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In most cases, patient samples have been limited to surgical specimens and peripheral blood collected over time. Table 5: Per Patient Incidence of Adverse Events in 10% or More Adult and Adolescent Patients Enrolled in Studies C08-002A/B, C08-003A/B and C10-004 Separately and in Total Number (%) of Patients C08-002A/B C08-003A/B C10-004 Total (N=17) (N=20) (N=forty one) (N=78) Vascular Disorders a Hypertension 10 (fifty nine) 9 (45) 7 (17) 26 (33) Hypotension 2 (12) 4 (20) 7 (17) 13 (17) Infections and Infestations Bronchitis three (18) 2 (10) 4 (10) 9 (12) Nasopharyngitis 3 (18) eleven (fifty five) 7 (17) 21 (27) Gastroenteritis 3 (18) 4 (20) 2 (5) 9 (12) Upper respiratory tract 5 (29) 8 (forty) 2 (5) 15 (19) an infection Urinary tract infection 6 (35) 3 (15) eight (20) 17 (22) Gastrointestinal Disorders Diarrhea 8 (47) 8 (forty) 12 (32) 29 (37) Vomiting 8 (forty seven) 9 (45) 6 (15) 23 (30) eleven Number (%) of Patients C08-002A/B C08-003A/B C10-004 Total (N=17) (N=20) (N=41) (N=seventy eight) Nausea 5 (29) 8 (forty) 5 (12) 18 (23) Abdominal pain three (18) 6 (30) 6 (15) 15 (19) Nervous System Disorders Headache 7 (forty one) 10 (50) 15 (37) 32 (forty one) Blood and Lymphatic System Disorders Anemia 6 (35) 7 (35) 7 (17) 20 (26) Leukopenia four (24) 3 (15) 5 (12) 12 (15) Psychiatric Disorders Insomnia 4 (24) 2 (10) 5 (12) eleven (14) Renal and Urinary Disorders Renal Impairment 5 (29) 3 (15) 6 (15) 14 (18) Proteinuria 2 (12) 1 (5) 5 (12) 8 (10) Respiratory, Thoracic and Mediastinal Disorders Cough 4 (24) 6 (30) eight (20) 18 (23) General Disorders and Administration Site Conditions Fatigue three (18) 4 (20) 3 (7) 10 (thirteen) Peripheral edema 5 (29) 4 (20) 9 (22) 18 (23) Pyrexia 4 (24) 5 (25) 7 (17) 16 (21) Asthenia three (18) four (20) 6 (15) 13 (17) Eye Disorder 5 (29) 2 (10) 8 (20) 15 (19) Metabolism and Nutrition Disorders Hypokalemia three (18) 2 (10) 4 (10) 9 (12) Neoplasms benign, malignant, and unspecified (including 1 (6) 6 (30) 1 (20) 8 (10) cysts and polyps) Skin and Subcutaneous Tissue Disorders Rash 2 (12) 3 (15) 6 (15) 11 (14) Pruritus 1 (6) three (15) four (10) 8 (10) Musculoskeletal and Connective Tissue Disorders Arthralgia 1 (6) 2 (10) 7 (17) 10 (13) Back ache 3 (18) 3 (15) 2 (5) eight (10) a. 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