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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
Chronic renal failure worsened 0 0 1 1 1 1 0 0
End stage renal failure 0 0 1 1 1 1 0 0
Hematuria 1 1 0 0 1 1 0 0
Kidney failure 1 1 0 0 1 1 0 0
Lupus nephritis 0 0 1 1 1 1 0 0
Nephrolithiasis 1 1 0 0 1 1 0 0
Renal artery stenosis 1 1 0 0 1 1 0 0
Renal function abnormal 1 1 0 0 1 1 0 0
Uremia 0 0 1 1 1 1 0 0
Urinary retention 0 0 1 1 1 1 2 2
Chronic renal failure 0 0 0 0 0 0 1 1
Kidney disorder 0 0 0 0 0 0 1 1
Renal disease 0 0 0 0 0 0 1 1
Renal failure acute on chronic 0 0 0 0 0 0 1 1
Gastrointestinal disorders 24 35 31 49 55 84 36 53
(8.9%) (11.1%) (10.0%) (10.4%)
GI bleed 6 7 7 7 13 14 9 10
Abdominal pain 3 3 5 6 8 9 2 2
Diarrhea 4 4 1 1 5 5 2 2
Nausea 4 4 1 1 5 5 0 0
Gastritis 3 3 1 1 4 4 1 1
Gastrointestinal bleed 0 0 4 6 4 6 6 8
Vomiting 2 2 2 4 4 6 1 1
Constipation 0 0 3 3 3 3 1 1
Pancreatitis 2 2 1 1 3 3 1 1
Ascites 2 2 0 0 2 2 0 0
Dysphagia 1 1 1 1 2 2 2 2
Emesis 2 2 0 0 2 2 0 0
Esophagitis 0 0 2 2 2 2 0 0
Gastroparesis 0 0 2 2 2 2 1 2
Abdominal bloating 1 1 0 0 1 1 0 0
Abdominal wall hematoma 0 0 1 1 1 1 0 0
Chronic epigastric pain 0 0 1 1 1 1 0 0
Dental caries 0 0 1 1 1 1 0 0
Esophageal spasm 1 1 0 0 1 1 0 0
Esophagitis ulcerative 1 1 0 0 1 1 0 0
Gastric polyps 0 0 1 1 1 1 0 0
Gastritis erosive 0 0 1 1 1 1 0 0
Ileus 0 0 1 1 1 1 0 0
Incarcerated umbilical hernia 0 0 1 1 1 1 0 0
Ischemic colitis 0 0 1 1 1 1 1 2
Melena 1 1 0 0 1 1 0 0
Odynophagia 0 0 1 1 1 1 0 0
Rectal bleeding 0 0 1 3 1 3 1 1
Rectal fistula 0 0 1 1 1 1 0 0
Rectal prolapse 0 0 1 1 1 1 0 0
Ventral hernia 1 1 0 0 1 1 2 4
Decay dental 0 0 0 0 0 0 1 1
Duodenitis 0 0 0 0 0 0 1 1
Fecal impaction (causing obstruction) 0 0 0 0 0 0 1 1
Gastric ulcer 0 0 0 0 0 0 1 1
Gastric ulcer haemorrhage 0 0 0 0 0 0 1 1
Gastro intestinal bleed 0 0 0 0 0 0 1 1
Gastrointestinal bleeding 0 0 0 0 0 0 2 2

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