Study: NCT01290263

Adverse event: Platelet count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 4 Platelet count decreased
Frequency: 1 affected / 37 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Notes: Grade 3 Edema Limbs
Frequency: 1 affected / 37 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grade 3 Fatigue
Frequency: 1 affected / 37 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grade 2 Fatigue
Frequency: 1 affected / 37 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Notes: Grade 4 Neutrophil Count Decreased
Frequency: 1 affected / 37 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2 Anemia
Frequency: 2 affected / 37 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Notes: Grade 2 Atrial Flutter
Frequency: 1 affected / 37 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Notes: Grade 2 Pericardial Effusion
Frequency: 1 affected / 37 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Grade 2 Blurred Vision
Frequency: 1 affected / 37 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 Abdominal Pain
Frequency: 1 affected / 37 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 Constipation
Frequency: 1 affected / 37 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 Diarrhea
Frequency: 1 affected / 37 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 Hemorrhoids
Frequency: 1 affected / 37 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 Nausea
Frequency: 3 affected / 37 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 Stomach Pain
Frequency: 1 affected / 37 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Notes: Grade 1 Edema Face
Frequency: 1 affected / 37 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Grade 1 Edema Limbs
Frequency: 3 affected / 37 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Grade 2 Edema Limbs
Frequency: 2 affected / 37 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1 Fatigue
Frequency: 3 affected / 37 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 2 Fatigue
Frequency: 3 affected / 37 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: General disorders
Notes: Grade 2 Infusion Related Reaction
Frequency: 1 affected / 37 at risk

Adverse event: Infusion site reaction
Serious: no
Organ System: General disorders
Notes: Grade 1 Infusion Site Reaction
Frequency: 1 affected / 37 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Notes: Grade 2 Localized Edema
Frequency: 1 affected / 37 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1 Bruising
Frequency: 1 affected / 37 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 2 Vascular Access Complication
Frequency: 1 affected / 37 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Alanine Aminotransferase Increased
Frequency: 2 affected / 37 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Alkaline Phosphatase Increased
Frequency: 1 affected / 37 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Aspartate Aminotransferase Increased
Frequency: 2 affected / 37 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Blood Bilirubin Increased
Frequency: 1 affected / 37 at risk

Adverse event: Troponin I increased
Serious: no
Organ System: Investigations
Notes: Grade 3 Cardiac Troponin I Increased
Frequency: 1 affected / 37 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1 Neutrophil Count Decreased
Frequency: 1 affected / 37 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Grade 2 Neutrophil Count Decreased
Frequency: 1 affected / 37 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1 Platelet Count Decreased
Frequency: 4 affected / 37 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Grade 4 Platelet Count Decreased
Frequency: 1 affected / 37 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1 White Blood Cell Decreased
Frequency: 1 affected / 37 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Anorexia
Frequency: 1 affected / 37 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Hyperglycemia
Frequency: 2 affected / 37 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Hypokalemia
Frequency: 2 affected / 37 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Hyponatremia
Frequency: 2 affected / 37 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3 Hypophosphatemia
Frequency: 1 affected / 37 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1 Arthralgia
Frequency: 2 affected / 37 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1 Generalized Muscle Weakness
Frequency: 1 affected / 37 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1 Myalgia
Frequency: 1 affected / 37 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 Dizziness
Frequency: 1 affected / 37 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 Headache
Frequency: 2 affected / 37 at risk

Adverse event: Haemorrhage intracranial
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 Intracranial Hemorrhage
Frequency: 1 affected / 37 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 Presyncope
Frequency: 1 affected / 37 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 1 Confusion
Frequency: 1 affected / 37 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 1 Insomnia
Frequency: 1 affected / 37 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1 Hematuria
Frequency: 3 affected / 37 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1 Proteinuria
Frequency: 1 affected / 37 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 2 Proteinuria
Frequency: 1 affected / 37 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 Epistaxis
Frequency: 3 affected / 37 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 Hoarseness
Frequency: 6 affected / 37 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1 Alopecia
Frequency: 2 affected / 37 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1 Rash Maculo-papular
Frequency: 1 affected / 37 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1 Skin Ulceration
Frequency: 1 affected / 37 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 Hypertension
Frequency: 2 affected / 37 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Grade 2 Hypertension
Frequency: 10 affected / 37 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Grade 3 Hypertension
Frequency: 3 affected / 37 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Notes: Grade 2 Thromboembolic Event
Frequency: 2 affected / 37 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Notes: Grade 3 Thromboembolic Event
Frequency: 1 affected / 37 at risk

Adverse event: Other - Conjunctival Hemorrhage
Serious: no
Organ System: Eye disorders
Notes: Grade 1 Other - Conjunctival Hemorrhage
Frequency: 1 affected / 37 at risk

Adverse event: Other - Livedo Reticularis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1 Other - Livedo Reticularis
Frequency: 1 affected / 37 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Grade 1 Blurred Vision
Frequency: 1 affected / 11 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 Abdominal Pain
Frequency: 1 affected / 11 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 Abdominal Pain
Frequency: 1 affected / 11 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 Constipation
Frequency: 2 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 Diarrhea
Frequency: 1 affected / 11 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 Dry Mouth
Frequency: 1 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 Nausea
Frequency: 2 affected / 11 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Grade 1 Edema Limbs
Frequency: 1 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 2 Fatigue
Frequency: 2 affected / 11 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Notes: Grade 1 Gait Disturbance
Frequency: 1 affected / 11 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Hyponatremia
Frequency: 1 affected / 11 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1 Generalized Muscle Weakness
Frequency: 1 affected / 11 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 2 Muscle Weakness Lower Limb
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 Headache
Frequency: 1 affected / 11 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 2 Insomnia
Frequency: 1 affected / 11 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 Hoarseness
Frequency: 1 affected / 11 at risk

Adverse event: Other - Indigestion/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 Other - Indigestion/heartburn
Frequency: 1 affected / 11 at risk