Study: NCT00855439

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Exacerbation of existing congestive heart failure
Frequency: 1 affected / 22 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 22 at risk

Adverse event: Pancreatic neuroendocrine tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 22 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 22 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Cholilithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Thyroidectomy
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 22 at risk

Adverse event: Bone Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 c-spine fracture due to motor vehicle accident

1 lower leg fracture because of fall
Frequency: 1 affected / 22 at risk

Adverse event: Non-Serious Adverse Event
Serious: no
Organ System: General disorders
Frequency: 9 affected / 22 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 24 at risk

Adverse event: Coronary artery bypass
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Exacerbation of existing congestive heart failure
Frequency: 1 affected / 24 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Non-ST elevation myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Incarcerated Ventral Hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: foot ulcer with cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Amputation of Toe
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: because of persistent cellulitis and non-healing ulcers
Frequency: 1 affected / 24 at risk

Adverse event: Bone Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 c-spine fracture due to motor vehicle accident

1 lower leg fracture because of fall
Frequency: 1 affected / 24 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 24 at risk

Adverse event: Non-Serious Adverse Event
Serious: no
Organ System: General disorders
Frequency: 19 affected / 24 at risk