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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
International normalized ratio decreased 0 0 1 1 1 1 0 0
Mediastinoscopy 1 1 0 0 1 1 0 0
Pulmonary arterial pressure increased 1 1 0 0 1 1 1 1
QT interval prolonged 1 1 0 0 1 1 0 0
Ventricular filling pressure increased 0 0 1 1 1 1 0 0
Blood sugar abnormal 0 0 0 0 0 0 1 1
INR decreased 0 0 0 0 0 0 1 1
Urinary output diminished 0 0 0 0 0 0 1 1
Psychiatric disorders 7 (2.6%) 7 7 (2.5%) 7 14 (2.5%) 14 6 (1.7%) 7
Acute mental status changes 3 3 7 7 10 10 4 4
Agitation 1 1 0 0 1 1 0 0
Delirium toxic 1 1 0 0 1 1 0 0
Panic attack 1 1 0 0 1 1 0 0
Suicidal ideation 1 1 0 0 1 1 0 0
Mental status changes 0 0 0 0 0 0 2 2
Withdrawal syndrome 0 0 0 0 0 0 1 1
Hepatobiliary disorders 6 (2.2%) 8 7 (2.5%) 8 13 (2.4%) 16 2 (0.6%) 3
Acute cholecystitis 4 4 0 0 4 4 0 0
Cholecystitis 1 1 3 3 4 4 0 0
Cholelithiasis 2 2 0 0 2 2 2 2
Gallstones 0 0 1 1 1 1 1 1
Hepatic fibrosis 0 0 1 2 1 2 0 0
Injury to liver 1 1 0 0 1 1 0 0
Liver disorder 0 0 1 1 1 1 0 0
Portal hypertension 0 0 1 1 1 1 0 0
Neoplasms benign, malignant and 5 (1.9%) 7 4 (1.4%) 5 9 (1.6%) 12 5 (1.4%) 5
unspecified (incl cysts and polyps)
Lung cancer 2 2 1 1 3 3 1 1
Large cell lung cancer 0 0 1 1 1 1 0 0
Lung nodule 0 0 1 1 1 1 0 0
Lymphocytic leukemia 0 0 1 1 1 1 0 0
Myelodysplastic syndrome 1 1 0 0 1 1 0 0
Ovarian cancer 1 1 0 0 1 1 0 0
Prostate cancer metastatic 0 0 1 1 1 1 0 0
Skin cancer 1 1 0 0 1 1 0 0
Small cell carcinoma of the lung 1 2 0 0 1 2 0 0
Adenoma 0 0 0 0 0 0 1 1
Breast cancer 0 0 0 0 0 0 1 1
Esophageal cancer 0 0 0 0 0 0 1 1
Lymphoma 0 0 0 0 0 0 1 1
Endocrine disorders 2 (0.7%) 2 1 (0.4%) 1 3 (0.5%) 3 1 (0.3%) 1
Adrenal insufficiency 1 1 0 0 1 1 0 0
Hypothyroidism 1 1 0 0 1 1 1 1
Myxedema 0 0 1 1 1 1 0 0
Immune system disorders 2 (0.7%) 2 1 (0.4%) 1 3 (0.5%) 3 0 (0.0%) 0
Amyloidosis 1 1 0 0 1 1 0 0
Heart transplant rejection 0 0 1 1 1 1 0 0
Transplant rejection 1 1 0 0 1 1 0 0
Skin and subcutaneous tissue disorders 0 (0.0%) 0 3 (1.1%) 3 3 (0.5%) 3 3 (0.9%) 4
Diabetic ulcer 0 0 1 1 1 1 0 0
Foot ulcer 0 0 1 1 1 1 0 0
Venous stasis ulcer 0 0 1 1 1 1 0 0
Decubitus ulcer 0 0 0 0 0 0 1 1
Rash 0 0 0 0 0 0 1 2

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