Study: NCT01106625

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Mechanical ileus
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Scrotal gangrene
Serious: yes
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 5 affected / 156 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 4 affected / 156 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 10 affected / 156 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 8 affected / 156 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 2 affected / 156 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 6 affected / 156 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 157 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 157 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 157 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 157 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 157 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 157 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 157 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 157 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 5 affected / 157 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 6 affected / 157 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 17 affected / 157 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 9 affected / 157 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 8 affected / 157 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 11 affected / 157 at risk

Adverse event: Ulcer haemorrhage
Serious: yes
Organ System: General disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Biliary dyskinesia
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 10 affected / 156 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 8 affected / 156 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 6 affected / 156 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 7 affected / 156 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 8 affected / 156 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 9 affected / 156 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Uterine enlargement
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Mechanical ileus
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Scrotal gangrene
Serious: yes
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 8 affected / 156 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 3 affected / 156 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 8 affected / 156 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 5 affected / 156 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 5 affected / 156 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 10 affected / 156 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 13 affected / 156 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 12 affected / 156 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 2 affected / 156 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 9 affected / 156 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 157 at risk

Adverse event: Uterine prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 157 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 157 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 157 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 157 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 157 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 157 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 157 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 157 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 157 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 4 affected / 157 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 8 affected / 157 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 8 affected / 157 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 11 affected / 157 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 8 affected / 157 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 9 affected / 157 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 21 affected / 157 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 12 affected / 157 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 9 affected / 157 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 13 affected / 157 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Ulcer haemorrhage
Serious: yes
Organ System: General disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Biliary dyskinesia
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 156 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 8 affected / 156 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 3 affected / 156 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 8 affected / 156 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 2 affected / 156 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 11 affected / 156 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 9 affected / 156 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 9 affected / 156 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 9 affected / 156 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 8 affected / 156 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 11 affected / 156 at risk