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Page 62 - 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
                   Hematemesis                        0       0      0       0      0       0      1      2
                   Hematochezia                       0       0      0       0      0       0      2      2
                   Mesenteric ischemia                0       0      0       0      0       0      1      1
                   Reflux esophagitis                 0       0      0       0      0       0      1      1
                   Right upper quadrant pain          0       0      0       0      0       0      1      1
                   Small bowel obstruction            0       0      0       0      0       0      1      1
                   Metabolism and nutrition disorders   26   33      28     38   54 (9.8%)   71   24      30
                                                     (9.6%)        (10.0%)                       (6.9%)
                   Dehydration                        7       9      5       5      12     14      8      8
                   Hyperglycemia                      3       4      5       6      8      10      1      1
                   Hypoglycemia                       4       4      2       2      6       6      2      2
                   Failure to thrive                  2       2      3       4      5       6      1      1
                   Hypokalemia                        2       2      3       3      5       5      3      3
                   Hypovolemia                        2       2      3       3      5       5      0      0
                   Electrolyte imbalance              2       2      2       2      4       4      0      0
                   Hypervolemia                       2       2      2       2      4       4      0      0
                   Hyponatremia                       1       1      3       3      4       4      4      4
                   Diabetes                           2       2      1       1      3       3      0      0
                   Hyperkalemia                       1       1      2       2      3       3      1      1
                   Diabetes mellitus loss of control   1      1      1       1      2       2      0      0
                   Anorexia                           0       0      1       1      1       1      0      0
                   Diabetes mellitus                  1       1      0       0      1       1      0      0
                   Hypercalcemia                      0       0      1       1      1       1      0      0
                   Ketoacidosis (diabetic)            0       0      1       1      1       1      0      0
                   Volume overload                    0       0      1       1      1       1      0      0
                   Diabetes mellitus inadequate control   0   0      0       0      0       0      1      1
                   Diabetic ketoacidosis              0       0      0       0      0       0      1      1
                   Gout                               0       0      0       0      0       0      1      1
                   Gout aggravated                    0       0      0       0      0       0      2      2
                   Gout flare                         0       0      0       0      0       0      2      3
                   Hyperosmolar state                 0       0      0       0      0       0      1      1
                   Hypoglycemic attack                0       0      0       0      0       0      1      1
                   Surgical and medical procedures    24     28      29     34   53 (9.6%)   62   14      15
                                                     (8.9%)        (10.4%)                       (4.0%)
                   Implantable cardioverter defibrillator insertion   4   4   2   2   6     6      0      0
                   Pacemaker battery replacement      1       1      5       5      6       6      3      3
                   Cardiac resynchronisation therapy   2      2      2       2      4       4      0      0
                   Heart transplant                   1       1      3       3      4       4      2      2
                   Cardiac catheterization            3       5      0       0      3       5      0      0
                   Implantable defibrillator replacement   0   0     3       3      3       3      0      0
                   Amputation                         0       0      2       2      2       2      0      0
                   Cardiac ablation                   1       1      1       1      2       2      0      0
                   Cardiac resynchronization therapy   0      0      2       2      2       2      0      0
                   Cardioversion                      1       1      1       1      2       2      0      0
                   Cholecystectomy                    0       0      2       2      2       2      0      0
                   Foot surgery                       1       1      1       1      2       2      1      1
                   Inguinal hernia repair             1       1      1       1      2       2      0      0
                   Abdominal hernia repair            1       1      0       0      1       1      0      0
                   Brachytherapy                      1       1      0       0      1       1      0      0
                   Cardiac pacemaker revision         1       1      0       0      1       1      0      0
                   Central line placement             0       0      1       1      1       1      0      0
                   Colostomy closure                  1       1      0       0      1       1      0      0
                   Epicardial lead placement          1       1      0       0      1       1      1      1
                   Gallbladder operation              0       0      1       1      1       1      0      0

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