Study: NCT01019694

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 157 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 157 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 157 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 157 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 157 at risk

Adverse event: Diabetic foot infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 157 at risk

Adverse event: Perirectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 157 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 157 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 157 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 157 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 157 at risk

Adverse event: B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 157 at risk

Adverse event: Pancreatic carcinoma metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 157 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 157 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 157 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 157 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 157 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 157 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Respiratory acidosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 157 at risk

Adverse event: Skin necrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 157 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 157 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 157 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 157 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 157 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 157 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 157 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 157 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 157 at risk

Adverse event: Normochromic normocytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 154 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 154 at risk

Adverse event: Arteriovenous malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 154 at risk

Adverse event: Pituitary haemorrhage
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 154 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 154 at risk

Adverse event: Clostridial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 154 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 154 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 154 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 154 at risk

Adverse event: Cervical vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 154 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 154 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 154 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 154 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 154 at risk

Adverse event: Chronic myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 154 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 154 at risk

Adverse event: Squamous cell carcinoma of lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 154 at risk

Adverse event: Nerve compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 154 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 154 at risk

Adverse event: Calculus bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 154 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 154 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 154 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 154 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 154 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 154 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 154 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 154 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 154 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 154 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 154 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 154 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 154 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 154 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 154 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 154 at risk

Adverse event: Inguinal hernia, obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Catheter site haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 154 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 154 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 154 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 154 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 154 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 154 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 154 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 154 at risk

Adverse event: Myocardial necrosis marker increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 154 at risk

Adverse event: Electrocardiogram T wave inversion
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 154 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 154 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 154 at risk

Adverse event: Colorectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 154 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 154 at risk

Adverse event: Metastases to liver
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 154 at risk

Adverse event: Non-small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 154 at risk

Adverse event: Non-small cell lung cancer stage IV
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 154 at risk

Adverse event: Ovarian fibroma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 154 at risk

Adverse event: Pancreatic carcinoma metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 154 at risk

Adverse event: Transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 154 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 154 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 154 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 154 at risk

Adverse event: Stress urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 154 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 154 at risk

Adverse event: Lung infiltration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Pulmonary mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 154 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 154 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 154 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 154 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 154 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 154 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 154 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 154 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 154 at risk