Study: NCT01175356

Adverse event: 39000-Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 98 at risk

Adverse event: 74500-Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 98 at risk

Adverse event: 10300-Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: 14900-Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 98 at risk

Adverse event: 55600-Mucositis oral
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 98 at risk

Adverse event: 24600-Death NOS
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 98 at risk

Adverse event: 37200-General disorders and administration site conditions - Other specify
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 98 at risk

Adverse event: 55700-Multi-organ failure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 98 at risk

Adverse event: 60600-Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 98 at risk

Adverse event: 21600-Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 98 at risk

Adverse event: 40000-Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 98 at risk

Adverse event: 40400-Hepatic pain
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 98 at risk

Adverse event: 40600-Hepatobiliary disorders - Other specify
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 98 at risk

Adverse event: 66500-Portal hypertension
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 98 at risk

Adverse event: 44800-Infections and infestations - Other specify
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 98 at risk

Adverse event: 53100-Lung infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: 73700-Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 98 at risk

Adverse event: 10900-Activated partial thromboplastin time prolonged
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 98 at risk

Adverse event: 11600-Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 98 at risk

Adverse event: 15000-Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 98 at risk

Adverse event: 17400-Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 98 at risk

Adverse event: 45800-INR increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 98 at risk

Adverse event: 88200-Weight gain
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 98 at risk

Adverse event: 88300-Weight loss
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 98 at risk

Adverse event: 10700-Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 98 at risk

Adverse event: 13500-Anorexia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 98 at risk

Adverse event: 41600-Hyperkalemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 98 at risk

Adverse event: 41800-Hypernatremia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 98 at risk

Adverse event: 42600-Hypoalbuminemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 98 at risk

Adverse event: 43100-Hypokalemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 98 at risk

Adverse event: 43300-Hyponatremia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 98 at risk

Adverse event: 58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 98 at risk

Adverse event: 72500-Reversible posterior leukoencephalopathy syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 98 at risk

Adverse event: 43900-Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 98 at risk

Adverse event: 65900-Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 98 at risk

Adverse event: 69000-Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: 71600-Respiratory thoracic and mediastinal disorders - Other specify
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: 43600-Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 98 at risk

Adverse event: 13200-Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 98 at risk

Adverse event: 33300-Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 54 affected / 98 at risk

Adverse event: 20000-Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 98 at risk

Adverse event: 78900-Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 98 at risk

Adverse event: 38900-Hearing impaired
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 9 affected / 98 at risk

Adverse event: 10100-Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: 10300-Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 98 at risk

Adverse event: 14900-Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 98 at risk

Adverse event: 22100-Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: 25700-Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 98 at risk

Adverse event: 29400-Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: 36400-Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: 44600-Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: 55600-Mucositis oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 98 at risk

Adverse event: 57600-Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 98 at risk

Adverse event: 59700-Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 98 at risk

Adverse event: 81900-Typhlitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: 87900-Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 98 at risk

Adverse event: 33900-Fever
Serious: no
Organ System: General disorders
Frequency: 1 affected / 98 at risk

Adverse event: 37200-General disorders and administration site conditions - Other specify
Serious: no
Organ System: General disorders
Frequency: 1 affected / 98 at risk

Adverse event: 60600-Pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 98 at risk

Adverse event: 12000-Allergic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 98 at risk

Adverse event: 13100-Anaphylaxis
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 98 at risk

Adverse event: 20500-Catheter related infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 98 at risk

Adverse event: 25600-Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: 44800-Infections and infestations - Other specify
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 98 at risk

Adverse event: 53100-Lung infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 98 at risk

Adverse event: 61100-Pancreas infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: 73700-Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 98 at risk

Adverse event: 74600-Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: 75200-Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: 76000-Small intestine infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: 82300-Upper respiratory infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: 83100-Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 98 at risk

Adverse event: 88900-Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 98 at risk

Adverse event: 13800-Aortic injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 98 at risk

Adverse event: 45700-Injury poisoning and procedural complications - Other specify
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 98 at risk

Adverse event: 47300-Intraoperative hepatobiliary injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 98 at risk

Adverse event: 47700-Intraoperative renal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 98 at risk

Adverse event: 10900-Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 98 at risk

Adverse event: 11600-Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 98 at risk

Adverse event: 15000-Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 98 at risk

Adverse event: 17400-Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 98 at risk

Adverse event: 24100-Creatinine increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 98 at risk

Adverse event: 34000-Fibrinogen decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 98 at risk

Adverse event: 37500-GGT increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 98 at risk

Adverse event: 52600-Lipase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 98 at risk

Adverse event: 53700-Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 21 affected / 98 at risk

Adverse event: 58300-Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 27 affected / 98 at risk

Adverse event: 65800-Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 28 affected / 98 at risk

Adverse event: 88200-Weight gain
Serious: no
Organ System: Investigations
Frequency: 1 affected / 98 at risk

Adverse event: 88300-Weight loss
Serious: no
Organ System: Investigations
Frequency: 1 affected / 98 at risk

Adverse event: 88500-White blood cell decreased
Serious: no
Organ System: Investigations
Frequency: 23 affected / 98 at risk

Adverse event: 10700-Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 98 at risk

Adverse event: 13500-Anorexia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 98 at risk

Adverse event: 24700-Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 98 at risk

Adverse event: 41300-Hypercalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 98 at risk

Adverse event: 41400-Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 98 at risk

Adverse event: 41600-Hyperkalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 98 at risk

Adverse event: 41700-Hypermagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 98 at risk

Adverse event: 41800-Hypernatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 98 at risk

Adverse event: 42600-Hypoalbuminemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 98 at risk

Adverse event: 42700-Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 98 at risk

Adverse event: 42900-Hypoglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 98 at risk

Adverse event: 43100-Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 98 at risk

Adverse event: 43200-Hypomagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 98 at risk

Adverse event: 43300-Hyponatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 98 at risk

Adverse event: 43500-Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 98 at risk

Adverse event: 54900-Metabolism and nutrition disorders - Other specify
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 98 at risk

Adverse event: 18200-Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: 37300-Generalized muscle weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: 60700-Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 98 at risk

Adverse event: 10500-Abducens nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 98 at risk

Adverse event: 38800-Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 98 at risk

Adverse event: 79100-Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 98 at risk

Adverse event: 11400-Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 98 at risk

Adverse event: 13700-Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 98 at risk

Adverse event: 25400-Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 98 at risk

Adverse event: 11100-Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 98 at risk

Adverse event: 39300-Hematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 98 at risk

Adverse event: 71100-Renal calculi
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 98 at risk

Adverse event: 19300-Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: 29700-Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 98 at risk

Adverse event: 43900-Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 98 at risk

Adverse event: 64900-Pharyngeal mucositis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: 66400-Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: 68700-Pulmonary edema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 98 at risk

Adverse event: 69000-Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: 71500-Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 98 at risk

Adverse event: 78100-Stridor
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: 74700-Skin and subcutaneous tissue disorders - Other specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: 79000-Surgical and medical procedures - Other specify
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 98 at risk

Adverse event: 39100-Hematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 98 at risk

Adverse event: 42100-Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 98 at risk

Adverse event: 43600-Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 98 at risk