population for whom Walking Impairment Questionnaire information was available from Baseline to each respective time point. An increase in a WIQ score signifies improvement.

Walking Impairment Questionnaire is a validated tool that has 4 domains (Walking Impairment, Walking Distance, Walking Speed, and Stair Climbing), each scored as a percent ranging from 0 (representing the inability to perform any of the tasks) to 100 (representing no difficulty with any of the tasks). A positive change in a score indicates an improvement.

Outcome measures

Measure	SurVeil DCB n=204 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=219 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Change in Walking Impairment Questionnaire (WIQ) Change from BL to 1-Month: Walking Impairment Score	50.0 score on a scale Interval 25.0 to 75.0	50.0 score on a scale Interval 25.0 to 75.0
Change in Walking Impairment Questionnaire (WIQ) Change from BL to 1-Month: Walking Distance Score	37.6 score on a scale Interval 1.8 to 70.3	23.4 score on a scale Interval 0.1 to 65.0
Change in Walking Impairment Questionnaire (WIQ) Change from BL to 1-Month: Walking Speed Score	15.2 score on a scale Interval 0.0 to 43.5	15.2 score on a scale Interval 0.0 to 34.8
Change in Walking Impairment Questionnaire (WIQ) Change from BL to 1-Month: Stair Climbing Score	20.8 score on a scale Interval 0.0 to 54.2	12.5 score on a scale Interval 0.0 to 45.8
Change in Walking Impairment Questionnaire (WIQ) Change from BL to 12-Months: Walking Impairment Score	25.0 score on a scale Interval 0.0 to 75.0	50.0 score on a scale Interval 25.0 to 75.0
Change in Walking Impairment Questionnaire (WIQ) Change from BL to 12-Months: Walking Distance Score	26.3 score on a scale Interval 0.0 to 62.9	27.7 score on a scale Interval 1.1 to 66.9
Change in Walking Impairment Questionnaire (WIQ) Change from BL to 12-Months: Walking Speed Score	17.4 score on a scale Interval 0.0 to 43.5	17.4 score on a scale Interval 0.0 to 43.5
Change in Walking Impairment Questionnaire (WIQ) Change from BL to 12-Months: Stair Climbing Score	20.8 score on a scale Interval -4.2 to 47.9	20.8 score on a scale Interval 0.0 to 54.2
Change in Walking Impairment Questionnaire (WIQ) Change from BL to 24-Months: Walking Impairment Score	50.0 score on a scale Interval 0.0 to 75.0	50.0 score on a scale Interval 0.0 to 75.0
Change in Walking Impairment Questionnaire (WIQ) Change from BL to 24-Months: Walking Distance Score	26.8 score on a scale Interval -0.4 to 61.8	27.6 score on a scale Interval 0.0 to 65.1
Change in Walking Impairment Questionnaire (WIQ) Change from BL to 24-Months: Walking Speed Score	10.9 score on a scale Interval -6.0 to 40.8	12.0 score on a scale Interval -3.8 to 39.1
Change in Walking Impairment Questionnaire (WIQ) Change from BL to 24-Months: Stair Climbing Score	20.8 score on a scale Interval -4.2 to 45.8	16.7 score on a scale Interval 0.0 to 45.8

SECONDARY outcome

Timeframe: Screening, 12 months, and 24 months

Population: Intention-to-Treat population for whom the 6-Minute Walk Test information from Baseline to each respective time point was available.

Change in 6MWT from baseline to 12 and 24 months.

Outcome measures

Measure	SurVeil DCB n=163 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=180 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Change in 6-Minute Walk Test (6MWT) Change from BL to 12-Months	45.8 Distance walked (meters) Standard Deviation 118.8	60.7 Distance walked (meters) Standard Deviation 113.6
Change in 6-Minute Walk Test (6MWT) Change from BL to 24-Months	25.7 Distance walked (meters) Standard Deviation 98.8	52.5 Distance walked (meters) Standard Deviation 122.4

SECONDARY outcome

Timeframe: Screening, 1 month, 12 months, and 24 months

Population: Intention-to-Treat Analysis Population for whom the PAQ score information from baseline to each respective time point was available.

The PAQ consists of 7 domains including physical function, stability, symptom, treatment satisfaction, quality of life, social limitation, and summary. Scores range from 0 to 100, with a positive change indicating an improvement. Questionnaire responses include: Extremely Limited, Quite a bit Limited, Moderately Limited, Slightly Limited, Not at all Limited, Limited for other reasons or did not do the activity.

Outcome measures

Measure	SurVeil DCB n=203 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=219 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Change in Peripheral Artery Questionnaire (PAQ) 1-Month: Physical Function Score	25.0 score on a scale Interval 4.2 to 58.3	29.2 score on a scale Interval 8.3 to 50.0
Change in Peripheral Artery Questionnaire (PAQ) 1-Month: Stability Score	50.0 score on a scale Interval 0.0 to 50.0	50.0 score on a scale Interval 25.0 to 50.0
Change in Peripheral Artery Questionnaire (PAQ) 1-Month: Symptom Score	33.3 score on a scale Interval 11.1 to 52.8	30.6 score on a scale Interval 8.3 to 50.0
Change in Peripheral Artery Questionnaire (PAQ) 1-Month: Treatment Satisfaction Score	0.0 score on a scale Interval 0.0 to 8.3	0.0 score on a scale Interval 0.0 to 16.7
Change in Peripheral Artery Questionnaire (PAQ) 1-Month: Quality of Life Score	41.7 score on a scale Interval 16.7 to 58.3	33.3 score on a scale Interval 16.7 to 50.0
Change in Peripheral Artery Questionnaire (PAQ) 1-Month: Social Limitation Score	25.0 score on a scale Interval 8.3 to 50.0	25.0 score on a scale Interval 8.3 to 50.0
Change in Peripheral Artery Questionnaire (PAQ) 1-Month: Summary Score	32.6 score on a scale Interval 10.4 to 52.8	30.2 score on a scale Interval 13.2 to 46.6
Change in Peripheral Artery Questionnaire (PAQ) 12-Months: Physical Function Score	25.0 score on a scale Interval 4.2 to 45.8	25.0 score on a scale Interval 8.3 to 54.2
Change in Peripheral Artery Questionnaire (PAQ) 12-Months: Stability Score	0.0 score on a scale Interval 0.0 to 25.0	0.0 score on a scale Interval 0.0 to 25.0
Change in Peripheral Artery Questionnaire (PAQ) 12-Months: Symptom Score	27.8 score on a scale Interval 8.3 to 47.2	30.6 score on a scale Interval 5.6 to 52.8
Change in Peripheral Artery Questionnaire (PAQ) 12-Months: Treatment Satisfaction Score	0.0 score on a scale Interval -8.3 to 8.3	0.0 score on a scale Interval 0.0 to 8.3
Change in Peripheral Artery Questionnaire (PAQ) 12-Months: Quality of Life Score	33.3 score on a scale Interval 16.7 to 58.3	33.3 score on a scale Interval 8.3 to 58.3
Change in Peripheral Artery Questionnaire (PAQ) 12-Months: Social Limitation Score	25.0 score on a scale Interval 8.3 to 50.0	25.0 score on a scale Interval 8.3 to 58.3
Change in Peripheral Artery Questionnaire (PAQ) 12-Months: Summary Score	29.7 score on a scale Interval 13.4 to 49.1	30.3 score on a scale Interval 9.7 to 52.8
Change in Peripheral Artery Questionnaire (PAQ) 24-Months: Physical Function Score	25.0 score on a scale Interval 4.2 to 50.0	29.2 score on a scale Interval 4.2 to 54.2
Change in Peripheral Artery Questionnaire (PAQ) 24-Month: Stability Score	0.0 score on a scale Interval 0.0 to 25.0	0.0 score on a scale Interval 0.0 to 25.0
Change in Peripheral Artery Questionnaire (PAQ) 24-Months: Symptom Score	27.8 score on a scale Interval 11.1 to 50.0	33.3 score on a scale Interval 13.9 to 52.8
Change in Peripheral Artery Questionnaire (PAQ) 24-Months: Treatment Satisfaction Score	0.0 score on a scale Interval 0.0 to 8.3	0.0 score on a scale Interval 0.0 to 8.3
Change in Peripheral Artery Questionnaire (PAQ) 24-Months: Quality of Life Score	41.7 score on a scale Interval 16.7 to 58.3	33.3 score on a scale Interval 16.7 to 58.3
Change in Peripheral Artery Questionnaire (PAQ) 24-Months: Social Limitation Score	25.0 score on a scale Interval 8.3 to 50.0	25.0 score on a scale Interval 8.3 to 50.0
Change in Peripheral Artery Questionnaire (PAQ) 24-Months: Summary Score	29.9 score on a scale Interval 12.5 to 48.3	28.5 score on a scale Interval 13.9 to 49.9

SECONDARY outcome

Timeframe: 36 months, 48 months, 60 months

Population: Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 1095 days for 36-month time point, 1460 days for 48-month time point,1825 days for 60-month time point) or who have adequate follow-up.

Includes participants experiencing a clinically-driven target lesion revascularization event as reported by sites and adjudicated by an independent CEC.

Outcome measures

Measure	SurVeil DCB n=179 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=195 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR) Clinically-driven TLR at 36-Months	36 Participants	39 Participants
Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR) Clinically-driven TLR at 486-Months	42 Participants	48 Participants
Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR) Clinically-driven TLR at 60-Months	44 Participants	50 Participants

SECONDARY outcome

Timeframe: 36 months, 48 months, 60 months

Population: Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 1095 days for 36-month time point, 1460 days for 48--month time point, 1825 days for 60-month time point) or who have adequate follow-up.

MAEs defined as composite of all-cause death, clinically-driven TLR, major target limb amputation, or thrombosis at the target lesion within 36, 48, and 60 months.

Outcome measures

Measure	SurVeil DCB n=198 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=214 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Proportion of Participants With a Historical Major Adverse Events (MAEs) Historical MAEs at 36-Months	56 Participants	62 Participants
Proportion of Participants With a Historical Major Adverse Events (MAEs) Historical MAEs at 48-Months	69 Participants	75 Participants
Proportion of Participants With a Historical Major Adverse Events (MAEs) Historical MAEs at 60-Months	79 Participants	83 Participants

SECONDARY outcome

Timeframe: 36 months, 48 months, 60 months

Population: Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 1095 days for 36-month time point, 1460 days for 48--month time point, 1825 days for 60-month time point) or who have adequate follow-up.

Major target limb amputation within 36, 48, and 60 months as reported by site and adjudicated by CEC.

Outcome measures

Measure	SurVeil DCB n=174 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=191 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Proportion of Participants With a Major Target Limb Amputation Major Target Limb Amputation at 36-Months	0 Participants	1 Participants
Proportion of Participants With a Major Target Limb Amputation Major Target Limb Amputation at 48-Months	0 Participants	2 Participants
Proportion of Participants With a Major Target Limb Amputation Major Target Limb Amputation at 60-Months	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 36 months, 48 months, 60 months

Population: Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 1095 days for 36-month time point, 1460 days for 48--month time point, 1825 days for 60-month time point) or who have adequate follow-up.

Thrombosis at target lesions within 36, 48, and 60 months as reported by the site and adjudicated by the CEC.

Outcome measures

Measure	SurVeil DCB n=175 Participants Participants randomized to receive treatment with the SurVeil DCB.	IN.PACT Admiral DCB n=191 Participants Participants randomized to receive treatment with the IN.PACT Admiral DCB.
Proportion of Participants With a Thrombosis at the Target Lesion Thrombosis at Target Lesion at 36-Months	1 Participants	0 Participants
Proportion of Participants With a Thrombosis at the Target Lesion Thrombosis at Target Lesion at 48-Months	2 Participants	1 Participants
Proportion of Participants With a Thrombosis at the Target Lesion Thrombosis at Target Lesion at 60-Months	3 Participants	1 Participants

Adverse Events

Surmodics SurVeil DCB

Serious events: 166 serious events

Other events: 159 other events

Deaths: 41 deaths

Medtronic IN.PACT Admiral DCB

Serious events: 162 serious events

Other events: 170 other events

Deaths: 37 deaths

Serious adverse events

Measure	Surmodics SurVeil DCB n=222 participants at risk Surmodics SurVeil Drug-Coated Balloon is an investigational device coated with paclitaxel. Surmodics SurVeil DCB: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.	Medtronic IN.PACT Admiral DCB n=224 participants at risk Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter. Medtronic IN.PACT Admiral DCB: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Blood and lymphatic system disorders Anaemia	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	1.8% 4/224 • Number of events 4 • Enrollment through 60-months
Blood and lymphatic system disorders Coagulopathy	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Blood and lymphatic system disorders Haemorrhagic anaemia	1.8% 4/222 • Number of events 4 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Blood and lymphatic system disorders Microcytic anaemia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Cardiac disorders Acute left ventricular failure	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Cardiac disorders Acute myocardial infarction	6.8% 15/222 • Number of events 19 • Enrollment through 60-months	10.3% 23/224 • Number of events 29 • Enrollment through 60-months
Cardiac disorders Angina pectoris	4.1% 9/222 • Number of events 10 • Enrollment through 60-months	1.8% 4/224 • Number of events 4 • Enrollment through 60-months
Cardiac disorders Angina unstable	1.8% 4/222 • Number of events 4 • Enrollment through 60-months	1.3% 3/224 • Number of events 4 • Enrollment through 60-months
Cardiac disorders Aortic valve stenosis	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Cardiac disorders Arrhythmia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Cardiac disorders Atrial fibrillation	4.1% 9/222 • Number of events 12 • Enrollment through 60-months	4.0% 9/224 • Number of events 12 • Enrollment through 60-months
Cardiac disorders Atrial flutter	1.4% 3/222 • Number of events 4 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Cardiac disorders Atrioventricular block	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Cardiac disorders Atrioventricular block complete	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Cardiac disorders Atrioventricular block second degree	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Cardiac disorders Bradycardia	1.8% 4/222 • Number of events 4 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Cardiac disorders Cardiac arrest	3.6% 8/222 • Number of events 8 • Enrollment through 60-months	1.8% 4/224 • Number of events 4 • Enrollment through 60-months
Cardiac disorders Cardiac failure	1.8% 4/222 • Number of events 4 • Enrollment through 60-months	1.3% 3/224 • Number of events 4 • Enrollment through 60-months
Cardiac disorders Cardiac failure acute	2.7% 6/222 • Number of events 14 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Cardiac disorders Cardiac failure congestive	4.1% 9/222 • Number of events 9 • Enrollment through 60-months	3.6% 8/224 • Number of events 10 • Enrollment through 60-months
Cardiac disorders Cardio-respiratory arrest	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Cardiac disorders Cardiogenic shock	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Cardiac disorders Cardiovascular disorder	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Cardiac disorders Coronary artery disease	4.1% 9/222 • Number of events 10 • Enrollment through 60-months	5.8% 13/224 • Number of events 18 • Enrollment through 60-months
Cardiac disorders Coronary artery occlusion	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Cardiac disorders Coronary artery perforation	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Cardiac disorders Coronary artery stenosis	1.8% 4/222 • Number of events 4 • Enrollment through 60-months	1.8% 4/224 • Number of events 5 • Enrollment through 60-months
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Cardiac disorders Microvascular coronary artery disease	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Cardiac disorders Myocardial infarction	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Cardiac disorders Myocardial ischaemia	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Cardiac disorders Palpitations	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Cardiac disorders Pericardial effusion	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Cardiac disorders Sinus node dysfunction	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Cardiac disorders Supraventricular tachycardia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Cardiac disorders Ventricular extrasystoles	0.45% 1/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Cardiac disorders Ventricular fibrillation	0.00% 0/222 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Cardiac disorders Ventricular tachycardia	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 4 • Enrollment through 60-months
Congenital, familial and genetic disorders Haemorrhagic arteriovenous malformation	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Congenital, familial and genetic disorders Left ventricle outflow tract obstruction	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Congenital, familial and genetic disorders Urachal abnormality	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Endocrine disorders Adrenal insufficiency	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Endocrine disorders Hyperparathyroidism primary	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Eye disorders Cataract	0.45% 1/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Eye disorders Diabetic retinopathy	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Eye disorders Glaucoma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Eye disorders Retinal artery occlusion	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Eye disorders Vitreous haemorrhage	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Gastrointestinal disorders Abdominal hernia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Gastrointestinal disorders Abdominal pain	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Abdominal pain upper	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Gastrointestinal disorders Barrett's oesophagus	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Colitis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Colitis ischaemic	0.45% 1/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Gastrointestinal disorders Colitis ulcerative	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Gastrointestinal disorders Dysphagia	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Gastritis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Gastritis haemorrhagic	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Gastrointestinal angiodysplasia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Gastrointestinal haemorrhage	2.3% 5/222 • Number of events 6 • Enrollment through 60-months	3.1% 7/224 • Number of events 9 • Enrollment through 60-months
Gastrointestinal disorders Haematochezia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Inguinal hernia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Inguinal hernia, obstructive	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Gastrointestinal disorders Intestinal obstruction	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Gastrointestinal disorders Large intestine polyp	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Melaena	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Gastrointestinal disorders Mesenteric artery stenosis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Nausea	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Neutropenic colitis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Oesophageal haemorrhage	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Retroperitoneal fibrosis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Umbilical hernia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Gastrointestinal disorders Vomiting	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
General disorders Asthenia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
General disorders Catheter site discharge	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
General disorders Catheter site haematoma	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
General disorders Catheter site haemorrhage	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
General disorders Death	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
General disorders Drug withdrawal syndrome	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
General disorders Fatigue	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
General disorders Impaired healing	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
General disorders Mass	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
General disorders Necrosis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
General disorders Non-cardiac chest pain	2.3% 5/222 • Number of events 8 • Enrollment through 60-months	1.8% 4/224 • Number of events 5 • Enrollment through 60-months
General disorders Oedema peripheral	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
General disorders Peripheral swelling	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
General disorders Pyrexia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
General disorders Vascular stent occlusion	0.90% 2/222 • Number of events 3 • Enrollment through 60-months	2.2% 5/224 • Number of events 5 • Enrollment through 60-months
General disorders Vascular stent restenosis	1.4% 3/222 • Number of events 5 • Enrollment through 60-months	3.1% 7/224 • Number of events 7 • Enrollment through 60-months
Hepatobiliary disorders Cholelithiasis	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Hepatobiliary disorders Liver disorder	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Immune system disorders Anaphylactic reaction	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Immune system disorders Anaphylactic shock	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Abscess limb	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Appendicitis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Arthritis bacterial	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Atypical pneumonia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Bacteraemia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Bronchitis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 2 • Enrollment through 60-months
Infections and infestations Bronchitis bacterial	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Bronchitis viral	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Bursitis infective	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Cellulitis	2.3% 5/222 • Number of events 6 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Infections and infestations Cholecystitis infective	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Corona virus infection	2.7% 6/222 • Number of events 6 • Enrollment through 60-months	4.5% 10/224 • Number of events 10 • Enrollment through 60-months
Infections and infestations Cystitis	0.00% 0/222 • Enrollment through 60-months	1.3% 3/224 • Number of events 4 • Enrollment through 60-months
Infections and infestations Diverticulitis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Endocarditis bacterial	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Enterococcal bacteraemia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Epididymitis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Erysipelas	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Escherichia bacteraemia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Escherichia urinary tract infection	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Gangrene	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Infections and infestations Gastroenteritis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Infections and infestations Haematoma infection	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Infected skin ulcer	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Infection	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Infectious colitis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Influenza	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Klebsiella bacteraemia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Localised infection	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Lung infection	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Oesophageal candidiasis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Osteomyelitis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Infections and infestations Pelvic abscess	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Perirectal abscess	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Peritonsillar abscess	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Pneumonia	6.3% 14/222 • Number of events 14 • Enrollment through 60-months	4.0% 9/224 • Number of events 11 • Enrollment through 60-months
Infections and infestations Post procedural cellulitis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Postoperative wound infection	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Pyelonephritis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Pyelonephritis acute	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Respiratory syncytial virus infection	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Sepsis	3.2% 7/222 • Number of events 8 • Enrollment through 60-months	3.1% 7/224 • Number of events 8 • Enrollment through 60-months
Infections and infestations Sepsis syndrome	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Septic shock	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Staphylococcal bacteraemia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Staphylococcal infection	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Urinary tract infection	1.8% 4/222 • Number of events 6 • Enrollment through 60-months	2.2% 5/224 • Number of events 5 • Enrollment through 60-months
Infections and infestations Vascular access site infection	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Wound infection	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Ankle fracture	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Arterial bypass occlusion	0.45% 1/222 • Number of events 3 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Arterial bypass stenosis	0.90% 2/222 • Number of events 3 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Arterial bypass thrombosis	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Injury, poisoning and procedural complications Comminuted fracture	0.45% 1/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Facial bones fracture	0.45% 1/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Fall	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Femoral neck fracture	1.8% 4/222 • Number of events 4 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Head injury	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Hip fracture	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Humerus fracture	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Incomplete spinal fusion	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Overdose	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Peripheral arterial reocclusion	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Injury, poisoning and procedural complications Peripheral artery restenosis	6.8% 15/222 • Number of events 17 • Enrollment through 60-months	4.9% 11/224 • Number of events 18 • Enrollment through 60-months
Injury, poisoning and procedural complications Periprosthetic fracture	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Peritoneal dialysis complication	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Postoperative ileus	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Postoperative wound complication	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Procedural hypotension	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Radius fracture	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Rib fracture	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Road traffic accident	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Scar	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Soft tissue injury	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Subarachnoid haematoma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Tibia fracture	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Transplant failure	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Traumatic haemothorax	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Upper limb fracture	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Vascular access site pseudoaneurysm	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Injury, poisoning and procedural complications Vascular pseudoaneurysm	2.3% 5/222 • Number of events 5 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Wound	0.90% 2/222 • Number of events 3 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Investigations Blood creatinine increased	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Investigations Blood pressure systolic increased	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Investigations Heart rate increased	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Investigations Troponin increased	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Metabolism and nutrition disorders Dehydration	0.90% 2/222 • Number of events 4 • Enrollment through 60-months	0.45% 1/224 • Number of events 2 • Enrollment through 60-months
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Metabolism and nutrition disorders Fluid overload	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Metabolism and nutrition disorders Hyperglycaemia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Metabolism and nutrition disorders Hyperkalaemia	0.90% 2/222 • Number of events 3 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Metabolism and nutrition disorders Hyperlipidaemia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Metabolism and nutrition disorders Hypoglycaemia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Metabolism and nutrition disorders Malnutrition	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Arthralgia	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Arthrofibrosis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Back disorder	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Back pain	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Bursitis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Compartment syndrome	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Fistula	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Flank pain	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Muscle spasms	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Osteoarthritis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	4.5% 10/224 • Number of events 10 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Pain in extremity	1.8% 4/222 • Number of events 4 • Enrollment through 60-months	1.8% 4/224 • Number of events 4 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Spinal pain	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Spondylolysis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Synovial cyst	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) 5q minus syndrome	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.45% 1/222 • Number of events 4 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.45% 1/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour of the small bowel	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrooesophageal cancer	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.90% 2/222 • Number of events 3 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer metastatic	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma recurrent	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm skin	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal cancer metastatic	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma metastatic	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 2 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland neoplasm	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sinonasal papilloma	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.90% 2/222 • Number of events 3 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Nervous system disorders Aphasia	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Carotid artery dissection	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Carotid artery occlusion	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Carotid artery stenosis	2.7% 6/222 • Number of events 6 • Enrollment through 60-months	2.7% 6/224 • Number of events 7 • Enrollment through 60-months
Nervous system disorders Cerebral haemorrhage	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Nervous system disorders Cerebral infarction	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Nervous system disorders Cerebrovascular accident	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	2.2% 5/224 • Number of events 5 • Enrollment through 60-months
Nervous system disorders Dementia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Dizziness	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Nervous system disorders Embolic stroke	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.89% 2/224 • Number of events 3 • Enrollment through 60-months
Nervous system disorders Encephalopathy	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.89% 2/224 • Number of events 3 • Enrollment through 60-months
Nervous system disorders Epidural lipomatosis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Epilepsy	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Haemorrhagic stroke	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Hypertensive encephalopathy	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Nervous system disorders Hypoaesthesia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Ischaemic stroke	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Nervous system disorders Lumbar radiculopathy	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Nervous system disorders Metabolic encephalopathy	0.00% 0/222 • Enrollment through 60-months	1.8% 4/224 • Number of events 4 • Enrollment through 60-months
Nervous system disorders Nerve compression	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Parkinson's disease	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Nervous system disorders Post herpetic neuralgia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Presyncope	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Nervous system disorders Sciatica	0.90% 2/222 • Number of events 3 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Syncope	3.6% 8/222 • Number of events 9 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Nervous system disorders Toxic encephalopathy	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Nervous system disorders Transient ischaemic attack	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Product Issues Device malfunction	0.45% 1/222 • Number of events 2 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Psychiatric disorders Completed suicide	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Psychiatric disorders Delirium	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Psychiatric disorders Delirium tremens	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Psychiatric disorders Mental disorder	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Psychiatric disorders Mental status changes	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Renal and urinary disorders Acute kidney injury	6.8% 15/222 • Number of events 18 • Enrollment through 60-months	5.4% 12/224 • Number of events 13 • Enrollment through 60-months
Renal and urinary disorders Azotaemia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Renal and urinary disorders Chronic kidney disease	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Renal and urinary disorders Haematuria	0.45% 1/222 • Number of events 2 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Renal and urinary disorders Hydronephrosis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Renal and urinary disorders Nephrolithiasis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Renal and urinary disorders Renal artery stenosis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Renal and urinary disorders Renal failure	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Renal and urinary disorders Renal mass	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Renal and urinary disorders Urinary bladder haemorrhage	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Renal and urinary disorders Urinary retention	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 2 • Enrollment through 60-months
Renal and urinary disorders Urinary tract obstruction	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Reproductive system and breast disorders Genital erosion	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Reproductive system and breast disorders Ovarian mass	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Reproductive system and breast disorders Pelvic haematoma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	2.3% 5/222 • Number of events 5 • Enrollment through 60-months	4.5% 10/224 • Number of events 10 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Aspiration	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.7% 6/222 • Number of events 9 • Enrollment through 60-months	2.7% 6/224 • Number of events 12 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	1.8% 4/224 • Number of events 4 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Epistaxis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 3 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Hypoxia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/222 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.4% 3/222 • Number of events 5 • Enrollment through 60-months	3.1% 7/224 • Number of events 8 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Wheezing	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Diabetic foot	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Diabetic ulcer	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Neuropathic ulcer	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Skin ulcer	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Aortic aneurysm	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.89% 2/224 • Number of events 3 • Enrollment through 60-months
Vascular disorders Aortic dissection	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 2 • Enrollment through 60-months
Vascular disorders Aortic intramural haematoma	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Aortic stenosis	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	1.8% 4/224 • Number of events 4 • Enrollment through 60-months
Vascular disorders Arterial spasm	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Arterial stenosis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Arteriosclerosis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Arteriovenous fistula	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Deep vein thrombosis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Vascular disorders Dry gangrene	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Extremity necrosis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Haematoma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Haemorrhage	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Hypertension	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Hypertensive crisis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Hypertensive emergency	0.00% 0/222 • Enrollment through 60-months	1.3% 3/224 • Number of events 4 • Enrollment through 60-months
Vascular disorders Hypotension	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	1.8% 4/224 • Number of events 4 • Enrollment through 60-months
Vascular disorders Iliac artery occlusion	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Intermittent claudication	0.90% 2/222 • Number of events 3 • Enrollment through 60-months	3.1% 7/224 • Number of events 8 • Enrollment through 60-months
Vascular disorders Ischaemic limb pain	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Orthostatic hypotension	0.00% 0/222 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Vascular disorders Penetrating aortic ulcer	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Peripheral arterial occlusive disease	4.5% 10/222 • Number of events 13 • Enrollment through 60-months	4.5% 10/224 • Number of events 12 • Enrollment through 60-months
Vascular disorders Peripheral artery aneurysm	0.90% 2/222 • Number of events 4 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Vascular disorders Peripheral artery dissection	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Peripheral artery occlusion	10.4% 23/222 • Number of events 35 • Enrollment through 60-months	9.8% 22/224 • Number of events 34 • Enrollment through 60-months
Vascular disorders Peripheral artery stenosis	19.8% 44/222 • Number of events 64 • Enrollment through 60-months	15.6% 35/224 • Number of events 50 • Enrollment through 60-months
Vascular disorders Peripheral embolism	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Peripheral ischaemia	5.0% 11/222 • Number of events 15 • Enrollment through 60-months	3.1% 7/224 • Number of events 11 • Enrollment through 60-months
Vascular disorders Peripheral vascular disorder	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Vascular disorders Peripheral venous disease	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Shock haemorrhagic	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Subclavian steal syndrome	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Varicose vein	0.45% 1/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Venous stenosis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months

Other adverse events

Measure	Surmodics SurVeil DCB n=222 participants at risk Surmodics SurVeil Drug-Coated Balloon is an investigational device coated with paclitaxel. Surmodics SurVeil DCB: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.	Medtronic IN.PACT Admiral DCB n=224 participants at risk Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter. Medtronic IN.PACT Admiral DCB: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Blood and lymphatic system disorders Anaemia	4.1% 9/222 • Number of events 10 • Enrollment through 60-months	1.8% 4/224 • Number of events 4 • Enrollment through 60-months
Blood and lymphatic system disorders Coagulopathy	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Blood and lymphatic system disorders Haemorrhagic anaemia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Blood and lymphatic system disorders Increased tendency to bruise	1.8% 4/222 • Number of events 4 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Blood and lymphatic system disorders Iron deficiency anaemia	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	1.8% 4/224 • Number of events 4 • Enrollment through 60-months
Blood and lymphatic system disorders Leukocytosis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Blood and lymphatic system disorders Lymphadenopathy	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Blood and lymphatic system disorders Thrombocytopenia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Cardiac disorders Angina pectoris	2.7% 6/222 • Number of events 6 • Enrollment through 60-months	2.7% 6/224 • Number of events 6 • Enrollment through 60-months
Cardiac disorders Angina unstable	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Cardiac disorders Aortic valve incompetence	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Cardiac disorders Arrhythmia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Cardiac disorders Atrial fibrillation	1.8% 4/222 • Number of events 4 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Cardiac disorders Atrial flutter	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Cardiac disorders Atrial thrombosis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Cardiac disorders Bradycardia	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Cardiac disorders Cardiac failure acute	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Cardiac disorders Cardiac failure congestive	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Cardiac disorders Coronary artery disease	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	1.8% 4/224 • Number of events 4 • Enrollment through 60-months
Cardiac disorders Coronary artery dissection	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Cardiac disorders Coronary artery stenosis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.89% 2/224 • Number of events 3 • Enrollment through 60-months
Cardiac disorders Hypertensive heart disease	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Cardiac disorders Ischaemic cardiomyopathy	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Cardiac disorders Mitral valve stenosis	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Cardiac disorders Myocardial ischaemia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Cardiac disorders Palpitations	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Cardiac disorders Sinus node dysfunction	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Cardiac disorders Sinus tachycardia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Cardiac disorders Supraventricular extrasystoles	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Cardiac disorders Tachycardia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Cardiac disorders Ventricular tachycardia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Congenital, familial and genetic disorders Arteriovenous malformation	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Congenital, familial and genetic disorders Hydrocele	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Ear and labyrinth disorders Cerumen impaction	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Ear and labyrinth disorders Ear pain	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Ear and labyrinth disorders Eustachian tube dysfunction	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Ear and labyrinth disorders Vertigo	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Ear and labyrinth disorders Vertigo positional	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Endocrine disorders Adrenal mass	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Endocrine disorders Goitre	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Endocrine disorders Hypothyroidism	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Endocrine disorders Thyroid mass	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Eye disorders Age-related macular degeneration	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Eye disorders Blepharitis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Eye disorders Cataract	0.90% 2/222 • Number of events 4 • Enrollment through 60-months	2.7% 6/224 • Number of events 8 • Enrollment through 60-months
Eye disorders Conjunctivitis allergic	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Eye disorders Corneal oedema	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Eye disorders Dry eye	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Eye disorders Eye disorder	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Eye disorders Eyelid dermatochalasis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Eye disorders Hypermetropia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Eye disorders Iridocyclitis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Eye disorders Ocular vascular disorder	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Eye disorders Retinal drusen	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Eye disorders Retinopathy hypertensive	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Eye disorders Vitreous adhesions	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Abdominal discomfort	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Gastrointestinal disorders Abdominal pain	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	2.2% 5/224 • Number of events 5 • Enrollment through 60-months
Gastrointestinal disorders Abdominal pain lower	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Gastrointestinal disorders Abdominal pain upper	0.00% 0/222 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Gastrointestinal disorders Abdominal wall haematoma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Gastrointestinal disorders Constipation	0.90% 2/222 • Number of events 6 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Dental caries	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Diarrhoea	2.7% 6/222 • Number of events 6 • Enrollment through 60-months	1.8% 4/224 • Number of events 4 • Enrollment through 60-months
Gastrointestinal disorders Duodenitis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Dyspepsia	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Gastrointestinal disorders Dysphagia	0.00% 0/222 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Gastrointestinal disorders Gastric disorder	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Gastrointestinal disorders Gastritis	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Gastrointestinal haemorrhage	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Gastrointestinal disorders Gastrointestinal wall thickening	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Gastrointestinal disorders Haematochezia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Hiatus hernia	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Gastrointestinal disorders Ileus	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Infrequent bowel movements	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Inguinal hernia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Intestinal angioedema	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Gastrointestinal disorders Large intestine polyp	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Gastrointestinal disorders Mesenteric artery stenosis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Gastrointestinal disorders Nausea	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Gastrointestinal disorders Pancreatitis	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Gastrointestinal disorders Reactive gastropathy	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Gastrointestinal disorders Rectal haemorrhage	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Gastrointestinal disorders Toothache	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Gastrointestinal disorders Uvulitis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Gastrointestinal disorders Vomiting	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	1.3% 3/224 • Number of events 5 • Enrollment through 60-months
General disorders Asthenia	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
General disorders Catheter site bruise	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
General disorders Catheter site haematoma	3.6% 8/222 • Number of events 8 • Enrollment through 60-months	3.6% 8/224 • Number of events 8 • Enrollment through 60-months
General disorders Catheter site haemorrhage	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
General disorders Catheter site pain	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
General disorders Chest discomfort	0.00% 0/222 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
General disorders Chest pain	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
General disorders Condition aggravated	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
General disorders Cyst	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
General disorders Fatigue	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
General disorders Gait disturbance	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
General disorders General physical health deterioration	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
General disorders Impaired healing	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
General disorders Implant site extravasation	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
General disorders Injection site haematoma	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
General disorders Non-cardiac chest pain	3.6% 8/222 • Number of events 12 • Enrollment through 60-months	2.7% 6/224 • Number of events 8 • Enrollment through 60-months
General disorders Oedema	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
General disorders Oedema peripheral	2.7% 6/222 • Number of events 7 • Enrollment through 60-months	7.1% 16/224 • Number of events 19 • Enrollment through 60-months
General disorders Peripheral swelling	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	3.6% 8/224 • Number of events 8 • Enrollment through 60-months
General disorders Vascular stent occlusion	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
General disorders Vascular stent restenosis	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
General disorders Vessel puncture site haematoma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Hepatobiliary disorders Biliary dyskinesia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Hepatobiliary disorders Hepatic function abnormal	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Hepatobiliary disorders Hepatic steatosis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Hepatobiliary disorders Hepatomegaly	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Acarodermatitis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Anal abscess	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Body tinea	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Bronchitis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	2.7% 6/224 • Number of events 6 • Enrollment through 60-months
Infections and infestations Cellulitis	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	1.8% 4/224 • Number of events 4 • Enrollment through 60-months
Infections and infestations Chronic sinusitis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Corona virus infection	5.4% 12/222 • Number of events 12 • Enrollment through 60-months	2.7% 6/224 • Number of events 6 • Enrollment through 60-months
Infections and infestations Cystitis	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Diverticulitis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Epididymitis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Erysipelas	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Gastroenteritis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Gastroenteritis viral	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Hepatitis C	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Herpes zoster	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Infections and infestations Infected cyst	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Infection	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Influenza	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Lower respiratory tract infection	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Onychomycosis	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Osteomyelitis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Paronychia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Pharyngitis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Pneumonia	2.3% 5/222 • Number of events 5 • Enrollment through 60-months	2.2% 5/224 • Number of events 5 • Enrollment through 60-months
Infections and infestations Post procedural infection	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Postoperative wound infection	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Pyuria	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Sinusitis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Subcutaneous abscess	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Tinea cruris	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Upper respiratory tract infection	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Infections and infestations Urinary tract infection	5.0% 11/222 • Number of events 12 • Enrollment through 60-months	3.1% 7/224 • Number of events 9 • Enrollment through 60-months
Infections and infestations Urinary tract infection bacterial	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Viral upper respiratory tract infection	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Infections and infestations Wound infection	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Anaemia postoperative	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Animal bite	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Injury, poisoning and procedural complications Arthropod bite	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Bone contusion	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Carbon monoxide poisoning	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Chemical burn	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Clavicle fracture	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Contusion	2.3% 5/222 • Number of events 5 • Enrollment through 60-months	2.2% 5/224 • Number of events 6 • Enrollment through 60-months
Injury, poisoning and procedural complications Epidural haemorrhage	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Extradural haematoma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Fall	2.3% 5/222 • Number of events 5 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Foot fracture	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Injury, poisoning and procedural complications Head injury	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Injury, poisoning and procedural complications Incision site haematoma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Joint injury	0.00% 0/222 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Injury, poisoning and procedural complications Laceration	0.90% 2/222 • Number of events 3 • Enrollment through 60-months	1.8% 4/224 • Number of events 5 • Enrollment through 60-months
Injury, poisoning and procedural complications Ligament sprain	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 2 • Enrollment through 60-months
Injury, poisoning and procedural complications Limb injury	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	2.2% 5/224 • Number of events 5 • Enrollment through 60-months
Injury, poisoning and procedural complications Meniscus injury	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Muscle strain	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Peripheral artery restenosis	3.2% 7/222 • Number of events 8 • Enrollment through 60-months	7.1% 16/224 • Number of events 17 • Enrollment through 60-months
Injury, poisoning and procedural complications Post procedural haematoma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Post procedural haemorrhage	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Post-traumatic pain	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Procedural haemorrhage	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Procedural nausea	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Procedural vomiting	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Pulmonary contusion	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Radius fracture	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Rib fracture	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Injury, poisoning and procedural complications Seroma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Tibia fracture	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Traumatic ulcer	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Upper limb fracture	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.45% 1/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Injury, poisoning and procedural complications Wound	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Investigations Blood glucose abnormal	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Investigations Glycosylated haemoglobin increased	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Investigations Haemoglobin decreased	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Investigations Heart sounds abnormal	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Investigations Lipoprotein (a) increased	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Investigations Occult blood positive	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Investigations Troponin increased	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Investigations Ultrasound Doppler abnormal	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Investigations Ultrasound scan abnormal	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Investigations Weight decreased	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Metabolism and nutrition disorders Cachexia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Metabolism and nutrition disorders Dehydration	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Metabolism and nutrition disorders Diabetes mellitus	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Metabolism and nutrition disorders Fluid retention	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Metabolism and nutrition disorders Glucose tolerance impaired	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Metabolism and nutrition disorders Gout	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Metabolism and nutrition disorders Hyperglycaemia	0.45% 1/222 • Number of events 2 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Metabolism and nutrition disorders Hyperkalaemia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Metabolism and nutrition disorders Hyperlipidaemia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Metabolism and nutrition disorders Hypokalaemia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Metabolism and nutrition disorders Hypomagnesaemia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/222 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Metabolism and nutrition disorders Magnesium deficiency	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Metabolism and nutrition disorders Malnutrition	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Metabolism and nutrition disorders Metabolic acidosis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Arthralgia	4.1% 9/222 • Number of events 9 • Enrollment through 60-months	4.5% 10/224 • Number of events 11 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Back pain	2.7% 6/222 • Number of events 6 • Enrollment through 60-months	4.0% 9/224 • Number of events 9 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Chondromalacia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Chondropathy	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Diastasis recti abdominis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Flank pain	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Foot deformity	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Gouty arthritis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Gouty tophus	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Groin pain	2.3% 5/222 • Number of events 5 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Joint swelling	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Limb discomfort	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Medial tibial stress syndrome	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Muscle spasms	0.90% 2/222 • Number of events 3 • Enrollment through 60-months	1.8% 4/224 • Number of events 5 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Muscular weakness	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	3.1% 7/224 • Number of events 8 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Myosclerosis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Neck pain	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Osteoarthritis	3.2% 7/222 • Number of events 7 • Enrollment through 60-months	1.8% 4/224 • Number of events 4 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Osteoporosis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Pain in extremity	9.0% 20/222 • Number of events 21 • Enrollment through 60-months	6.7% 15/224 • Number of events 17 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Soft tissue mass	0.45% 1/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/222 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	1.8% 4/222 • Number of events 4 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Synovial cyst	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Tendonitis	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Trigger finger	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Duodenal neoplasm	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kidney angiomyolipoma	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangioma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Monoclonal gammopathy	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	1.8% 4/222 • Number of events 7 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Nervous system disorders Amnesia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Nervous system disorders Ataxia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Carotid artery stenosis	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Carpal tunnel syndrome	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Nervous system disorders Cervical myelopathy	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Cervical radiculopathy	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Cervicobrachial syndrome	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Cluster headache	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Cognitive disorder	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Dementia Alzheimer's type	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Dizziness	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	3.1% 7/224 • Number of events 8 • Enrollment through 60-months
Nervous system disorders Dysgeusia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Nervous system disorders Encephalomalacia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Nervous system disorders Encephalopathy	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Nervous system disorders Headache	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Nervous system disorders Hypoaesthesia	2.3% 5/222 • Number of events 5 • Enrollment through 60-months	1.8% 4/224 • Number of events 4 • Enrollment through 60-months
Nervous system disorders Lumbar radiculopathy	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Nervous system disorders Neuralgia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Neuropathy peripheral	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Paraesthesia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Polyneuropathy	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Post herpetic neuralgia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Post-traumatic headache	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Nervous system disorders Presyncope	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Nervous system disorders Radiculopathy	0.45% 1/222 • Number of events 3 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Nervous system disorders Restless legs syndrome	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Nervous system disorders Sciatica	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Nervous system disorders Somnolence	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Syncope	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Tremor	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Nervous system disorders Vascular dementia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Psychiatric disorders Anxiety	0.00% 0/222 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Psychiatric disorders Delirium	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Psychiatric disorders Depression	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Psychiatric disorders Depression suicidal	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Renal and urinary disorders Acute kidney injury	2.3% 5/222 • Number of events 6 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Renal and urinary disorders Bladder mass	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Renal and urinary disorders Chronic kidney disease	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Renal and urinary disorders Renal artery stenosis	0.45% 1/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Renal and urinary disorders Renal failure	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Renal and urinary disorders Renal impairment	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Renal and urinary disorders Renal mass	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Renal and urinary disorders Renal tubular acidosis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Renal and urinary disorders Urge incontinence	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Renal and urinary disorders Urinary incontinence	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Renal and urinary disorders Urinary retention	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Reproductive system and breast disorders Benign prostatic hyperplasia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Reproductive system and breast disorders Breast cyst	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Reproductive system and breast disorders Haematospermia	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Reproductive system and breast disorders Penile discharge	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Reproductive system and breast disorders Vulvovaginal pain	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Asthma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.4% 3/222 • Number of events 4 • Enrollment through 60-months	2.2% 5/224 • Number of events 9 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Cough	2.7% 6/222 • Number of events 6 • Enrollment through 60-months	1.8% 4/224 • Number of events 5 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Diaphragmatic disorder	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.2% 7/222 • Number of events 8 • Enrollment through 60-months	3.6% 8/224 • Number of events 9 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Epistaxis	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/222 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Productive cough	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Pulmonary granuloma	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Respiratory symptom	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Rhinitis atrophic	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Actinic keratosis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Blister	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Decubitus ulcer	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Dermatitis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Ecchymosis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Erythema	0.00% 0/222 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Ingrowing nail	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Pruritus	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Rash	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Rash pruritic	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Rosacea	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Skin discolouration	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Skin lesion	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Skin necrosis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Skin ulcer	2.3% 5/222 • Number of events 7 • Enrollment through 60-months	2.2% 5/224 • Number of events 6 • Enrollment through 60-months
Skin and subcutaneous tissue disorders Swelling face	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Accelerated hypertension	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Aortic aneurysm	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Aortic dilatation	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Aortic occlusion	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Aortic stenosis	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Arterial haemorrhage	0.45% 1/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Arterial insufficiency	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Arterial stenosis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Arteriosclerosis Moenckeberg-type	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Arteriovenous fistula	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Atheroembolism	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Deep vein thrombosis	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	0.89% 2/224 • Number of events 2 • Enrollment through 60-months
Vascular disorders Femoral artery dissection	8.1% 18/222 • Number of events 18 • Enrollment through 60-months	9.8% 22/224 • Number of events 22 • Enrollment through 60-months
Vascular disorders Haematoma	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Vascular disorders Haemorrhage	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Hypertension	5.0% 11/222 • Number of events 12 • Enrollment through 60-months	4.0% 9/224 • Number of events 10 • Enrollment through 60-months
Vascular disorders Hypertensive crisis	1.4% 3/222 • Number of events 3 • Enrollment through 60-months	1.3% 3/224 • Number of events 3 • Enrollment through 60-months
Vascular disorders Hypotension	3.6% 8/222 • Number of events 8 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Intermittent claudication	8.6% 19/222 • Number of events 21 • Enrollment through 60-months	6.2% 14/224 • Number of events 16 • Enrollment through 60-months
Vascular disorders Lower limb artery perforation	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Orthostatic hypotension	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Peripheral arterial occlusive disease	3.2% 7/222 • Number of events 7 • Enrollment through 60-months	2.7% 6/224 • Number of events 6 • Enrollment through 60-months
Vascular disorders Peripheral artery aneurysm	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Peripheral artery dissection	0.90% 2/222 • Number of events 2 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Peripheral artery occlusion	3.2% 7/222 • Number of events 8 • Enrollment through 60-months	4.5% 10/224 • Number of events 11 • Enrollment through 60-months
Vascular disorders Peripheral artery stenosis	13.5% 30/222 • Number of events 37 • Enrollment through 60-months	15.2% 34/224 • Number of events 41 • Enrollment through 60-months
Vascular disorders Peripheral artery thrombosis	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Peripheral vascular disorder	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Raynaud's phenomenon	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Secondary hypertension	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Subclavian artery stenosis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Thrombophlebitis	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Varicose vein	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Vasospasm	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months
Vascular disorders Venous occlusion	0.45% 1/222 • Number of events 1 • Enrollment through 60-months	0.00% 0/224 • Enrollment through 60-months
Vascular disorders Venous thrombosis limb	0.00% 0/222 • Enrollment through 60-months	0.45% 1/224 • Number of events 1 • Enrollment through 60-months

Additional Information

Kimberly Hawkinson

Surmodics

Phone: 952-500-7563

Email: khawkinson@surmodics.com

Results disclosure agreements

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

Restriction type: LTE60