Trial Outcomes & Findings for Coronary Artery Revascularization in Diabetes (NCT NCT00326196)
NCT ID: NCT00326196
Last Updated: 2014-04-25
Results Overview
Participants were monitored for up to 4 years. This is the number of particiapnts who have died or had at least one myocardial infarction.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
198 participants
Primary outcome timeframe
Date of Death and non-fatal MI
Results posted on
2014-04-25
Participant Flow
The study recruitment occured at 23 VA medical centers and thestudy recruitment lasted from 8/25/2006 thru 3/24/2010.
Study participants were were pre-screened by Cath lab. The remaining participants were consented and screened for study eligibility.
Participant milestones
| Measure |
Percutaneous Coronary Intervention
Initial revascularization with Percutaneous coronary intervention. Whenever possible, drug-eluting stents will be used in the percutaneous treatment. The use of multiple stents to achieve a "complete" revascularization will be encouraged in the PCI treatment
|
Coronary Artery Bypass Graft
Initial revascularization with Coronary artery bypass graft (CABG). Multiple arterial conduits for suitable target vessels will be encouraged in the surgical treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
97
|
|
Overall Study
COMPLETED
|
101
|
97
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Coronary Artery Revascularization in Diabetes
Baseline characteristics by cohort
| Measure |
Percutaneous Coronary Intervention
n=101 Participants
Percutaneous coronary intervention
|
Coronary Artery Bypass Graft
n=97 Participants
Coronary artery bypass graft (CABG)
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
62.1 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
62.4 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
101 participants
n=5 Participants
|
97 participants
n=7 Participants
|
198 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Date of Death and non-fatal MIPopulation: The number of participants for analysis was determined by intent to treat principal.
Participants were monitored for up to 4 years. This is the number of particiapnts who have died or had at least one myocardial infarction.
Outcome measures
| Measure |
Percutaneous Coronary Intervention
n=101 Participants
Percutaneous coronary intervention
|
Coronary Artery Bypass Graft
n=97 Participants
Coronary artery bypass graft (CABG)
|
|---|---|---|
|
The Hypothesis Being Tested is That a Strategy of Initial Surgical Revascularization is Superior to Percutaneous Intervention in Preventing Death or Myocardial Infarction in Diabetics With Severe Ischemic Heart Disease Assessed up to 4 Years.
|
21 participants
|
16 participants
|
Adverse Events
Percutaneous Coronary Intervention
Serious events: 23 serious events
Other events: 7 other events
Deaths: 0 deaths
Coronary Artery Bypass Graft
Serious events: 46 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Percutaneous Coronary Intervention
n=101 participants at risk
Percutaneous coronary intervention
|
Coronary Artery Bypass Graft
n=97 participants at risk
Coronary artery bypass graft (CABG)
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Angina pectoris
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
0.00%
0/97 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Angina unstable
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
0.00%
0/97 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
2.1%
2/97 • Number of events 3 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Cardiac tamponade
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
0.00%
0/97 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Coronary artery disease
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
0.00%
0/97 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
3.1%
3/97 • Number of events 3 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
2.1%
2/97 • Number of events 2 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Chest pain
|
3.0%
3/101 • Number of events 3 • Date of Death and non-fatal MI, assessed up to 4 years.
|
0.00%
0/97 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
General disorders
Death
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
General disorders
Thrombosis in device
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Infections and infestations
Cellulitis
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
0.00%
0/97 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Infections and infestations
Pneumonia
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
0.00%
0/97 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Infections and infestations
Postoperative wound infection
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
2.1%
2/97 • Number of events 2 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
3.0%
3/101 • Number of events 3 • Date of Death and non-fatal MI, assessed up to 4 years.
|
2.1%
2/97 • Number of events 2 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
0.00%
0/97 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
0.00%
0/97 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
0.00%
0/97 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
3.1%
3/97 • Number of events 3 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic hernia
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
3.1%
3/97 • Number of events 3 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
3.1%
3/97 • Number of events 3 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Vascular disorders
Hypotension
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
2.1%
2/97 • Number of events 2 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Vascular disorders
Peripheral embolism
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
0.00%
0/97 • Date of Death and non-fatal MI, assessed up to 4 years.
|
Other adverse events
| Measure |
Percutaneous Coronary Intervention
n=101 participants at risk
Percutaneous coronary intervention
|
Coronary Artery Bypass Graft
n=97 participants at risk
Coronary artery bypass graft (CABG)
|
|---|---|---|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Atrial fibrillation
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
5.2%
5/97 • Number of events 6 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
2.1%
2/97 • Number of events 2 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Pericardial disease
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
General disorders
Chest discomfort
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
General disorders
Chest Pain
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
2.1%
2/97 • Number of events 2 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
General disorders
Fatigue
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
General disorders
Oedema peripheral
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Infections and infestations
Incision site abscess
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Infections and infestations
Incision site cellulitis
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
2.1%
2/97 • Number of events 2 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Infections and infestations
Pneumonia
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
0.00%
0/97 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
6.2%
6/97 • Number of events 6 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Infections and infestations
Wound Infection
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Injury, poisoning and procedural complications
Graft complication
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Investigations
Catheterisation cardiac
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Investigations
Troponin increased
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Investigations
Weight decreased
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
0.00%
0/97 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Nervous system disorders
Neuritis
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
2.1%
2/97 • Number of events 2 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic hernia
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
8.2%
8/97 • Number of events 8 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Surgical and medical procedures
Pleuritic pain
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Surgical and medical procedures
Pulmonary oedema
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Surgical and medical procedures
Respiratory failure
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Surgical and medical procedures
Transfusion
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Surgical and medical procedures
Wound drainage
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Vascular disorders
Deep vein thrombosis
|
0.99%
1/101 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
1.0%
1/97 • Number of events 1 • Date of Death and non-fatal MI, assessed up to 4 years.
|
|
Vascular disorders
Hypotension
|
0.00%
0/101 • Date of Death and non-fatal MI, assessed up to 4 years.
|
2.1%
2/97 • Number of events 2 • Date of Death and non-fatal MI, assessed up to 4 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place