Study: NCT02422940

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: Cellutiis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 151 at risk

Adverse event: Post procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 151 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 151 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 151 at risk

Adverse event: Focal dyscognitive seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: Ear And Labyrinth Disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 151 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 151 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 151 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 151 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 151 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 151 at risk

Adverse event: Gastro esophageal Reflux Disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 151 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 151 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 3 affected / 151 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 151 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 151 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 151 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 151 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 151 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 151 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 151 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 151 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 151 at risk

Adverse event: Blood Creatinine Phosphokinase Increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 151 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 151 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 151 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 151 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 151 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 151 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 151 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 151 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 151 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 151 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 151 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 151 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 151 at risk

Adverse event: Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 151 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 151 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 151 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 151 at risk

Adverse event: Balance disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 151 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 151 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 151 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 151 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 151 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 151 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 151 at risk

Adverse event: Renal cyst
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 151 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 151 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 151 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 151 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 151 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 151 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 151 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Acute myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Angina unstable
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Antrial Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 142 at risk

Adverse event: Cellutiis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 142 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 142 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 142 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 142 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 142 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 142 at risk

Adverse event: Ear And Labyrinth Disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 142 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 142 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 142 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 142 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 142 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 142 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 142 at risk

Adverse event: Gastro esophageal Reflux Disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 142 at risk

Adverse event: Large intestine polyp
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 142 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 142 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 142 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 2 affected / 142 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 142 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 142 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 142 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 142 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 142 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 142 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 142 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 142 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 142 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 142 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 142 at risk

Adverse event: Blood Creatinine Phosphokinase Increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 142 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 142 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 142 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 142 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 142 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 142 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 142 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 142 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 142 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 142 at risk

Adverse event: Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 142 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 142 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 142 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 142 at risk

Adverse event: Balance disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 142 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 142 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 142 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 142 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 142 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 142 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 142 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 142 at risk

Adverse event: Renal cyst
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 142 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 142 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 142 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 142 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 142 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 142 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 142 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 142 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 142 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 142 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 142 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 142 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 142 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 142 at risk

Adverse event: Diastolic dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 142 at risk

Adverse event: Dilatation ventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 142 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 142 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 142 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 142 at risk

Adverse event: Tricuspid valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 142 at risk