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Table 13. Serious Adverse Events Over Part 1 and Part 2

Part 1 Part 2
Treatment Control All Patients All Patients
(270) (280) (550) (347)
Subjects Events Subjects Events Subjects Events Subjects Events
Arrhythmia ventricular 1 1 0 0 1 1 0 0
Arrhythmia ventricular (NOS) 1 1 0 0 1 1 0 0
Atrial tachycardia 0 0 1 1 1 1 0 0
Bradycardia 0 0 1 1 1 1 2 2
Bradycardia-tachycardia syndrome 0 0 1 1 1 1 0 0
Cardiac arrhythmia 1 1 0 0 1 1 1 1
Cardiomegaly 0 0 1 1 1 1 0 0
Cardiorenal syndrome 1 1 0 0 1 1 1 2
Chronic heart failure 1 1 0 0 1 1 0 0
Congestive cardiac failure aggravated 0 0 1 1 1 1 0 0
Coronary artery disease progression 1 1 0 0 1 1 0 0
Coronary atherosclerosis 1 1 0 0 1 1 0 0
Coronary spasm 0 0 1 1 1 1 0 0
Decompensated heart failure 1 1 0 0 1 1 0 0
End stage cardiac failure 0 0 1 1 1 1 0 0
Heart failure, congestive 0 0 1 1 1 1 0 0
Heart valve incompetence 1 1 0 0 1 1 0 0
Intermediate coronary syndrome 0 0 1 1 1 1 0 0
Junctional tachycardia 0 0 1 1 1 1 0 0
Left ventricular dysfunction 1 1 0 0 1 1 0 0
Mitral valve incompetence 1 1 0 0 1 1 1 1
Multi-valvular regurgitation 0 0 1 1 1 1 0 0
Non ST segment elevation myocardial 1 1 0 0 1 1 0 0
infarction
Non-sustained ventricular tachycardia 1 1 0 0 1 1 0 0
Pacemaker mediated tachycardia 1 1 0 0 1 1 0 0
Paroxysmal supraventricular tachycardia 1 1 0 0 1 1 0 0
Pericardial disease 1 1 0 0 1 1 0 0
Pericardial effusion 1 1 0 0 1 1 0 0
Pericarditis 0 0 1 1 1 1 1 1
Premature ventricular contractions 0 0 1 1 1 1 0 0
Supraventricular tachycardia 0 0 1 1 1 1 0 0
Sustained ventricular tachycardia 1 1 0 0 1 1 0 0
Tachycardia 0 0 1 1 1 1 0 0
Tricuspid insufficiency 0 0 1 1 1 1 0 0
Ventricular ectopic beats 1 1 0 0 1 1 0 0
Ventricular rhythm 0 0 1 1 1 1 0 0
Wide complex tachycardia 0 0 1 1 1 1 0 0
Wide complex ventricular tachycardia 1 1 0 0 1 1 0 0
Asystole 0 0 0 0 0 0 2 2
Congestive cardiomyopathy 0 0 0 0 0 0 1 1
End stage heart disease 0 0 0 0 0 0 1 1
Hemopericardium 0 0 0 0 0 0 1 1
Palpitation 0 0 0 0 0 0 1 1
Paroxysmal atrial fibrillation 0 0 0 0 0 0 1 1
Polymorphic ventricular tachycardia 0 0 0 0 0 0 1 1
Tachycardia supraventricular 0 0 0 0 0 0 1 1
Infections and infestations 45 62 61 90 106 152 52 76
(16.7%) (21.8%) (19.3%) (15.0%)
Pneumonia 11 11 15 16 26 27 17 19
Urinary tract infection 5 7 5 6 10 13 5 5
Bronchitis 3 3 5 6 8 9 3 3
Cellulitis 1 1 6 7 7 8 1 1
Sepsis 3 4 4 4 7 8 7 9

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