Study: NCT01064414

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Infective exacerbation of chronic obstructive airways disease
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 90 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Bladder neck obstruction
Serious: yes
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 5 affected / 90 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 10 affected / 90 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 5 affected / 90 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 4 affected / 90 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52. In the Week 26 study report, 1 patient (placebo) had vitamin D deficiency recorded in error by the investigator which was corrected in the Week 52 study report.
Frequency: 5 affected / 90 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 5 affected / 90 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 4 affected / 90 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 4 affected / 90 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52. Events for 2 patients in the placebo group in the Week 26 study report were reassessed as "chronic bronchitis" in the Week 52 study report.
Frequency: 3 affected / 90 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 3 affected / 90 at risk

Adverse event: Upper respiratory tract
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 3 affected / 90 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 4 affected / 90 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 90 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 3 affected / 90 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Campylobacter gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52. In the Week 26 study report, this event was coded as "campylobacter intestinal infection"; it was subsequently re-coded in the Week 52 study report as "campylobacter gastroenteritis".
Frequency: 1 affected / 90 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Small cell lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 3 affected / 90 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 3 affected / 90 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 4 affected / 90 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 13 affected / 90 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 90 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52. Events for 2 patients in the placebo group in the Week 26 study report were reassessed as "chronic bronchitis" in the Week 52 study report.
Frequency: 4 affected / 90 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 3 affected / 90 at risk

Adverse event: Upper respiratory tract
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 3 affected / 90 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 90 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 90 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 4 affected / 90 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 90 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Infected skin ulcer
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Splenic rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Troponin increased
Serious: yes
Organ System: Investigations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Arteritis
Serious: yes
Organ System: Vascular disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 4 affected / 89 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 7 affected / 89 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 7 affected / 89 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 10 affected / 89 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52. In the Week 26 study report, 1 patient (placebo) had vitamin D deficiency recorded in error by the investigator which was corrected in the Week 52 study report.
Frequency: 1 affected / 89 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 89 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 5 affected / 89 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 6 affected / 89 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 4 affected / 89 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 3 affected / 89 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52. Events for 2 patients in the placebo group in the Week 26 study report were reassessed as "chronic bronchitis" in the Week 52 study report.
Frequency: 3 affected / 89 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 89 at risk

Adverse event: Upper respiratory tract
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 89 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 89 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 89 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 90 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Infective exacerbation of chronic obstructive airways disease
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 90 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Bladder neck obstruction
Serious: yes
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 90 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Coronary artery insufficiency
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Cor pulmonale
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 9 affected / 90 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 13 affected / 90 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 6 affected / 90 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 4 affected / 90 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52. In the Week 26 study report, 1 patient (placebo) had vitamin D deficiency recorded in error by the investigator which was corrected in the Week 52 study report.
Frequency: 4 affected / 90 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 5 affected / 90 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 90 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 3 affected / 90 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 5 affected / 90 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 6 affected / 90 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52. Events for 2 patients in the placebo group in the Week 26 study report were reassessed as "chronic bronchitis" in the Week 52 study report.
Frequency: 1 affected / 90 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 6 affected / 90 at risk

Adverse event: Upper respiratory tract
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 5 affected / 90 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 5 affected / 90 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 3 affected / 90 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 5 affected / 90 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Small cell lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Atrial fibrilation
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 90 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Neophrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Skin necrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Campylobacter gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52. In the Week 26 study report, this event was coded as "campylobacter intestinal infection"; it was subsequently re-coded in the Week 52 study report as "campylobacter gastroenteritis".
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 4 affected / 90 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 5 affected / 90 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 4 affected / 90 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 18 affected / 90 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52. In the Week 26 study report, 1 patient (placebo) had vitamin D deficiency recorded in error by the investigator which was corrected in the Week 52 study report.
Frequency: 2 affected / 90 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 90 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 5 affected / 90 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52. Events for 2 patients in the placebo group in the Week 26 study report were reassessed as "chronic bronchitis" in the Week 52 study report.
Frequency: 5 affected / 90 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 3 affected / 90 at risk

Adverse event: Upper respiratory tract
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 5 affected / 90 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 3 affected / 90 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 90 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 5 affected / 90 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 3 affected / 90 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 89 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 89 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Infected skin ulcer
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Splenic rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Troponin increased
Serious: yes
Organ System: Investigations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Arteritis
Serious: yes
Organ System: Vascular disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Diabetic complications
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 4 affected / 89 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 9 affected / 89 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 12 affected / 89 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 20 affected / 89 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52. In the Week 26 study report, 1 patient (placebo) had vitamin D deficiency recorded in error by the investigator which was corrected in the Week 52 study report.
Frequency: 1 affected / 89 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 4 affected / 89 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 5 affected / 89 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 6 affected / 89 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 5 affected / 89 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 6 affected / 89 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52. Events for 2 patients in the placebo group in the Week 26 study report were reassessed as "chronic bronchitis" in the Week 52 study report.
Frequency: 5 affected / 89 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 3 affected / 89 at risk

Adverse event: Upper respiratory tract
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 4 affected / 89 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 89 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 89 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 3 affected / 89 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 3 affected / 89 at risk