Study: NCT01106677

Adverse event: Acute coronary syndrome
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 / 183 at risk

Adverse event: Inguinal hernia
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 / 183 at risk

Adverse event: Incisional hernia
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 / 183 at risk

Adverse event: Gastric 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 / 183 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: 12 affected / 183 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: 13 affected / 183 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: 12 affected / 183 at risk

Adverse event: Pollakiuria
Serious: no
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 / 183 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 / 183 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: 4 affected / 183 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: 9 affected / 183 at risk

Adverse event: Back pain
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: 6 affected / 183 at risk

Adverse event: Coronary artery disease
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 / 368 at risk

Adverse event: Supraventricular tachycardia
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 / 368 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 368 at risk

Adverse event: Inguinal hernia
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 / 368 at risk

Adverse event: Umbilical hernia
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 / 368 at risk

Adverse event: Cholangitis
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 / 368 at risk

Adverse event: Gastroenteritis
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 / 368 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 / 368 at risk

Adverse event: Infectious pleural effusion
Serious: yes
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52. In the Week 26 study report, this event was coded as "pyothorax"; it was subsequently re-coded in the Week 52 study report as "infectious pleural effusion".
Frequency: 1 affected / 368 at risk

Adverse event: Sepsis
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 / 368 at risk

Adverse event: Subcutaneous abscess
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 / 368 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 / 368 at risk

Adverse event: Burns second degree
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 / 368 at risk

Adverse event: Cervical vertebral 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 / 368 at risk

Adverse event: Transient ischaemic attack
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 / 368 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: 12 affected / 368 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: 15 affected / 368 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: 12 affected / 368 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 21 affected / 368 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: 5 affected / 368 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: 18 affected / 368 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: 7 affected / 368 at risk

Adverse event: Back pain
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 / 368 at risk

Adverse event: Cataract nuclear
Serious: yes
Organ System: Eye disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52. NOTE: event was reassessed as non-serious in the Week 52 study report.
Frequency: 1 affected / 367 at risk

Adverse event: Constipation
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 / 367 at risk

Adverse event: Inguinal hernia
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 / 367 at risk

Adverse event: Cholecystitis acute
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 / 367 at risk

Adverse event: Plantar fasciitis
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 / 367 at risk

Adverse event: Breast cancer in situ
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 / 367 at risk

Adverse event: Meningioma
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 / 367 at risk

Adverse event: Brain oedema
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 / 367 at risk

Adverse event: Coma
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 / 367 at risk

Adverse event: Ischaemic stroke
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 / 367 at risk

Adverse event: High risk pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 367 at risk

Adverse event: Arterial 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 / 367 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: 18 affected / 367 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 / 367 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: 10 affected / 367 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 10 affected / 367 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: 18 affected / 367 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: 13 affected / 367 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: 4 affected / 367 at risk

Adverse event: Back pain
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: 12 affected / 367 at risk

Adverse event: Angina unstable
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 / 366 at risk

Adverse event: Stress cardiomyopathy
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 / 366 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. In the Week 26 study report, this event was coded as "abdominal pain"; it was subsequently re-coded in the Week 52 study report as "abdominal hernia".
Frequency: 1 affected / 366 at risk

Adverse event: Hernia obstructive
Serious: yes
Organ System: General disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52. In the Week 26 study report, this event was coded as "hernia obstructive"; it was subsequently re-coded in the Week 52 study report as "incisional hernia, obstructive".
Frequency: 1 affected / 366 at risk

Adverse event: Cellulitis
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 / 366 at risk

Adverse event: Spinal stenosis
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 / 366 at risk

Adverse event: Malignant mesenchymoma
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 / 366 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 366 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 366 at risk

Adverse event: Hypertensive crisis
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 / 366 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: 16 affected / 366 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: 14 affected / 366 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: 16 affected / 366 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 2 affected / 366 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: 18 affected / 366 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 / 366 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: 11 affected / 366 at risk

Adverse event: Back pain
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: 4 affected / 366 at risk

Adverse event: Acute coronary syndrome
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 / 183 at risk

Adverse event: Inguinal hernia
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 / 183 at risk

Adverse event: Cellulitis
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 / 183 at risk

Adverse event: Sepsis
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 / 183 at risk

Adverse event: Incisional hernia
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 / 183 at risk

Adverse event: Gastric 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 / 183 at risk

Adverse event: Hypertensive crisis
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 / 183 at risk

Adverse event: Trigeminal neuralgia
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 / 183 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: 13 affected / 183 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: 13 affected / 183 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: 13 affected / 183 at risk

Adverse event: Pollakiuria
Serious: no
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 / 183 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 / 183 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 / 183 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: 11 affected / 183 at risk

Adverse event: Back pain
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: 10 affected / 183 at risk

Adverse event: Coronary artery disease
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 / 368 at risk

Adverse event: Supraventricular tachycardia
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 / 368 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 368 at risk

Adverse event: Inguinal hernia
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 / 368 at risk

Adverse event: Umbilical hernia
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 / 368 at risk

Adverse event: Cholangitis
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 / 368 at risk

Adverse event: Gastroenteritis
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 / 368 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 / 368 at risk

Adverse event: Sepsis
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 / 368 at risk

Adverse event: Subcutaneous abscess
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 / 368 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 / 368 at risk

Adverse event: Burns second degree
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 / 368 at risk

Adverse event: Cervical vertebral 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 / 368 at risk

Adverse event: Transient ischaemic attack
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 / 368 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 / 368 at risk

Adverse event: Cardiomyopathy
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 / 368 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 / 368 at risk

Adverse event: Infectious pleural effusion
Serious: yes
Organ System: Infections and infestations
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52. In the Week 26 study report, this event was coded as "pyothorax"; it was subsequently re-coded in the Week 52 study report as "infectious pleural effusion".
Frequency: 1 affected / 368 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: 15 affected / 368 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: 18 affected / 368 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: 19 affected / 368 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 21 affected / 368 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: 12 affected / 368 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: 27 affected / 368 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: 10 affected / 368 at risk

Adverse event: Back pain
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: 13 affected / 368 at risk

Adverse event: Constipation
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 / 367 at risk

Adverse event: Inguinal hernia
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 / 367 at risk

Adverse event: Cholecystitis acute
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 / 367 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 / 367 at risk

Adverse event: Plantar fasciitis
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 / 367 at risk

Adverse event: Breast cancer in situ
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 / 367 at risk

Adverse event: Meningioma
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 / 367 at risk

Adverse event: Brain oedema
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 / 367 at risk

Adverse event: Coma
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 / 367 at risk

Adverse event: Ischaemic stroke
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 / 367 at risk

Adverse event: High risk pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 367 at risk

Adverse event: Arterial 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 / 367 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 / 367 at risk

Adverse event: Overdose
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 / 367 at risk

Adverse event: Bronchial carcinoma
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 / 367 at risk

Adverse event: Colorectal 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 / 367 at risk

Adverse event: Prostate 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 / 367 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: 23 affected / 367 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: 16 affected / 367 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: 13 affected / 367 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 11 affected / 367 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: 23 affected / 367 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: 17 affected / 367 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: 9 affected / 367 at risk

Adverse event: Back pain
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: 15 affected / 367 at risk

Adverse event: Angina unstable
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 / 366 at risk

Adverse event: Coronary artery disease
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 / 366 at risk

Adverse event: Stress cardiomyopathy
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 / 366 at risk

Adverse event: Cellulitis
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 / 366 at risk

Adverse event: Gastroenteritis
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 / 366 at risk

Adverse event: Spinal stenosis
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 / 366 at risk

Adverse event: Malignant mesenchymoma
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 / 366 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 366 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 1 affected / 366 at risk

Adverse event: Hypertensive crisis
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 / 366 at risk

Adverse event: Acute 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 / 366 at risk

Adverse event: Cardiac arrest
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 / 366 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52. In the Week 26 study report, this event was coded as "abdominal pain"; it was subsequently re-coded in the Week 52 study report as "abdominal hernia".
Frequency: 1 affected / 366 at risk

Adverse event: Diverticulum
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 / 366 at risk

Adverse event: Dengue fever
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 / 366 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 / 366 at risk

Adverse event: Septic shock
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 / 366 at risk

Adverse event: Incisional hernia, obstructive
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. In the Week 26 study report, this event was coded as "hernia obstructive"; it was subsequently re-coded in the Week 52 study report as "incisional hernia, obstructive".
Frequency: 1 affected / 366 at risk

Adverse event: Thermal burn
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 / 366 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 / 366 at risk

Adverse event: Intervertebral disc protrusion
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 / 366 at risk

Adverse event: Large cell lung cancer stage III
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 / 366 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 / 366 at risk

Adverse event: Acute kidney injury
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 / 366 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: 23 affected / 366 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: 22 affected / 366 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: 19 affected / 366 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Frequency: 2 affected / 366 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: 22 affected / 366 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: 22 affected / 366 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: 17 affected / 366 at risk

Adverse event: Back pain
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: 10 affected / 366 at risk