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Page 60 - Abbott
P. 60

    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
                   Ischemia                           0       0      0       0      0       0      1      1
                   Nervous system disorders           29     37      28     38      57     75     27      32
                                                    (10.7%)        (10.0%)        (10.4%)        (7.8%)
                   Syncope                            12     15      7       8      19     23      9      13
                   CVA                                2       2      4       4      6       6      2      2
                   Stroke                             3       3      2       2      5       5      3      3
                   Presyncope                         0       0      3       3      3       3      2      2
                   Carotid artery stenosis            1       1      1       1      2       2      0      0
                   Dizziness                          1       1      1       1      2       2      1      1
                   Embolic stroke                     1       1      1       1      2       2      0      0
                   Subarachnoid hemorrhage            1       1      1       1      2       2      0      0
                   Anoxic encephalopathy              0       0      1       1      1       1      0      0
                   Ataxia                             1       1      0       0      1       1      0      0
                   Cerebellar infarction              1       1      0       0      1       1      0      0
                   Cerebral degeneration              1       1      0       0      1       1      0      0
                   Cerebral infarct                   0       0      1       1      1       1      0      0
                   Cerebrovascular accident           1       1      0       0      1       1      0      0
                   Disorder brain (chronic)           1       1      0       0      1       1      0      0
                   Embolic cerebral infarction        0       0      1       1      1       1      0      0
                   Encephalopathy                     0       0      1       1      1       1      1      1
                   Headache                           0       0      1       1      1       1      0      0
                   Hemorrhagic stroke                 0       0      1       1      1       1      0      0
                   Hepatic encephalopathy             1       1      0       0      1       1      0      0
                   Hypertensive encephalopathy        0       0      1       1      1       1      0      0
                   Intracranial hemorrhage            1       1      0       0      1       1      0      0
                   Ischemic stroke                    0       0      1       1      1       1      0      0
                   Loss of consciousness              1       2      0       0      1       2      1      1
                   Numbness                           0       0      1       2      1       2      0      0
                   Ophthalmoplegic migraine           0       0      1       1      1       1      0      0
                   Paresthesia                        0       0      1       1      1       1      0      0
                   Sciatica                           1       1      0       0      1       1      0      0
                   Seizure                            1       1      0       0      1       1      0      0
                   Slurred speech                     0       0      1       1      1       1      0      0
                   Somnolence                         1       1      0       0      1       1      0      0
                   Syncope convulsive                 1       1      0       0      1       1      0      0
                   TIA                                0       0      1       1      1       1      2      2
                   Unresponsive to stimuli            0       0      1       1      1       1      1      1
                   Vasovagal symptoms                 0       0      1       1      1       1      0      0
                   Weakness left or right side        0       0      1       1      1       1      0      0
                   Brain injury                       0       0      0       0      0       0      1      1
                   Restless leg syndrome              0       0      0       0      0       0      1      1
                   Todd's paralysis                   0       0      0       0      0       0      1      1
                   Transient ischemic attacks         0       0      0       0      0       0      2      2
                   Vocal cord paralysis               0       0      0       0      0       0      1      1
                   Renal and urinary disorders        33     41      24     34      57     75     20      22
                                                    (12.2%)        (8.6%)         (10.4%)        (5.8%)
                   Acute on chronic renal failure     11     12      9      10      20     22      1      1
                   Acute renal failure                9      10      7       9      16     19      8      9
                   Renal insufficiency                9      11      3       4      12     15      5      5
                   Acute renal insufficiency          0       0      2       2      2       2      0      0
                   Azotemia                           1       1      1       1      2       2      0      0
                   Chronic kidney disease             1       1      1       1      2       2      0      0
                   Renal failure                      1       1      1       1      2       2      1      1
                   Acute tubular necrosis             0       0      1       1      1       1      0      0

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