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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
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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