Study: NCT02787746

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 241 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 241 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 241 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 241 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 241 at risk

Adverse event: Hyperhomocysteinaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 241 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 241 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 241 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 241 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 241 at risk

Adverse event: Cardiac discomfort
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 241 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 241 at risk

Adverse event: hypogastralgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 241 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 241 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 241 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 241 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 241 at risk

Adverse event: hygrostomia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 241 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 241 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 241 at risk

Adverse event: abnormal liver function
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 241 at risk

Adverse event: urocystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 241 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 241 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 241 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 241 at risk

Adverse event: Bacterial infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 241 at risk

Adverse event: pulmonary infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 241 at risk

Adverse event: Wrist fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 241 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 241 at risk

Adverse event: thoracic injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 241 at risk

Adverse event: Elevated alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 241 at risk

Adverse event: Decreased aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 241 at risk

Adverse event: Decreased blood albumin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 241 at risk

Adverse event: Elevated blood bilirubin
Serious: no
Organ System: Investigations
Frequency: 2 affected / 241 at risk

Adverse event: Reduced blood chloride
Serious: no
Organ System: Investigations
Frequency: 2 affected / 241 at risk

Adverse event: Increased blood creatine phosphokinase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 241 at risk

Adverse event: Increased blood creatinine
Serious: no
Organ System: Investigations
Frequency: 3 affected / 241 at risk

Adverse event: Increased blood glucose
Serious: no
Organ System: Investigations
Frequency: 2 affected / 241 at risk

Adverse event: Decreased blood lactate dehydrogenase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 241 at risk

Adverse event: Increased blood lactate dehydrogenase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 241 at risk

Adverse event: Decreased blood sodium
Serious: no
Organ System: Investigations
Frequency: 2 affected / 241 at risk

Adverse event: Increased blood urea
Serious: no
Organ System: Investigations
Frequency: 2 affected / 241 at risk

Adverse event: Electrocardiogram abnormal
Serious: no
Organ System: Investigations
Frequency: 4 affected / 241 at risk

Adverse event: Electroencephalogram abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 241 at risk

Adverse event: Reduced heart rate
Serious: no
Organ System: Investigations
Frequency: 3 affected / 241 at risk

Adverse event: Decreased red blood cell count
Serious: no
Organ System: Investigations
Frequency: 1 affected / 241 at risk

Adverse event: Urinary erythrocyte positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 241 at risk

Adverse event: Increased white blood cell count
Serious: no
Organ System: Investigations
Frequency: 1 affected / 241 at risk

Adverse event: Urine leukocyte positive
Serious: no
Organ System: Investigations
Frequency: 3 affected / 241 at risk

Adverse event: Increased platelet count
Serious: no
Organ System: Investigations
Frequency: 1 affected / 241 at risk

Adverse event: Decreased blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 241 at risk

Adverse event: Decreased blood creatine phosphokinase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 241 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 241 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 241 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 241 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 241 at risk

Adverse event: Type 2 diabetes
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 241 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 241 at risk

Adverse event: Skeletal muscle pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 241 at risk

Adverse event: Spinal stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 241 at risk

Adverse event: Physical discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 241 at risk

Adverse event: Spondylolisthesis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 241 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 241 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 241 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 241 at risk

Adverse event: Trigeminal neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 241 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 241 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 241 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 241 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 241 at risk

Adverse event: Amnesia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 241 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 241 at risk

Adverse event: hidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 241 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 241 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 241 at risk

Adverse event: skin disease
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 241 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 241 at risk