Time Frame |
Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10.
|
Adverse Event Reporting Description |
Serious definition
|
|
Arm/Group Title
|
CRT OFF
|
CRT ON
|
Not Randomized
|
Arm/Group Description |
Cardiac Resynchronization Therapy (...
|
Cardiac Resynchronization Therapy (...
|
These patients were enrolled in the...
|
Arm/Group Description |
Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
|
Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
|
These patients were enrolled in the study, but not randomized to CRT ON or CRT OFF. Their adverse events were collected until they exited the study.
|
|
|
CRT OFF
|
CRT ON
|
Not Randomized
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
--/--
|
|
--/--
|
|
--/--
|
|
|
|
CRT OFF
|
CRT ON
|
Not Randomized
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
122/191 (63.87%)
|
|
268/419 (63.96%)
|
|
13/38 (34.21%)
|
|
General disorders |
|
|
|
Cardiac failure acute |
30/191 (15.71%)
|
52 |
56/419 (13.37%)
|
98 |
2/38 (5.26%)
|
5 |
Medical device change |
19/191 (9.95%)
|
19 |
45/419 (10.74%)
|
46 |
1/38 (2.63%)
|
1 |
Ventricular tachycardia |
11/191 (5.76%)
|
14 |
30/419 (7.16%)
|
43 |
1/38 (2.63%)
|
1 |
LV lead dislodgement |
13/191 (6.81%)
|
15 |
26/419 (6.21%)
|
28 |
2/38 (5.26%)
|
2 |
Chest pain |
4/191 (2.09%)
|
4 |
21/419 (5.01%)
|
25 |
0/38 (0.00%)
|
0 |
Pneumonia |
8/191 (4.19%)
|
9 |
16/419 (3.82%)
|
19 |
1/38 (2.63%)
|
1 |
Atrial fibrillation |
8/191 (4.19%)
|
8 |
15/419 (3.58%)
|
19 |
0/38 (0.00%)
|
0 |
Device lead damage |
8/191 (4.19%)
|
8 |
18/419 (4.30%)
|
18 |
0/38 (0.00%)
|
0 |
Inappropriate device therapy |
3/191 (1.57%)
|
3 |
16/419 (3.82%)
|
16 |
0/38 (0.00%)
|
0 |
Ventricular fibrillation |
4/191 (2.09%)
|
4 |
8/419 (1.91%)
|
11 |
1/38 (2.63%)
|
1 |
Cardiac failure chronic |
5/191 (2.62%)
|
6 |
5/419 (1.19%)
|
6 |
2/38 (5.26%)
|
2 |
Chronic obstructive pulmonary disease |
3/191 (1.57%)
|
3 |
7/419 (1.67%)
|
11 |
0/38 (0.00%)
|
0 |
RV lead dislodgement |
1/191 (0.52%)
|
1 |
13/419 (3.10%)
|
13 |
0/38 (0.00%)
|
0 |
Syncope |
5/191 (2.62%)
|
7 |
5/419 (1.19%)
|
5 |
1/38 (2.63%)
|
1 |
Angina pectoris |
4/191 (2.09%)
|
4 |
8/419 (1.91%)
|
8 |
0/38 (0.00%)
|
0 |
Atrial flutter |
6/191 (3.14%)
|
6 |
4/419 (0.95%)
|
5 |
1/38 (2.63%)
|
1 |
Inappropriate device irritation of tissue |
3/191 (1.57%)
|
3 |
9/419 (2.15%)
|
9 |
0/38 (0.00%)
|
0 |
Cerebrovascular accident |
4/191 (2.09%)
|
5 |
5/419 (1.19%)
|
6 |
0/38 (0.00%)
|
0 |
Gastrointestinal hemorrhage |
6/191 (3.14%)
|
6 |
4/419 (0.95%)
|
5 |
0/38 (0.00%)
|
0 |
Hypotension |
1/191 (0.52%)
|
1 |
9/419 (2.15%)
|
9 |
1/38 (2.63%)
|
1 |
Dyspnea |
2/191 (1.05%)
|
3 |
7/419 (1.67%)
|
7 |
0/38 (0.00%)
|
0 |
Failure to capture |
5/191 (2.62%)
|
6 |
4/419 (0.95%)
|
4 |
0/38 (0.00%)
|
0 |
Lead dislodgement |
0/191 (0.00%)
|
0 |
8/419 (1.91%)
|
10 |
0/38 (0.00%)
|
0 |
RA lead dislodgement |
2/191 (1.05%)
|
2 |
8/419 (1.91%)
|
8 |
0/38 (0.00%)
|
0 |
Renal failure acute |
4/191 (2.09%)
|
4 |
6/419 (1.43%)
|
6 |
0/38 (0.00%)
|
0 |
Transient ischemic attack |
2/191 (1.05%)
|
2 |
8/419 (1.91%)
|
8 |
0/38 (0.00%)
|
0 |
Coronary artery disease |
4/191 (2.09%)
|
5 |
3/419 (0.72%)
|
3 |
0/38 (0.00%)
|
0 |
Carotid artery stenosis |
2/191 (1.05%)
|
2 |
5/419 (1.19%)
|
5 |
0/38 (0.00%)
|
0 |
Implant site hematoma |
1/191 (0.52%)
|
1 |
6/419 (1.43%)
|
6 |
0/38 (0.00%)
|
0 |
Myocardial infarction |
3/191 (1.57%)
|
3 |
4/419 (0.95%)
|
4 |
0/38 (0.00%)
|
0 |
Osteoarthritis |
2/191 (1.05%)
|
2 |
5/419 (1.19%)
|
5 |
0/38 (0.00%)
|
0 |
Pneumothorax |
0/191 (0.00%)
|
0 |
5/419 (1.19%)
|
6 |
0/38 (0.00%)
|
0 |
Acute myocardial infarction |
1/191 (0.52%)
|
1 |
4/419 (0.95%)
|
4 |
0/38 (0.00%)
|
0 |
Atrial tachycardia |
1/191 (0.52%)
|
1 |
3/419 (0.72%)
|
3 |
1/38 (2.63%)
|
1 |
Ischemic stroke |
0/191 (0.00%)
|
0 |
3/419 (0.72%)
|
5 |
0/38 (0.00%)
|
0 |
Pericardial effusion |
2/191 (1.05%)
|
2 |
3/419 (0.72%)
|
3 |
0/38 (0.00%)
|
0 |
Peripheral vascular disorder |
1/191 (0.52%)
|
3 |
1/419 (0.24%)
|
1 |
1/38 (2.63%)
|
1 |
Renal failure |
2/191 (1.05%)
|
2 |
3/419 (0.72%)
|
3 |
0/38 (0.00%)
|
0 |
Sudden cardiac death |
2/191 (1.05%)
|
2 |
3/419 (0.72%)
|
3 |
0/38 (0.00%)
|
0 |
Acute pulmonary edema |
0/191 (0.00%)
|
0 |
3/419 (0.72%)
|
3 |
1/38 (2.63%)
|
1 |
Anemia |
0/191 (0.00%)
|
0 |
4/419 (0.95%)
|
4 |
0/38 (0.00%)
|
0 |
Asthma |
0/191 (0.00%)
|
0 |
2/419 (0.48%)
|
3 |
1/38 (2.63%)
|
1 |
Atrioventricular block complete |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
3/38 (7.89%)
|
3 |
Bradycardia |
1/191 (0.52%)
|
1 |
3/419 (0.72%)
|
3 |
0/38 (0.00%)
|
0 |
Bronchitis |
0/191 (0.00%)
|
0 |
3/419 (0.72%)
|
4 |
0/38 (0.00%)
|
0 |
Cardiac arrest |
2/191 (1.05%)
|
2 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Cholecystitis acute |
2/191 (1.05%)
|
2 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Deep vein thrombosis |
2/191 (1.05%)
|
2 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Implant site infection |
2/191 (1.05%)
|
2 |
1/419 (0.24%)
|
2 |
0/38 (0.00%)
|
0 |
Inappropriate device signal detection |
3/191 (1.57%)
|
3 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Ischemic cardiomyopathy |
1/191 (0.52%)
|
1 |
2/419 (0.48%)
|
2 |
1/38 (2.63%)
|
1 |
Lung neoplasm malignant |
2/191 (1.05%)
|
2 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Respiratory failure |
1/191 (0.52%)
|
1 |
3/419 (0.72%)
|
3 |
0/38 (0.00%)
|
0 |
Acute respiratory failure |
2/191 (1.05%)
|
2 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Angina unstable |
0/191 (0.00%)
|
0 |
3/419 (0.72%)
|
3 |
0/38 (0.00%)
|
0 |
Aortic aneurysm |
2/191 (1.05%)
|
2 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Atrioventricular block third degree |
1/191 (0.52%)
|
1 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Back pain |
1/191 (0.52%)
|
1 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Bronchitis acute |
0/191 (0.00%)
|
0 |
3/419 (0.72%)
|
3 |
0/38 (0.00%)
|
0 |
Cardiac perforation |
0/191 (0.00%)
|
0 |
2/419 (0.48%)
|
2 |
1/38 (2.63%)
|
1 |
Cardiac tamponade |
1/191 (0.52%)
|
1 |
1/419 (0.24%)
|
1 |
1/38 (2.63%)
|
1 |
Contusion |
1/191 (0.52%)
|
1 |
1/419 (0.24%)
|
1 |
1/38 (2.63%)
|
1 |
Defibrillation threshold increased |
1/191 (0.52%)
|
1 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Dehydration |
1/191 (0.52%)
|
1 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Dizziness |
0/191 (0.00%)
|
0 |
2/419 (0.48%)
|
3 |
0/38 (0.00%)
|
0 |
Esophageal carcinoma |
0/191 (0.00%)
|
0 |
3/419 (0.72%)
|
3 |
0/38 (0.00%)
|
0 |
Hematoma |
0/191 (0.00%)
|
0 |
3/419 (0.72%)
|
3 |
0/38 (0.00%)
|
0 |
Intracardiac thrombus |
1/191 (0.52%)
|
1 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Myocardial ischemia |
1/191 (0.52%)
|
1 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Non-cardiac chest pain |
0/191 (0.00%)
|
0 |
3/419 (0.72%)
|
3 |
0/38 (0.00%)
|
0 |
Pericarditis |
0/191 (0.00%)
|
0 |
2/419 (0.48%)
|
3 |
0/38 (0.00%)
|
0 |
Presyncope |
1/191 (0.52%)
|
1 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Prostate examination abnormal |
0/191 (0.00%)
|
0 |
3/419 (0.72%)
|
3 |
0/38 (0.00%)
|
0 |
Pulmonary edema |
2/191 (1.05%)
|
2 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Subclavian vein thrombosis |
1/191 (0.52%)
|
1 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Therapeutic agent toxicity |
1/191 (0.52%)
|
2 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Anxiety |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
1/38 (2.63%)
|
1 |
Aortic stenosis |
1/191 (0.52%)
|
1 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Arrhythmia supraventricular |
0/191 (0.00%)
|
0 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Arteriovenous fistula |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
1/38 (2.63%)
|
1 |
Biliary colic |
1/191 (0.52%)
|
1 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Cholecystitis |
1/191 (0.52%)
|
1 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Cholelithiasis |
0/191 (0.00%)
|
0 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Coronary artery dissection |
0/191 (0.00%)
|
0 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Coronary artery stenosis |
2/191 (1.05%)
|
2 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Death |
1/191 (0.52%)
|
1 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Diabetes mellitus |
1/191 (0.52%)
|
1 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Diabetes mellitus inadequate control |
1/191 (0.52%)
|
1 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Drug hypersensitivity |
1/191 (0.52%)
|
1 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Drug toxicity |
1/191 (0.52%)
|
2 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Dyspnea exertional |
1/191 (0.52%)
|
1 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Electromechanical dissociation |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
1/38 (2.63%)
|
1 |
Fatigue |
0/191 (0.00%)
|
0 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Heart transplant |
1/191 (0.52%)
|
1 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Hyperglycemia |
0/191 (0.00%)
|
0 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Inappropriate device stimulation of tissue |
2/191 (1.05%)
|
2 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Mental status changes |
1/191 (0.52%)
|
1 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Mitral valve incompetence |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
2 |
0/38 (0.00%)
|
0 |
Orthostatic hypotension |
0/191 (0.00%)
|
0 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Oversensing |
0/191 (0.00%)
|
0 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Paraesthesia |
1/191 (0.52%)
|
1 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Pneumonia aspiration |
0/191 (0.00%)
|
0 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Postoperative wound infection |
1/191 (0.52%)
|
1 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Pulmonary embolism |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
2 |
0/38 (0.00%)
|
0 |
Pulmonary fibrosis |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
2 |
0/38 (0.00%)
|
0 |
Sepsis |
1/191 (0.52%)
|
1 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Syncope vasovagal |
0/191 (0.00%)
|
0 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Tachycardia |
0/191 (0.00%)
|
0 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Urinary tract infection |
0/191 (0.00%)
|
0 |
2/419 (0.48%)
|
2 |
0/38 (0.00%)
|
0 |
Abdominal abscess |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Abdominal discomfort |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Abdominal pain upper |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Acute coronary syndrome |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Adverse drug reaction |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Ankle fracture |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Anorexia |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Anxiety disorder |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Aortic thrombosis |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Arrhythmia |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Arterial disorder |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Arterial stenosis |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Arteriogram coronary |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Arteriopathic disease |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Arthralgia |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Asthenia |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Bacteraemia |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Balance disorder |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Biopsy liver |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Bronchopulmonary aspergillosis |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Cardiac ablation |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Cardiac failure |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Cardiac procedure complication |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Cardio-renal syndrome |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Cardiomyopathy |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Cardiomyopathy alcoholic |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Cellulitis |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Cervical dysplasia |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Chest discomfort |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Colon cancer |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Colonic obstruction |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Colostomy |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Constipation |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Contrast media reaction |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Convulsion |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Coronary artery restenosis |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Decreased RV Sensing |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Depressed level of consciousness |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Device electrical finding |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Device migration |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Device related infection |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Diabetes mellitus insulin-dependent |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Dislodgement of LV lead |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Diverticulitis esophageal |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Duodenal ulcer |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Edema peripheral |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Elevated pacing threshold |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Endocarditis |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Epistaxis |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Extrasystoles |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Fluid overload |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Gastroenteritis |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
General physical health deterioration |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Goiter |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Hairy cell leukemia |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Headache |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Hematoma evacuation |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Hemianopsia homonymous |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Hemoglobin decreased |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Hemorrhage |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Hemorrhoids |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Hepatic function abnormal |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Hip arthroplasty |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Hypersensitivity |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Hyperthyroidism |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Hypervolemic |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Hypoglycemia |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Hypokalemia |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Hyponatremia |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Hypothyroidism |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Hypoxia |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Implant site erosion |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Implant site inflammation |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Implant site irritation |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
In-stent arterial restenosis |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Incision site complication |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Infection |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Inguinal hernia repair |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Intermittent claudication |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Intestinal obstruction |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Iodine allergy |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Joint dislocation |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Joint swelling |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Knee arthroplasty |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Leukothrombopenia |
0/191 (0.00%)
|
0 |
0/419 (0.00%)
|
0 |
1/38 (2.63%)
|
1 |
Low cardiac output syndrome |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Lower respiratory tract infection |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Lower respiratory tract infection viral |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Lumbar spinal stenosis |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Lung adenocarcinoma |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Lung consolidation |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Malaise |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Medical device complication |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Melaena |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Metastases to bone |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Metastatic neoplasm |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Mitral valve disease |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Mitral valve repair |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Multi-organ failure |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Musculoskeletal chest pain |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Neoplasm malignant |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Nephrolithiasis |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Nodal arrhythmia |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Orthostatic intolerance |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Oxygen saturation decreased |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Palpitations |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Perianal abscess |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Peripheral arterial occlusive disease |
0/191 (0.00%)
|
0 |
0/419 (0.00%)
|
0 |
1/38 (2.63%)
|
1 |
Peripheral ischemia |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Phlebitis |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Pituitary tumor |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Pleural effusion |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Polyneuropathy |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Prostate cancer |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Pulmonary hypertension |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Pulmonary mass |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Rectal hemorrhage |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Renal cancer metastatic |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Renal impairment |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Retinal detachment |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Retroperitoneal hemorrhage |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Sinusitis |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Sinusitis |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Skin irritation |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Skin ulcer |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Small cell lung cancer stage unspecified |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Small intestinal obstruction |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Spondylolysis |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Squamous cell carcinoma |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Subarachnoid hemorrhage |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Subdural hematoma |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Supraventricular tachycardia |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Throat lesion |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Thrombocytopenia |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Tonsillar disorder |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Tooth disorder |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Twiddler's syndrome |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Urinary bladder adenoma |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Valvuloplasty cardiac |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Vascular pseudoaneurysm |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Venous stenosis |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Ventricular arrhythmia |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Ventricular assist device insertion |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Vertigo CNS origin |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Vestibular neuronitis |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Viral infection |
1/191 (0.52%)
|
1 |
0/419 (0.00%)
|
0 |
0/38 (0.00%)
|
0 |
Vocal cord polyp |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Vocal cord thickening |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Wound dehiscence |
0/191 (0.00%)
|
0 |
1/419 (0.24%)
|
1 |
0/38 (0.00%)
|
0 |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
CRT OFF
|
CRT ON
|
Not Randomized
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
61/119 (51.26%)
|
|
140/491 (28.51%)
|
|
2/38 (5.26%)
|
|
General disorders |
|
|
|
Cardiac failure chronic |
24/119 (20.17%)
|
30 |
31/491 (6.31%)
|
35 |
1/38 (2.63%)
|
1 |
Atrial fibrillation |
8/119 (6.72%)
|
8 |
47/491 (9.57%)
|
57 |
0/38 (0.00%)
|
0 |
Dizziness |
9/119 (7.56%)
|
9 |
25/491 (5.09%)
|
29 |
1/38 (2.63%)
|
1 |
Inappropriate device stimulation of tissue |
11/119 (9.24%)
|
12 |
21/491 (4.28%)
|
25 |
0/38 (0.00%)
|
0 |
Inappropriate device irritation of tissue |
4/119 (3.36%)
|
4 |
26/491 (5.30%)
|
30 |
1/38 (2.63%)
|
1 |
Hypotension |
10/119 (8.40%)
|
12 |
16/491 (3.26%)
|
16 |
0/38 (0.00%)
|
0 |
Fatigue |
12/119 (10.08%)
|
12 |
15/491 (3.05%)
|
15 |
0/38 (0.00%)
|
0 |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA
|