Study: NCT00739648

Adverse event: Condition aggravated
Serious: yes
Organ System: General disorders
Notes: Pulmonary exacerbation
Frequency: 22 affected / 108 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 108 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Bursitis infective staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Stress cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Tachyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 108 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 108 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 108 at risk

Adverse event: Peripheral vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 108 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Upper gsatrointestinal hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 108 at risk

Adverse event: Paresis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 108 at risk

Adverse event: Post procedureal hematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 108 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 108 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 108 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 108 at risk

Adverse event: Condition aggravated
Serious: no
Organ System: General disorders
Notes: Pulmonary exacerbation
Frequency: 58 affected / 108 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 7 affected / 108 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 108 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 6 affected / 108 at risk

Adverse event: Sinusititis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 108 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 108 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 108 at risk

Adverse event: Dyspenea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 108 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 108 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 108 at risk

Adverse event: Pharynlaryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 108 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Taste complaint
Frequency: 3 affected / 108 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 108 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 108 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 108 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 108 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 108 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 108 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 108 at risk

Adverse event: Condition aggravated
Serious: yes
Organ System: General disorders
Notes: Pulmonary exacerbation
Frequency: 39 affected / 214 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 214 at risk

Adverse event: Catheter site haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 214 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 214 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 214 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 214 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 214 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 214 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Hepatitis C
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Nocardiosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Streptococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 214 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 214 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 214 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 214 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 214 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 214 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 214 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 214 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 214 at risk

Adverse event: Respiratory depression
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Aoritic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 214 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 214 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 214 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 214 at risk

Adverse event: Malignant hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 214 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 214 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 214 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 214 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 214 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 214 at risk

Adverse event: Alcohol withdrawal syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 214 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 214 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 214 at risk

Adverse event: Mental status change
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 214 at risk

Adverse event: Cervical vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 214 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 214 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 214 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 214 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 214 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 214 at risk

Adverse event: Cholecystitits
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 214 at risk

Adverse event: Vaginal prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 214 at risk

Adverse event: Condition aggravated
Serious: no
Organ System: General disorders
Notes: Pulmonary exacerbation
Frequency: 114 affected / 214 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 16 affected / 214 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 13 affected / 214 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 11 affected / 214 at risk

Adverse event: Sinusititis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 214 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 214 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 214 at risk

Adverse event: Dyspenea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 214 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 214 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 214 at risk

Adverse event: Pharynlaryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 214 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Taste complaint
Frequency: 62 affected / 214 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 214 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 214 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 214 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 214 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 214 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 214 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 214 at risk