Study: NCT00325442

Adverse event: Pulmonary arterial hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 176 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 176 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 176 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 176 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 176 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 176 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 176 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 176 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 176 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 176 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 176 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 176 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 176 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 176 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 176 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 176 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 176 at risk

Adverse event: Fluid retention
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 176 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 176 at risk

Adverse event: Hepatitis toxic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 176 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 176 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 176 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 176 at risk

Adverse event: Multiple sclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 176 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 176 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 176 at risk

Adverse event: Pericarditis constrictive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 176 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 176 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 176 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 176 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 176 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 176 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 65 affected / 176 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 176 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 176 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 27 affected / 176 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 176 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 176 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 176 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 28 affected / 176 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 17 affected / 176 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 176 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 176 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 176 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 176 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 176 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 176 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 176 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 176 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 176 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 176 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 176 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 176 at risk

Adverse event: abdominal distention
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 176 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 176 at risk

Adverse event: Pulmonary arterial hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 176 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 176 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 11 affected / 176 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 176 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 176 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 176 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 176 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 176 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 176 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 176 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 176 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 176 at risk

Adverse event: Pulmonary arterial hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 174 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 174 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 174 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 174 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 174 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 174 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 174 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 174 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 174 at risk

Adverse event: Diarrhoea haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 174 at risk

Adverse event: Hyperparathyroidism secondary
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 174 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 174 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 174 at risk

Adverse event: Low cardiac output syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 174 at risk

Adverse event: Mallory-Weiss syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 174 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 174 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 174 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 174 at risk

Adverse event: Bradyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 174 at risk

Adverse event: Large intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Vascular device infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 174 at risk

Adverse event: Streptococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 150 affected / 174 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 112 affected / 174 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 106 affected / 174 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 85 affected / 174 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 75 affected / 174 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 76 affected / 174 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 54 affected / 174 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 30 affected / 174 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 25 affected / 174 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 174 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 174 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 174 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 174 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 174 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 174 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 174 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 174 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 17 affected / 174 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 174 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 174 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 174 at risk

Adverse event: abdominal distention
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 174 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 174 at risk

Adverse event: Pulmonary arterial hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 174 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 174 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 7 affected / 174 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 174 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 174 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 174 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 174 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 174 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 174 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 174 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 174 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 174 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 174 at risk