Basic HTML Version

|  | Table of Contents |  | View Full Version

Page 55 - Abbott
P. 55

    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

                                                                51

| 50 51 52 53 54 55 56 57 58 59 60 |