Study: NCT00325403

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 77 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 77 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 77 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 77 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 77 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 77 at risk

Adverse event: Collagen-vascular disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 77 at risk

Adverse event: Diarrhoea infectious
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: paroxysmal noturnal dypsnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 77 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 77 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 77 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 77 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 77 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 77 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 77 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 77 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 77 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 77 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 77 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 77 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 4 affected / 77 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 77 at risk

Adverse event: Right ventricular failure
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 77 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 77 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 77 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 77 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 77 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 77 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 77 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 77 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 11 affected / 77 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 77 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 77 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 77 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 77 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 151 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 151 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 151 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 151 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 151 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Anterograde amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Cor pulmonale acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Presyncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 151 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 151 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: Systemic lupus erythematosus
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 151 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 151 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 95 affected / 151 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 151 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 151 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 151 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 23 affected / 151 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 151 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 151 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 151 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 151 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 151 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 13 affected / 151 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 12 affected / 151 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 151 at risk

Adverse event: Right ventricular failure
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 151 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 151 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 151 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 151 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 151 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 151 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 151 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 151 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 151 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 151 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 151 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 151 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 17 affected / 151 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 151 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 151 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 151 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 151 at risk