Trial Outcomes & Findings for The Medtronic RESOLUTE US Clinical Trial (NCT NCT00726453)
NCT ID: NCT00726453
Last Updated: 2016-05-23
Results Overview
Target Lesion Failure (TLF) at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically-driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1516 participants
Primary outcome timeframe
12 Months
Results posted on
2016-05-23
Participant Flow
Participant milestones
| Measure |
Primary Enrollment Group
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.
Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG).
|
38 mm Length Sub-study
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed.
|
|---|---|---|
|
Primary Enrollment Group
STARTED
|
1402
|
0
|
|
Primary Enrollment Group
COMPLETED
|
1371
|
0
|
|
Primary Enrollment Group
NOT COMPLETED
|
31
|
0
|
|
38 mm Length Group
STARTED
|
0
|
114
|
|
38 mm Length Group
COMPLETED
|
0
|
111
|
|
38 mm Length Group
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Primary Enrollment Group
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.
Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG).
|
38 mm Length Sub-study
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed.
|
|---|---|---|
|
Primary Enrollment Group
Death
|
18
|
0
|
|
Primary Enrollment Group
Withdrawal by Subject
|
13
|
0
|
|
38 mm Length Group
Death
|
0
|
3
|
Baseline Characteristics
The Medtronic RESOLUTE US Clinical Trial
Baseline characteristics by cohort
| Measure |
Primary Enrollment Group
n=1402 Participants
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.
Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG).
|
38 mm Length Sub-study
n=114 Participants
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed. This sub-study completed the primary endpoint in March 2012 results not yet available.
|
Total
n=1516 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
64.5 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
444 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
474 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
958 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
1042 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1402 participants
n=5 Participants
|
114 participants
n=7 Participants
|
1516 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsTarget Lesion Failure (TLF) at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically-driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.
Outcome measures
| Measure |
Primary Enrollment Group
n=1376 Participants
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.
Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG).
|
|---|---|
|
Target Lesion Failure (TLF)
|
4.7 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsTarget Vessel Failure (TVF) composite endpoint and each individual component (Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods).
Outcome measures
| Measure |
Primary Enrollment Group
n=1376 Participants
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.
Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG).
|
|---|---|
|
Target Vessel Failure (TVF)
|
6.3 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsMajor Adverse Cardiac Event (MACE) composite endpoint and each individual component (death, Target Vessel MI (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods).
Outcome measures
| Measure |
Primary Enrollment Group
n=1376 Participants
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.
Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG).
|
|---|---|
|
Major Adverse Cardiac Event (MACE)
|
5.5 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Primary Enrollment Group
n=1376 Participants
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.
Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG).
|
|---|---|
|
Death
|
1.3 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsTarget Vessel MI (as determined by extended historical and ARC definitions).
Outcome measures
| Measure |
Primary Enrollment Group
n=1376 Participants
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.
Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG).
|
|---|---|
|
Target Vessel MI
|
1.4 percentage of eligible participants
|
SECONDARY outcome
Timeframe: 12 monthsStent Thrombosis (ST) (as determined by historic and ARC definitions).
Outcome measures
| Measure |
Primary Enrollment Group
n=1376 Participants
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.
Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG).
|
|---|---|
|
Stent Thrombosis (ST)
|
0.1 percentage of participants
|
Adverse Events
Primary Enrollment Group
Serious events: 509 serious events
Other events: 724 other events
Deaths: 0 deaths
38 mm Length Sub-Study
Serious events: 71 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Primary Enrollment Group
n=1402 participants at risk
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study and are collectively referred to as the Primary Enrollment Group (PEG).
|
38 mm Length Sub-Study
n=114 participants at risk
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.86%
12/1402 • Number of events 16 • 12 months
|
0.00%
0/114 • 12 months
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.21%
3/1402 • Number of events 3 • 12 months
|
0.00%
0/114 • 12 months
|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.5%
21/1402 • Number of events 21 • 12 months
|
2.6%
3/114 • Number of events 3 • 12 months
|
|
Cardiac disorders
Angina Pectoris
|
4.9%
68/1402 • Number of events 83 • 12 months
|
5.3%
6/114 • Number of events 6 • 12 months
|
|
Cardiac disorders
Angina Unstable
|
1.4%
19/1402 • Number of events 19 • 12 months
|
1.8%
2/114 • Number of events 2 • 12 months
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Cardiac disorders
Arrhythmia
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Cardiac disorders
Arteriospasm Coronary
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Cardiac disorders
Atrial Fibrillation
|
1.2%
17/1402 • Number of events 20 • 12 months
|
1.8%
2/114 • Number of events 3 • 12 months
|
|
Cardiac disorders
Atrial Flutter
|
0.21%
3/1402 • Number of events 3 • 12 months
|
0.00%
0/114 • 12 months
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Cardiac disorders
Bradycardia
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiac Arrest
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiac Failure
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.3%
18/1402 • Number of events 21 • 12 months
|
2.6%
3/114 • Number of events 7 • 12 months
|
|
Cardiac disorders
Cardiac Valve Disease
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Cardiac disorders
Cardiogenic Shock
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Cardiac disorders
Coronary Artery Disease
|
4.0%
56/1402 • Number of events 60 • 12 months
|
9.6%
11/114 • Number of events 12 • 12 months
|
|
Cardiac disorders
Coronary Artery Dissection
|
0.93%
13/1402 • Number of events 13 • 12 months
|
6.1%
7/114 • Number of events 7 • 12 months
|
|
Cardiac disorders
Coronary Artery Embolism
|
0.00%
0/1402 • 12 months
|
1.8%
2/114 • Number of events 2 • 12 months
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Cardiac disorders
Coronary Artery Perforation
|
0.00%
0/1402 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Cardiac disorders
Coronary Artery Restenosis
|
0.86%
12/1402 • Number of events 12 • 12 months
|
1.8%
2/114 • Number of events 2 • 12 months
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.93%
13/1402 • Number of events 14 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Cardiac disorders
In-Stent Coronary Artery Restenosis
|
0.93%
13/1402 • Number of events 14 • 12 months
|
0.00%
0/114 • 12 months
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.50%
7/1402 • Number of events 7 • 12 months
|
1.8%
2/114 • Number of events 2 • 12 months
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/1402 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Cardiac disorders
Palpitations
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Cardiac disorders
Pericarditis
|
0.21%
3/1402 • Number of events 3 • 12 months
|
0.00%
0/114 • 12 months
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.21%
3/1402 • Number of events 3 • 12 months
|
0.00%
0/114 • 12 months
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.29%
4/1402 • Number of events 5 • 12 months
|
0.00%
0/114 • 12 months
|
|
Cardiac disorders
Tachycardia
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.29%
4/1402 • Number of events 4 • 12 months
|
0.00%
0/114 • 12 months
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.21%
3/1402 • Number of events 3 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Congenital, familial and genetic disorders
Arteriovenous Malformation
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Congenital, familial and genetic disorders
Atrial Septal Defect
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Endocrine disorders
Hyperparathyroidism Primary
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Eye disorders
Amaurosis Fugax
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Eye disorders
Cataract
|
0.00%
0/1402 • 12 months
|
2.6%
3/114 • Number of events 5 • 12 months
|
|
Eye disorders
Conjunctivitis
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Eye disorders
Eye Swelling
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.71%
10/1402 • Number of events 13 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Barrett's Oesophagus
|
0.00%
0/1402 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Colitis
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
0.07%
1/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1402 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gastritis
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.5%
21/1402 • Number of events 23 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Haematemesis
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Ileus
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.21%
3/1402 • Number of events 4 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Large Intestinal Haemorrhage
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Pancreatitis Chronic
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Pancreatitis Necrotising
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.14%
2/1402 • Number of events 5 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Retroperitoneal Haemorrhage
|
0.21%
3/1402 • Number of events 4 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Splenic Artery Aneurysm
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
0.21%
3/1402 • Number of events 3 • 12 months
|
0.00%
0/114 • 12 months
|
|
General disorders
Adverse Drug Reaction
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
General disorders
Asthenia
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
General disorders
Catheter Site Haemorrhage
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
General disorders
Chest Discomfort
|
0.50%
7/1402 • Number of events 8 • 12 months
|
0.00%
0/114 • 12 months
|
|
General disorders
Chest Pain
|
5.6%
79/1402 • Number of events 98 • 12 months
|
6.1%
7/114 • Number of events 7 • 12 months
|
|
General disorders
Death
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
General disorders
Fatigue
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
General disorders
Granuloma
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
General disorders
Hernia
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
General disorders
Implant Site Effusion
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
General disorders
Injection Site Haematoma
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
General disorders
Injection Site Haemorrhage
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
General disorders
Mass
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
General disorders
Multi-Organ Failure
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
General disorders
Non-Cardiac Chest Pain
|
2.3%
32/1402 • Number of events 39 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
General disorders
Pain
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Hepatobiliary disorders
Biliary Colic
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Hepatobiliary disorders
Cholangitis
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.21%
3/1402 • Number of events 3 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Hepatobiliary disorders
Cholestasis
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Hepatobiliary disorders
Gallbladder Disorder
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Hepatobiliary disorders
Ischaemic Hepatitis
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Immune system disorders
Anaphylactic Reaction
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Immune system disorders
Hypersensitivity
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Abscess Limb
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Abscess Neck
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Appendicitis
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Bronchitis
|
0.21%
3/1402 • Number of events 3 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Bronchopneumonia
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Catheter Site Infection
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Cellulitis
|
0.21%
3/1402 • Number of events 3 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Cellulitis Staphylococcal
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Clostridial Infection
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Diverticulitis
|
0.36%
5/1402 • Number of events 8 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Endocarditis Bacterial
|
0.07%
1/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Escherichia Bacteraemia
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Gastroenteritis
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Gastroenteritis Viral
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Infection
|
0.64%
9/1402 • Number of events 13 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Liver Abscess
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Perirectal Abscess
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Pneumonia
|
1.4%
20/1402 • Number of events 20 • 12 months
|
1.8%
2/114 • Number of events 2 • 12 months
|
|
Infections and infestations
Pyelonephritis
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Sepsis
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Septic Shock
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Staphylococcal Infection
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Syphilitic Endocarditis Of Heart Valve
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.29%
4/1402 • Number of events 4 • 12 months
|
0.00%
0/114 • 12 months
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Injury, poisoning and procedural complications
Arteriovenous Graft Thrombosis
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1402 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/1402 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Meniscus Lesion
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Overdose
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Injury, poisoning and procedural complications
Stent Occlusion
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Injury, poisoning and procedural complications
Sternal Fracture
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/1402 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Therapeutic Agent Toxicity
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Injury, poisoning and procedural complications
Thrombosis In Device
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Injury, poisoning and procedural complications
Urethral Injury
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Investigations
Blood Creatine Phosphokinase Mb Increased
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Investigations
Blood Creatinine Increased
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Investigations
Blood Glucose Increased
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Investigations
Cardiac Enzymes Increased
|
0.50%
7/1402 • Number of events 7 • 12 months
|
2.6%
3/114 • Number of events 3 • 12 months
|
|
Investigations
Cardiac Stress Test Abnormal
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Investigations
Ejection Fraction Decreased
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Investigations
Troponin T Increased
|
0.00%
0/1402 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.21%
3/1402 • Number of events 3 • 12 months
|
0.00%
0/114 • 12 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.21%
3/1402 • Number of events 5 • 12 months
|
0.00%
0/114 • 12 months
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Metabolism and nutrition disorders
Obesity
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.29%
4/1402 • Number of events 4 • 12 months
|
0.00%
0/114 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Bone Lesion
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/1402 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.78%
11/1402 • Number of events 12 • 12 months
|
0.00%
0/114 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.21%
3/1402 • Number of events 3 • 12 months
|
0.00%
0/114 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.00%
0/1402 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.21%
3/1402 • Number of events 3 • 12 months
|
0.00%
0/114 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchioloalveolar Carcinoma
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid Melanoma
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.21%
3/1402 • Number of events 3 • 12 months
|
0.00%
0/114 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative Disorder
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.29%
4/1402 • Number of events 4 • 12 months
|
0.00%
0/114 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Metastatic
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma Stage Unspecified
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer Stage Unspecified
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue Neoplasm Malignant Stage Unspecified
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil Cancer
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.93%
13/1402 • Number of events 14 • 12 months
|
0.00%
0/114 • 12 months
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.00%
14/1402 • Number of events 14 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Nervous system disorders
Cervical Myelopathy
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Nervous system disorders
Dizziness
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Nervous system disorders
Encephalopathy
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Nervous system disorders
Headache
|
0.14%
2/1402 • Number of events 4 • 12 months
|
0.00%
0/114 • 12 months
|
|
Nervous system disorders
Hydrocephalus
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Nervous system disorders
Lethargy
|
0.00%
0/1402 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Nervous system disorders
Nerve Compression
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Nervous system disorders
Presyncope
|
0.29%
4/1402 • Number of events 4 • 12 months
|
0.00%
0/114 • 12 months
|
|
Nervous system disorders
Syncope
|
0.64%
9/1402 • Number of events 10 • 12 months
|
2.6%
3/114 • Number of events 3 • 12 months
|
|
Nervous system disorders
Syncope Vasovagal
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.36%
5/1402 • Number of events 6 • 12 months
|
0.88%
1/114 • Number of events 2 • 12 months
|
|
Psychiatric disorders
Anxiety
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Psychiatric disorders
Completed Suicide
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Psychiatric disorders
Confusional State
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Psychiatric disorders
Mental Status Changes
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Bladder Neck Sclerosis
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Renal and urinary disorders
Bladder Obstruction
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Renal and urinary disorders
Haematuria
|
0.50%
7/1402 • Number of events 7 • 12 months
|
0.00%
0/114 • 12 months
|
|
Renal and urinary disorders
Haemorrhage Urinary Tract
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.29%
4/1402 • Number of events 4 • 12 months
|
0.00%
0/114 • 12 months
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
0.00%
0/1402 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Renal and urinary disorders
Renal Failure
|
0.78%
11/1402 • Number of events 11 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Renal Mass
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Reproductive system and breast disorders
Uterine Haemorrhage
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Reproductive system and breast disorders
Uterine Prolapse
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.71%
10/1402 • Number of events 10 • 12 months
|
1.8%
2/114 • Number of events 3 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
19/1402 • Number of events 20 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.21%
3/1402 • Number of events 3 • 12 months
|
0.00%
0/114 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.21%
3/1402 • Number of events 3 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia Facial
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin Atrophy
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Surgical and medical procedures
Carotid Endarterectomy
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Surgical and medical procedures
Coronary Revascularisation
|
0.43%
6/1402 • Number of events 7 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Hip Arthroplasty
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Surgical and medical procedures
Hysterosalpingo-Oophorectomy
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Surgical and medical procedures
Knee Arthroplasty
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Surgical and medical procedures
Medical Device Implantation
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Surgical and medical procedures
Renal Artery Stent Placement
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Surgical and medical procedures
Therapeutic Embolisation
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Vascular disorders
Accelerated Hypertension
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Vascular disorders
Aneurysm
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Vascular disorders
Aortic Aneurysm
|
0.21%
3/1402 • Number of events 3 • 12 months
|
0.00%
0/114 • 12 months
|
|
Vascular disorders
Arterial Stenosis
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Vascular disorders
Arterial Stenosis Limb
|
0.07%
1/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Vascular disorders
Arteriovenous Fistula
|
0.00%
0/1402 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Vascular disorders
Artery Dissection
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.14%
2/1402 • Number of events 3 • 12 months
|
0.00%
0/114 • 12 months
|
|
Vascular disorders
Femoral Arterial Stenosis
|
0.21%
3/1402 • Number of events 5 • 12 months
|
0.00%
0/114 • 12 months
|
|
Vascular disorders
Femoral Artery Occlusion
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Vascular disorders
Haemorrhage
|
0.21%
3/1402 • Number of events 3 • 12 months
|
1.8%
2/114 • Number of events 2 • 12 months
|
|
Vascular disorders
Hypertension
|
0.93%
13/1402 • Number of events 14 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Vascular disorders
Hypotension
|
0.86%
12/1402 • Number of events 12 • 12 months
|
0.00%
0/114 • 12 months
|
|
Vascular disorders
Iliac Artery Stenosis
|
0.14%
2/1402 • Number of events 2 • 12 months
|
0.00%
0/114 • 12 months
|
|
Vascular disorders
Intermittent Claudication
|
0.43%
6/1402 • Number of events 7 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Vascular disorders
Ischaemia
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Vascular disorders
Peripheral Artery Aneurysm
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Vascular disorders
Peripheral Ischaemia
|
0.21%
3/1402 • Number of events 7 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.50%
7/1402 • Number of events 8 • 12 months
|
1.8%
2/114 • Number of events 2 • 12 months
|
|
Vascular disorders
Poor Peripheral Circulation
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Vascular disorders
Shock
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Vascular disorders
Subclavian Steal Syndrome
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Vascular disorders
Thrombosis
|
0.07%
1/1402 • Number of events 1 • 12 months
|
0.00%
0/114 • 12 months
|
|
Vascular disorders
Vascular Pseudoaneurysm
|
0.21%
3/1402 • Number of events 4 • 12 months
|
0.00%
0/114 • 12 months
|
|
Vascular disorders
Venous Insufficiency
|
0.00%
0/1402 • 12 months
|
0.88%
1/114 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Primary Enrollment Group
n=1402 participants at risk
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study and are collectively referred to as the Primary Enrollment Group (PEG).
|
38 mm Length Sub-Study
n=114 participants at risk
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed.
|
|---|---|---|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/1402 • 12 months
|
8.8%
10/114 • Number of events 11 • 12 months
|
|
Cardiac disorders
Angina Pectoris
|
12.2%
171/1402 • Number of events 212 • 12 months
|
14.0%
16/114 • Number of events 20 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1402 • 12 months
|
8.8%
10/114 • Number of events 10 • 12 months
|
|
General disorders
Chest Pain
|
14.6%
204/1402 • Number of events 256 • 12 months
|
20.2%
23/114 • Number of events 32 • 12 months
|
|
General disorders
Fatigue
|
0.00%
0/1402 • 12 months
|
7.0%
8/114 • Number of events 8 • 12 months
|
|
General disorders
Oedema
|
0.00%
0/1402 • 12 months
|
5.3%
6/114 • Number of events 6 • 12 months
|
|
General disorders
Oedema Peripheral
|
0.00%
0/1402 • 12 months
|
7.9%
9/114 • Number of events 11 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.6%
92/1402 • Number of events 99 • 12 months
|
0.00%
0/114 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
5.5%
77/1402 • Number of events 81 • 12 months
|
14.9%
17/114 • Number of events 18 • 12 months
|
|
Nervous system disorders
Dizziness
|
5.3%
74/1402 • Number of events 79 • 12 months
|
7.0%
8/114 • Number of events 9 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.6%
106/1402 • Number of events 113 • 12 months
|
11.4%
13/114 • Number of events 15 • 12 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/1402 • 12 months
|
12.3%
14/114 • Number of events 15 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER