Study: NCT00141739

Adverse event: Adult Respiratory Distress Syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Allergic Reaction / Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Blood Bone Marrow - Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 100 at risk

Adverse event: CNS Cerebrovascular Ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Catheter - Related Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 100 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 100 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 100 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 100 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 100 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 100 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 100 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 100 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 100 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 100 at risk

Adverse event: Infection wtih Unknown ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Infection without Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 100 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Personality / Behavioral
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 100 at risk

Adverse event: Rash / Desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 100 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Sexual / Reproductive Function
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 100 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 100 at risk

Adverse event: Thrombosis / Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 100 at risk

Adverse event: Ureteral Obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 100 at risk

Adverse event: Abdominal Pain or Cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 100 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 100 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 100 at risk

Adverse event: Constitutional Symptoms - Other
Serious: no
Organ System: General disorders
Frequency: 7 affected / 100 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 100 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 100 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 100 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 11 affected / 100 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 100 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 100 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 100 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 100 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 30 affected / 100 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 100 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 24 affected / 100 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 100 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 100 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 100 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 100 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 100 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 22 affected / 100 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 100 at risk

Adverse event: Infection with Grade 3 or 4 Neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 100 at risk

Adverse event: Mood Alteration - Anxiety, Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 100 at risk

Adverse event: Mood Alteration - Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 100 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 100 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 100 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 5 affected / 100 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 100 at risk

Adverse event: Pneumonitis / Pulmonary Infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 100 at risk

Adverse event: Rash / Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 100 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 100 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 100 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 100 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 100 at risk

Adverse event: Stomatitis Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 100 at risk

Adverse event: Stomatitis Pharyngitis BMT
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 100 at risk