Trial Outcomes & Findings for ION US Post-Approval Study (NCT NCT01422889)
NCT ID: NCT01422889
Last Updated: 2016-02-04
Results Overview
Cardiac Death or myocardial infarction (CD/MI) in the ION registry population. For the protocol specified primary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.
Recruitment status
COMPLETED
Target enrollment
1120 participants
Primary outcome timeframe
12 Months
Results posted on
2016-02-04
Participant Flow
Subject recruitment began on 19 September 2011 and was completed on 24 April 2012.
Participant milestones
| Measure |
ION Registry
The ION Registry population consists of 1111 subjects that were enrolled and received a study stent.
|
|---|---|
|
Overall Study
STARTED
|
1120
|
|
Overall Study
COMPLETED
|
1111
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
ION Registry
The ION Registry population consists of 1111 subjects that were enrolled and received a study stent.
|
|---|---|
|
Overall Study
No Data Entered for Study Stent
|
9
|
Baseline Characteristics
ION US Post-Approval Study
Baseline characteristics by cohort
| Measure |
ION Registry
n=1111 Participants
The ION Registry population contains 1120 enrolled subjects with 1111 eligible for analysis. Subjects eligible for analysis includes subjects with at least one study stent implanted.
|
|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 10.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
330 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
781 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1111 participants
n=5 Participants
|
|
Cardiac Risk Factors
Diabetes
|
376 participants
n=5 Participants
|
|
Cardiac Risk Factors
Current Smoker
|
275 participants
n=5 Participants
|
|
Cardiac Risk Factors
Hypertension
|
905 participants
n=5 Participants
|
|
Cardiac Risk Factors
Hyperlipidemia
|
869 participants
n=5 Participants
|
|
Cardiac Risk Factors
Unstable Angina
|
485 participants
n=5 Participants
|
|
Cardiac Risk Factors
Prior PCI
|
522 participants
n=5 Participants
|
|
Lesion Characteristics
RVD<=2.5mm
|
387 participants
n=5 Participants
|
|
Lesion Characteristics
Long Lesions (>=28mm)
|
235 participants
n=5 Participants
|
|
Lesion Characteristics
Bifurcation
|
116 participants
n=5 Participants
|
|
Lesion Characteristics:Lesion Based
Culprit for STEMI
|
108 Lesions
n=5 Participants
|
|
Lesion Characteristics:Lesion Based
Severe Calcification
|
79 Lesions
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: There were 83 subjects not evaluable for 12-month cardiac events (No follow-up ≥ 335 days and events-free within 365-day) leaving a total of 1028 subjects evaluated for 12 month CD/MI.
Cardiac Death or myocardial infarction (CD/MI) in the ION registry population. For the protocol specified primary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.
Outcome measures
| Measure |
ION Registry
n=1028 Participants
The ION Registry includes the 1111 enrolled subjects that received a study stent.
|
|---|---|
|
Cardiac Death or Myocardial Infarction (CD/MI)
|
2.2 percentage of paricipants
|
SECONDARY outcome
Timeframe: Annually, after the first year, through 2 years.Population: There were 57 subjects not evaluable for 2-year cardiac events (No follow-up ≥ 700 days and events-free within 730-day) leaving a total of 1054 subjects evaluated for ARC ST Definite/Probable.
Academic Research Consortium (ARC) defined (definite/probable) stent thrombosis (ST) in the ION registry population. For the protocol specified secondary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.
Outcome measures
| Measure |
ION Registry
n=1054 Participants
The ION Registry includes the 1111 enrolled subjects that received a study stent.
|
|---|---|
|
Stent Thrombosis
|
2.6 percentage of participants
|
Adverse Events
ION Registry
Serious events: 324 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ION Registry
n=1111 participants at risk
The ION Registry population will contain the first 1115 consecutive, consenting patients
|
|---|---|
|
Cardiac disorders
Angina Pectoris
|
5.3%
59/1111 • Number of events 70 • 1 year
|
|
Cardiac disorders
Angina Unstable
|
2.1%
23/1111 • Number of events 31 • 1 year
|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.4%
27/1111 • Number of events 27 • 1 year
|
|
Cardiac disorders
Cardiac Congestive Failure
|
2.1%
23/1111 • Number of events 26 • 1 year
|
|
Cardiac disorders
Coronary artery thrombosis
|
1.4%
15/1111 • Number of events 18 • 1 year
|
|
Cardiac disorders
Myocardial Infarction
|
1.5%
17/1111 • Number of events 17 • 1 year
|
|
Cardiac disorders
Atrial Fibriliation
|
1.3%
14/1111 • Number of events 17 • 1 year
|
|
Cardiac disorders
Coronary artery disease
|
1.2%
13/1111 • Number of events 14 • 1 year
|
|
Cardiac disorders
Cardiac arrest
|
0.63%
7/1111 • Number of events 7 • 1 year
|
|
Cardiac disorders
Acute Coronary System
|
0.45%
5/1111 • Number of events 5 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
0.36%
4/1111 • Number of events 4 • 1 year
|
|
Cardiac disorders
Coronary artery stenosis
|
0.36%
4/1111 • Number of events 4 • 1 year
|
|
Cardiac disorders
Ventricular fibrillation
|
0.36%
4/1111 • Number of events 4 • 1 year
|
|
Cardiac disorders
Atrial flutter
|
0.27%
3/1111 • Number of events 4 • 1 year
|
|
Cardiac disorders
Cardiac failure chronic
|
0.27%
3/1111 • Number of events 4 • 1 year
|
|
Cardiac disorders
Cardiogenic shock
|
0.27%
3/1111 • Number of events 4 • 1 year
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.27%
3/1111 • Number of events 4 • 1 year
|
|
Cardiac disorders
Ventricular tachycardia
|
0.18%
2/1111 • Number of events 4 • 1 year
|
|
Cardiac disorders
Cardiomyopathy
|
0.27%
3/1111 • Number of events 3 • 1 year
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Cardiac disorders
Atrioventricular block
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary artery dissection
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Cardiac disorders
Pericarditis
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Cardiac disorders
Sick sinus syndrome
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Cardiac disorders
Atrial tachycardia
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Cardiac disorders
Bradycardia
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac tamponade
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Cardiac disorders
Chronotropic incompetence
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Cardiac disorders
Intracardiac thrombus
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Cardiac disorders
Mitral valve incompetence
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Cardiac disorders
Myocardial ischaemia
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Cardiac disorders
Palpitations
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Cardiac disorders
Pericardial effusion
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sinus arrest
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Cardiac disorders
Tachycardia
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
1.6%
18/1111 • Number of events 22 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.90%
10/1111 • Number of events 10 • 1 year
|
|
Infections and infestations
Sepsis
|
0.45%
5/1111 • Number of events 5 • 1 year
|
|
Infections and infestations
Diverticulitis
|
0.36%
4/1111 • Number of events 5 • 1 year
|
|
Infections and infestations
Bronchitis
|
0.27%
3/1111 • Number of events 3 • 1 year
|
|
Infections and infestations
Cellulitis
|
0.27%
3/1111 • Number of events 3 • 1 year
|
|
Infections and infestations
Abscess
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Infections and infestations
Appendicitis
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Infections and infestations
Gastroenteritis
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Infections and infestations
Arthritis bacterial
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Infections and infestations
Bacteraemia
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Infections and infestations
Gangrene
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Infections and infestations
Gastroenteritis viral
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Infections and infestations
Herpes zoster
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Infections and infestations
Infected skin ulcer
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Infections and infestations
Lobar pneumonia
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Infections and infestations
Meningitis
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Infections and infestations
Osteomyelitis acute
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Infections and infestations
Periorbital abscess
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Infections and infestations
Peritonitis bacterial
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia influenzal
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Infections and infestations
Postoperative wound infection
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Infections and infestations
Pyelonephritis
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Infections and infestations
Septic shock
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Infections and infestations
Tooth infection
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
3.2%
35/1111 • Number of events 46 • 1 year
|
|
General disorders
Chest pain
|
0.54%
6/1111 • Number of events 6 • 1 year
|
|
General disorders
Chest discomfort
|
0.27%
3/1111 • Number of events 3 • 1 year
|
|
General disorders
Pyrexia
|
0.27%
3/1111 • Number of events 3 • 1 year
|
|
General disorders
Asthenia
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
General disorders
Catheter site haematoma
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
General disorders
Hernia obstructive
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
General disorders
Sudden cardiac death
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.99%
11/1111 • Number of events 12 • 1 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.27%
3/1111 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Colonic polyp
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.09%
1/1111 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Ascites
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Epiploic appendagitis
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastritis
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Ileus
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Intestional perforation
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.72%
8/1111 • Number of events 8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.54%
6/1111 • Number of events 8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.36%
4/1111 • Number of events 4 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.36%
4/1111 • Number of events 4 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.36%
4/1111 • Number of events 4 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypertension
|
0.36%
4/1111 • Number of events 6 • 1 year
|
|
Vascular disorders
Peripheral vascular disorder
|
0.36%
4/1111 • Number of events 5 • 1 year
|
|
Vascular disorders
Aortic stenosis
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Vascular disorders
Deep vein thrombosis
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Vascular disorders
Femoral arterial stenosis
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Vascular disorders
Intermittent claudication
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Vascular disorders
Aortic aneurysm
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Vascular disorders
Arterial haemorrhage
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Vascular disorders
Haemorrhage
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypotension
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Vascular disorders
Iliac artery embolism
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Vascular disorders
Iliac artery occlusion
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Vascular disorders
Leriche syndrome
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Vascular disorders
Orthostatic hypotension
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral ischaemia
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Nervous system disorders
Syncope
|
0.72%
8/1111 • Number of events 8 • 1 year
|
|
Nervous system disorders
Cerebrovascular accident
|
0.54%
6/1111 • Number of events 6 • 1 year
|
|
Nervous system disorders
Carotid artery stenosis
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Nervous system disorders
Ataxia
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Nervous system disorders
Embolic stroke
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Nervous system disorders
Hemiparesis
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Nervous system disorders
Ischaemic stroke
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Nervous system disorders
Migrane
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Nervous system disorders
Neuropathy peripheral
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Nervous system disorders
Presyncope
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
14/1111 • Number of events 17 • 1 year
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.63%
7/1111 • Number of events 7 • 1 year
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Device malfunction
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Renal injury
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal failure
|
0.36%
4/1111 • Number of events 4 • 1 year
|
|
Renal and urinary disorders
Renal failure acute
|
0.27%
3/1111 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
Renal failure chronic
|
0.27%
3/1111 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal disorder
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal impairment
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vaginal cancer
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Hepatic artery stenosis
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Hepatic congestion
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Investigations
Cardiac stress test abnormal
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Investigations
Blood creatinine increased
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Investigations
Heart rate increased
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Investigations
International normalized ratio increased
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protusion
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Eye disorders
Cataract
|
0.18%
2/1111 • Number of events 2 • 1 year
|
|
Eye disorders
Conjunctival haemorrhage
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Eye disorders
Vision blurred
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Bipolar I disorder
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Deperession
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Suicidal ideation
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Congenital, familial and genetic disorders
Congenital coronary artery malformation
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Vertigo
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Endocrine disorders
Hyperthyroidism
|
0.09%
1/1111 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Cardiac pacemaker battery replacement
|
0.09%
1/1111 • Number of events 1 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Peter Maurer, MPH; Director, Clinical Trials
Boston Scientific
Phone: 508-683-6678
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60