Trial Outcomes & Findings for EVOLVE II QCA: A Prospective, Multicenter Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s) (NCT NCT01787799)
NCT ID: NCT01787799
Last Updated: 2016-03-16
Results Overview
In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
9 month
Results posted on
2016-03-16
Participant Flow
A total of 100 subjects were enrolled at 12 centers in Australia, New Zealand, Singapore and Japan between March 25, 2013 and October 15, 2013.
Participant milestones
| Measure |
SYNERGY Stent System
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)
SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EVOLVE II QCA: A Prospective, Multicenter Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)
Baseline characteristics by cohort
| Measure |
SYNERGY Stent System
n=100 Participants
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)
SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating.
|
|---|---|
|
Age, Continuous
|
64.49 years
STANDARD_DEVIATION 10.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
28 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, of African Heritage
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
70 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islader
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not disclosed
|
0 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
69 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
10 participants
n=5 Participants
|
|
Cardiac Risk Factors
Hyperlipidemia Requiring Medication
|
90 participants
n=5 Participants
|
|
Cardiac Risk Factors
Hypertension Requiring Medication
|
71 participants
n=5 Participants
|
|
Cardiac Risk Factors
Family History of Coronary Artery Disease
|
57 participants
n=5 Participants
|
|
Cardiac Risk Factors
History of PCI
|
33 participants
n=5 Participants
|
|
Cardiac Risk Factors
History of Myocardial Infarction
|
18 participants
n=5 Participants
|
|
Cardiac Risk Factors
Current Diabetes Mellitus; Medically Treated
|
17 participants
n=5 Participants
|
|
Lesion Characteristics
Reference Vessel Diameter
|
2.66 mm
STANDARD_DEVIATION 0.46 • n=5 Participants
|
|
Lesion Characteristics
Lesion Length
|
14.38 mm
STANDARD_DEVIATION 7.49 • n=5 Participants
|
|
Lesion Characteristics
Minimum Lumen Diameter
|
0.86 mm
STANDARD_DEVIATION 0.28 • n=5 Participants
|
|
Lesion Characteristics
Percent Diameter Stenosis
|
67.54 mm
STANDARD_DEVIATION 9.59 • n=5 Participants
|
PRIMARY outcome
Timeframe: 9 monthPopulation: The primary endpoint would be considered to have been met if the SYNERGY in-stent late loss was less than the performance goal of 0.40 mm. The Intent To Treat (ITT) and per protocol populations were identical.
In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA)
Outcome measures
| Measure |
SYNERGY Stent System
n=100 Participants
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)
SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating.
|
|---|---|
|
In-stent Late Loss
|
0.23 mm
Interval 0.16 to 0.29
|
Adverse Events
SYNERGY Stent System
Serious events: 38 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SYNERGY Stent System
n=100 participants at risk
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)
SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating.
|
|---|---|
|
Cardiac disorders
Coronary Artery Dissection
|
7.0%
7/100 • Number of events 7 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Cardiac disorders
Angina Pectoris
|
6.0%
6/100 • Number of events 6 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Cardiac disorders
Myocardial Ischemia
|
3.0%
3/100 • Number of events 3 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Cardiac disorders
Coronary Artery Stenosis
|
2.0%
2/100 • Number of events 2 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Cardiac disorders
Palpitations
|
2.0%
2/100 • Number of events 2 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Cardiac disorders
Angina Unstable
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Cardiac disorders
Myocardial Infarction
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Nervous system disorders
Presyncope
|
2.0%
2/100 • Number of events 2 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Nervous system disorders
Dizziness
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Nervous system disorders
Dizziness postrual
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Nervous system disorders
Ischaemic stroke
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Nervous system disorders
Syncope
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Nervous system disorders
Tension Headache
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
General disorders
Non-cardiac chest pain
|
5.0%
5/100 • Number of events 5 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
General disorders
Chest discomfort
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
General disorders
General physical health deterioration
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Gastrointestinal disorders
Diverticulitis intestional haemorrhagic
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Gastrointestinal disorders
Umbilical hernia
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Infections and infestations
Meningitis
|
2.0%
2/100 • Number of events 2 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Infections and infestations
Pneumonia
|
2.0%
2/100 • Number of events 2 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Eye disorders
Cataract
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Eye disorders
Entropion
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Vascular disorders
Arterial rupture
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Vascular disorders
Haematoma
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Psychiatric disorders
Depression
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Renal and urinary disorders
Renal failure acute
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Surgical and medical procedures
Wound drainage
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
Other adverse events
| Measure |
SYNERGY Stent System
n=100 participants at risk
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)
SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating.
|
|---|---|
|
General disorders
Catheter site haematoma
|
10.0%
10/100 • Number of events 13 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
General disorders
Adverse drug reaction
|
7.0%
7/100 • Number of events 8 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
General disorders
Non-cardiac chest pain
|
7.0%
7/100 • Number of events 7 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
General disorders
Catheter site haemorrhage
|
3.0%
3/100 • Number of events 3 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
General disorders
Fatigue
|
3.0%
3/100 • Number of events 3 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
General disorders
Chest discomfort
|
2.0%
2/100 • Number of events 2 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
General disorders
Catheter site pain
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
General disorders
Pyrexia
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Cardiac disorders
Myocardial Infarction
|
23.0%
23/100 • Number of events 23 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Cardiac disorders
Angina Pectoris
|
5.0%
5/100 • Number of events 5 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
1/100 • Number of events 2 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Cardiac disorders
Arteriospasm coronary
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Cardiac disorders
Bradycardia
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Cardiac disorders
Bundle branch block left
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Cardiac disorders
Coronary artery disease
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Cardiac disorders
Coronary artery stenosis
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Cardiac disorders
Myocardial ischaemia
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Nervous system disorders
Headache
|
7.0%
7/100 • Number of events 7 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Nervous system disorders
Presyncope
|
5.0%
5/100 • Number of events 7 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Nervous system disorders
Syncope
|
2.0%
2/100 • Number of events 2 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Nervous system disorders
Dementia
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Nervous system disorders
Dizziness
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Nervous system disorders
Dizziness ppostural
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Nervous system disorders
Migrane without aura
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.0%
6/100 • Number of events 6 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Injury, poisoning and procedural complications
Back injury
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Injury, poisoning and procedural complications
Head injury
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Injury, poisoning and procedural complications
Laceration
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Injury, poisoning and procedural complications
Road traffic acciedent
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
2/100 • Number of events 2 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Gastrointestinal disorders
Constipation
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Gastrointestinal disorders
Dental caries
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Gastrointestinal disorders
Haematochezia
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
2/100 • Number of events 2 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
2/100 • Number of events 2 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Infections and infestations
Gastroenteritis
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Infections and infestations
Helicobacter infection
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Infections and infestations
Herpes zoster
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Infections and infestations
Influenza
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Infections and infestations
Otitis media
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Infections and infestations
Viral infection
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Vascular disorders
Hypotension
|
4.0%
4/100 • Number of events 4 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Vascular disorders
Arteriosclerosis
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Vascular disorders
Haematoma
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Vascular disorders
Haemorrhage
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Vascular disorders
Hypertension
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Renal and urinary disorders
Haematuria
|
2.0%
2/100 • Number of events 2 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Renal and urinary disorders
Neophrolithiasis
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Renal and urinary disorders
Pollakiuria
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
2/100 • Number of events 2 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Ear and labyrinth disorders
Vertigo
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Ear and labyrinth disorders
Vertigo positional
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Eye disorders
Blepharospasm
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Eye disorders
Cataract
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Eye disorders
Entropion
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
2.0%
2/100 • Number of events 2 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage unspecified
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Psychiatric disorders
Depression
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Psychiatric disorders
Psychogenic pain disorder
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Immune system disorders
Drug hypersensitivity
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Investigations
Blood triglycerides increased
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.0%
1/100 • Number of events 1 • Adverse event information was collected through 12 months.
The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.
|
Additional Information
Peter Maurer, MPH; Director of Clinical Trials
Boston Scientific
Phone: 508-683-6678
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60