Study: NCT01731990

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 18 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Mesenteric arterial occlusion
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Mesenteric arteriosclerosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Groin abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 18 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 18 at risk

Adverse event: Atrioventricular block first degree
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 18 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Deafness unilateral
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 18 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Diverticulum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Erosive oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hiatus hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Large intestine polyp
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 18 at risk

Adverse event: Oesophageal mucosa erythema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Oesophageal stenosis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pancreatic cyst
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Drug intolerance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Escherichia urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 18 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 18 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 18 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 18 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 18 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 18 at risk

Adverse event: Soft tissue injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 18 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Oesophagogastroduodenoscopy abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 18 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Intervertebral disc degeneration
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Plantar fasciitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Areflexia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 18 at risk

Adverse event: Polyuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Renal cyst
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hyperkeratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Skin plaque
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Aortic aneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 18 at risk

Adverse event: Aortic thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 18 at risk

Adverse event: Intermittent claudication
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 18 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 18 at risk

Adverse event: Peripheral ischaemia
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 18 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Helicobacter gastritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 20 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pulmonary vascular disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 20 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Plasma cell disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 20 at risk

Adverse event: Goitre
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Feeling cold
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Conjunctivitis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 20 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Tinea pedis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 20 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Concussion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypochloraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Plantar fasciitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Muscle contractions involuntary
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Renal artery stenosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Genital pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 20 at risk

Adverse event: Prostatitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 20 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pulmonary mass
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Eczema asteatotic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hyperkeratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Lichen nitidus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nail discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 20 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Peripheral ischaemia
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk