Study: NCT01106690

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 / 115 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 115 at risk

Adverse event: Escherichia bacteraemia
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 115 at risk

Adverse event: Gastrointestinal 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 / 115 at risk

Adverse event: Sepsis syndrome
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 115 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 115 at risk

Adverse event: Chronic obstructive pulmonary disease
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 / 115 at risk

Adverse event: Dyspnoea
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 / 115 at risk

Adverse event: Hypercapnia
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 / 115 at risk

Adverse event: Restrictive pulmonary disease
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 / 115 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 / 115 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: 6 affected / 115 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: 6 affected / 115 at risk

Adverse event: Upper respiratory 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 / 115 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 / 115 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. In the Week 26 study report, 2 patients had hypoglycaemia recorded in error by the investigator, which were corrected in the Week 52 study report.
Frequency: 2 affected / 115 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 / 115 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: 3 affected / 115 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 115 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 6 affected / 115 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 / 115 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: 4 affected / 115 at risk

Adverse event: Muscle spasms
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 / 115 at risk

Adverse event: 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 / 113 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 113 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 113 at risk

Adverse event: Periprosthetic 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 / 113 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 / 113 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: 6 affected / 113 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 9 affected / 113 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 / 113 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 3 affected / 113 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. In the Week 26 study report, 2 patients had hypoglycaemia recorded in error by the investigator, which were corrected in the Week 52 study report.
Frequency: 1 affected / 113 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: 1 affected / 113 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: 8 affected / 113 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 5 affected / 113 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 3 affected / 113 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 / 113 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 / 113 at risk

Adverse event: Muscle spasms
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 / 113 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 114 at risk

Adverse event: Concussion
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 / 114 at risk

Adverse event: Skin laceration
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 / 114 at risk

Adverse event: Subdural haematoma
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 / 114 at risk

Adverse event: Breast cancer
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 / 114 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 / 114 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: 11 affected / 114 at risk

Adverse event: Upper respiratory 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 / 114 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 / 114 at risk

Adverse event: Vulvovaginal mycotic 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 / 114 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. In the Week 26 study report, 2 patients had hypoglycaemia recorded in error by the investigator, which were corrected in the Week 52 study report.
Frequency: 6 affected / 114 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: 6 affected / 114 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 / 114 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 7 affected / 114 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 114 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 / 114 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 / 114 at risk

Adverse event: Muscle spasms
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 / 114 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 / 115 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 115 at risk

Adverse event: Escherichia bacteraemia
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 115 at risk

Adverse event: Gastrointestinal 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 / 115 at risk

Adverse event: Sepsis syndrome
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 115 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 115 at risk

Adverse event: Chronic obstructive pulmonary disease
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 / 115 at risk

Adverse event: Dyspnoea
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 / 115 at risk

Adverse event: Hypercapnia
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 / 115 at risk

Adverse event: Restrictive pulmonary disease
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 / 115 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 / 115 at risk

Adverse event: Dupuytren's contracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 115 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: 7 affected / 115 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 / 115 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 9 affected / 115 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: 9 affected / 115 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 115 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. In the Week 26 study report, 2 patients had hypoglycaemia recorded in error by the investigator, which were corrected in the Week 52 study report.
Frequency: 3 affected / 115 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 / 115 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 / 115 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 115 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 7 affected / 115 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 / 115 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 / 115 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52.
Frequency: 6 affected / 115 at risk

Adverse event: 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 / 113 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 113 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 113 at risk

Adverse event: Periprosthetic 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 / 113 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 / 113 at risk

Adverse event: Bacterial 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 / 113 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 / 113 at risk

Adverse event: Angiocardiogram
Serious: yes
Organ System: Investigations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 113 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 113 at risk

Adverse event: Pelvic organ prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 113 at risk

Adverse event: Dizziness postural
Serious: yes
Organ System: Nervous system disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 113 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: 7 affected / 113 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: 11 affected / 113 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 14 affected / 113 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 / 113 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 3 affected / 113 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. In the Week 26 study report, 2 patients had hypoglycaemia recorded in error by the investigator, which were corrected in the Week 52 study report.
Frequency: 3 affected / 113 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 / 113 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: 10 affected / 113 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 6 affected / 113 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 5 affected / 113 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 / 113 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 / 113 at risk

Adverse event: Muscle spasms
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 / 113 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 1 affected / 114 at risk

Adverse event: Concussion
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 / 114 at risk

Adverse event: Skin laceration
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 / 114 at risk

Adverse event: Subdural haematoma
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 / 114 at risk

Adverse event: Breast cancer
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 / 114 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 / 114 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 / 114 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 / 114 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: 6 affected / 114 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: 15 affected / 114 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 8 affected / 114 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: 9 affected / 114 at risk

Adverse event: Vulvovaginal mycotic 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 / 114 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. In the Week 26 study report, 2 patients had hypoglycaemia recorded in error by the investigator, which were corrected in the Week 52 study report.
Frequency: 5 affected / 114 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: 9 affected / 114 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: 7 affected / 114 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 8 affected / 114 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
Frequency: 2 affected / 114 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 / 114 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: 6 affected / 114 at risk

Adverse event: Muscle spasms
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 / 114 at risk