Study: NCT01712308

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 35 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 35 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 35 at risk

Adverse event: Non cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 35 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 35 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 35 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 35 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 9 affected / 35 at risk

Adverse event: Elevated Albumin/Creatinine Ratio
Serious: no
Organ System: Investigations
Frequency: 4 affected / 35 at risk

Adverse event: elevated transaminase levels
Serious: no
Organ System: Investigations
Frequency: 1 affected / 35 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 35 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 35 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 35 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 9 affected / 35 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 35 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 35 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 35 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 35 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 35 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 35 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 35 at risk

Adverse event: Musculoskeletal and connective tissue disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 35 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 16 affected / 35 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 35 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 35 at risk

Adverse event: Rash maculo papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 35 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 35 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 35 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 35 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 35 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 35 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 35 at risk

Adverse event: Bleeding Hemorrhage
Serious: no
Organ System: General disorders
Frequency: 8 affected / 35 at risk

Adverse event: Psychiatric Disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 35 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 21 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 21 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 21 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 21 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 21 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 21 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Elevated Albumin/Creatinine Ratio
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: elevated transaminase levels
Serious: no
Organ System: Investigations
Frequency: 3 affected / 21 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 14 affected / 21 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 21 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 21 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 21 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 21 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 21 at risk

Adverse event: Iron overload
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 21 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 21 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Musculoskeletal and connective tissue disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 21 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 21 at risk

Adverse event: Rash maculo papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 21 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 21 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 21 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Bleeding Hemorrhage
Serious: no
Organ System: General disorders
Frequency: 6 affected / 21 at risk

Adverse event: Psychiatric Disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 21 at risk