Study: NCT01079936

Adverse event: Fever, Flu-like
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: GI DPH
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Infection, Neutropenic fever
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3 at risk

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

Adverse event: Hepatobiliary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: GI DPH
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 6 at risk

Adverse event: Infection, Neutropenic fever
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 6 at risk

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

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: High blood pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 24 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 24 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 9 affected / 24 at risk

Adverse event: Herpetic lip leson
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 24 at risk

Adverse event: GU HEM
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 24 at risk

Adverse event: Hepatobiliary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 24 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 24 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Other Skin Disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 24 at risk

Adverse event: Fever, Flu-like
Serious: no
Organ System: General disorders
Frequency: 5 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 24 at risk

Adverse event: GI DPH
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 24 at risk

Adverse event: Infection, Neutropenic fever
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 24 at risk

Adverse event: Blood Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Change in Platelet levels
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: High blood pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 26 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 26 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 13 affected / 26 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 26 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hepatobiliary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 26 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 26 at risk

Adverse event: Other Neurologic Disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 26 at risk

Adverse event: Fever, Flu-like
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 26 at risk

Adverse event: GI DPH
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 26 at risk

Adverse event: Infection, Neutropenic fever
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 26 at risk