Trial Outcomes & Findings for IN.PACT Global Clinical Study (NCT NCT01609296)

Last Updated: 2021-03-25

Results Overview

Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Recruitment status

COMPLETED

Study phase

Target enrollment

1535 participants

Primary outcome timeframe

12 months

Results posted on

2021-03-25

Participant Flow

Participant milestones

Participant milestones
Measure	Clinical Cohort ITT
Overall Study STARTED	1406
Overall Study COMPLETED	918
Overall Study NOT COMPLETED	488

Reasons for withdrawal

Reasons for withdrawal
Measure	Clinical Cohort ITT
Overall Study Death	253
Overall Study Withdrawal by Subject	151
Overall Study Lost to Follow-up	21
Overall Study Exit reason other than withdrawal, death or lost to follow up	35
Overall Study missed visit but known to be alive	28

Baseline Characteristics

Due to missing data number analyzed for age differs from overall number of participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clinical Cohort ITT n=1406 Participants
Age, Continuous	68.6 years STANDARD_DEVIATION 10.1 • n=1396 Participants • Due to missing data number analyzed for age differs from overall number of participants
Sex: Female, Male Female	453 Participants n=1406 Participants
Sex: Female, Male Male	953 Participants n=1406 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1361 Participants
Clinical Cohort ITT - Primary Effectiveness Endpoint	1263 Participants

PRIMARY outcome

Timeframe: 12 months

A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1361 Participants
Clinical Cohort ITT - Primary Safety Endpoint	1254 Participants

PRIMARY outcome

Timeframe: 12 months

Primary Patency within 12 months post-index procedure, which is defined as: * Freedom from clinically-driven TLR and * Freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) ≤ 2.4. * Restenosis determined by either PSVR \>2.4 as assessed by an independent DUS core lab or \>50% stenosis as assessed by an independent angiographic core lab.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=323 Participants
Imaging Cohort ITT - Primary Effectiveness Endpoint	217 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=112 Participants
150mm DEB ITT Cohort - Primary Effectiveness Endpoint	106 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Event rates are based on number of evaluable subjects - subjects with at least one MAE event within 360-day or subjects without any MAE event but had at least 300 days of clinical follow-up.

MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR (Target Vessel Revascularization), major target limb amputation, thrombosis at the target lesion site.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1361 Participants
Clinical Cohort ITT - MAEs All MAE	161 Participants
Clinical Cohort ITT - MAEs All cause death	49 Participants
Clinical Cohort ITT - MAEs CD-TVR	107 Participants
Clinical Cohort ITT - MAEs Major Target Limb Amputation	3 Participants
Clinical Cohort ITT - MAEs Thrombosis at Target Lesion Site	38 Participants

SECONDARY outcome

Timeframe: 12 months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1361 Participants
Clinical Cohort ITT - TLR	101 Participants

SECONDARY outcome

Timeframe: 12 months.

Any Target vessel revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1361 Participants
Clinical Cohort ITT - TVR	110 Participants

SECONDARY outcome

Timeframe: Index-procedure

Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=3006 Admiral™ Drug-Eluting Balloon
Clinical Cohort ITT - Device Success	2988 Admiral™ Drug-Eluting Balloon

SECONDARY outcome

Timeframe: prior to discharge

Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1396 Participants
Clinical Cohort ITT - Clinical Success	1376 Participants

SECONDARY outcome

Timeframe: 60 months

MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1215 Participants
Clinical Cohort ITT - MAEs MAEs	589 Participants
Clinical Cohort ITT - MAEs Deaths	244 Participants
Clinical Cohort ITT - MAEs CD-TVR	381 Participants
Clinical Cohort ITT - MAEs Major Target Limb Amputation	19 Participants
Clinical Cohort ITT - MAEs Thrombosis At Target Lesion Site	73 Participants

SECONDARY outcome

Timeframe: 60 months

Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1215 Participants
Clinical Cohort ITT - Clinically-driven TLR	366 Participants

SECONDARY outcome

Timeframe: 60 months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1215 Participants
Clinical Cohort ITT - TVR	390 Participants

SECONDARY outcome

Timeframe: 60 months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1215 Participants
Clinical Cohort ITT - TLR	374 Participants

SECONDARY outcome

Timeframe: 60 months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=366 Participants
Clinical Cohort ITT - Time to First Clinically-driven TLR (Days)	669.2 Days Standard Deviation 462.5

SECONDARY outcome

Timeframe: 30 days

Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1403 Participants
Clinical Cohort ITT - MAEs MAEs	19 Participants
Clinical Cohort ITT - MAEs Death	3 Participants
Clinical Cohort ITT - MAEs CD-TVR	13 Participants
Clinical Cohort ITT - MAEs Major Target Limb Amputation	0 Participants
Clinical Cohort ITT - MAEs Thrombosis at Target Lesion Site	14 Participants

SECONDARY outcome

Timeframe: 6 Months

MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1386 Participants
Clinical Cohort ITT - MAEs MAEs	82 Participants
Clinical Cohort ITT - MAEs Death	23 Participants
Clinical Cohort ITT - MAEs CD-TVR	54 Participants
Clinical Cohort ITT - MAEs Major Target Limb Amputation	3 Participants
Clinical Cohort ITT - MAEs Thrombosis at Target Lesion Site	28 Participants

SECONDARY outcome

Timeframe: 24 Months

MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1313 Participants
Clinical Cohort ITT - MAEs MAEs	325 Participants
Clinical Cohort ITT - MAEs Deaths	101 Participants
Clinical Cohort ITT - MAEs CD-TVR	224 Participants
Clinical Cohort ITT - MAEs Major Target Limb Amputation	9 Participants
Clinical Cohort ITT - MAEs Thrombosis at Target Lesion Site	57 Participants

SECONDARY outcome

Timeframe: 36 Months

MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1277 Participants
Clinical Cohort ITT - MAEs MAEs	438 Participants
Clinical Cohort ITT - MAEs All cause deaths	147 Participants
Clinical Cohort ITT - MAEs CD-TVR	298 Participants
Clinical Cohort ITT - MAEs Major Target Limb Amputation	12 Participants
Clinical Cohort ITT - MAEs Thrombosis at Target Lesion Site	71 Participants

SECONDARY outcome

Timeframe: 48 Months

MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1242 Participants
Clinical Cohort ITT - MAEs MAEs	517 Participants
Clinical Cohort ITT - MAEs All cause deaths	196 Participants
Clinical Cohort ITT - MAEs CD-TVR	342 Participants
Clinical Cohort ITT - MAEs Major Target Limb Amputation	15 Participants
Clinical Cohort ITT - MAEs Thrombosis at Target Lesion Site	71 Participants

SECONDARY outcome

Timeframe: 30 days

Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1403 Participants
Clinical Cohort ITT - Clinically-driven TLR	13 Participants

SECONDARY outcome

Timeframe: 6 Months

Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1386 Participants
Clinical Cohort ITT - Clinically-driven TLR	51 Participants

SECONDARY outcome

Timeframe: 24 Months

Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1313 Participants
Clinical Cohort ITT - Clinically-driven TLR	214 Participants

SECONDARY outcome

Timeframe: 36 Months

Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1277 Participants
Clinical Cohort ITT - Clinically-driven TLR	288 Participants

SECONDARY outcome

Timeframe: 48 Months

Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1242 Participants
Clinical Cohort ITT - Clinically-driven TLR	331 Participants

SECONDARY outcome

Timeframe: 6 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1386 Participants
Clinical Cohort ITT - TLR	53 Participants

SECONDARY outcome

Timeframe: 24 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1313 Participants
Clinical Cohort ITT - TLR	218 Participants

SECONDARY outcome

Timeframe: 36 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1277 Participants
Clinical Cohort ITT - TLR	294 Participants

SECONDARY outcome

Timeframe: 48 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1242 Participants
Clinical Cohort ITT - TLR	338 Participants

SECONDARY outcome

Timeframe: 24 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1313 Participants
Clinical Cohort ITT - TVR	229 Participants

SECONDARY outcome

Timeframe: 36 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1277 Participants
Clinical Cohort ITT - TVR	305 Participants

SECONDARY outcome

Timeframe: 48 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1242 Participants
Clinical Cohort ITT - TVR	350 Participants

SECONDARY outcome

Timeframe: 6 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1386 Participants
Clinical Cohort ITT - TVR	56 Participants

SECONDARY outcome

Timeframe: 60 months

All-cause mortality is reported by using the survival estimate of all cause mortality through 60 months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1406 Participants
Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure.	80.5 percentage of survival Interval 78.2 to 82.6

SECONDARY outcome

Timeframe: 6 Months

Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1235 Participants
Clinical Cohort ITT - Primary Sustained Clinical Improvement	1068 Participants

SECONDARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1183 Participants
Clinical Cohort ITT - Primary Sustained Clinical Improvement	959 Participants

SECONDARY outcome

Timeframe: 24 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1073 Participants
Clinical Cohort ITT - Primary Sustained Clinical Improvement	745 Participants

SECONDARY outcome

Timeframe: 36 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1009 Participants
Clinical Cohort ITT - Primary Sustained Clinical Improvement	606 Participants

SECONDARY outcome

Timeframe: 6 Months

Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1230 Participants
Clinical Cohort ITT - Secondary Sustained Clinical Improvement	1105 Participants

SECONDARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1168 Participants
Clinical Cohort ITT - Secondary Sustained Clinical Improvement	1019 Participants

SECONDARY outcome

Timeframe: 24 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1033 Participants
Clinical Cohort ITT - Secondary Sustained Clinical Improvement	876 Participants

SECONDARY outcome

Timeframe: 36 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=940 Participants
Clinical Cohort ITT - Secondary Sustained Clinical Improvement	762 Participants

SECONDARY outcome

Timeframe: Post procedure

Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1225 Participants
Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure	1086 Participants

SECONDARY outcome

Timeframe: 6 Months

Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1114 Participants
Clinical Cohort ITT - Sustained Hemodynamic Improvement	908 Participants

SECONDARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1088 Participants
Clinical Cohort ITT - Sustained Hemodynamic Improvement	797 Participants

SECONDARY outcome

Timeframe: 24 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=986 Participants
Clinical Cohort ITT - Sustained Hemodynamic Improvement	584 Participants

SECONDARY outcome

Timeframe: 36 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=900 Participants
Clinical Cohort ITT - Sustained Hemodynamic Improvement	437 Participants

SECONDARY outcome

Timeframe: 6 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1141 Participants
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)	79.7 percentage of impairment Standard Deviation 29.0

SECONDARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1109 Participants
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)	76.2 percentage of impairment Standard Deviation 30.7

SECONDARY outcome

Timeframe: 24 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=952 Participants
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)	75.1 percentage of impairment Standard Deviation 30.9

SECONDARY outcome

Timeframe: 36 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=831 Participants
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)	74.4 percentage of impairment Standard Deviation 30.6

SECONDARY outcome

Timeframe: 6 Months

The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1154 Participants
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)	0.8124 score on a scale Standard Deviation 0.2323

SECONDARY outcome

Timeframe: 12 Months

The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1114 Participants
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)	0.7970 score on a scale Standard Deviation 0.2413

SECONDARY outcome

Timeframe: 24 Months

The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=964 Participants
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)	0.7744 score on a scale Standard Deviation 0.2551

SECONDARY outcome

Timeframe: 36 Months

The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=837 Participants
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)	0.7629 score on a scale Standard Deviation 0.2641

SECONDARY outcome

Timeframe: at procedure

Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1761 lesions
Clinical Cohort ITT - Procedural Success	1750 lesions

SECONDARY outcome

Timeframe: at 12 months, or at the time of re-intervention

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=252 Participants
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 2.0) of the Target Lesion	111 Participants

SECONDARY outcome

Timeframe: At 12 months, or at the time of re-intervention

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=308 Participants
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 3.4) of the Target Lesion	71 Participants

SECONDARY outcome

Timeframe: 30 days

Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=114 Participants
150mm DEB ITT Cohort - MAEs MAEs	0 Participants
150mm DEB ITT Cohort - MAEs Death	0 Participants
150mm DEB ITT Cohort - MAEs CD-TVR	0 Participants
150mm DEB ITT Cohort - MAEs Major Target Limb Amputation	0 Participants
150mm DEB ITT Cohort - MAEs Thrombosis at Target Lesion Site	0 Participants

SECONDARY outcome

Timeframe: 6 months

Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 6 months.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=112 Participants
150mm DEB ITT Cohort - MAEs MAEs	6 Participants
150mm DEB ITT Cohort - MAEs Death	1 Participants
150mm DEB ITT Cohort - MAEs CD-TVR	5 Participants
150mm DEB ITT Cohort - MAEs Major Target Limb Amputation	0 Participants
150mm DEB ITT Cohort - MAEs Thrombosis at Target Lesion Site	1 Participants

SECONDARY outcome

Timeframe: 12 months

Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 12 months.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=112 Participants
150mm DEB ITT Cohort - MAEs MAEs	9 Participants
150mm DEB ITT Cohort - MAEs Death	2 Participants
150mm DEB ITT Cohort - MAEs CD-TVR	7 Participants
150mm DEB ITT Cohort - MAEs Major Target Limb Amputation	0 Participants
150mm DEB ITT Cohort - MAEs Thrombosis at Target Lesion Site	1 Participants

SECONDARY outcome

Timeframe: 24 months

Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 24 months.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=110 Participants
150mm DEB ITT Cohort - MAEs MAEs	22 Participants
150mm DEB ITT Cohort - MAEs Death	6 Participants
150mm DEB ITT Cohort - MAEs CD-TVR	17 Participants
150mm DEB ITT Cohort - MAEs Major Target Limb Amputation	1 Participants
150mm DEB ITT Cohort - MAEs Thrombosis at Target Lesion Site	2 Participants

SECONDARY outcome

Timeframe: 36 months

Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 36 months.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=107 Participants
150mm DEB ITT Cohort - MAEs MAEs	37 Participants
150mm DEB ITT Cohort - MAEs Death	13 Participants
150mm DEB ITT Cohort - MAEs CD-TVR	26 Participants
150mm DEB ITT Cohort - MAEs Major Target Limb Amputation	1 Participants
150mm DEB ITT Cohort - MAEs Thrombosis at Target Lesion Site	2 Participants

SECONDARY outcome

Timeframe: 48 months

Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 48 months.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=106 Participants
150mm DEB ITT Cohort - MAEs Death	18 Participants
150mm DEB ITT Cohort - MAEs CD-TVR	29 Participants
150mm DEB ITT Cohort - MAEs Major Target Limb Amputation	1 Participants
150mm DEB ITT Cohort - MAEs Thrombosis at Target Lesion Site	3 Participants
150mm DEB ITT Cohort - MAEs MAEs	45 Participants

SECONDARY outcome

Timeframe: 60 months

Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 60 months.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=102 Participants
150mm DEB ITT Cohort - MAEs MAEs	47 Participants
150mm DEB ITT Cohort - MAEs Death	20 Participants
150mm DEB ITT Cohort - MAEs CD-TVR	30 Participants
150mm DEB ITT Cohort - MAEs Major Target Limb Amputation	1 Participants
150mm DEB ITT Cohort - MAEs Thrombosis at Target Lesion Site	3 Participants

SECONDARY outcome

Timeframe: 30 days

Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=114 Participants
150mm DEB ITT Cohort - Clinically-driven TLR	0 Participants

SECONDARY outcome

Timeframe: 6 months

Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=112 Participants
150mm DEB ITT Cohort - Clinically-driven TLR	4 Participants

SECONDARY outcome

Timeframe: 24 months

Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=110 Participants
150mm DEB ITT Cohort - Clinically-driven TLR	16 Participants

SECONDARY outcome

Timeframe: 36 months

Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=107 Participants
150mm DEB ITT Cohort - Clinically-driven TLR	25 Participants

SECONDARY outcome

Timeframe: 48 months

Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=106 Participants
150mm DEB ITT Cohort - Clinically-driven TLR	27 Participants

SECONDARY outcome

Timeframe: 60 months

Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=102 Participants
150mm DEB ITT Cohort - Clinically-driven TLR	28 Participants

SECONDARY outcome

Timeframe: 6 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=112 Participants
150mm DEB ITT Cohort - TLR	5 Participants

SECONDARY outcome

Timeframe: 12 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=112 Participants
150mm DEB ITT Cohort - TLR	7 Participants

SECONDARY outcome

Timeframe: 24 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=110 Participants
150mm DEB ITT Cohort - TLR	17 Participants

SECONDARY outcome

Timeframe: 36 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=107 Participants
150mm DEB ITT Cohort - TLR	26 Participants

SECONDARY outcome

Timeframe: 48 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=106 Participants
150mm DEB ITT Cohort - TLR	28 Participants

SECONDARY outcome

Timeframe: 60 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=102 Participants
150mm DEB ITT Cohort - TLR	29 Participants

SECONDARY outcome

Timeframe: 6 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=112 Participants
150mm DEB ITT Cohort - TVR	6 Participants

SECONDARY outcome

Timeframe: 12 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=112 Participants
150mm DEB ITT Cohort - TVR	8 Participants

SECONDARY outcome

Timeframe: 24 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=110 Participants
150mm DEB ITT Cohort - TVR	18 Participants

SECONDARY outcome

Timeframe: 36 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=107 Participants
150mm DEB ITT Cohort - TVR	27 Participants

SECONDARY outcome

Timeframe: 48 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=106 Participants
150mm DEB ITT Cohort - TVR	30 Participants

SECONDARY outcome

Timeframe: 60 Months

Any Target lesion revascularisation

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=102 Participants
150mm DEB ITT Cohort - TVR	31 Participants

SECONDARY outcome

Timeframe: 60 months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=28 Participants
150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days)	622.2 Days Standard Deviation 352.8

SECONDARY outcome

Timeframe: 60 months

All-cause mortality is reported by using the survival estimate of all-cause mortality through 60 months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=116 Participants
150mm DEB ITT Cohort - Time to All-cause Mortality Through 60 Months Post-index Procedure.	81.1 percentage of survival Interval 72.2 to 87.3

SECONDARY outcome

Timeframe: 6 months.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=107 Participants
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement	97 Participants

SECONDARY outcome

Timeframe: 12 months.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=102 Participants
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement	87 Participants

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=96 Participants
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement	68 Participants

SECONDARY outcome

Timeframe: 36 months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=92 Participants
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement	62 Participants

SECONDARY outcome

Timeframe: 6 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=106 Participants
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement	101 Participants

SECONDARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=101 Participants
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement	90 Participants

SECONDARY outcome

Timeframe: 24 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=94 Participants
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement	76 Participants

SECONDARY outcome

Timeframe: 36 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=89 Participants
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement	74 Participants

SECONDARY outcome

Timeframe: Post procedure

Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=102 Participants
150mm DEB ITT Cohort - Immediate Hemodynamic Improvement at Post-index Procedure	90 Participants

SECONDARY outcome

Timeframe: 6 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=94 Participants
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement	78 Participants

SECONDARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=88 Participants
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement	72 Participants

SECONDARY outcome

Timeframe: 24 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=85 Participants
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement	52 Participants

SECONDARY outcome

Timeframe: 36 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=79 Participants
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement	43 Participants

SECONDARY outcome

Timeframe: 6 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=92 Participants
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)	85.9 percentage of impairment Standard Deviation 23.5

SECONDARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=86 Participants
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)	78.5 percentage of impairment Standard Deviation 27.4

SECONDARY outcome

Timeframe: 24 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=83 Participants
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)	77.4 percentage of impairment Standard Deviation 27.8

SECONDARY outcome

Timeframe: 36 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=71 Participants
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)	78.5 percentage of impairment Standard Deviation 25.8

SECONDARY outcome

Timeframe: 6 Months

The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=92 Participants
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)	0.8463 score on a scale Standard Deviation 0.1771

SECONDARY outcome

Timeframe: 12 Months

The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=86 Participants
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)	0.8257 score on a scale Standard Deviation 0.1853

SECONDARY outcome

Timeframe: 24 Months

The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=85 Participants
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)	0.7858 score on a scale Standard Deviation 0.2215

SECONDARY outcome

Timeframe: 36 Months

The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=78 Participants
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)	0.8278 score on a scale Standard Deviation 0.2003

SECONDARY outcome

Timeframe: Index-procedure

Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=233 Admiral™ Drug-Eluting Balloon
150mm DEB ITT Cohort - Device Success	231 Admiral™ Drug-Eluting Balloon

SECONDARY outcome

Timeframe: at procedure

Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=130 lesions
150mm DEB ITT Cohort - Procedural Success	130 lesions

SECONDARY outcome

Timeframe: prior to discharge

Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=116 Participants
150mm DEB ITT Cohort - Clinical Success	115 Participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1403 Participants
Clinical Cohort ITT - All-cause Mortality	3 Participants

SECONDARY outcome

Timeframe: 6 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1386 Participants
Clinical Cohort ITT - All-cause Mortality	23 Participants

SECONDARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1361 Participants
Clinical Cohort ITT - All-cause Mortality	49 Participants

SECONDARY outcome

Timeframe: 24 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1313 Participants
Clinical Cohort ITT - All-cause Mortality	101 Participants

SECONDARY outcome

Timeframe: 36 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1277 Participants
Clinical Cohort ITT - All-cause Mortality	147 Participants

SECONDARY outcome

Timeframe: 48 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1242 Participants
Clinical Cohort ITT - All-cause Mortality	196 Participants

SECONDARY outcome

Timeframe: 60 Months

The difference in death count calculation between the compliance table (participant flow: 253 deaths) and the event table (244 deaths) is explained as follow: 1. Calendar days (365/year) is used for compliance table whereas 360-day annual cutoff is used for event rate calculation 2. Compliance table used visit window as specified by protocol (60 days for 5-year follow-up) whereas, not window is used for event rate calculation 3. Nine patients died between 1801 and 1885 (1825 + 60) and were therefore not included in the 5-year death rate summary but were included in the compliance summary for patients that died through the upper window of the 60 month visit. 4. The denominator of 1215 for 1800-day event rate includes those who had an event within 1800 days and those who did not have any event but had at least 1740 days of follow-up (1740 is the low bound of the 60-day visit window from the target day of 1800)

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1215 Participants
Clinical Cohort ITT - All-cause Mortality	244 Participants

SECONDARY outcome

Timeframe: 30 days

Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1403 Participants
Clinical Cohort ITT - Clinically-driven TVR	13 Participants

SECONDARY outcome

Timeframe: 6 Months

Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1386 Participants
Clinical Cohort ITT - Clinically-driven TVR	54 Participants

SECONDARY outcome

Timeframe: 12 Months

Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1361 Participants
Clinical Cohort ITT - Clinically-driven TVR	107 Participants

SECONDARY outcome

Timeframe: 24 Months

Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1313 Participants
Clinical Clinical Cohort ITT - Clinically-driven TVR	224 Participants

SECONDARY outcome

Timeframe: 36 Months

Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1277 Participants
Clinical Cohort ITT - Clinically-driven TVR	298 Participants

SECONDARY outcome

Timeframe: 48 Months

Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1242 Participants
Clinical Cohort ITT - Clinically-driven TVR	342 Participants

SECONDARY outcome

Timeframe: 60 Months

Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1215 Participants
Clinical Cohort ITT - Clinically-driven TVR	381 Participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1403 Participants
Clinical Cohort ITT - Major Target Limb Amputation	0 Participants

SECONDARY outcome

Timeframe: 6 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1386 Participants
Clinical Cohort ITT - Major Target Limb Amputation	3 Participants

SECONDARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1361 Participants
Clinical Cohort ITT - Major Target Limb Amputation	3 Participants

SECONDARY outcome

Timeframe: 24 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1313 Participants
Clinical Cohort ITT - Major Target Limb Amputation	57 Participants

SECONDARY outcome

Timeframe: 36 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1277 Participants
Clinical Cohort ITT - Major Target Limb Amputation	12 Participants

SECONDARY outcome

Timeframe: 48 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1242 Participants
Clinical Cohort ITT - Major Target Limb Amputation	15 Participants

SECONDARY outcome

Timeframe: 60 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=1215 Participants
Clinical Cohort ITT - Major Target Limb Amputation	19 Participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=114 Participants
150mm DEB ITT Cohort - All-cause Mortality	0 Participants

SECONDARY outcome

Timeframe: 6 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=112 Participants
150mm DEB ITT Cohort - All-cause Mortality	1 Participants

SECONDARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=112 Participants
150mm DEB ITT Cohort - All-cause Mortality	2 Participants

SECONDARY outcome

Timeframe: 24 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=110 Participants
150mm DEB ITT Cohort - All-cause Mortality	6 Participants

SECONDARY outcome

Timeframe: 36 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=107 Participants
150mm DEB ITT Cohort - All-cause Mortality	13 Participants

SECONDARY outcome

Timeframe: 48 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=106 Participants
150mm DEB ITT Cohort - All-cause Mortality	18 Participants

SECONDARY outcome

Timeframe: 60 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=102 Participants
150mm DEB ITT Cohort - All-cause Mortality	20 Participants

SECONDARY outcome

Timeframe: 30 days

Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=114 Participants
150mm DEB ITT Cohort - Clinically-driven TVR	0 Participants

SECONDARY outcome

Timeframe: 6 Months

Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=112 Participants
150mm DEB ITT Cohort - Clinically-driven TVR	5 Participants

SECONDARY outcome

Timeframe: 12 Months

Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=112 Participants
150mm DEB ITT Cohort - Clinically-driven TVR	7 Participants

SECONDARY outcome

Timeframe: 24 Months

Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=110 Participants
150mm DEB ITT Cohort - Clinically-driven TVR	17 Participants

SECONDARY outcome

Timeframe: 36 Months

Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=107 Participants
150mm DEB ITT Cohort - Clinically-driven TVR	26 Participants

SECONDARY outcome

Timeframe: 48 Months

Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=106 Participants
150mm DEB ITT Cohort - Clinically-driven TVR	29 Participants

SECONDARY outcome

Timeframe: 60 Months

Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=102 Participants
150mm DEB ITT Cohort - Clinically-driven TVR	30 Participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=114 Participants
150mm DEB ITT Cohort - Major Target Limb Amputation	0 Participants

SECONDARY outcome

Timeframe: 6 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=112 Participants
150mm DEB ITT Cohort - Major Target Limb Amputation	0 Participants

SECONDARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=112 Participants
150mm DEB ITT Cohort - Major Target Limb Amputation	0 Participants

SECONDARY outcome

Timeframe: 24 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=110 Participants
150mm DEB ITT Cohort - Major Target Limb Amputation	1 Participants

SECONDARY outcome

Timeframe: 36 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=107 Participants
150mm DEB ITT Cohort - Major Target Limb Amputation	1 Participants

SECONDARY outcome

Timeframe: 48 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=106 Participants
150mm DEB ITT Cohort - Major Target Limb Amputation	1 Participants

SECONDARY outcome

Timeframe: 60 Months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=102 Participants
150mm DEB ITT Cohort - Major Target Limb Amputation	1 Participants

SECONDARY outcome

Timeframe: 60 months

Outcome measures

Outcome measures
Measure	Clinical Cohort ITT n=28 Participants
150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days)	622.2 Days Standard Deviation 352.8

Adverse Events

Clinical Cohort 60M

Serious events: 1074 serious events

Other events: 287 other events

Deaths: 253 deaths

Serious adverse events

Serious adverse events
Measure	Clinical Cohort 60M n=1406 participants at risk Events through the entire 60 months follow-up period are included
Blood and lymphatic system disorders Anaemia	1.6% 23/1406 • Number of events 24 • 60 Months
Blood and lymphatic system disorders Febrile Neutropenia	0.07% 1/1406 • Number of events 1 • 60 Months
Blood and lymphatic system disorders Haemorrhagic Anaemia	0.36% 5/1406 • Number of events 5 • 60 Months
Blood and lymphatic system disorders Haemorrhagic Disorder	0.14% 2/1406 • Number of events 2 • 60 Months
Blood and lymphatic system disorders Hypochromic Anaemia	0.07% 1/1406 • Number of events 1 • 60 Months
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.50% 7/1406 • Number of events 7 • 60 Months
Blood and lymphatic system disorders Leukocytosis	0.07% 1/1406 • Number of events 1 • 60 Months
Blood and lymphatic system disorders Lymphadenopathy Mediastinal	0.07% 1/1406 • Number of events 1 • 60 Months
Blood and lymphatic system disorders Nephrogenic Anaemia	0.07% 1/1406 • Number of events 1 • 60 Months
Blood and lymphatic system disorders Neutropenia	0.07% 1/1406 • Number of events 1 • 60 Months
Blood and lymphatic system disorders Normochromic Normocytic Anaemia	0.14% 2/1406 • Number of events 2 • 60 Months
Blood and lymphatic system disorders Pancytopenia	0.14% 2/1406 • Number of events 2 • 60 Months
Cardiac disorders Acute Coronary Syndrome	0.43% 6/1406 • Number of events 6 • 60 Months
Cardiac disorders Acute Myocardial Infarction	3.7% 52/1406 • Number of events 57 • 60 Months
Cardiac disorders Angina Pectoris	2.4% 34/1406 • Number of events 37 • 60 Months
Cardiac disorders Angina Unstable	1.4% 20/1406 • Number of events 22 • 60 Months
Cardiac disorders Aortic Valve Incompetence	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Aortic Valve Stenosis	0.57% 8/1406 • Number of events 9 • 60 Months
Cardiac disorders Arteriosclerosis Coronary Artery	0.28% 4/1406 • Number of events 4 • 60 Months
Cardiac disorders Atrial Fibrillation	2.2% 31/1406 • Number of events 34 • 60 Months
Cardiac disorders Atrial Flutter	0.43% 6/1406 • Number of events 6 • 60 Months
Cardiac disorders Atrial Thrombosis	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Atrioventricular Block	0.36% 5/1406 • Number of events 5 • 60 Months
Cardiac disorders Atrioventricular Block Complete	0.21% 3/1406 • Number of events 3 • 60 Months
Cardiac disorders Atrioventricular Block Second Degree	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Atrioventricular Dissociation	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Bradycardia	0.57% 8/1406 • Number of events 8 • 60 Months
Cardiac disorders Bundle Branch Block Left	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Cardiac Arrest	1.4% 19/1406 • Number of events 19 • 60 Months
Cardiac disorders Cardiac Disorder	0.14% 2/1406 • Number of events 2 • 60 Months
Cardiac disorders Cardiac Failure	3.8% 53/1406 • Number of events 66 • 60 Months
Cardiac disorders Cardiac Failure Acute	0.43% 6/1406 • Number of events 6 • 60 Months
Cardiac disorders Cardiac Failure Congestive	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Cardiac Tamponade	0.21% 3/1406 • Number of events 3 • 60 Months
Cardiac disorders Cardiac Valve Disease	0.14% 2/1406 • Number of events 2 • 60 Months
Cardiac disorders Cardio-Respiratory Arrest	0.14% 2/1406 • Number of events 2 • 60 Months
Cardiac disorders Cardiogenic Shock	0.36% 5/1406 • Number of events 5 • 60 Months
Cardiac disorders Cardiomegaly	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Cardiomyopathy	0.14% 2/1406 • Number of events 2 • 60 Months
Cardiac disorders Cardiopulmonary Failure	0.28% 4/1406 • Number of events 4 • 60 Months
Cardiac disorders Cardiovascular Insufficiency	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Congestive Cardiomyopathy	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Coronary Artery Disease	3.6% 51/1406 • Number of events 54 • 60 Months
Cardiac disorders Coronary Artery Insufficiency	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Coronary Artery Occlusion	0.43% 6/1406 • Number of events 7 • 60 Months
Cardiac disorders Coronary Artery Stenosis	1.8% 26/1406 • Number of events 32 • 60 Months
Cardiac disorders Coronary Artery Thrombosis	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Diastolic Dysfunction	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Heart Valve Incompetence	0.14% 2/1406 • Number of events 2 • 60 Months
Cardiac disorders Hypertensive Cardiomyopathy	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Hypertensive Heart Disease	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Intracardiac Thrombus	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Ischaemic Cardiomyopathy	0.21% 3/1406 • Number of events 3 • 60 Months
Cardiac disorders Left Ventricular Dysfunction	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Left Ventricular Failure	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Low Cardiac Output Syndrome	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Mitral Valve Incompetence	0.28% 4/1406 • Number of events 4 • 60 Months
Cardiac disorders Mitral Valve Stenosis	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Myocardial Fibrosis	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Myocardial Infarction	1.8% 25/1406 • Number of events 25 • 60 Months
Cardiac disorders Myocardial Ischaemia	0.57% 8/1406 • Number of events 8 • 60 Months
Cardiac disorders Pericardial Effusion	0.14% 2/1406 • Number of events 2 • 60 Months
Cardiac disorders Pericarditis	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Rhythm Idioventricular	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Sick Sinus Syndrome	0.21% 3/1406 • Number of events 3 • 60 Months
Cardiac disorders Sinus Bradycardia	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Stress Cardiomyopathy	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Tachyarrhythmia	0.21% 3/1406 • Number of events 3 • 60 Months
Cardiac disorders Trifascicular Block	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Ventricle Rupture	0.07% 1/1406 • Number of events 1 • 60 Months
Cardiac disorders Ventricular Fibrillation	0.14% 2/1406 • Number of events 2 • 60 Months
Cardiac disorders Ventricular Tachycardia	0.07% 1/1406 • Number of events 1 • 60 Months
Congenital, familial and genetic disorders Congenital Arterial Malformation	0.07% 1/1406 • Number of events 1 • 60 Months
Congenital, familial and genetic disorders Gastrointestinal Angiodysplasia	0.14% 2/1406 • Number of events 2 • 60 Months
Congenital, familial and genetic disorders Phimosis	0.07% 1/1406 • Number of events 1 • 60 Months
Ear and labyrinth disorders Deafness	0.14% 2/1406 • Number of events 2 • 60 Months
Ear and labyrinth disorders Hypoacusis	0.07% 1/1406 • Number of events 1 • 60 Months
Ear and labyrinth disorders Tympanic Membrane Perforation	0.07% 1/1406 • Number of events 1 • 60 Months
Ear and labyrinth disorders Vertigo	0.64% 9/1406 • Number of events 10 • 60 Months
Ear and labyrinth disorders Vertigo Positional	0.14% 2/1406 • Number of events 2 • 60 Months
Endocrine disorders Goitre	0.14% 2/1406 • Number of events 2 • 60 Months
Endocrine disorders Hyperparathyroidism Tertiary	0.07% 1/1406 • Number of events 1 • 60 Months
Eye disorders Amaurosis Fugax	0.07% 1/1406 • Number of events 1 • 60 Months
Eye disorders Blindness Unilateral	0.07% 1/1406 • Number of events 1 • 60 Months
Eye disorders Cataract	1.3% 18/1406 • Number of events 25 • 60 Months
Eye disorders Cataract Cortical	0.07% 1/1406 • Number of events 1 • 60 Months
Eye disorders Dacryostenosis Acquired	0.07% 1/1406 • Number of events 1 • 60 Months
Eye disorders Diplopia	0.07% 1/1406 • Number of events 1 • 60 Months
Eye disorders Lens Dislocation	0.07% 1/1406 • Number of events 1 • 60 Months
Eye disorders Macular Degeneration	0.14% 2/1406 • Number of events 2 • 60 Months
Eye disorders Retinal Artery Occlusion	0.07% 1/1406 • Number of events 1 • 60 Months
Eye disorders Retinal Detachment	0.14% 2/1406 • Number of events 2 • 60 Months
Eye disorders Visual Impairment	0.14% 2/1406 • Number of events 3 • 60 Months
Eye disorders Vitreous Adhesions	0.07% 1/1406 • Number of events 1 • 60 Months
Eye disorders Vitreous Haemorrhage	0.14% 2/1406 • Number of events 3 • 60 Months
Gastrointestinal disorders Abdominal Hernia	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Abdominal Pain	0.21% 3/1406 • Number of events 4 • 60 Months
Gastrointestinal disorders Abdominal Pain Lower	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Abdominal Pain Upper	0.21% 3/1406 • Number of events 5 • 60 Months
Gastrointestinal disorders Abdominal Symptom	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Abdominal Wall Haematoma	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Acute Abdomen	0.14% 2/1406 • Number of events 2 • 60 Months
Gastrointestinal disorders Anal Haemorrhage	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Anal Skin Tags	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Colitis	0.36% 5/1406 • Number of events 5 • 60 Months
Gastrointestinal disorders Colitis Ischaemic	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Colitis Ulcerative	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Colonic Polyp	0.57% 8/1406 • Number of events 8 • 60 Months
Gastrointestinal disorders Constipation	0.21% 3/1406 • Number of events 3 • 60 Months
Gastrointestinal disorders Dental Caries	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Diarrhoea	0.14% 2/1406 • Number of events 2 • 60 Months
Gastrointestinal disorders Diverticulum	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Duodenal Ulcer	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Dysphagia	0.36% 5/1406 • Number of events 5 • 60 Months
Gastrointestinal disorders Enteritis	0.14% 2/1406 • Number of events 2 • 60 Months
Gastrointestinal disorders Erosive Duodenitis	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Faecal Vomiting	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Faecaloma	0.14% 2/1406 • Number of events 2 • 60 Months
Gastrointestinal disorders Food Poisoning	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Gastric Haemorrhage	0.14% 2/1406 • Number of events 2 • 60 Months
Gastrointestinal disorders Gastric Perforation	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Gastric Ulcer	0.28% 4/1406 • Number of events 4 • 60 Months
Gastrointestinal disorders Gastric Ulcer Haemorrhage	0.21% 3/1406 • Number of events 3 • 60 Months
Gastrointestinal disorders Gastric Ulcer Perforation	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Gastritis	0.50% 7/1406 • Number of events 8 • 60 Months
Gastrointestinal disorders Gastritis Erosive	0.14% 2/1406 • Number of events 2 • 60 Months
Gastrointestinal disorders Gastrointestinal Haemorrhage	1.1% 15/1406 • Number of events 15 • 60 Months
Gastrointestinal disorders Gastrointestinal Ulcer Haemorrhage	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Haematochezia	0.14% 2/1406 • Number of events 2 • 60 Months
Gastrointestinal disorders Ileus	0.28% 4/1406 • Number of events 4 • 60 Months
Gastrointestinal disorders Inguinal Hernia	0.64% 9/1406 • Number of events 9 • 60 Months
Gastrointestinal disorders Intestinal Ischaemia	0.36% 5/1406 • Number of events 5 • 60 Months
Gastrointestinal disorders Intestinal Obstruction	0.14% 2/1406 • Number of events 2 • 60 Months
Gastrointestinal disorders Intestinal Perforation	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Intestinal Polyp	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Intra-Abdominal Haematoma	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Jejunal Ulcer	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Large Intestine Perforation	0.14% 2/1406 • Number of events 2 • 60 Months
Gastrointestinal disorders Lumbar Hernia	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Malignant Dysphagia	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Mechanical Ileus	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Mesenteric Artery Stenosis	0.43% 6/1406 • Number of events 7 • 60 Months
Gastrointestinal disorders Oesophageal Achalasia	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Oesophageal Haemorrhage	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Oesophageal Stenosis	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Oesophageal Varices Haemorrhage	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Oesophagitis	0.21% 3/1406 • Number of events 4 • 60 Months
Gastrointestinal disorders Pancreatitis	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Pancreatitis Acute	0.14% 2/1406 • Number of events 2 • 60 Months
Gastrointestinal disorders Pancreatitis Chronic	0.14% 2/1406 • Number of events 2 • 60 Months
Gastrointestinal disorders Peptic Ulcer	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Peritonitis	0.28% 4/1406 • Number of events 4 • 60 Months
Gastrointestinal disorders Rectal Polyp	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Reflux Oesophagitis	0.21% 3/1406 • Number of events 3 • 60 Months
Gastrointestinal disorders Retroperitoneal Haematoma	0.14% 2/1406 • Number of events 2 • 60 Months
Gastrointestinal disorders Retroperitoneal Haemorrhage	0.21% 3/1406 • Number of events 3 • 60 Months
Gastrointestinal disorders Sigmoiditis	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Small Intestinal Haemorrhage	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Spigelian Hernia	0.07% 1/1406 • Number of events 1 • 60 Months
Gastrointestinal disorders Subileus	0.14% 2/1406 • Number of events 2 • 60 Months
Gastrointestinal disorders Umbilical Hernia	0.14% 2/1406 • Number of events 2 • 60 Months
Gastrointestinal disorders Vomiting	0.07% 1/1406 • Number of events 1 • 60 Months
General disorders Asthenia	0.21% 3/1406 • Number of events 3 • 60 Months
General disorders Cardiac Death	0.21% 3/1406 • Number of events 3 • 60 Months
General disorders Chest Discomfort	0.14% 2/1406 • Number of events 2 • 60 Months
General disorders Chest Pain	0.85% 12/1406 • Number of events 14 • 60 Months
General disorders Death	3.9% 55/1406 • Number of events 55 • 60 Months
General disorders Device Breakage	0.21% 3/1406 • Number of events 3 • 60 Months
General disorders Device Dislocation	0.14% 2/1406 • Number of events 2 • 60 Months
General disorders Device Malfunction	0.07% 1/1406 • Number of events 1 • 60 Months
General disorders Device Occlusion	3.2% 45/1406 • Number of events 49 • 60 Months
General disorders Euthanasia	0.07% 1/1406 • Number of events 1 • 60 Months
General disorders Exercise Tolerance Decreased	0.07% 1/1406 • Number of events 1 • 60 Months
General disorders Gait Disturbance	0.07% 1/1406 • Number of events 1 • 60 Months
General disorders General Physical Health Deterioration	0.28% 4/1406 • Number of events 4 • 60 Months
General disorders Hernia	0.07% 1/1406 • Number of events 1 • 60 Months
General disorders Hernia Obstructive	0.14% 2/1406 • Number of events 2 • 60 Months
General disorders Hyperplasia	0.14% 2/1406 • Number of events 2 • 60 Months
General disorders Impaired Healing	0.64% 9/1406 • Number of events 13 • 60 Months
General disorders Inflammation	0.07% 1/1406 • Number of events 1 • 60 Months
General disorders Infusion Site Extravasation	0.07% 1/1406 • Number of events 1 • 60 Months
General disorders Malaise	0.28% 4/1406 • Number of events 4 • 60 Months
General disorders Multi-Organ Failure	0.36% 5/1406 • Number of events 5 • 60 Months
General disorders Oedema Peripheral	0.21% 3/1406 • Number of events 3 • 60 Months
General disorders Puncture Site Haemorrhage	0.07% 1/1406 • Number of events 1 • 60 Months
General disorders Sudden Cardiac Death	0.07% 1/1406 • Number of events 1 • 60 Months
General disorders Sudden Death	0.07% 1/1406 • Number of events 1 • 60 Months
General disorders Thrombosis In Device	0.64% 9/1406 • Number of events 12 • 60 Months
General disorders Vessel Puncture Site Discharge	0.07% 1/1406 • Number of events 1 • 60 Months
General disorders Vessel Puncture Site Haematoma	0.21% 3/1406 • Number of events 3 • 60 Months
General disorders Vessel Puncture Site Haemorrhage	0.50% 7/1406 • Number of events 7 • 60 Months
General disorders Vessel Puncture Site Reaction	0.07% 1/1406 • Number of events 1 • 60 Months
Hepatobiliary disorders Bile Duct Stone	0.14% 2/1406 • Number of events 2 • 60 Months
Hepatobiliary disorders Cholangitis	0.21% 3/1406 • Number of events 3 • 60 Months
Hepatobiliary disorders Cholangitis Acute	0.07% 1/1406 • Number of events 2 • 60 Months
Hepatobiliary disorders Cholecystitis	0.28% 4/1406 • Number of events 4 • 60 Months
Hepatobiliary disorders Cholecystitis Acute	0.14% 2/1406 • Number of events 2 • 60 Months
Hepatobiliary disorders Cholelithiasis	0.43% 6/1406 • Number of events 6 • 60 Months
Hepatobiliary disorders Cholestasis	0.07% 1/1406 • Number of events 1 • 60 Months
Hepatobiliary disorders Gallbladder Necrosis	0.07% 1/1406 • Number of events 1 • 60 Months
Hepatobiliary disorders Hepatic Cirrhosis	0.14% 2/1406 • Number of events 2 • 60 Months
Hepatobiliary disorders Hepatitis	0.07% 1/1406 • Number of events 1 • 60 Months
Hepatobiliary disorders Liver Disorder	0.14% 2/1406 • Number of events 2 • 60 Months
Immune system disorders Anaphylactic Reaction	0.14% 2/1406 • Number of events 3 • 60 Months
Immune system disorders Drug Hypersensitivity	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Abscess	0.14% 2/1406 • Number of events 2 • 60 Months
Infections and infestations Appendicitis	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Appendicitis Perforated	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Bacteraemia	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Bone Abscess	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Bronchitis	0.28% 4/1406 • Number of events 4 • 60 Months
Infections and infestations Bronchopneumonia	0.28% 4/1406 • Number of events 4 • 60 Months
Infections and infestations Cellulitis	0.64% 9/1406 • Number of events 10 • 60 Months
Infections and infestations Clostridium Difficile Colitis	0.14% 2/1406 • Number of events 3 • 60 Months
Infections and infestations Cystitis	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Device Related Infection	0.36% 5/1406 • Number of events 6 • 60 Months
Infections and infestations Diabetic Gangrene	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Diverticulitis	0.21% 3/1406 • Number of events 3 • 60 Months
Infections and infestations Endocarditis	0.14% 2/1406 • Number of events 2 • 60 Months
Infections and infestations Enterococcal Infection	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Erysipelas	0.92% 13/1406 • Number of events 13 • 60 Months
Infections and infestations Febrile Infection	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Fungal Infection	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Gangrene	1.4% 19/1406 • Number of events 21 • 60 Months
Infections and infestations Gastroenteritis	0.21% 3/1406 • Number of events 4 • 60 Months
Infections and infestations Gastroenteritis Viral	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Gastrointestinal Candidiasis	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Graft Infection	0.14% 2/1406 • Number of events 2 • 60 Months
Infections and infestations Groin Abscess	0.14% 2/1406 • Number of events 2 • 60 Months
Infections and infestations Groin Infection	0.14% 2/1406 • Number of events 2 • 60 Months
Infections and infestations Haematoma Infection	0.14% 2/1406 • Number of events 2 • 60 Months
Infections and infestations Helicobacter Gastritis	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Hepatic Infection	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Herpes Zoster	0.21% 3/1406 • Number of events 3 • 60 Months
Infections and infestations Herpes Zoster Infection Neurological	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Herpes Zoster Ophthalmic	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Infected Lymphocele	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Infected Skin Ulcer	0.28% 4/1406 • Number of events 4 • 60 Months
Infections and infestations Infection	0.57% 8/1406 • Number of events 8 • 60 Months
Infections and infestations Infective Exacerbation Of Chronic Obstructive Airways Disease	0.14% 2/1406 • Number of events 2 • 60 Months
Infections and infestations Influenza	0.28% 4/1406 • Number of events 4 • 60 Months
Infections and infestations Kidney Infection	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Localised Infection	0.14% 2/1406 • Number of events 2 • 60 Months
Infections and infestations Lower Respiratory Tract Infection	0.14% 2/1406 • Number of events 2 • 60 Months
Infections and infestations Lung Infection	0.14% 2/1406 • Number of events 2 • 60 Months
Infections and infestations Necrotising Fasciitis	0.14% 2/1406 • Number of events 2 • 60 Months
Infections and infestations Onychomycosis	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Osteomyelitis	0.78% 11/1406 • Number of events 12 • 60 Months
Infections and infestations Osteomyelitis Chronic	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Periorbital Cellulitis	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Peritoneal Abscess	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Pneumonia	5.0% 70/1406 • Number of events 85 • 60 Months
Infections and infestations Post Procedural Infection	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Postoperative Abscess	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Postoperative Wound Infection	0.43% 6/1406 • Number of events 7 • 60 Months
Infections and infestations Prostatic Abscess	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Pseudomembranous Colitis	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Pulmonary Sepsis	0.50% 7/1406 • Number of events 7 • 60 Months
Infections and infestations Pyelonephritis	0.14% 2/1406 • Number of events 2 • 60 Months
Infections and infestations Pyothorax	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Sepsis	0.71% 10/1406 • Number of events 10 • 60 Months
Infections and infestations Septic Shock	0.28% 4/1406 • Number of events 4 • 60 Months
Infections and infestations Severe Acute Respiratory Syndrome	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Sinusitis	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Staphylococcal Infection	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Upper Respiratory Tract Infection	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Urinary Tract Infection	0.85% 12/1406 • Number of events 13 • 60 Months
Infections and infestations Urosepsis	0.43% 6/1406 • Number of events 7 • 60 Months
Infections and infestations Viral Infection	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Wound Infection	0.57% 8/1406 • Number of events 8 • 60 Months
Infections and infestations Wound Infection Bacterial	0.07% 1/1406 • Number of events 1 • 60 Months
Infections and infestations Wound Infection Staphylococcal	0.14% 2/1406 • Number of events 3 • 60 Months
Infections and infestations Wound Sepsis	0.14% 2/1406 • Number of events 3 • 60 Months
Injury, poisoning and procedural complications Alcohol Poisoning	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Anaemia Postoperative	0.36% 5/1406 • Number of events 5 • 60 Months
Injury, poisoning and procedural complications Anastomotic Haemorrhage	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Ankle Fracture	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Arterial Injury	0.14% 2/1406 • Number of events 2 • 60 Months
Injury, poisoning and procedural complications Arterial Restenosis	10.2% 143/1406 • Number of events 204 • 60 Months
Injury, poisoning and procedural complications Arteriovenous Fistula Site Haemorrhage	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Arteriovenous Fistula Thrombosis	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Cervical Vertebral Fracture	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Chemical Peritonitis	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Colon Injury	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Concussion	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Contusion	0.21% 3/1406 • Number of events 3 • 60 Months
Injury, poisoning and procedural complications Coronary Artery Restenosis	0.28% 4/1406 • Number of events 5 • 60 Months
Injury, poisoning and procedural complications Drug Toxicity	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Facial Bones Fracture	0.14% 2/1406 • Number of events 2 • 60 Months
Injury, poisoning and procedural complications Fall	0.43% 6/1406 • Number of events 6 • 60 Months
Injury, poisoning and procedural complications Femoral Neck Fracture	0.21% 3/1406 • Number of events 3 • 60 Months
Injury, poisoning and procedural complications Femoral Nerve Injury	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Femur Fracture	0.43% 6/1406 • Number of events 6 • 60 Months
Injury, poisoning and procedural complications Fibula Fracture	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Foot Fracture	0.21% 3/1406 • Number of events 3 • 60 Months
Injury, poisoning and procedural complications Foreign Body	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Fractured Sacrum	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Gastrointestinal Anastomotic Leak	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Hand Fracture	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Head Injury	0.14% 2/1406 • Number of events 2 • 60 Months
Injury, poisoning and procedural complications Hip Fracture	0.21% 3/1406 • Number of events 3 • 60 Months
Injury, poisoning and procedural complications Humerus Fracture	0.21% 3/1406 • Number of events 4 • 60 Months
Injury, poisoning and procedural complications In-Stent Arterial Restenosis	6.2% 87/1406 • Number of events 113 • 60 Months
Injury, poisoning and procedural complications In-Stent Coronary Artery Restenosis	0.21% 3/1406 • Number of events 3 • 60 Months
Injury, poisoning and procedural complications Incisional Hernia	0.14% 2/1406 • Number of events 3 • 60 Months
Injury, poisoning and procedural complications Joint Dislocation	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Limb Injury	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Lower Limb Fracture	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Meniscus Lesion	0.28% 4/1406 • Number of events 4 • 60 Months
Injury, poisoning and procedural complications Multiple Fractures	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Multiple Injuries	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Nerve Injury	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Overdose	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Patella Fracture	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Pelvic Fracture	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Peripheral Arterial Reocclusion	2.8% 40/1406 • Number of events 52 • 60 Months
Injury, poisoning and procedural complications Periprosthetic Fracture	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Post Laminectomy Syndrome	0.07% 1/1406 • Number of events 3 • 60 Months
Injury, poisoning and procedural complications Post Procedural Complication	0.21% 3/1406 • Number of events 3 • 60 Months
Injury, poisoning and procedural complications Post Procedural Haematoma	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.21% 3/1406 • Number of events 3 • 60 Months
Injury, poisoning and procedural complications Post Procedural Swelling	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Postoperative Thrombosis	0.14% 2/1406 • Number of events 2 • 60 Months
Injury, poisoning and procedural complications Postoperative Wound Complication	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Procedural Hypotension	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Procedural Pain	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Pubis Fracture	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Radiation Oesophagitis	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Radius Fracture	0.21% 3/1406 • Number of events 3 • 60 Months
Injury, poisoning and procedural complications Rib Fracture	0.21% 3/1406 • Number of events 4 • 60 Months
Injury, poisoning and procedural complications Shunt Occlusion	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Shunt Thrombosis	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Skin Laceration	0.14% 2/1406 • Number of events 2 • 60 Months
Injury, poisoning and procedural complications Spinal Compression Fracture	0.14% 2/1406 • Number of events 2 • 60 Months
Injury, poisoning and procedural complications Spinal Fracture	0.14% 2/1406 • Number of events 2 • 60 Months
Injury, poisoning and procedural complications Sternal Fracture	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Subdural Haematoma	0.36% 5/1406 • Number of events 5 • 60 Months
Injury, poisoning and procedural complications Tendon Rupture	0.14% 2/1406 • Number of events 2 • 60 Months
Injury, poisoning and procedural complications Thermal Burn	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Thoracic Vertebral Fracture	0.21% 3/1406 • Number of events 3 • 60 Months
Injury, poisoning and procedural complications Traumatic Brain Injury	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Traumatic Haematoma	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Ulna Fracture	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Upper Limb Fracture	0.14% 2/1406 • Number of events 2 • 60 Months
Injury, poisoning and procedural complications Urinary Retention Postoperative	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Vascular Graft Complication	0.78% 11/1406 • Number of events 11 • 60 Months
Injury, poisoning and procedural complications Vascular Graft Occlusion	1.4% 20/1406 • Number of events 23 • 60 Months
Injury, poisoning and procedural complications Vascular Graft Thrombosis	0.64% 9/1406 • Number of events 13 • 60 Months
Injury, poisoning and procedural complications Vascular Procedure Complication	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Vascular Pseudoaneurysm	2.3% 33/1406 • Number of events 36 • 60 Months
Injury, poisoning and procedural complications Venous Injury	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Wound	0.43% 6/1406 • Number of events 6 • 60 Months
Injury, poisoning and procedural complications Wound Complication	0.14% 2/1406 • Number of events 2 • 60 Months
Injury, poisoning and procedural complications Wound Decomposition	0.07% 1/1406 • Number of events 1 • 60 Months
Injury, poisoning and procedural complications Wound Dehiscence	0.14% 2/1406 • Number of events 2 • 60 Months
Injury, poisoning and procedural complications Wound Necrosis	0.14% 2/1406 • Number of events 2 • 60 Months
Investigations Arteriogram Coronary	0.07% 1/1406 • Number of events 1 • 60 Months
Investigations Blood Creatinine Increased	0.36% 5/1406 • Number of events 5 • 60 Months
Investigations Blood Glucose Abnormal	0.07% 1/1406 • Number of events 1 • 60 Months
Investigations Blood Glucose Fluctuation	0.07% 1/1406 • Number of events 1 • 60 Months
Investigations Blood Glucose Increased	0.07% 1/1406 • Number of events 1 • 60 Months
Investigations Blood Sodium Decreased	0.07% 1/1406 • Number of events 1 • 60 Months
Investigations C-Reactive Protein Increased	0.07% 1/1406 • Number of events 1 • 60 Months
Investigations Chest X-Ray Abnormal	0.07% 1/1406 • Number of events 1 • 60 Months
Investigations Clostridium Test Positive	0.07% 1/1406 • Number of events 1 • 60 Months
Investigations Haemoglobin Decreased	0.28% 4/1406 • Number of events 4 • 60 Months
Investigations International Normalised Ratio Increased	0.14% 2/1406 • Number of events 2 • 60 Months
Investigations Investigation	0.14% 2/1406 • Number of events 2 • 60 Months
Investigations Scan Abnormal	0.07% 1/1406 • Number of events 1 • 60 Months
Investigations Transplant Evaluation	0.07% 1/1406 • Number of events 1 • 60 Months
Metabolism and nutrition disorders Cachexia	0.07% 1/1406 • Number of events 1 • 60 Months
Metabolism and nutrition disorders Decreased Appetite	0.28% 4/1406 • Number of events 4 • 60 Months
Metabolism and nutrition disorders Dehydration	0.07% 1/1406 • Number of events 1 • 60 Months
Metabolism and nutrition disorders Diabetes Mellitus	0.50% 7/1406 • Number of events 7 • 60 Months
Metabolism and nutrition disorders Diabetes Mellitus Inadequate Control	0.28% 4/1406 • Number of events 4 • 60 Months
Metabolism and nutrition disorders Diabetic Foot	0.71% 10/1406 • Number of events 11 • 60 Months
Metabolism and nutrition disorders Fluid Overload	0.14% 2/1406 • Number of events 2 • 60 Months
Metabolism and nutrition disorders Gout	0.36% 5/1406 • Number of events 5 • 60 Months
Metabolism and nutrition disorders Hyperglycaemia	0.07% 1/1406 • Number of events 1 • 60 Months
Metabolism and nutrition disorders Hyperkalaemia	0.07% 1/1406 • Number of events 1 • 60 Months
Metabolism and nutrition disorders Hypoalbuminaemia	0.07% 1/1406 • Number of events 1 • 60 Months
Metabolism and nutrition disorders Hypoglycaemia	0.36% 5/1406 • Number of events 5 • 60 Months
Metabolism and nutrition disorders Hypokalaemia	0.28% 4/1406 • Number of events 4 • 60 Months
Metabolism and nutrition disorders Hypomagnesaemia	0.07% 1/1406 • Number of events 1 • 60 Months
Metabolism and nutrition disorders Hyponatraemia	0.36% 5/1406 • Number of events 6 • 60 Months
Metabolism and nutrition disorders Insulin Resistance	0.07% 1/1406 • Number of events 1 • 60 Months
Metabolism and nutrition disorders Malnutrition	0.07% 1/1406 • Number of events 1 • 60 Months
Metabolism and nutrition disorders Metabolic Acidosis	0.07% 1/1406 • Number of events 1 • 60 Months
Metabolism and nutrition disorders Metabolic Syndrome	0.07% 1/1406 • Number of events 1 • 60 Months
Metabolism and nutrition disorders Type 1 Diabetes Mellitus	0.07% 1/1406 • Number of events 1 • 60 Months
Musculoskeletal and connective tissue disorders Arthralgia	0.21% 3/1406 • Number of events 3 • 60 Months
Musculoskeletal and connective tissue disorders Arthritis	0.14% 2/1406 • Number of events 2 • 60 Months
Musculoskeletal and connective tissue disorders Arthropathy	0.07% 1/1406 • Number of events 1 • 60 Months
Musculoskeletal and connective tissue disorders Back Pain	0.92% 13/1406 • Number of events 13 • 60 Months
Musculoskeletal and connective tissue disorders Bursitis	0.21% 3/1406 • Number of events 3 • 60 Months
Musculoskeletal and connective tissue disorders Cervical Spinal Stenosis	0.07% 1/1406 • Number of events 1 • 60 Months
Musculoskeletal and connective tissue disorders Chondrocalcinosis	0.07% 1/1406 • Number of events 1 • 60 Months
Musculoskeletal and connective tissue disorders Chondropathy	0.07% 1/1406 • Number of events 1 • 60 Months
Musculoskeletal and connective tissue disorders Compartment Syndrome	0.07% 1/1406 • Number of events 1 • 60 Months
Musculoskeletal and connective tissue disorders Dupuytren's Contracture	0.07% 1/1406 • Number of events 2 • 60 Months
Musculoskeletal and connective tissue disorders Fistula	0.14% 2/1406 • Number of events 2 • 60 Months
Musculoskeletal and connective tissue disorders Foot Deformity	0.21% 3/1406 • Number of events 3 • 60 Months
Musculoskeletal and connective tissue disorders Gouty Arthritis	0.14% 2/1406 • Number of events 2 • 60 Months
Musculoskeletal and connective tissue disorders Groin Pain	0.07% 1/1406 • Number of events 1 • 60 Months
Musculoskeletal and connective tissue disorders Haemarthrosis	0.07% 1/1406 • Number of events 1 • 60 Months
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.71% 10/1406 • Number of events 10 • 60 Months
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	0.71% 10/1406 • Number of events 10 • 60 Months
Musculoskeletal and connective tissue disorders Meniscal Degeneration	0.07% 1/1406 • Number of events 1 • 60 Months
Musculoskeletal and connective tissue disorders Musculoskeletal Disorder	0.07% 1/1406 • Number of events 1 • 60 Months
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.43% 6/1406 • Number of events 6 • 60 Months
Musculoskeletal and connective tissue disorders Myalgia	0.07% 1/1406 • Number of events 1 • 60 Months
Musculoskeletal and connective tissue disorders Neck Pain	0.07% 1/1406 • Number of events 1 • 60 Months
Musculoskeletal and connective tissue disorders Nodule On Extremity	0.07% 1/1406 • Number of events 1 • 60 Months
Musculoskeletal and connective tissue disorders Osteoarthritis	1.6% 23/1406 • Number of events 24 • 60 Months
Musculoskeletal and connective tissue disorders Pain In Extremity	0.78% 11/1406 • Number of events 11 • 60 Months
Musculoskeletal and connective tissue disorders Polymyositis	0.07% 1/1406 • Number of events 1 • 60 Months
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.07% 1/1406 • Number of events 1 • 60 Months
Musculoskeletal and connective tissue disorders Rheumatoid Arthritis	0.07% 1/1406 • Number of events 1 • 60 Months
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.21% 3/1406 • Number of events 3 • 60 Months
Musculoskeletal and connective tissue disorders Soft Tissue Necrosis	0.07% 1/1406 • Number of events 1 • 60 Months
Musculoskeletal and connective tissue disorders Spinal Column Stenosis	0.43% 6/1406 • Number of events 7 • 60 Months
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.14% 2/1406 • Number of events 2 • 60 Months
Musculoskeletal and connective tissue disorders Systemic Sclerosis	0.07% 1/1406 • Number of events 1 • 60 Months
Musculoskeletal and connective tissue disorders Tendon Disorder	0.07% 1/1406 • Number of events 1 • 60 Months
Musculoskeletal and connective tissue disorders Tenosynovitis	0.21% 3/1406 • Number of events 3 • 60 Months
Musculoskeletal and connective tissue disorders Trigger Finger	0.14% 2/1406 • Number of events 5 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Pancreas	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.28% 4/1406 • Number of events 4 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Lung Neoplasm	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Renal Neoplasm	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Spleen Tumour	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile Duct Cancer	0.14% 2/1406 • Number of events 4 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.28% 4/1406 • Number of events 4 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer Recurrent	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Neoplasm	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Papilloma	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Transitional Cell Carcinoma	0.14% 2/1406 • Number of events 2 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Transitional Cell Carcinoma Recurrent	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone Neoplasm Malignant	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Neoplasm	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Neoplasm Malignant	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.50% 7/1406 • Number of events 7 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Metastatic	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial Carcinoma	0.14% 2/1406 • Number of events 2 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid Tumour Of The Caecum	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma In Situ Of Skin	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Adenoma	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.36% 5/1406 • Number of events 5 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Neoplasm	0.14% 2/1406 • Number of events 2 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Cancer	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial Cancer	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	0.14% 2/1406 • Number of events 2 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal Carcinoma	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Neoplasm	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Neoplasm Malignant	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal Cancer	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal Cancer	0.28% 4/1406 • Number of events 4 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal Cancer Recurrent	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo Maligna Stage Unspecified	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.21% 3/1406 • Number of events 3 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma Stage I	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma Stage Iii	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer Metastatic	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm	0.43% 6/1406 • Number of events 6 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	1.1% 15/1406 • Number of events 15 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm Of Uterine Adnexa	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm Progression	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Bone	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Liver	0.28% 4/1406 • Number of events 4 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Lymph Nodes	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Bronchial Carcinoma	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mixed Hepatocellular Cholangiocarcinoma	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple Myeloma	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Malignant	0.14% 2/1406 • Number of events 2 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Skin	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine Tumour	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's Lymphoma Recurrent	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's Lymphoma Stage Iv	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer Metastatic	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Carcinoma	0.14% 2/1406 • Number of events 2 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral Fibroma	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral Neoplasm	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cancer	0.14% 2/1406 • Number of events 2 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma	0.14% 2/1406 • Number of events 2 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penis Carcinoma	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.85% 12/1406 • Number of events 12 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer Metastatic	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer Stage Iii	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	0.28% 4/1406 • Number of events 4 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Respiratory Tract Neoplasm	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary Gland Adenoma	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Cancer	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Lung Cancer Stage Unspecified	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	0.64% 9/1406 • Number of events 10 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of Skin	0.21% 3/1406 • Number of events 4 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional Cell Carcinoma	0.21% 3/1406 • Number of events 3 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Undifferentiated Sarcoma	0.07% 1/1406 • Number of events 1 • 60 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval Cancer	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Altered State Of Consciousness	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Amnesia	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Basal Ganglia Haemorrhage	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Basal Ganglia Infarction	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Brain Oedema	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Carotid Artery Occlusion	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Carotid Artery Stenosis	2.3% 33/1406 • Number of events 38 • 60 Months
Nervous system disorders Carpal Tunnel Syndrome	0.57% 8/1406 • Number of events 11 • 60 Months
Nervous system disorders Cerebral Artery Occlusion	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Cerebral Haemorrhage	0.36% 5/1406 • Number of events 5 • 60 Months
Nervous system disorders Cerebral Infarction	0.28% 4/1406 • Number of events 4 • 60 Months
Nervous system disorders Cerebral Ischaemia	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Cerebral Thrombosis	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Cerebrovascular Accident	2.1% 29/1406 • Number of events 30 • 60 Months
Nervous system disorders Cervical Root Pain	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Coordination Abnormal	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Critical Illness Polyneuropathy	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Dementia	0.21% 3/1406 • Number of events 3 • 60 Months
Nervous system disorders Dementia Alzheimer's Type	0.14% 2/1406 • Number of events 2 • 60 Months
Nervous system disorders Dizziness	0.14% 2/1406 • Number of events 2 • 60 Months
Nervous system disorders Embolic Cerebral Infarction	0.14% 2/1406 • Number of events 2 • 60 Months
Nervous system disorders Embolic Stroke	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Encephalopathy	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Epilepsy	0.21% 3/1406 • Number of events 4 • 60 Months
Nervous system disorders Facial Palsy	0.14% 2/1406 • Number of events 2 • 60 Months
Nervous system disorders Guillain-Barre Syndrome	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Haemorrhage Intracranial	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Haemorrhagic Stroke	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Hemiparesis	0.21% 3/1406 • Number of events 3 • 60 Months
Nervous system disorders Intracranial Aneurysm	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Ischaemic Cerebral Infarction	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Ischaemic Stroke	0.85% 12/1406 • Number of events 12 • 60 Months
Nervous system disorders Lacunar Infarction	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Metabolic Encephalopathy	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Myoclonus	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Neuralgia	0.14% 2/1406 • Number of events 2 • 60 Months
Nervous system disorders Neuropathy Peripheral	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Normal Pressure Hydrocephalus	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Parkinson's Disease	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Partial Seizures	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Post-Traumatic Headache	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Presyncope	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Reversible Ischaemic Neurological Deficit	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Sciatica	0.21% 3/1406 • Number of events 3 • 60 Months
Nervous system disorders Speech Disorder	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Spinal Claudication	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Status Epilepticus	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Subarachnoid Haemorrhage	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Syncope	1.00% 14/1406 • Number of events 14 • 60 Months
Nervous system disorders Thoracic Outlet Syndrome	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Thrombotic Stroke	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Toxic Neuropathy	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Transient Global Amnesia	0.07% 1/1406 • Number of events 1 • 60 Months
Nervous system disorders Transient Ischaemic Attack	0.71% 10/1406 • Number of events 10 • 60 Months
Nervous system disorders Vascular Encephalopathy	0.07% 1/1406 • Number of events 1 • 60 Months
Psychiatric disorders Alcohol Abuse	0.07% 1/1406 • Number of events 3 • 60 Months
Psychiatric disorders Alcohol Withdrawal Syndrome	0.07% 1/1406 • Number of events 1 • 60 Months
Psychiatric disorders Anxiety	0.07% 1/1406 • Number of events 1 • 60 Months
Psychiatric disorders Behavioural And Psychiatric Symptoms Of Dementia	0.07% 1/1406 • Number of events 1 • 60 Months
Psychiatric disorders Breathing-Related Sleep Disorder	0.07% 1/1406 • Number of events 1 • 60 Months
Psychiatric disorders Confusional State	0.07% 1/1406 • Number of events 1 • 60 Months
Psychiatric disorders Delirium	0.50% 7/1406 • Number of events 7 • 60 Months
Psychiatric disorders Depression	0.28% 4/1406 • Number of events 5 • 60 Months
Psychiatric disorders Disorientation	0.14% 2/1406 • Number of events 3 • 60 Months
Psychiatric disorders Insomnia	0.07% 1/1406 • Number of events 1 • 60 Months
Psychiatric disorders Mood Disorder Due To A General Medical Condition	0.07% 1/1406 • Number of events 1 • 60 Months
Psychiatric disorders Panic Attack	0.07% 1/1406 • Number of events 1 • 60 Months
Psychiatric disorders Paranoia	0.07% 1/1406 • Number of events 1 • 60 Months
Psychiatric disorders Psychotic Disorder	0.07% 1/1406 • Number of events 1 • 60 Months
Psychiatric disorders Suicide Attempt	0.14% 2/1406 • Number of events 2 • 60 Months
Renal and urinary disorders Azotaemia	0.07% 1/1406 • Number of events 1 • 60 Months
Renal and urinary disorders Bladder Prolapse	0.07% 1/1406 • Number of events 1 • 60 Months
Renal and urinary disorders Bladder Tamponade	0.07% 1/1406 • Number of events 1 • 60 Months
Renal and urinary disorders Cystitis Haemorrhagic	0.14% 2/1406 • Number of events 2 • 60 Months
Renal and urinary disorders Haematuria	0.28% 4/1406 • Number of events 4 • 60 Months
Renal and urinary disorders Hydronephrosis	0.07% 1/1406 • Number of events 1 • 60 Months
Renal and urinary disorders Nephrolithiasis	0.21% 3/1406 • Number of events 3 • 60 Months
Renal and urinary disorders Nephropathy Toxic	0.07% 1/1406 • Number of events 1 • 60 Months
Renal and urinary disorders Renal Artery Stenosis	0.21% 3/1406 • Number of events 3 • 60 Months
Renal and urinary disorders Renal Colic	0.07% 1/1406 • Number of events 1 • 60 Months
Renal and urinary disorders Renal Cyst	0.14% 2/1406 • Number of events 2 • 60 Months
Renal and urinary disorders Renal Disorder	0.07% 1/1406 • Number of events 1 • 60 Months
Renal and urinary disorders Renal Failure	1.2% 17/1406 • Number of events 17 • 60 Months
Renal and urinary disorders Renal Failure Acute	1.6% 22/1406 • Number of events 26 • 60 Months
Renal and urinary disorders Renal Failure Chronic	0.57% 8/1406 • Number of events 8 • 60 Months
Renal and urinary disorders Renal Impairment	0.28% 4/1406 • Number of events 4 • 60 Months
Renal and urinary disorders Stress Urinary Incontinence	0.07% 1/1406 • Number of events 1 • 60 Months
Renal and urinary disorders Ureteric Stenosis	0.07% 1/1406 • Number of events 1 • 60 Months
Renal and urinary disorders Urinary Retention	0.36% 5/1406 • Number of events 5 • 60 Months
Renal and urinary disorders Urinary Tract Disorder	0.07% 1/1406 • Number of events 1 • 60 Months
Reproductive system and breast disorders Adnexa Uteri Mass	0.07% 1/1406 • Number of events 1 • 60 Months
Reproductive system and breast disorders Balanitis	0.07% 1/1406 • Number of events 1 • 60 Months
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.57% 8/1406 • Number of events 8 • 60 Months
Reproductive system and breast disorders Cervical Polyp	0.07% 1/1406 • Number of events 1 • 60 Months
Reproductive system and breast disorders Endometrial Hypertrophy	0.07% 1/1406 • Number of events 1 • 60 Months
Reproductive system and breast disorders Ovarian Cyst	0.07% 1/1406 • Number of events 1 • 60 Months
Reproductive system and breast disorders Pelvic Haematoma	0.07% 1/1406 • Number of events 1 • 60 Months
Reproductive system and breast disorders Postmenopausal Haemorrhage	0.14% 2/1406 • Number of events 2 • 60 Months
Reproductive system and breast disorders Prostatic Obstruction	0.07% 1/1406 • Number of events 1 • 60 Months
Reproductive system and breast disorders Prostatism	0.07% 1/1406 • Number of events 1 • 60 Months
Reproductive system and breast disorders Uterine Polyp	0.07% 1/1406 • Number of events 1 • 60 Months
Reproductive system and breast disorders Uterine Prolapse	0.07% 1/1406 • Number of events 1 • 60 Months
Reproductive system and breast disorders Vaginal Haemorrhage	0.07% 1/1406 • Number of events 1 • 60 Months
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.43% 6/1406 • Number of events 7 • 60 Months
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.21% 3/1406 • Number of events 3 • 60 Months
Respiratory, thoracic and mediastinal disorders Asthma	0.14% 2/1406 • Number of events 2 • 60 Months
Respiratory, thoracic and mediastinal disorders Atelectasis	0.07% 1/1406 • Number of events 1 • 60 Months
Respiratory, thoracic and mediastinal disorders Bronchial Disorder	0.07% 1/1406 • Number of events 1 • 60 Months
Respiratory, thoracic and mediastinal disorders Bronchitis Chronic	0.07% 1/1406 • Number of events 1 • 60 Months
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	1.2% 17/1406 • Number of events 20 • 60 Months
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.00% 14/1406 • Number of events 16 • 60 Months
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.14% 2/1406 • Number of events 2 • 60 Months
Respiratory, thoracic and mediastinal disorders Epiglottic Oedema	0.07% 1/1406 • Number of events 1 • 60 Months
Respiratory, thoracic and mediastinal disorders Epistaxis	0.14% 2/1406 • Number of events 2 • 60 Months
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.14% 2/1406 • Number of events 2 • 60 Months
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.07% 1/1406 • Number of events 1 • 60 Months
Respiratory, thoracic and mediastinal disorders Hypoxia	0.07% 1/1406 • Number of events 1 • 60 Months
Respiratory, thoracic and mediastinal disorders Laryngeal Leukoplakia	0.14% 2/1406 • Number of events 2 • 60 Months
Respiratory, thoracic and mediastinal disorders Lung Cyst	0.07% 1/1406 • Number of events 1 • 60 Months
Respiratory, thoracic and mediastinal disorders Obstructive Airways Disorder	0.07% 1/1406 • Number of events 1 • 60 Months
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.78% 11/1406 • Number of events 11 • 60 Months
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.36% 5/1406 • Number of events 5 • 60 Months
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.14% 2/1406 • Number of events 2 • 60 Months
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.36% 5/1406 • Number of events 5 • 60 Months
Respiratory, thoracic and mediastinal disorders Pulmonary Fibrosis	0.07% 1/1406 • Number of events 1 • 60 Months
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	0.07% 1/1406 • Number of events 1 • 60 Months
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.28% 4/1406 • Number of events 4 • 60 Months
Respiratory, thoracic and mediastinal disorders Respiratory Acidosis	0.07% 1/1406 • Number of events 1 • 60 Months
Respiratory, thoracic and mediastinal disorders Respiratory Arrest	0.14% 2/1406 • Number of events 3 • 60 Months
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.43% 6/1406 • Number of events 6 • 60 Months
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	0.14% 2/1406 • Number of events 2 • 60 Months
Skin and subcutaneous tissue disorders Decubitus Ulcer	0.14% 2/1406 • Number of events 3 • 60 Months
Skin and subcutaneous tissue disorders Dry Gangrene	0.14% 2/1406 • Number of events 2 • 60 Months
Skin and subcutaneous tissue disorders Eczema	0.07% 1/1406 • Number of events 1 • 60 Months
Skin and subcutaneous tissue disorders Erythema	0.14% 2/1406 • Number of events 2 • 60 Months
Skin and subcutaneous tissue disorders Leukoplakia	0.07% 1/1406 • Number of events 1 • 60 Months
Skin and subcutaneous tissue disorders Photosensitivity Reaction	0.07% 1/1406 • Number of events 1 • 60 Months
Skin and subcutaneous tissue disorders Psoriasis	0.07% 1/1406 • Number of events 2 • 60 Months
Skin and subcutaneous tissue disorders Rash	0.07% 1/1406 • Number of events 1 • 60 Months
Skin and subcutaneous tissue disorders Skin Lesion	0.07% 1/1406 • Number of events 1 • 60 Months
Skin and subcutaneous tissue disorders Skin Necrosis	0.07% 1/1406 • Number of events 1 • 60 Months
Skin and subcutaneous tissue disorders Skin Ulcer	1.9% 27/1406 • Number of events 31 • 60 Months
Surgical and medical procedures Abdominal Hernia Repair	0.07% 1/1406 • Number of events 1 • 60 Months
Surgical and medical procedures Aortic Aneurysm Repair	0.07% 1/1406 • Number of events 1 • 60 Months
Surgical and medical procedures Arterial Stent Insertion	0.07% 1/1406 • Number of events 1 • 60 Months
Surgical and medical procedures Arteriovenous Fistula Operation	0.14% 2/1406 • Number of events 2 • 60 Months
Surgical and medical procedures Cardiac Pacemaker Battery Replacement	0.14% 2/1406 • Number of events 2 • 60 Months
Surgical and medical procedures Cataract Operation	0.07% 1/1406 • Number of events 1 • 60 Months
Surgical and medical procedures Central Venous Catheterisation	0.07% 1/1406 • Number of events 1 • 60 Months
Surgical and medical procedures Coronary Artery Bypass	0.07% 1/1406 • Number of events 1 • 60 Months
Surgical and medical procedures Debridement	0.07% 1/1406 • Number of events 1 • 60 Months
Surgical and medical procedures Hospitalisation	0.07% 1/1406 • Number of events 1 • 60 Months
Surgical and medical procedures Ileostomy Closure	0.07% 1/1406 • Number of events 1 • 60 Months
Surgical and medical procedures Implantable Defibrillator Replacement	0.07% 1/1406 • Number of events 1 • 60 Months
Surgical and medical procedures Knee Arthroplasty	0.14% 2/1406 • Number of events 3 • 60 Months
Surgical and medical procedures Leg Amputation	0.14% 2/1406 • Number of events 2 • 60 Months
Surgical and medical procedures Medical Device Change	0.07% 1/1406 • Number of events 1 • 60 Months
Surgical and medical procedures Medical Device Removal	0.07% 1/1406 • Number of events 1 • 60 Months
Surgical and medical procedures Peripheral Artery Angioplasty	0.21% 3/1406 • Number of events 3 • 60 Months
Surgical and medical procedures Peripheral Revascularisation	0.21% 3/1406 • Number of events 4 • 60 Months
Surgical and medical procedures Portal Shunt	0.07% 1/1406 • Number of events 2 • 60 Months
Surgical and medical procedures Renal Transplant	0.07% 1/1406 • Number of events 1 • 60 Months
Surgical and medical procedures Toe Amputation	0.07% 1/1406 • Number of events 1 • 60 Months
Surgical and medical procedures Tympanoplasty	0.07% 1/1406 • Number of events 1 • 60 Months
Surgical and medical procedures Vitrectomy	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Aneurysm	0.07% 1/1406 • Number of events 2 • 60 Months
Vascular disorders Aortic Aneurysm	0.28% 4/1406 • Number of events 4 • 60 Months
Vascular disorders Aortic Aneurysm Rupture	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Aortic Arteriosclerosis	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Aortic Disorder	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Aortic Stenosis	0.14% 2/1406 • Number of events 2 • 60 Months
Vascular disorders Arterial Disorder	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Arterial Haemorrhage	0.43% 6/1406 • Number of events 7 • 60 Months
Vascular disorders Arterial Rupture	0.28% 4/1406 • Number of events 4 • 60 Months
Vascular disorders Arterial Spasm	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Arterial Stenosis	0.36% 5/1406 • Number of events 5 • 60 Months
Vascular disorders Arterial Stenosis Limb	6.3% 89/1406 • Number of events 115 • 60 Months
Vascular disorders Arterial Thrombosis	0.28% 4/1406 • Number of events 5 • 60 Months
Vascular disorders Arterial Thrombosis Limb	4.4% 62/1406 • Number of events 76 • 60 Months
Vascular disorders Arteriosclerosis	0.28% 4/1406 • Number of events 4 • 60 Months
Vascular disorders Arteriosclerosis Obliterans	0.21% 3/1406 • Number of events 4 • 60 Months
Vascular disorders Artery Dissection	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Circulatory Collapse	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Embolism	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Embolism Venous	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Extremity Necrosis	0.92% 13/1406 • Number of events 13 • 60 Months
Vascular disorders Femoral Arterial Stenosis	18.5% 260/1406 • Number of events 397 • 60 Months
Vascular disorders Femoral Artery Aneurysm	0.21% 3/1406 • Number of events 5 • 60 Months
Vascular disorders Femoral Artery Dissection	0.28% 4/1406 • Number of events 4 • 60 Months
Vascular disorders Femoral Artery Embolism	0.14% 2/1406 • Number of events 2 • 60 Months
Vascular disorders Femoral Artery Occlusion	9.7% 137/1406 • Number of events 170 • 60 Months
Vascular disorders Haematoma	1.4% 19/1406 • Number of events 21 • 60 Months
Vascular disorders Haemorrhage	0.14% 2/1406 • Number of events 2 • 60 Months
Vascular disorders Hypertension	0.64% 9/1406 • Number of events 11 • 60 Months
Vascular disorders Hypertensive Crisis	0.64% 9/1406 • Number of events 10 • 60 Months
Vascular disorders Hypovolaemic Shock	0.14% 2/1406 • Number of events 2 • 60 Months
Vascular disorders Iliac Artery Embolism	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Iliac Artery Occlusion	0.71% 10/1406 • Number of events 11 • 60 Months
Vascular disorders Iliac Artery Stenosis	6.8% 95/1406 • Number of events 123 • 60 Months
Vascular disorders Iliac Artery Thrombosis	0.21% 3/1406 • Number of events 3 • 60 Months
Vascular disorders Intermittent Claudication	3.9% 55/1406 • Number of events 64 • 60 Months
Vascular disorders Ischaemia	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Ischaemic Limb Pain	0.28% 4/1406 • Number of events 4 • 60 Months
Vascular disorders Leriche Syndrome	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Lymphatic Fistula	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Lymphocele	0.14% 2/1406 • Number of events 2 • 60 Months
Vascular disorders Necrosis Ischaemic	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Orthostatic Hypotension	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Peripheral Arterial Occlusive Disease	8.7% 122/1406 • Number of events 161 • 60 Months
Vascular disorders Peripheral Artery Aneurysm	0.21% 3/1406 • Number of events 3 • 60 Months
Vascular disorders Peripheral Artery Dissection	0.36% 5/1406 • Number of events 5 • 60 Months
Vascular disorders Peripheral Embolism	0.92% 13/1406 • Number of events 13 • 60 Months
Vascular disorders Peripheral Ischaemia	2.3% 33/1406 • Number of events 41 • 60 Months
Vascular disorders Shock	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Steal Syndrome	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Subclavian Artery Occlusion	0.07% 1/1406 • Number of events 2 • 60 Months
Vascular disorders Subclavian Artery Stenosis	0.14% 2/1406 • Number of events 2 • 60 Months
Vascular disorders Subclavian Steal Syndrome	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Thromboangiitis Obliterans	0.14% 2/1406 • Number of events 3 • 60 Months
Vascular disorders Varicophlebitis	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Varicose Vein	0.21% 3/1406 • Number of events 3 • 60 Months
Vascular disorders Vascular Calcification	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Vasculitis	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Venous Haemorrhage	0.07% 1/1406 • Number of events 1 • 60 Months
Vascular disorders Venous Stenosis	0.14% 2/1406 • Number of events 2 • 60 Months
Vascular disorders Venous Thrombosis Limb	0.14% 2/1406 • Number of events 2 • 60 Months
Vascular disorders Vessel Perforation	0.21% 3/1406 • Number of events 3 • 60 Months

Other adverse events

Other adverse events
Measure	Clinical Cohort 60M n=1406 participants at risk Events through the entire 60 months follow-up period are included
Vascular disorders Femoral Arterial Stenosis	10.1% 142/1406 • Number of events 175 • 60 Months
Vascular disorders Intermittent Claudication	5.2% 73/1406 • Number of events 80 • 60 Months
Vascular disorders Peripheral Arterial Occlusive Disease	5.1% 72/1406 • Number of events 85 • 60 Months

Additional Information

Kristel Wittebols Clinical Research Director

Medtronic

Phone: +31433566580

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60