Study: NCT02259088

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 307 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 307 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 307 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 307 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 307 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 307 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 307 at risk

Adverse event: Cataract (Fellow eye)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 307 at risk

Adverse event: Cataract (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 307 at risk

Adverse event: Diabetic retinal oedema (Fellow eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 307 at risk

Adverse event: Diabetic retinopathy (Fellow eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 307 at risk

Adverse event: Eye haemorrhage (Fellow eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 307 at risk

Adverse event: Glaucoma (Fellow eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 307 at risk

Adverse event: Vitreous haemorrhage (Fellow eye)
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 307 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 307 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 307 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 307 at risk

Adverse event: Chronic sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 307 at risk

Adverse event: Conjunctivitis viral (Fellow eye)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 307 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 307 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 307 at risk

Adverse event: Otitis media chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 307 at risk

Adverse event: Periodontitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 307 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 307 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 307 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 307 at risk

Adverse event: Poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 307 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 307 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 307 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 307 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 307 at risk

Adverse event: Polydipsia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 307 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 307 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 307 at risk

Adverse event: Limb mass
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 307 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 307 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 307 at risk

Adverse event: Spinal flattening
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 307 at risk

Adverse event: Benign ovarian tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 307 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 307 at risk

Adverse event: Papillary thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 307 at risk

Adverse event: Pituitary tumour benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 307 at risk

Adverse event: Basilar artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 307 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 307 at risk

Adverse event: Diabetic neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 307 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 307 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 307 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 307 at risk

Adverse event: Vertebrobasilar insufficiency
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 307 at risk

Adverse event: Diabetic nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 307 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 307 at risk

Adverse event: Pollakiuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 307 at risk

Adverse event: Renal arteriosclerosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 307 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 307 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 307 at risk

Adverse event: Nasal polyps
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 307 at risk

Adverse event: Diabetic dermopathy
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 307 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 307 at risk

Adverse event: Diabetic vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 307 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 307 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 307 at risk

Adverse event: Conjunctival haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 307 at risk

Adverse event: Dry eye (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 307 at risk

Adverse event: Dry eye (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 307 at risk

Adverse event: Vitreous haemorrhage (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 307 at risk

Adverse event: Vitreous haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 307 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 307 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 307 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 307 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 307 at risk

Adverse event: Intraocular pressure increased (Study eye)
Serious: no
Organ System: Investigations
Frequency: 16 affected / 307 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 307 at risk

Adverse event: Diabetic nephropathy
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 307 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 307 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 307 at risk

Adverse event: Diabetic retinal oedema (Fellow eye)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 75 at risk

Adverse event: Retinal detachment (Fellow eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Vitreous haemorrhage (Fellow eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Vitreous haemorrhage (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 75 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Hepatitis B
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 75 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 75 at risk

Adverse event: Diabetic neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 75 at risk

Adverse event: Diabetic nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 75 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 75 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 75 at risk

Adverse event: Conjunctival haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Dry eye (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Dry eye (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Vitreous haemorrhage (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 75 at risk

Adverse event: Vitreous haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 75 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 75 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 75 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 75 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 75 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 75 at risk

Adverse event: Diabetic nephropathy
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 75 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 75 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 75 at risk