Study: NCT00553202

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers submitted
Frequency: 1 affected / 90 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Notes: Adeers submitted
Frequency: 1 affected / 90 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adeers submitted
Frequency: 1 affected / 90 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers submitted
Frequency: 1 affected / 90 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Notes: Adeers submitted
Frequency: 1 affected / 90 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Notes: Adeers submitted
Frequency: 1 affected / 90 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Adeers submitted
Frequency: 2 affected / 90 at risk

Adverse event: Hepatobiliary disorders - Other, specify
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Adeers submitted
Frequency: 1 affected / 90 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adeers submitted
Frequency: 1 affected / 90 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers submitted
Frequency: 1 affected / 90 at risk

Adverse event: Immune system disorders - Other, specify
Serious: yes
Organ System: Immune system disorders
Notes: Adeers submitted
Frequency: 1 affected / 90 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Notes: Adeers submitted
Frequency: 2 affected / 90 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adeers submitted
Frequency: 1 affected / 90 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Notes: Adeers submitted
Frequency: 1 affected / 90 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers submitted
Frequency: 1 affected / 90 at risk

Adverse event: Portal hypertension
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Adeers submitted
Frequency: 1 affected / 90 at risk

Adverse event: Productive cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers submitted
Frequency: 1 affected / 90 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers submitted
Frequency: 1 affected / 90 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: yes
Organ System: Renal and urinary disorders
Notes: Adeers submitted
Frequency: 1 affected / 90 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers submitted
Frequency: 3 affected / 90 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers submitted
Frequency: 1 affected / 90 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Adeers submitted
Frequency: 2 affected / 90 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: Adeers not subm
Frequency: 5 affected / 90 at risk

Adverse event: Acute respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 8 affected / 90 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 2 affected / 90 at risk

Adverse event: Bladder spasm
Serious: no
Organ System: Renal and urinary disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 11 affected / 90 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Cardiac disorders - Other, specify
Serious: no
Organ System: Cardiac disorders
Notes: Adeers not subm
Frequency: 2 affected / 90 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Cystitis noninfective
Serious: no
Organ System: Renal and urinary disorders
Notes: Adeers not subm
Frequency: 3 affected / 90 at risk

Adverse event: Cytokine release syndrome
Serious: no
Organ System: Immune system disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Death
Serious: no
Organ System: General disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 3 affected / 90 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 5 affected / 90 at risk

Adverse event: Encephalitis
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Gastric haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Adeers not subm
Frequency: 2 affected / 90 at risk

Adverse event: Hepatic pain
Serious: no
Organ System: Hepatobiliary disorders
Notes: Adeers not subm
Frequency: 4 affected / 90 at risk

Adverse event: Hepatobiliary disorders - Other, specify
Serious: no
Organ System: Hepatobiliary disorders
Notes: Adeers not subm
Frequency: 2 affected / 90 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 3 affected / 90 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 2 affected / 90 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 2 affected / 90 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 2 affected / 90 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 4 affected / 90 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Adeers not subm
Frequency: 2 affected / 90 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 3 affected / 90 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 3 affected / 90 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Notes: Adeers not subm
Frequency: 4 affected / 90 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 2 affected / 90 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: no
Organ System: General disorders
Notes: Adeers not subm
Frequency: 2 affected / 90 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Pharyngeal haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Portal hypertension
Serious: no
Organ System: Hepatobiliary disorders
Notes: Adeers not subm
Frequency: 3 affected / 90 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 2 affected / 90 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 5 affected / 90 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 2 affected / 90 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 2 affected / 90 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Stevens-Johnson syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Urine output decreased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 2 affected / 90 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk

Adverse event: Vascular disorders - Other, specify
Serious: no
Organ System: Vascular disorders
Notes: Adeers not subm
Frequency: 2 affected / 90 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 8 affected / 90 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 1 affected / 90 at risk