Page 55 - Abbott

Table 12. Non-Serious Adverse Events not related to the device Over Part 1 and Part 2

Part 1 Part 2
Treatment (270) Control (280) All Patients (550) All Patients (347)
Subjects Events Subjects Events Subjects Events Subjects Events
Psychiatric disorders 34 (12.6%) 46 29 (10.4%) 36 63 (11.5%) 82 25 (7.2%) 31
Renal and urinary 33 (12.2%) 55 35 (12.5%) 45 68 (12.4%) 100 21 (6.1%) 21
disorders
Reproductive system 7 (2.6%) 8 16 (5.7%) 16 23 (4.2%) 24 11 (3.2%) 13
and breast disorders
Respiratory, thoracic 68 (25.2%) 97 70 (25.0%) 117 138 214 47 (13.5%) 66
and mediastinal (25.1%)
disorders
Skin and 23 (8.5%) 26 24 (8.6%) 28 47 (8.5%) 54 9 (2.6%) 9
subcutaneous tissue
disorders
Surgical and medical 17 (6.3%) 21 16 (5.7%) 20 33 (6.0%) 41 16 (4.6%) 19
procedures
Vascular disorders 41 (15.2%) 57 39 (13.9%) 46 80 (14.5%) 103 27 (7.8%) 29

Serious Adverse Events Over Part 1 and Part 2

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

All Patients with an Event 198 797 217 956 415 1753 201 647
(73.3%) (77.5%) (75.5%) (57.9%)
Cardiac disorders 138 333 151 443 289 776 119 238
(51.1%) (53.9%) (52.5%) (34.3%)
Congestive heart failure 99 204 121 274 220 478 80 140
Heart failure 10 15 13 22 23 37 10 12
Ventricular tachycardia 10 14 12 16 22 30 8 9
Myocardial infarction 7 7 14 14 21 21 9 9
Cardiac pain 13 19 7 22 20 41 0 0
Atrial fibrillation 3 5 10 11 13 16 4 4
Cardiomyopathy 5 6 8 11 13 17 6 7
Cardiopulmonary arrest 3 3 7 7 10 10 3 3
Unstable angina 4 4 5 5 9 9 4 6
Coronary artery disease 5 5 3 3 8 8 4 4
Ventricular arrhythmia 3 3 5 7 8 10 0 0
Ventricular fibrillation 5 6 2 2 7 8 2 2
Anginal discomfort 1 1 5 8 6 9 2 4
Cardiac arrest 2 2 4 4 6 6 6 6
Ischemic cardiomyopathy 3 4 3 3 6 7 6 7
Atrial flutter 2 2 3 3 5 5 3 3
Cardiogenic shock 2 2 3 3 5 5 3 3
Acute decompensated heart failure 2 2 1 1 3 3 0 0
ADHF 2 2 0 0 2 2 0 0
Acute coronary syndrome 1 2 1 1 2 3 1 1
Arrhythmia 1 1 1 1 2 2 1 1
Atrial arrhythmia 1 1 1 1 2 2 0 0
Cardiac failure 0 0 2 2 2 2 0 0
Heart disease, unspecified 1 1 1 1 2 2 1 1
Non-ischemic cardiomyopathy 1 1 1 1 2 2 0 0
Sick sinus syndrome 1 1 1 1 2 2 0 0
Angina unstable 0 0 1 1 1 1 0 0

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