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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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