Trial Outcomes & Findings for Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent (NCT NCT00617084)
NCT ID: NCT00617084
Last Updated: 2014-06-06
Results Overview
Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated) after one year. MI: Q MI if new pathological Q waves and chest pain, non Q MI if CK elevated more than two times normal, troponin elevated more than normal, according to ARC definitions. TLR, clinically indicated if associated with ischemic symptoms and angiographic min lumen diameter bigger than fifty percent by QCA or without symptoms and min lumen diameter bigger than seventy percent. Measure average.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
2292 participants
Primary outcome timeframe
12 months
Results posted on
2014-06-06
Participant Flow
Start recruitment: April 30, 2008 \> End recruitment: October 28, 2008 \> Types of location: medical clinic
Participant milestones
| Measure |
1. Resolute - 12-13 Months
Medtronic Resolute - 12-13 Months
|
2. XIENCE V - 12-13 Months
Abbott Xience V - 12-13 Months
|
|---|---|---|
|
Overall Study
STARTED
|
1140
|
1152
|
|
Overall Study
COMPLETED
|
1119
|
1126
|
|
Overall Study
NOT COMPLETED
|
21
|
26
|
Reasons for withdrawal
| Measure |
1. Resolute - 12-13 Months
Medtronic Resolute - 12-13 Months
|
2. XIENCE V - 12-13 Months
Abbott Xience V - 12-13 Months
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
|
Overall Study
Missed 12 Months visit
|
16
|
19
|
Baseline Characteristics
Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent
Baseline characteristics by cohort
| Measure |
1. Resolute - 12-13 Months
n=1140 Participants
Medtronic Resolute - 12-13 Months
|
2. XIENCE V - 12-13 Months
n=1152 Participants
Abbott Xience V - 12-13 Months
|
Total
n=2292 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
545 Participants
n=5 Participants
|
563 Participants
n=7 Participants
|
1108 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
595 Participants
n=5 Participants
|
589 Participants
n=7 Participants
|
1184 Participants
n=5 Participants
|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
266 Participants
n=5 Participants
|
263 Participants
n=7 Participants
|
529 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
874 Participants
n=5 Participants
|
889 Participants
n=7 Participants
|
1763 Participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
1122 participants
n=5 Participants
|
1132 participants
n=7 Participants
|
2254 participants
n=5 Participants
|
|
Region of Enrollment
Middle East
|
18 participants
n=5 Participants
|
20 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analysis per intention to treat
Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated) after one year. MI: Q MI if new pathological Q waves and chest pain, non Q MI if CK elevated more than two times normal, troponin elevated more than normal, according to ARC definitions. TLR, clinically indicated if associated with ischemic symptoms and angiographic min lumen diameter bigger than fifty percent by QCA or without symptoms and min lumen diameter bigger than seventy percent. Measure average.
Outcome measures
| Measure |
1. Resolute - 12-13 Months
n=1140 Participants
Medtronic Resolute - 12-13 Months
|
2. XIENCE V - 12-13 Months
n=1152 Participants
Abbott Xience V - 12-13 Months
|
|---|---|---|
|
Target Lesion Failure
|
8.2 percentage of participants
Interval 8.2 to 8.2
|
8.3 percentage of participants
Interval 8.3 to 8.3
|
SECONDARY outcome
Timeframe: 13 MonthsIn Stent Percent Diameter Stenosis at thirteen months. In Stent Percent Diameter Stenosis: measured percent of diameter stenosis at the region of the stent (calculated as 100x(RVD-MLD)/RVD using the mean values from 2 orthogonal views by QCA. RVD (Reference Vessel Diameter): average of normal segments within 10mm proximal and distal to target lesion from 2 orthogonal views using QCA. MLD (Minimal Lumen Diameter): average of 2 orthogonal views of the narrowest point wihtin the area of assessment. MLD measured during QCA by the angiographic core laboratory.
Outcome measures
| Measure |
1. Resolute - 12-13 Months
n=1140 Participants
Medtronic Resolute - 12-13 Months
|
2. XIENCE V - 12-13 Months
n=1152 Participants
Abbott Xience V - 12-13 Months
|
|---|---|---|
|
In-Stent Percent Diameter Stenosis
|
21.65 Percentage diameter stenosis
Standard Deviation 14.42
|
19.76 Percentage diameter stenosis
Standard Deviation 14.64
|
Adverse Events
1. Resolute - 12-13 Months
Serious events: 435 serious events
Other events: 0 other events
Deaths: 0 deaths
2. XIENCE V - 12-13 Months
Serious events: 432 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1. Resolute - 12-13 Months
n=1140 participants at risk
Medtronic Resolute - 12-13 Months
|
2. XIENCE V - 12-13 Months
n=1152 participants at risk
Abbott Xience V - 12-13 Months
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.96%
11/1140 • Number of events 15 • 12 months
|
0.61%
7/1152 • Number of events 10 • 12 months
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Cardiac disorders
Acute Myocardial Infarction
|
5.0%
57/1140 • Number of events 60 • 12 months
|
3.9%
45/1152 • Number of events 45 • 12 months
|
|
Cardiac disorders
Angina Pectoris
|
7.8%
89/1140 • Number of events 104 • 12 months
|
8.1%
93/1152 • Number of events 101 • 12 months
|
|
Cardiac disorders
Angina Unstable
|
2.4%
27/1140 • Number of events 32 • 12 months
|
2.3%
27/1152 • Number of events 29 • 12 months
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Cardiac disorders
Arteriospasm Coronary
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Cardiac disorders
Atrial Fibrillation
|
1.1%
13/1140 • Number of events 18 • 12 months
|
1.4%
16/1152 • Number of events 16 • 12 months
|
|
Cardiac disorders
Atrial Flutter
|
0.26%
3/1140 • Number of events 4 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Cardiac disorders
Atrioventricular Block
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.00%
0/1140 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Cardiac disorders
Bradycardia
|
0.61%
7/1140 • Number of events 7 • 12 months
|
0.35%
4/1152 • Number of events 4 • 12 months
|
|
Cardiac disorders
Bundle Branch Block Left
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Cardiac disorders
Bundle Branch Block Right
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Cardiac disorders
Cardiac Arrest
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiac Failure
|
0.35%
4/1140 • Number of events 4 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.61%
7/1140 • Number of events 9 • 12 months
|
0.61%
7/1152 • Number of events 7 • 12 months
|
|
Cardiac disorders
Cardiac Tamponade
|
0.26%
3/1140 • Number of events 3 • 12 months
|
0.26%
3/1152 • Number of events 3 • 12 months
|
|
Cardiac disorders
Cardiogenic Shock
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.43%
5/1152 • Number of events 5 • 12 months
|
|
Cardiac disorders
Cardiomyopathy
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Cardiac disorders
Congestive Cardiomyopathy
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Cardiac disorders
Cor Pulmonale Acute
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Cardiac disorders
Coronary Artery Disease
|
0.79%
9/1140 • Number of events 9 • 12 months
|
0.69%
8/1152 • Number of events 9 • 12 months
|
|
Cardiac disorders
Coronary Artery Dissection
|
0.44%
5/1140 • Number of events 5 • 12 months
|
0.26%
3/1152 • Number of events 3 • 12 months
|
|
Cardiac disorders
Coronary Artery Embolism
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.53%
6/1140 • Number of events 6 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Cardiac disorders
Coronary Artery Perforation
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.35%
4/1152 • Number of events 4 • 12 months
|
|
Cardiac disorders
Coronary Artery Restenosis
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.35%
4/1140 • Number of events 4 • 12 months
|
0.26%
3/1152 • Number of events 3 • 12 months
|
|
Cardiac disorders
Dressler's Syndrome
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Cardiac disorders
Extrasystoles
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Cardiac disorders
In-Stent Coronary Artery Restenosis
|
0.35%
4/1140 • Number of events 4 • 12 months
|
0.35%
4/1152 • Number of events 4 • 12 months
|
|
Cardiac disorders
Intracardiac Thrombus
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Cardiac disorders
Left Ventricular Failure
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.00%
0/1140 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Cardiac disorders
Myocardial Infarction
|
1.3%
15/1140 • Number of events 16 • 12 months
|
0.78%
9/1152 • Number of events 9 • 12 months
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Cardiac disorders
Palpitations
|
0.26%
3/1140 • Number of events 3 • 12 months
|
0.26%
3/1152 • Number of events 3 • 12 months
|
|
Cardiac disorders
Papillary Muscle Disorder
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Cardiac disorders
Pericardial Effusion
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Cardiac disorders
Pericardial Rub
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Cardiac disorders
Pericarditis
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.26%
3/1152 • Number of events 3 • 12 months
|
|
Cardiac disorders
Right Ventricular Failure
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Cardiac disorders
Tachyarrhythmia
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Cardiac disorders
Tachycardia
|
0.09%
1/1140 • Number of events 2 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.53%
6/1140 • Number of events 6 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Cardiac disorders
Ventricular Flutter
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.43%
5/1152 • Number of events 5 • 12 months
|
|
Congenital, familial and genetic disorders
Atrial Septal Defect
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Ear and labyrinth disorders
Meniere's Disease
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Endocrine disorders
Adrenal Disorder
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Endocrine disorders
Goitre
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Endocrine disorders
Thyroid Disorder
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Eye disorders
Cataract
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Eye disorders
Visual Acuity Reduced
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Eye disorders
Vitreous Haemorrhage
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.44%
5/1140 • Number of events 5 • 12 months
|
0.52%
6/1152 • Number of events 8 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1140 • 12 months
|
0.26%
3/1152 • Number of events 4 • 12 months
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.53%
6/1140 • Number of events 7 • 12 months
|
0.35%
4/1152 • Number of events 4 • 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Enteritis
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gastritis
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.88%
10/1140 • Number of events 10 • 12 months
|
1.4%
16/1152 • Number of events 18 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Ulcer
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Melaena
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Pancreatic Disorder
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Retroperitoneal Haemorrhage
|
0.00%
0/1140 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
General disorders
Chest Discomfort
|
0.44%
5/1140 • Number of events 6 • 12 months
|
0.61%
7/1152 • Number of events 7 • 12 months
|
|
General disorders
Chest Pain
|
4.0%
46/1140 • Number of events 54 • 12 months
|
4.0%
46/1152 • Number of events 50 • 12 months
|
|
General disorders
Death
|
0.88%
10/1140 • Number of events 10 • 12 months
|
1.2%
14/1152 • Number of events 14 • 12 months
|
|
General disorders
Fatigue
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
General disorders
Gait Disturbance
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
General disorders
General Physical Health Deterioration
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
General disorders
Hernia
|
0.44%
5/1140 • Number of events 5 • 12 months
|
0.00%
0/1152 • 12 months
|
|
General disorders
Injection Site Haematoma
|
0.88%
10/1140 • Number of events 10 • 12 months
|
0.69%
8/1152 • Number of events 11 • 12 months
|
|
General disorders
Injection Site Haemorrhage
|
0.26%
3/1140 • Number of events 3 • 12 months
|
0.26%
3/1152 • Number of events 3 • 12 months
|
|
General disorders
Injection Site Pain
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
General disorders
Non-Cardiac Chest Pain
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.00%
0/1152 • 12 months
|
|
General disorders
Oedema
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
General disorders
Orthostatic Intolerance
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
General disorders
Pyrexia
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
General disorders
Unevaluable Event
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Hepatitis Acute
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/1140 • 12 months
|
0.26%
3/1152 • Number of events 3 • 12 months
|
|
Infections and infestations
Abscess Limb
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Infections and infestations
Bronchitis
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/1140 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Infections and infestations
Erysipelas
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Infections and infestations
Gangrene
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Infections and infestations
Gastrointestinal Infection
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Infections and infestations
Haemophilus Infection
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Infections and infestations
Implant Site Infection
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Infections and infestations
Infection
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.78%
9/1152 • Number of events 9 • 12 months
|
|
Infections and infestations
Intervertebral Discitis
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Infections and infestations
Nasopharyngitis
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Infections and infestations
Oesophageal Candidiasis
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Infections and infestations
Orchitis
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Infections and infestations
Perianal Abscess
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Infections and infestations
Peritonsillar Abscess
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Infections and infestations
Pneumonia
|
0.96%
11/1140 • Number of events 12 • 12 months
|
0.95%
11/1152 • Number of events 14 • 12 months
|
|
Infections and infestations
Pyelonephritis
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Infections and infestations
Sepsis
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Infections and infestations
Septic Shock
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.26%
3/1140 • Number of events 3 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/1140 • 12 months
|
0.26%
3/1152 • Number of events 3 • 12 months
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Concussion
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Contrast Media Reaction
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Device Malfunction
|
0.00%
0/1140 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Injury, poisoning and procedural complications
Foreign Body Trauma
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Injury, poisoning and procedural complications
Haemothorax
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/1140 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Implantable Defibrillator Malfunction
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Injury, poisoning and procedural complications
Injury
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Multiple Injuries
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Pacemaker Complication
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Injury, poisoning and procedural complications
Postoperative Thoracic Procedure Complication
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Postoperative Thrombosis
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Stent Occlusion
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Injury, poisoning and procedural complications
Thrombosis In Device
|
0.70%
8/1140 • Number of events 10 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Tracheal Obstruction
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Injury, poisoning and procedural complications
Transfusion Reaction
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/1140 • 12 months
|
0.17%
2/1152 • Number of events 3 • 12 months
|
|
Investigations
Angiogram
|
1.1%
13/1140 • Number of events 16 • 12 months
|
1.0%
12/1152 • Number of events 18 • 12 months
|
|
Investigations
Arteriogram Coronary
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Investigations
Biopsy Lung
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Investigations
Blood Creatine Phosphokinase MB Increased
|
0.00%
0/1140 • 12 months
|
0.35%
4/1152 • Number of events 4 • 12 months
|
|
Investigations
Blood Creatinine Increased
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Investigations
Blood Test Abnormal
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Investigations
C-Reactive Protein Increased
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Investigations
Cardiac Enzymes Increased
|
0.53%
6/1140 • Number of events 6 • 12 months
|
0.69%
8/1152 • Number of events 8 • 12 months
|
|
Investigations
Cardiac Stress Test
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Investigations
Cardiac Stress Test Abnormal
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Investigations
Carotid Pulse Decreased
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Investigations
Colonoscopy
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Investigations
Electrocardiogram ST Segment Depression
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Investigations
Electrocardiogram ST Segment Elevation
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Investigations
Investigation
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Investigations
Sleep Study
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Investigations
Troponin I Increased
|
0.26%
3/1140 • Number of events 3 • 12 months
|
0.61%
7/1152 • Number of events 7 • 12 months
|
|
Investigations
Troponin Increased
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Investigations
Troponin T Increased
|
0.00%
0/1140 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.09%
1/1140 • Number of events 2 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Metabolism and nutrition disorders
Gout
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.26%
3/1140 • Number of events 3 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.26%
3/1140 • Number of events 3 • 12 months
|
0.43%
5/1152 • Number of events 5 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Collagen Disorder
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.17%
2/1152 • Number of events 4 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.26%
3/1152 • Number of events 3 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.44%
5/1140 • Number of events 5 • 12 months
|
0.17%
2/1152 • Number of events 4 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm Of Thyroid Gland
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Female
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial Carcinoma
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal Cancer
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.00%
0/1140 • 12 months
|
0.17%
2/1152 • Number of events 5 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Abdominal Cavity
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Meninges
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple Myeloma
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Malignant
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Adenocarcinoma
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Carcinoma
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Recurrent
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Adenoma
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urethral Cancer
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vocal Cord Neoplasm
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Nervous system disorders
Apraxia
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.26%
3/1140 • Number of events 3 • 12 months
|
0.61%
7/1152 • Number of events 7 • 12 months
|
|
Nervous system disorders
Dizziness
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.35%
4/1152 • Number of events 4 • 12 months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Nervous system disorders
Epilepsy
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Nervous system disorders
Headache
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Nervous system disorders
IIIrd Nerve Disorder
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Nervous system disorders
Memory Impairment
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Nervous system disorders
Paraesthesia
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Nervous system disorders
Parkinson's Disease
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Nervous system disorders
Partial Seizures
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Nervous system disorders
Presyncope
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Nervous system disorders
Radicular Syndrome
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Nervous system disorders
Sciatica
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Nervous system disorders
Syncope
|
0.70%
8/1140 • Number of events 8 • 12 months
|
0.43%
5/1152 • Number of events 5 • 12 months
|
|
Nervous system disorders
Syncope Vasovagal
|
0.26%
3/1140 • Number of events 3 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.44%
5/1140 • Number of events 5 • 12 months
|
0.26%
3/1152 • Number of events 4 • 12 months
|
|
Psychiatric disorders
Alcohol Withdrawal Syndrome
|
0.00%
0/1140 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Psychiatric disorders
Alcoholism
|
0.09%
1/1140 • Number of events 4 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Psychiatric disorders
Delirium
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Psychiatric disorders
Depression
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.35%
4/1152 • Number of events 4 • 12 months
|
|
Psychiatric disorders
Disorientation
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Psychiatric disorders
Psychosomatic Disease
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Psychiatric disorders
Psychotic Disorder
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Psychiatric disorders
Schizophrenia, Paranoid Type
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Calculus Urinary
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Renal and urinary disorders
Haematuria
|
0.26%
3/1140 • Number of events 3 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Renal and urinary disorders
Renal Failure
|
0.79%
9/1140 • Number of events 10 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Urethral Stenosis
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Urinary Bladder Haemorrhage
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Reproductive system and breast disorders
Prostatitis
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.26%
3/1140 • Number of events 5 • 12 months
|
0.26%
3/1152 • Number of events 5 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.26%
3/1140 • Number of events 3 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
13/1140 • Number of events 14 • 12 months
|
1.1%
13/1152 • Number of events 14 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.18%
2/1140 • Number of events 3 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.35%
4/1140 • Number of events 4 • 12 months
|
0.09%
1/1152 • Number of events 2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.35%
4/1152 • Number of events 5 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.44%
5/1140 • Number of events 5 • 12 months
|
0.52%
6/1152 • Number of events 6 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash Generalised
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Angioplasty
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Surgical and medical procedures
Aortic Valve Replacement
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Arterial Aneurysm Repair
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Arteriovenous Shunt Operation
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Surgical and medical procedures
Baker's Cyst Excision
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Surgical and medical procedures
Bladder Operation
|
0.09%
1/1140 • Number of events 3 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Surgical and medical procedures
Cardiac Pacemaker Insertion
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Cardioversion
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Cataract Operation
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Surgical and medical procedures
Colon Operation
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Surgical and medical procedures
Coronary Angioplasty
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Coronary Artery Bypass
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Coronary Revascularisation
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Surgical and medical procedures
Foot Amputation
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Hysterosalpingo-Oophorectomy
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Ileostomy
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Implantable Defibrillator Insertion
|
0.35%
4/1140 • Number of events 4 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Knee Arthroplasty
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Knee Meniscectomy
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Surgical and medical procedures
Knee Operation
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Leg Amputation
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Meniscus Operation
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Surgical and medical procedures
Nephrectomy
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Percutaneous Coronary Intervention
|
0.35%
4/1140 • Number of events 4 • 12 months
|
0.26%
3/1152 • Number of events 3 • 12 months
|
|
Surgical and medical procedures
Preoperative Care
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Radiotherapy
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Rehabilitation Therapy
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Surgical and medical procedures
Skin Graft
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Surgical and medical procedures
Thrombectomy
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Surgical and medical procedures
Toe Amputation
|
0.00%
0/1140 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Surgical and medical procedures
Trabeculectomy
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Vascular disorders
Aortic Aneurysm
|
0.44%
5/1140 • Number of events 6 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Vascular disorders
Aortic Dissection
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Vascular disorders
Arterial Rupture
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Vascular disorders
Arteriovenous Fistula
|
0.00%
0/1140 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Vascular disorders
Embolism
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Vascular disorders
Essential Hypertension
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Vascular disorders
Extremity Necrosis
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Vascular disorders
Haematoma
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Vascular disorders
Haemorrhage
|
0.61%
7/1140 • Number of events 10 • 12 months
|
0.61%
7/1152 • Number of events 7 • 12 months
|
|
Vascular disorders
Hypertension
|
0.70%
8/1140 • Number of events 8 • 12 months
|
0.35%
4/1152 • Number of events 4 • 12 months
|
|
Vascular disorders
Hypertensive Crisis
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/1140 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Vascular disorders
Hypovolaemic Shock
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Vascular disorders
Iliac Artery Stenosis
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Vascular disorders
Intermittent Claudication
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Vascular disorders
Necrosis Ischaemic
|
0.09%
1/1140 • Number of events 3 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/1140 • 12 months
|
0.09%
1/1152 • Number of events 1 • 12 months
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.00%
0/1140 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
|
Vascular disorders
Peripheral Artery Dissection
|
0.18%
2/1140 • Number of events 2 • 12 months
|
0.00%
0/1152 • 12 months
|
|
Vascular disorders
Peripheral Ischaemia
|
0.61%
7/1140 • Number of events 10 • 12 months
|
0.35%
4/1152 • Number of events 6 • 12 months
|
|
Vascular disorders
Vascular Pseudoaneurysm
|
0.09%
1/1140 • Number of events 1 • 12 months
|
0.17%
2/1152 • Number of events 2 • 12 months
|
Other adverse events
| Measure |
1. Resolute - 12-13 Months
n=1140 participants at risk
Medtronic Resolute - 12-13 Months
|
2. XIENCE V - 12-13 Months
n=1152 participants at risk
Abbott Xience V - 12-13 Months
|
|---|---|---|
|
General disorders
Chest Pain
|
0.00%
0/1140 • 12 months
|
5.1%
59/1152 • Number of events 62 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to submission the Publication Committee (PC) and all co-authors will review and authorize the publication.\> * Abstracts to be submitted to the PC at least 30 days before submission for publication or presentation.\> * Manuscripts to be submitted to the PC at least 60 days before submission for publication or presentation. \> The Sponsor can review results communications, and can embargo communications regarding trial results prior to public release.
- Publication restrictions are in place
Restriction type: OTHER