Study: NCT00254163

Adverse event: ABDO ENLARGE
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: ALLERG REACT
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 88 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 88 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: IMMUNOGLOBUL DEC
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 88 at risk

Adverse event: INFECT
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: LUNG DIS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 88 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 88 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 88 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Tumour lysis syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 88 at risk

Adverse event: VOMIT
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: ALLERG REACT
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 88 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 88 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 45 affected / 88 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 88 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 88 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 88 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 48 affected / 88 at risk

Adverse event: BILIRUBINEM
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 88 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 18 affected / 88 at risk

Adverse event: CONSTIP
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 88 at risk

Adverse event: COUGH INC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 88 at risk

Adverse event: CREATININE INC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 88 at risk

Adverse event: DEHYDRAT
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 88 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 88 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 88 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 88 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 88 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 88 at risk

Adverse event: EDEMA PERIPH
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 88 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 88 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 10 affected / 88 at risk

Adverse event: HYPERGLYCEM
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 88 at risk

Adverse event: INFECT
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 88 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 88 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 88 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 41 affected / 88 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 88 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 88 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 72 affected / 88 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 88 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 88 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 88 at risk

Adverse event: SGOT INC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 88 at risk

Adverse event: SGPT INC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 88 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 88 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 88 at risk

Adverse event: TASTE PERVERS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 88 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 33 affected / 88 at risk

Adverse event: URIN FREQUENCY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 88 at risk

Adverse event: VOMIT
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 88 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 89 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 89 at risk

Adverse event: CARDIOVASC DIS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 89 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 89 at risk

Adverse event: CONFUS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 89 at risk

Adverse event: COUGH INC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: DEHYDRAT
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 89 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 89 at risk

Adverse event: Oedema
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 89 at risk

Adverse event: EFFUS PLEURAL
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 89 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 89 at risk

Adverse event: HEART FAIL RIGHT
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 89 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 89 at risk

Adverse event: INFECT
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 89 at risk

Adverse event: KIDNEY FAIL
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 89 at risk

Adverse event: LIVER FAIL
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 89 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 89 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 89 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 89 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 89 at risk

Adverse event: RESPIRAT DIS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 89 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 89 at risk

Adverse event: ALLERG REACT
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 89 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 89 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 34 affected / 89 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 89 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 89 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 89 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 53 affected / 89 at risk

Adverse event: BILIRUBINEM
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 89 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 16 affected / 89 at risk

Adverse event: CONSTIP
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 89 at risk

Adverse event: COUGH INC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 89 at risk

Adverse event: CREATININE INC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 89 at risk

Adverse event: DEHYDRAT
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 89 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 89 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 89 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 89 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 89 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 89 at risk

Adverse event: EDEMA PERIPH
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 89 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 30 affected / 89 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 89 at risk

Adverse event: HYPERGLYCEM
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 89 at risk

Adverse event: INFECT
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 89 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 89 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 89 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 34 affected / 89 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 89 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 89 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 68 affected / 89 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 89 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 89 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 89 at risk

Adverse event: SGOT INC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 89 at risk

Adverse event: SGPT INC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 89 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 89 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 89 at risk

Adverse event: TASTE PERVERS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 89 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 89 at risk

Adverse event: URIN FREQUENCY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 89 at risk

Adverse event: VOMIT
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 89 at risk