Study: NCT00978068

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 84 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Dyspnea/respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 84 at risk

Adverse event: Elevated ALT
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 84 at risk

Adverse event: Elevated Temperature/Fever
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 84 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 84 at risk

Adverse event: Neutropenia/Absolute neutrophil count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 84 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 84 at risk

Adverse event: Thrombocytopenia Platelets, decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 84 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 84 at risk

Adverse event: Chills
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 84 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 84 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 84 at risk

Adverse event: Elevated Temperature
Serious: no
Organ System: Endocrine disorders
Frequency: 19 affected / 84 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 84 at risk

Adverse event: Thrombocytopenia Platelets, decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 84 at risk

Adverse event: Abnormal loss of weight
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 84 at risk

Adverse event: WBC, decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 86 at risk

Adverse event: Altered mental status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 86 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 86 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Dyspnea/respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 86 at risk

Adverse event: Elevated ALT
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 86 at risk

Adverse event: Elevated Temperature/Fever
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 86 at risk

Adverse event: Neutropenia/Absolute neutrophil count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 86 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 86 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 86 at risk

Adverse event: Stevens-Johnson syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Thrombocytopenia Platelets, decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 86 at risk

Adverse event: Abnormal loss of weight
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 86 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 86 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 86 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 86 at risk

Adverse event: Elevated Temperature
Serious: no
Organ System: Endocrine disorders
Frequency: 24 affected / 86 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 86 at risk

Adverse event: Pallor
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Rash (non-infectious)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Severe Malnutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 86 at risk

Adverse event: Thrombocytopenia Platelets, decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 86 at risk

Adverse event: WBC, decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 86 at risk