Study: NCT02414958

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 243 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 243 at risk

Adverse event: Normal tension glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 243 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 243 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 243 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 243 at risk

Adverse event: Procedural pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 243 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 243 at risk

Adverse event: Ulna fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 243 at risk

Adverse event: Clostridium test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 243 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 243 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 243 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 243 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 243 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 243 at risk

Adverse event: Ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 243 at risk

Adverse event: Ketosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 243 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 243 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 243 at risk

Adverse event: Hypoglycaemic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 243 at risk

Adverse event: Sensory disturbance
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 243 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 243 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 243 at risk

Adverse event: Nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 243 at risk

Adverse event: Menstrual disorder
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 243 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 243 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 243 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 243 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 243 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 243 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 243 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 243 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 243 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 243 at risk

Adverse event: Blood ketone body increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 243 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 152 affected / 243 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 243 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 243 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 243 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 243 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 243 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 243 at risk

Adverse event: Pleurisy viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 243 at risk

Adverse event: Pneumonia klebsiella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 243 at risk

Adverse event: Rhinovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 243 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 243 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 243 at risk

Adverse event: Carbon monoxide poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 243 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 243 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 243 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 243 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 243 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 243 at risk

Adverse event: Bacterial test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 243 at risk

Adverse event: Blood ketone body increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 243 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 243 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 243 at risk

Adverse event: Diabetic metabolic decompensation
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 243 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 243 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 243 at risk

Adverse event: Ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 243 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 243 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 243 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 243 at risk

Adverse event: Benign breast neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 243 at risk

Adverse event: Dystonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 243 at risk

Adverse event: Embolic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 243 at risk

Adverse event: Lacunar stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 243 at risk

Adverse event: Partial seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 243 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 243 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 243 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 243 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 243 at risk

Adverse event: Dermal cyst
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 243 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 243 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 243 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 243 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 243 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 243 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 243 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 52 affected / 243 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 243 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 243 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 243 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 243 at risk

Adverse event: Blood ketone body increased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 243 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 154 affected / 243 at risk

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 244 at risk

Adverse event: Macular fibrosis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 244 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 244 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Tinea versicolour
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 244 at risk

Adverse event: Shunt malfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 244 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 244 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 244 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 244 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 244 at risk

Adverse event: Ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 244 at risk

Adverse event: Periarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Toxic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Psychiatric decompensation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 244 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 244 at risk

Adverse event: Acquired phimosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 244 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 244 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 244 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 244 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 244 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 244 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 43 affected / 244 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 244 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 244 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 244 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 244 at risk

Adverse event: Blood ketone body increased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 244 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 147 affected / 244 at risk