Study: NCT02197247

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 41 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hepatitis B
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Pulmonary sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 41 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Thrombotic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 41 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 41 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 41 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 41 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 41 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 7 affected / 41 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 41 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 41 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 41 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 41 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 41 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 41 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 41 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 41 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 41 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 41 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 41 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 41 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 41 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 41 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 41 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 41 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 41 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 41 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 41 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 41 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 41 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 41 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 3 affected / 41 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 41 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 41 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 41 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 41 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 41 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 41 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 41 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 41 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 41 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 41 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 41 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 41 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 41 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 41 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 41 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 41 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 41 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 41 at risk

Adverse event: Nail discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 41 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 41 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 41 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 41 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 41 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 41 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 41 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 41 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 41 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 41 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 41 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 41 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 41 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 41 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 41 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 41 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 41 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 41 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 41 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 41 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 41 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 41 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 41 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 41 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 41 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 41 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 41 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 41 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 41 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 41 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 41 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 41 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 41 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 41 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 41 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 41 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 41 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 41 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 41 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hepatitis B
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Pulmonary sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Thrombotic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 34 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 34 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 34 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 34 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 3 affected / 34 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 34 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 34 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 34 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 34 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 34 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 34 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 34 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 34 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 34 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 34 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 34 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 34 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 34 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 34 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 34 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 34 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 34 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 34 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 34 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 3 affected / 34 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 34 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 34 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 34 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 34 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 34 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 34 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 34 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 34 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 34 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 34 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 34 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 34 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 34 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 34 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 34 at risk

Adverse event: Nail discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 34 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 34 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 34 at risk