Trial Outcomes & Findings for Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia (NCT NCT00941733)
NCT ID: NCT00941733
Last Updated: 2018-02-28
Results Overview
The difference between minimum lumen diameter (MLD) immediately after Percutaneous Transluminal Angioplasty (PTA) and MLD at 12 months follow-up
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
358 participants
Primary outcome timeframe
12 months or at Target Lesion Revascularization (TLR) time
Results posted on
2018-02-28
Participant Flow
Participant milestones
| Measure |
Drug Eluting Balloon
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Overall Study
STARTED
|
239
|
119
|
|
Overall Study
COMPLETED
|
165
|
91
|
|
Overall Study
NOT COMPLETED
|
74
|
28
|
Reasons for withdrawal
| Measure |
Drug Eluting Balloon
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Overall Study
Death
|
24
|
10
|
|
Overall Study
Withdrawal by Subject
|
14
|
6
|
|
Overall Study
Adverse Event
|
20
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Protocol Violation
|
15
|
6
|
Baseline Characteristics
Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia
Baseline characteristics by cohort
| Measure |
Drug Eluting Balloon
n=239 Participants
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=119 Participants
Standard PTA balloon: Balloon Angioplasty
|
Total
n=358 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.3 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
71.7 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
72.5 years
STANDARD_DEVIATION 9.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
182 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
266 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
73 participants
n=5 Participants
|
35 participants
n=7 Participants
|
108 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
31 participants
n=5 Participants
|
15 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
60 participants
n=5 Participants
|
31 participants
n=7 Participants
|
91 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
47 participants
n=5 Participants
|
25 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
26 participants
n=5 Participants
|
13 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months or at Target Lesion Revascularization (TLR) timePopulation: ITT
The difference between minimum lumen diameter (MLD) immediately after Percutaneous Transluminal Angioplasty (PTA) and MLD at 12 months follow-up
Outcome measures
| Measure |
Drug Eluting Balloon
n=239 Participants
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=119 Participants
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA)
|
0.605 mm
Standard Deviation 0,775
|
0.616 mm
Standard Deviation 0.781
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Amputation free surviving meaning participants without an amputation at 12 months. This analysis population consists of 196 participants in the Drug Eluting Balloon arm and 107 participants in the Standard PTA arm.
Percentage of participants in the amputation free survival population with Clinically driven Target Lesion Revascularization (CD-TLR) at 12 months, CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s).
Outcome measures
| Measure |
Drug Eluting Balloon
n=196 Participants
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=107 Participants
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients
|
9.2 percentage of participants analyzed
|
13.1 percentage of participants analyzed
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Percentage based on number of evaluable subjects for safety events (232 participants in the drug eluting balloon arm and 114 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.
Percentage of participants experiencing all cause death, major amputation and clinically driven Target Lesion Revascularization (CD-TLR) at 6 months. CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s)
Outcome measures
| Measure |
Drug Eluting Balloon
n=232 Participants
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=114 Participants
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR)
|
17.67 percentage of participants analyzed
|
15.79 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.
Percentage of participants with a 1 year amputation free survival.
Outcome measures
| Measure |
Drug Eluting Balloon
n=227 Participants
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=111 Participants
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Amputation Free Survival
|
81.1 percentage of participants analyzed
|
89.2 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Patients with pre-existing wounds and/or occurence of new wounds
Percentage of participants with completed wound healing, wound healing as defined as core lab adjudication of \> 50% area/volume reduction of baseline ulcer(s) in the treated leg at 1 year.
Outcome measures
| Measure |
Drug Eluting Balloon
n=164 Participants
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=91 Participants
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Rate of Wound Healing
|
73.8 percentage of patients analyzed
|
76.9 percentage of patients analyzed
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Percentage based on number of evaluable subjects for safety events (206 participants in the drug eluting balloon arm and 103 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.
Percentage of participants with a 1 year amputation free survival and wound healing. Wound healing is defined as core lab adjudication of \> 50% area/volume reduction of baseline ulcer(s) in the treated leg at a specified time point.
Outcome measures
| Measure |
Drug Eluting Balloon
n=206 Participants
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=103 Participants
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Amputation Free Survival and Wound Healing
|
58.7 percentage of participants analyzed
|
68.0 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Percentage based on number of evaluable subjects for safety events (205 participants in the drug eluting balloon arm and 103 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.
Percentage of participants with an amputation free survival and resolved Critical Limb Ischemia (CLI) at 1 year.
Outcome measures
| Measure |
Drug Eluting Balloon
n=205 Participants
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=103 Participants
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Amputation Free Survival and Resolved Critical Limb Ischemia (CLI)
|
57.1 percentage of participants analyzed
|
66.0 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.
Percentage of participants that experienced death, amputation and clinically driven Target Lesion Revascularization (TLR) at 1 year.
Outcome measures
| Measure |
Drug Eluting Balloon
n=227 Participants
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=111 Participants
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Death, Amputation and Clinically Driven Target Lesion Revascularization (TLR)
|
39.6 percentage of participants analyzed
|
34.2 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis population consists of amputation free, clinically driven (target lesion revascularization)TLR free surviving subjects
Percentage of participants that experienced primary sustained clinical improvement at 1 year, specified as an improvement shift in the Rutherford classification of one class in amputation free, clinically driven target lesion revascularization (TLR) free surviving subjects.
Outcome measures
| Measure |
Drug Eluting Balloon
n=163 Participants
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=91 Participants
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Primary Sustained Clinical Improvement
|
69.3 percentage of participants analyzed
|
68.1 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis population consists of amputation free, clinically driven (target lesion revascularization)TLR free surviving subjects
Percentage of participants that experienced a secondary sustained clinical improvement, specified as an improvement shift in the Rutherford classification of one class including the need for clinically driven TLR in amputation free surviving subjects at 1 year.
Outcome measures
| Measure |
Drug Eluting Balloon
n=163 Participants
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=91 Participants
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Secondary Sustained Clinical Improvement
|
73.6 percentage of participants analyzed
|
78.0 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Effectiveness Analysis sets - all randomized subjects with available data for EQ5D at baseline and 1 year
Quality of life assessment by EQ5D at 1 year compared to baseline. EQ-5D is a standardised measure of health status and economic appraisal. The EQ-5D-3L essentially consists of 2 parts:the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. EQ-5D health states can be converted into a single summary index where 0.0='worst possible outcome' and 1.0='best possible outcome'.
Outcome measures
| Measure |
Drug Eluting Balloon
n=157 Participants
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=91 Participants
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Quality of Life Assessment by EQ5D
|
0.6975 units on a scale
Standard Deviation 0.3080
|
0.7445 units on a scale
Standard Deviation 0.3035
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Effectiveness Analysis sets - all randomized subjects with available data for Walking Impairment assessment at baseline and 1 year
Walking Impairment assessment by WIQ at 1 year compared to baseline. The Walking Impairment Questionnaire (WIQ) is a questionnaire for evaluating walking impairment in patients with peripheral arterial disease (PAD). This can be used to identify patients with significant impairment and to monitor effectiveness of therapeutic interventions. The questionnaire was self-administered by the patients and contains three domains measuring three important factors of walking impairment in patients with intermittent claudication: (1) difficulty walking a distance during the past month, (2) difficulty walking at a certain speed during the past month, (3) symptoms associated with walking impairment. For each separate domain, a subscore was calculated. The total WIQ score was defined as the mean of the three subscores. A WIQ score of 42.5 or less identified low performers; while a score of 75.5 or more identified high performers. The WIQ score range is 0 (minimum) - 100 (maximum).
Outcome measures
| Measure |
Drug Eluting Balloon
n=76 Participants
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=38 Participants
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Walking Capacity Assessment
|
74.6 units on a scale
Standard Deviation 35.2
|
75.4 units on a scale
Standard Deviation 31.7
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.
Percentage of participants with a MAE (Major Adverse Events) at 1 year. Major Adverse Events, defined as Death of any Cause, Major Amputation of target limb, Minor Amputation of target limb
Outcome measures
| Measure |
Drug Eluting Balloon
n=227 Participants
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=111 Participants
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
MAE (Major Adverse Events)
|
35.2 percentage of participants analyzed
|
25.2 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: Day 1Population: Number of device deployments
Percentage of device success defined as exact deployment of the device according to the instructions for use as documented with suitable imaging modalities
Outcome measures
| Measure |
Drug Eluting Balloon
n=355 Participants
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=189 Participants
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Device Success
|
98.0 percentage of device deployments
|
96.3 percentage of device deployments
|
SECONDARY outcome
Timeframe: Day 1Population: Number of device deployments
Percentage of technical success defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with less or equal to 50% residual diameter reduction of the treated lesion on completion angiography
Outcome measures
| Measure |
Drug Eluting Balloon
n=355 Participants
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=189 Participants
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Technical Success
|
93.2 percentage of device deployments
|
88.4 percentage of device deployments
|
SECONDARY outcome
Timeframe: Day 1Population: All randomized subjects with available data
Percentage of patients with a procedural success defined as combination of technical success, device success and absence of procedural complications
Outcome measures
| Measure |
Drug Eluting Balloon
n=238 Participants
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=119 Participants
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Procedural Success
|
98.3 percentage of participants analyzed
|
100 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All randomized subjects with available data
Days of hospitalization at 1 year
Outcome measures
| Measure |
Drug Eluting Balloon
n=238 Participants
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=119 Participants
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Days of Hospitalization
|
4.5 days
Standard Deviation 8.5
|
4.0 days
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Angiographic subgroup only. Angio-target lesion is one identifiable single solitary or series of multiple adjacent lesions with a diameter stenosis higher than 70% and a cumulative length less than 100 mm that can be covered by a single IN.PACT Amphirion™; and Angio-target lesion is the only lesion in that vessel.
Percentage of participants with an improvement in percent diameter stenosis (%DS) of the target leasion (TL) assessed by Quantitative Vascular Angiography (QVA)
Outcome measures
| Measure |
Drug Eluting Balloon
n=61 Participants
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=31 Participants
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Improvement % Diameter Stenosis (%DS) of the Target Leasion (TL) Assessed by Quantitative Vascular Angiography (QVA)
|
82.0 percentage of participants analyzed
|
71.0 percentage of participants analyzed
|
Adverse Events
Drug Eluting Balloon
Serious events: 197 serious events
Other events: 220 other events
Deaths: 0 deaths
Standard PTA
Serious events: 92 serious events
Other events: 108 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Drug Eluting Balloon
n=239 participants at risk
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=119 participants at risk
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/239 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
4.2%
10/239 • Number of events 12 • 1 year
|
2.5%
3/119 • Number of events 3 • 1 year
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Cardiac disorders
Acute myocardial infarction
|
2.5%
6/239 • Number of events 6 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Cardiac disorders
Angina pectoris
|
0.42%
1/239 • Number of events 1 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Cardiac disorders
Angina unstable
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Cardiac disorders
Arrhythmia
|
0.84%
2/239 • Number of events 3 • 1 year
|
0.00%
0/119 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
4/239 • Number of events 4 • 1 year
|
3.4%
4/119 • Number of events 4 • 1 year
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 2 • 1 year
|
|
Cardiac disorders
Atrioventricular block
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Cardiac disorders
Cardiac arrest
|
1.7%
4/239 • Number of events 4 • 1 year
|
0.00%
0/119 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
10.0%
24/239 • Number of events 32 • 1 year
|
8.4%
10/119 • Number of events 11 • 1 year
|
|
Cardiac disorders
Cardiac failure acute
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Cardiac disorders
Cardiac failure congestive
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Cardiac disorders
Cardiogenic shock
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiovascular disorder
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Cardiac disorders
Coronary artery disease
|
1.7%
4/239 • Number of events 4 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary artery stenosis
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Cardiac disorders
Heart valve stenosis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Cardiac disorders
Hypertrophic cardiomyopathy
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
2.9%
7/239 • Number of events 8 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Cardiac disorders
Right ventricular failure
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Cardiac disorders
Sick sinus syndrome
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Cardiac disorders
Tachyarrhythmia
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Cardiac disorders
Ventricular tachycardia
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 2 • 1 year
|
|
Congenital, familial and genetic disorders
Adenomatous polyposis coli
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Vertigo
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Endocrine disorders
Hyperthyroidism
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Eye disorders
Cataract
|
1.3%
3/239 • Number of events 3 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Eye disorders
Diplopia
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Eye disorders
Eye inflammation
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Eye disorders
Maculopathy
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Eye disorders
Vitreous haemorrhage
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Gastrointestinal disorders
Enteritis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Gastrointestinal disorders
Gastric dilatation
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.7%
4/239 • Number of events 6 • 1 year
|
1.7%
2/119 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.3%
3/239 • Number of events 3 • 1 year
|
0.00%
0/119 • 1 year
|
|
Gastrointestinal disorders
Melaena
|
0.42%
1/239 • Number of events 3 • 1 year
|
1.7%
2/119 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
General disorders
Application site rash
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
General disorders
Asthenia
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
General disorders
Chest pain
|
2.9%
7/239 • Number of events 11 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
General disorders
Death
|
1.7%
4/239 • Number of events 4 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
General disorders
Device dislocation
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
General disorders
Device occlusion
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
General disorders
General physical health deterioration
|
1.3%
3/239 • Number of events 4 • 1 year
|
0.00%
0/119 • 1 year
|
|
General disorders
Impaired healing
|
11.7%
28/239 • Number of events 36 • 1 year
|
7.6%
9/119 • Number of events 13 • 1 year
|
|
General disorders
Inflammation
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
General disorders
Local swelling
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
General disorders
Multi-organ failure
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
General disorders
Necrosis
|
0.42%
1/239 • Number of events 1 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
General disorders
Oedema
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
General disorders
Oedema peripheral
|
2.1%
5/239 • Number of events 5 • 1 year
|
0.00%
0/119 • 1 year
|
|
General disorders
Pain
|
0.84%
2/239 • Number of events 3 • 1 year
|
4.2%
5/119 • Number of events 5 • 1 year
|
|
General disorders
Puncture site haemorrhage
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
General disorders
Pyrexia
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
General disorders
Thrombosis in device
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Immune system disorders
Hypersensitivity
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Abscess limb
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Appendicitis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Cellulitis
|
1.7%
4/239 • Number of events 5 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Infections and infestations
Clostridium colitis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Device related infection
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 2 • 1 year
|
|
Infections and infestations
Erysipelas
|
1.3%
3/239 • Number of events 3 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Infections and infestations
Escherichia infection
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Gangrene
|
5.4%
13/239 • Number of events 15 • 1 year
|
5.9%
7/119 • Number of events 7 • 1 year
|
|
Infections and infestations
Gastroenteritis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Haematoma infection
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Herpes zoster ophthalmic
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Infections and infestations
Infection
|
4.2%
10/239 • Number of events 10 • 1 year
|
3.4%
4/119 • Number of events 4 • 1 year
|
|
Infections and infestations
Intervertebral discitis
|
0.42%
1/239 • Number of events 1 • 1 year
|
2.5%
3/119 • Number of events 3 • 1 year
|
|
Infections and infestations
Localised infection
|
2.9%
7/239 • Number of events 11 • 1 year
|
4.2%
5/119 • Number of events 5 • 1 year
|
|
Infections and infestations
Meningoencephalitis herpetic
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Osteomyelitis
|
2.9%
7/239 • Number of events 8 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Infections and infestations
Pneumonia
|
2.9%
7/239 • Number of events 8 • 1 year
|
3.4%
4/119 • Number of events 5 • 1 year
|
|
Infections and infestations
Respiratory tract infection
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Sepsis
|
1.3%
3/239 • Number of events 3 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Septic shock
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Staphylococcal sepsis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
2.1%
5/239 • Number of events 5 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Infections and infestations
Wound infection
|
1.7%
4/239 • Number of events 4 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Arterial restenosis
|
5.0%
12/239 • Number of events 12 • 1 year
|
6.7%
8/119 • Number of events 16 • 1 year
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Contusion
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.3%
3/239 • Number of events 3 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.42%
1/239 • Number of events 1 • 1 year
|
2.5%
3/119 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Head injury
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
1.7%
4/239 • Number of events 4 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
1.3%
3/239 • Number of events 3 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Peripheral arterial reocclusion
|
2.1%
5/239 • Number of events 5 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Postoperative renal failure
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
2.5%
6/239 • Number of events 6 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Wound
|
3.3%
8/239 • Number of events 10 • 1 year
|
1.7%
2/119 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Investigations
Arteriogram coronary abnormal
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Investigations
Blood creatinine increased
|
0.00%
0/239 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Investigations
Blood glucose fluctuation
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Investigations
Brain natriuretic peptide increased
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Investigations
Troponin increased
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Investigations
White blood cell count
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Metabolism and nutrition disorders
Diabetic foot
|
1.3%
3/239 • Number of events 3 • 1 year
|
0.00%
0/119 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.84%
2/239 • Number of events 2 • 1 year
|
2.5%
3/119 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.42%
1/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
3/239 • Number of events 3 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Meniscal degeneration
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
6/239 • Number of events 6 • 1 year
|
0.84%
1/119 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of skin
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.42%
1/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.42%
1/239 • Number of events 3 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebral infarction
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Cerebrovascular accident
|
4.2%
10/239 • Number of events 10 • 1 year
|
1.7%
2/119 • Number of events 3 • 1 year
|
|
Nervous system disorders
Cerebrovascular stenosis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Convulsion
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.42%
1/239 • Number of events 1 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Nervous system disorders
Neurological symptom
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Paraesthesia
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Parkinson's disease
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Restless legs syndrome
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Spinal claudication
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Syncope
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Delirium
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Bladder tamponade
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Renal and urinary disorders
Haematuria
|
1.3%
3/239 • Number of events 5 • 1 year
|
0.00%
0/119 • 1 year
|
|
Renal and urinary disorders
Incontinence
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Renal and urinary disorders
Renal failure
|
2.1%
5/239 • Number of events 6 • 1 year
|
2.5%
3/119 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
Renal failure acute
|
1.3%
3/239 • Number of events 3 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal failure chronic
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
5/239 • Number of events 7 • 1 year
|
7.6%
9/119 • Number of events 10 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry gangrene
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
4.2%
10/239 • Number of events 10 • 1 year
|
1.7%
2/119 • Number of events 3 • 1 year
|
|
Social circumstances
Social stay hospitalisation
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Surgical and medical procedures
Amputation
|
1.3%
3/239 • Number of events 3 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Angioplasty
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Arterial bypass operation
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Surgical and medical procedures
Arteriovenous shunt operation
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Debridement
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Dialysis device insertion
|
0.00%
0/239 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Hospitalisation
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.42%
1/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Surgical and medical procedures
Leg amputation
|
2.1%
5/239 • Number of events 5 • 1 year
|
0.00%
0/119 • 1 year
|
|
Surgical and medical procedures
Nail operation
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Peripheral revascularisation
|
5.0%
12/239 • Number of events 25 • 1 year
|
5.9%
7/119 • Number of events 9 • 1 year
|
|
Surgical and medical procedures
Spinal decompression
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Surgical and medical procedures
Toe amputation
|
2.9%
7/239 • Number of events 7 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Tracheostomy
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Aortic aneurysm
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Arterial rupture
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Arterial spasm
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Vascular disorders
Arterial stenosis limb
|
8.8%
21/239 • Number of events 25 • 1 year
|
9.2%
11/119 • Number of events 14 • 1 year
|
|
Vascular disorders
Arterial thrombosis limb
|
1.3%
3/239 • Number of events 3 • 1 year
|
1.7%
2/119 • Number of events 5 • 1 year
|
|
Vascular disorders
Artery dissection
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Vascular disorders
Extremity necrosis
|
8.8%
21/239 • Number of events 28 • 1 year
|
3.4%
4/119 • Number of events 5 • 1 year
|
|
Vascular disorders
Femoral arterial stenosis
|
7.9%
19/239 • Number of events 28 • 1 year
|
3.4%
4/119 • Number of events 6 • 1 year
|
|
Vascular disorders
Haematoma
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Haemorrhage
|
0.84%
2/239 • Number of events 4 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypertensive crisis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypovolaemic shock
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Vascular disorders
Iliac artery stenosis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Vascular disorders
Intermittent claudication
|
2.5%
6/239 • Number of events 6 • 1 year
|
0.84%
1/119 • Number of events 3 • 1 year
|
|
Vascular disorders
Necrosis ischaemic
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
17.6%
42/239 • Number of events 64 • 1 year
|
18.5%
22/119 • Number of events 59 • 1 year
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Vascular disorders
Peripheral artery dissection
|
0.42%
1/239 • Number of events 1 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Vascular disorders
Peripheral embolism
|
1.3%
3/239 • Number of events 3 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral ischaemia
|
0.42%
1/239 • Number of events 1 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Vascular disorders
Reperfusion injury
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Thrombosis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
Other adverse events
| Measure |
Drug Eluting Balloon
n=239 participants at risk
IN.PACT Amphirion: Balloon Angioplasty
|
Standard PTA
n=119 participants at risk
Standard PTA balloon: Balloon Angioplasty
|
|---|---|---|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
4/239 • Number of events 4 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Cardiac disorders
Acute myocardial infarction
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Cardiac disorders
Angina pectoris
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Cardiac disorders
Aortic valve stenosis
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.84%
2/239 • Number of events 2 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Cardiac disorders
Bradycardia
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
2.1%
5/239 • Number of events 6 • 1 year
|
2.5%
3/119 • Number of events 4 • 1 year
|
|
Cardiac disorders
Coronary artery disease
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Cardiac disorders
Mitral valve incompetence
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
0.84%
2/239 • Number of events 2 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Ear and labyrinth disorders
Vertigo
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Endocrine disorders
Goitre
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Endocrine disorders
Hyperthyroidism
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Endocrine disorders
Hypothyroidism
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Eye disorders
Cataract
|
0.84%
2/239 • Number of events 3 • 1 year
|
0.00%
0/119 • 1 year
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Eye disorders
Diabetic retinal oedema
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Eye disorders
Diabetic retinopathy
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Eye disorders
Hyalosis asteroid
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Eye disorders
Macular oedema
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Eye disorders
Vitreous haemorrhage
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Gastrointestinal disorders
Abdominal distension
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/239 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
General disorders
Catheter site pain
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
General disorders
Chest pain
|
0.84%
2/239 • Number of events 3 • 1 year
|
0.00%
0/119 • 1 year
|
|
General disorders
Death
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
General disorders
Device breakage
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
General disorders
Extravasation
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
General disorders
General physical health deterioration
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
General disorders
Impaired healing
|
4.6%
11/239 • Number of events 12 • 1 year
|
6.7%
8/119 • Number of events 10 • 1 year
|
|
General disorders
Inflammation
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
General disorders
Necrosis
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
General disorders
Oedema peripheral
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
General disorders
Pain
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
General disorders
Pyrexia
|
1.3%
3/239 • Number of events 3 • 1 year
|
0.00%
0/119 • 1 year
|
|
General disorders
Ulcer haemorrhage
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
General disorders
Vessel puncture site haematoma
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Infections and infestations
Abscess
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Infections and infestations
Abscess limb
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Infections and infestations
Carbuncle
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Cellulitis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Diabetic gangrene
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Erysipelas
|
0.84%
2/239 • Number of events 2 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Infections and infestations
Fungal infection
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Gangrene
|
2.5%
6/239 • Number of events 6 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Infections and infestations
Gastroenteritis viral
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Groin abscess
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Infection
|
2.5%
6/239 • Number of events 6 • 1 year
|
3.4%
4/119 • Number of events 4 • 1 year
|
|
Infections and infestations
Influenza
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Infections and infestations
Localised infection
|
2.5%
6/239 • Number of events 6 • 1 year
|
4.2%
5/119 • Number of events 5 • 1 year
|
|
Infections and infestations
Oesophageal candidiasis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Osteomyelitis
|
1.3%
3/239 • Number of events 3 • 1 year
|
2.5%
3/119 • Number of events 3 • 1 year
|
|
Infections and infestations
Paronychia
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Pneumonia
|
2.1%
5/239 • Number of events 6 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Infections and infestations
Respiratory tract infection
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Sepsis
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Infections and infestations
Wound infection
|
2.1%
5/239 • Number of events 5 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Arterial restenosis
|
1.3%
3/239 • Number of events 4 • 1 year
|
2.5%
3/119 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Contusion
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
3/239 • Number of events 3 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Injury
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Osteoradionecrosis
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Overdose
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Peripheral arterial reocclusion
|
0.42%
1/239 • Number of events 1 • 1 year
|
5.0%
6/119 • Number of events 7 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Psychosis postoperative
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/239 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
2.5%
6/239 • Number of events 6 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Wound
|
5.4%
13/239 • Number of events 17 • 1 year
|
5.0%
6/119 • Number of events 6 • 1 year
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Investigations
Angiogram
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Investigations
Blood calcium decreased
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Investigations
Blood cholesterol abnormal
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Investigations
Blood cholesterol increased
|
0.42%
1/239 • Number of events 1 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Investigations
Blood creatine increased
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Investigations
Blood creatinine increased
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Investigations
Blood glucose fluctuation
|
0.84%
2/239 • Number of events 2 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Investigations
Blood glucose increased
|
0.84%
2/239 • Number of events 2 • 1 year
|
2.5%
3/119 • Number of events 3 • 1 year
|
|
Investigations
Blood potassium increased
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Investigations
Blood triglycerides increased
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Investigations
Haemoglobin decreased
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Investigations
International normalised ratio increased
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Investigations
Platelet count decreased
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Investigations
Red blood cell count increased
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Investigations
Scan myocardial perfusion
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Investigations
Weight increased
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Investigations
White blood cell count
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Investigations
White blood cell count decreased
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Investigations
White blood cell count increased
|
1.3%
3/239 • Number of events 3 • 1 year
|
0.00%
0/119 • 1 year
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.3%
3/239 • Number of events 3 • 1 year
|
0.00%
0/119 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.3%
3/239 • Number of events 3 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.1%
5/239 • Number of events 5 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
3/239 • Number of events 3 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint destruction
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.3%
3/239 • Number of events 3 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
6/239 • Number of events 6 • 1 year
|
5.0%
6/119 • Number of events 6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign spleen tumour
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Cerebrovascular accident
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Cerebrovascular stenosis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Dementia
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Diabetic neuropathy
|
1.3%
3/239 • Number of events 3 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Nervous system disorders
Headache
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Mental impairment
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Neuralgia
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Nervous system disorders
Polyneuropathy
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Nervous system disorders
Presyncope
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Nervous system disorders
Syncope
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Agitation
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Psychiatric disorders
Confusional state
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Psychiatric disorders
Delirium
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Renal and urinary disorders
Dysuria
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Renal and urinary disorders
Haematuria
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Renal and urinary disorders
Renal failure
|
1.7%
4/239 • Number of events 4 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Renal failure acute
|
0.84%
2/239 • Number of events 2 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Renal impairment
|
2.1%
5/239 • Number of events 5 • 1 year
|
3.4%
4/119 • Number of events 4 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
5/239 • Number of events 5 • 1 year
|
5.9%
7/119 • Number of events 7 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.42%
1/239 • Number of events 1 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.3%
3/239 • Number of events 3 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.84%
2/239 • Number of events 3 • 1 year
|
0.00%
0/119 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
4.6%
11/239 • Number of events 13 • 1 year
|
3.4%
4/119 • Number of events 4 • 1 year
|
|
Skin and subcutaneous tissue disorders
Transient acantholytic dermatosis
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Surgical and medical procedures
Amputation
|
0.84%
2/239 • Number of events 2 • 1 year
|
0.00%
0/119 • 1 year
|
|
Surgical and medical procedures
Bile duct stent insertion
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Surgical and medical procedures
Peripheral revascularisation
|
2.5%
6/239 • Number of events 7 • 1 year
|
4.2%
5/119 • Number of events 6 • 1 year
|
|
Surgical and medical procedures
Toe amputation
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Aneurysm
|
0.42%
1/239 • Number of events 1 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Vascular disorders
Arterial occlusive disease
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Arterial spasm
|
7.5%
18/239 • Number of events 22 • 1 year
|
4.2%
5/119 • Number of events 6 • 1 year
|
|
Vascular disorders
Arterial stenosis limb
|
6.7%
16/239 • Number of events 17 • 1 year
|
4.2%
5/119 • Number of events 6 • 1 year
|
|
Vascular disorders
Arterial thrombosis limb
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Artery dissection
|
2.9%
7/239 • Number of events 8 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Vascular disorders
Embolism
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Extremity necrosis
|
4.2%
10/239 • Number of events 10 • 1 year
|
1.7%
2/119 • Number of events 2 • 1 year
|
|
Vascular disorders
Femoral arterial stenosis
|
2.9%
7/239 • Number of events 8 • 1 year
|
5.0%
6/119 • Number of events 7 • 1 year
|
|
Vascular disorders
Haematoma
|
3.8%
9/239 • Number of events 9 • 1 year
|
2.5%
3/119 • Number of events 3 • 1 year
|
|
Vascular disorders
Haemorrhage
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Vascular disorders
Hypertension
|
2.9%
7/239 • Number of events 8 • 1 year
|
2.5%
3/119 • Number of events 3 • 1 year
|
|
Vascular disorders
Hypertensive crisis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Intermittent claudication
|
1.7%
4/239 • Number of events 4 • 1 year
|
2.5%
3/119 • Number of events 3 • 1 year
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Necrosis ischaemic
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
11.7%
28/239 • Number of events 34 • 1 year
|
9.2%
11/119 • Number of events 14 • 1 year
|
|
Vascular disorders
Peripheral artery dissection
|
1.3%
3/239 • Number of events 3 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral embolism
|
1.3%
3/239 • Number of events 3 • 1 year
|
2.5%
3/119 • Number of events 3 • 1 year
|
|
Vascular disorders
Peripheral ischaemia
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Thrombosis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Varicose vein
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Vascular disorders
Vascular shunt
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Vascular disorders
Vasospasm
|
0.00%
0/239 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Venous insufficiency
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.84%
1/119 • Number of events 1 • 1 year
|
|
Vascular disorders
Venous thrombosis
|
0.42%
1/239 • Number of events 1 • 1 year
|
0.00%
0/119 • 1 year
|
|
Vascular disorders
Vessel perforation
|
2.1%
5/239 • Number of events 5 • 1 year
|
2.5%
3/119 • Number of events 3 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60