Study: NCT00945009

Adverse event: 11600-Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 189 at risk

Adverse event: 15000-Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 189 at risk

Adverse event: 24600-Death NOS
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 189 at risk

Adverse event: 40600-Hepatobiliary disorders - Other specify
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 189 at risk

Adverse event: 43100-Hypokalemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 189 at risk

Adverse event: 71500-Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: 83600-Urine output decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 189 at risk

Adverse event: 10300-Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: 10700-Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 189 at risk

Adverse event: 11100-Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 189 at risk

Adverse event: 11600-Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 189 at risk

Adverse event: 11900-Alkalosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 189 at risk

Adverse event: 13200-Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 189 at risk

Adverse event: 14000-Aphonia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 189 at risk

Adverse event: 14100-Apnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: 15000-Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 189 at risk

Adverse event: 15400-Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: 18800-Bronchial infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 189 at risk

Adverse event: 20100-Cardiac disorders - Other specify
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 189 at risk

Adverse event: 23400-Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: 24100-Creatinine increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 189 at risk

Adverse event: 24700-Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 189 at risk

Adverse event: 27800-Dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: 28600-Ejection fraction decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 189 at risk

Adverse event: 33300-Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 189 at risk

Adverse event: 41400-Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 189 at risk

Adverse event: 41600-Hyperkalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 189 at risk

Adverse event: 42100-Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 189 at risk

Adverse event: 42500-Hyperuricemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 189 at risk

Adverse event: 42700-Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 189 at risk

Adverse event: 42900-Hypoglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 189 at risk

Adverse event: 43100-Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 189 at risk

Adverse event: 43200-Hypomagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 189 at risk

Adverse event: 43500-Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 189 at risk

Adverse event: 43900-Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 189 at risk

Adverse event: 50700-Laryngeal edema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: 51300-Laryngeal stenosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: 58300-Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 189 at risk

Adverse event: 63900-Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 189 at risk

Adverse event: 65800-Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 189 at risk

Adverse event: 66300-Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: 68700-Pulmonary edema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: 71000-Renal and urinary disorders - Other specify
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 189 at risk

Adverse event: 71500-Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: 72500-Reversible posterior leukoencephalopathy syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 189 at risk

Adverse event: 73700-Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 189 at risk

Adverse event: 75700-Small intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: 78100-Stridor
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: 78900-Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 189 at risk

Adverse event: 79600-Thromboembolic event
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 189 at risk

Adverse event: 83100-Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 189 at risk

Adverse event: 83600-Urine output decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 189 at risk

Adverse event: 87900-Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: 88500-White blood cell decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 189 at risk

Adverse event: 40600-Hepatobiliary disorders - Other specify
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 36 at risk

Adverse event: 11600-Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: 15000-Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: 42700-Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: 43100-Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: 43900-Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk