Study: NCT00590902

Adverse event: Abdominal pain/cramping
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 81 at risk

Adverse event: Adult Respiratory Distress Syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 81 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 81 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 81 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 81 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 81 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 81 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 81 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 81 at risk

Adverse event: Infection without neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 81 at risk

Adverse event: Mood alteration - Agitation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 81 at risk

Adverse event: Mood alteration - Anxiety
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 81 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 81 at risk

Adverse event: Neurology, other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 81 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 81 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 81 at risk

Adverse event: Pulmonary, other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 81 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 81 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 81 at risk

Adverse event: Vision-double vision
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 81 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 81 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 81 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 81 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 81 at risk

Adverse event: Dermatology, skin other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 81 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 81 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 81 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 20 affected / 81 at risk

Adverse event: Hemoglobin (Hgb)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 81 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 81 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 81 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 81 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 81 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 81 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 81 at risk

Adverse event: Prothrombin time (PT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 81 at risk

Adverse event: Rash, desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 81 at risk

Adverse event: SGPT (ALT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 81 at risk