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Page 56 - Abbott
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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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