Study: NCT00072358

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 291 at risk

Adverse event: Allergic Reaction/Hyper
Serious: yes
Organ System: Immune system disorders
Frequency: 11 affected / 291 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 291 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 291 at risk

Adverse event: Blood,Bone marrow,other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 291 at risk

Adverse event: CNS hemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 291 at risk

Adverse event: Cardiac left vent
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 291 at risk

Adverse event: Cardiovascular, Arrhythmia other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 291 at risk

Adverse event: Cardiovascular, other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 291 at risk

Adverse event: Catheter-rel inf
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 291 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 291 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 291 at risk

Adverse event: Depressed level of cons
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 291 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 291 at risk

Adverse event: Dysphagia, esophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 291 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 291 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 291 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 291 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 121 affected / 291 at risk

Adverse event: GI, other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 291 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 291 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 291 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 291 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 291 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 291 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 291 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 291 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 291 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 291 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 291 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 291 at risk

Adverse event: Infection unk ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 291 at risk

Adverse event: Infection w.out neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 57 affected / 291 at risk

Adverse event: Infection with grade 3/4 neut
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 291 at risk

Adverse event: Infection/Feb Neut-Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 291 at risk

Adverse event: Irritability < 3 years
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 291 at risk

Adverse event: Leukocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 291 at risk

Adverse event: Middle ear/hearing
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 291 at risk

Adverse event: Mood alteration-anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 291 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 291 at risk

Adverse event: Neurology, other
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 291 at risk

Adverse event: Neutrophils/gran
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 291 at risk

Adverse event: Pain, other
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 291 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 291 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 291 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 291 at risk

Adverse event: Pulmonary, other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 291 at risk

Adverse event: Rash, desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 291 at risk

Adverse event: Rigors, chills
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 291 at risk

Adverse event: SGPT (ALT)
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 291 at risk

Adverse event: Secondary malignancy, other
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 291 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 291 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 291 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 291 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 291 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 291 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 291 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 291 at risk

Adverse event: Pain, other
Serious: no
Organ System: General disorders
Frequency: 157 affected / 291 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 142 affected / 291 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 103 affected / 291 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 100 affected / 291 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 90 affected / 291 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 80 affected / 291 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 78 affected / 291 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 63 affected / 291 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 58 affected / 291 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 53 affected / 291 at risk

Adverse event: Rash, desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 42 affected / 291 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 40 affected / 291 at risk

Adverse event: Diarrhea (Pts w/out col)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 291 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 35 affected / 291 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 33 affected / 291 at risk

Adverse event: Pulmonary, other
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 32 affected / 291 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 291 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 291 at risk

Adverse event: Mood alteration-anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 291 at risk

Adverse event: Abdominal pain/cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 291 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 291 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 291 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 291 at risk

Adverse event: Allergy, other
Serious: no
Organ System: Immune system disorders
Frequency: 16 affected / 291 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 291 at risk

Adverse event: Irritability < 3 years
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 291 at risk