Study: NCT01601236

Adverse event: Gastric antral vascular ectasia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hydronephrosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Mastitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Blood creatinine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Gastritis erosive
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Gastrointestinal angiodysplasia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Melaena
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: Aortic stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Meniscus injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Tibia fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Wrist fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 3 affected / 7 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 7 at risk

Adverse event: Nephropathy
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 7 at risk

Adverse event: Plantar fasciitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk

Adverse event: Stress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hyperkeratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Cardiogenic shock
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 17 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 17 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 17 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 8 affected / 17 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 17 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 17 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 17 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 17 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 17 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 17 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 17 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 17 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Viral diarrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Blood creatinine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Albumin urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Blood ketone body increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Urine protein/creatinine ratio increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 17 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 17 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 17 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Abdominal tenderness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Impaired gastric emptying
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 17 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hair growth abnormal
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Post-traumatic headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 17 at risk

Adverse event: Retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 17 at risk

Adverse event: Gastric antral vascular ectasia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

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

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

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

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

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 34 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 34 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 34 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 13 affected / 34 at risk

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

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

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

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

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

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 34 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 34 at risk

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

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

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

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

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

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

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 34 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 34 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 34 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 34 at risk

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

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

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

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 34 at risk

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

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

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Mastitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

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

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

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

Adverse event: Viral diarrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Blood creatinine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 34 at risk

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

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

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Albumin urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Blood ketone body increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Urine protein/creatinine ratio increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

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

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

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Plantar fasciitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 34 at risk

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Adverse event: Aortic stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 34 at risk

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

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

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

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

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

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

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

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

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Post-traumatic headache
Serious: no
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: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 34 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 34 at risk

Adverse event: Meniscus injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 34 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 34 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 34 at risk

Adverse event: Tibia fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 34 at risk

Adverse event: Wrist fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 34 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 34 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Cardiogenic shock
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 34 at risk

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

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 34 at risk

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

Adverse event: Amenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 34 at risk