Study: NCT00430716

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Cor pulmonale
Serious: yes
Organ System: Cardiac disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Cor pulmonale
Serious: yes
Organ System: Cardiac disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Blood electrolytes abnormal
Serious: yes
Organ System: Investigations
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Right ventricular failure
Serious: no
Organ System: Cardiac disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Periorbital oedema
Serious: no
Organ System: Eye disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Double Blind Phase
Frequency: 2 affected / 41 at risk

Adverse event: Medical device pain
Serious: no
Organ System: General disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Double Blind Phase
Frequency: 2 affected / 41 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Tinea barbae
Serious: no
Organ System: Infections and infestations
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Double Blind Phase
Frequency: 2 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Double Blind Phase
Frequency: 2 affected / 41 at risk

Adverse event: Orthopnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Upper airway obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Double Blind Phase
Frequency: 1 affected / 41 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Right ventricular failure
Serious: no
Organ System: Cardiac disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Goitre
Serious: no
Organ System: Endocrine disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Periorbital oedema
Serious: no
Organ System: Eye disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Open Label Phase
Frequency: 3 affected / 41 at risk

Adverse event: Medical device pain
Serious: no
Organ System: General disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Open Label Phase
Frequency: 2 affected / 41 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 2 affected / 41 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Subcutaneous abscess
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Tinea barbae
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Notes: Open Label Phase
Frequency: 2 affected / 41 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Open Label Phase
Frequency: 2 affected / 41 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Open Label Phase
Frequency: 2 affected / 41 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Open Label Phase
Frequency: 3 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Open Label Phase
Frequency: 2 affected / 41 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 2 affected / 41 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Orthopnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Upper airway obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Butterfly rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Increased tendency to bruise
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Open Label Phase
Frequency: 1 affected / 41 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Pulmonary infarction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Pulmonary infarction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Cyanosis
Serious: no
Organ System: Cardiac disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Tachyarrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Double Blind Phase
Frequency: 2 affected / 43 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Prostatic specific antigen increased
Serious: no
Organ System: Investigations
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Double Blind Phase
Frequency: 3 affected / 43 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Double Blind Phase
Frequency: 2 affected / 43 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Pulmonary fibrosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Lichen planus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Double Blind Phase
Frequency: 1 affected / 43 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Notes: Double Blind Phase
Frequency: 2 affected / 43 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Cyanosis
Serious: no
Organ System: Cardiac disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Tachyarrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Blindness transient
Serious: no
Organ System: Eye disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 2 affected / 43 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: Open Label Phase
Frequency: 2 affected / 43 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: Open Label Phase
Frequency: 2 affected / 43 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Open Label Phase
Frequency: 2 affected / 43 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Infected bite
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 2 affected / 43 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Prostatic specific antigen increased
Serious: no
Organ System: Investigations
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: Open Label Phase
Frequency: 2 affected / 43 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Open Label Phase
Frequency: 2 affected / 43 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Open Label Phase
Frequency: 3 affected / 43 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Notes: Open Label Phase
Frequency: 2 affected / 43 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 4 affected / 43 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 3 affected / 43 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Pulmonary fibrosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Lichen planus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Palmar erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 43 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Notes: Open Label Phase
Frequency: 2 affected / 43 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Notes: Open Label Phase
Frequency: 2 affected / 45 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Pulmonary arterial hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Double Blind Phase
Frequency: 2 affected / 45 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Hereditary haemorrhagic telangiectasia
Serious: no
Organ System: Congenital, familial and genetic disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Exercise tolerance decreased
Serious: no
Organ System: General disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Double Blind Phase
Frequency: 2 affected / 45 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Double Blind Phase
Frequency: 2 affected / 45 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Double Blind Phase
Frequency: 2 affected / 45 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Double Blind Phase
Frequency: 3 affected / 45 at risk

Adverse event: Loss of consciousness
Serious: no
Organ System: Nervous system disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Double Blind Phase
Frequency: 3 affected / 45 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Double Blind Phase
Frequency: 2 affected / 45 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Notes: Double Blind Phase
Frequency: 1 affected / 45 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Open Label Phase
Frequency: 2 affected / 45 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Hereditary haemorrhagic telangiectasia
Serious: no
Organ System: Congenital, familial and genetic disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Blindness transient
Serious: no
Organ System: Eye disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Glossodynia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: Open Label Phase
Frequency: 2 affected / 45 at risk

Adverse event: Exercise tolerance decreased
Serious: no
Organ System: General disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Open Label Phase
Frequency: 2 affected / 45 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 3 affected / 45 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Open Label Phase
Frequency: 3 affected / 45 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Open Label Phase
Frequency: 2 affected / 45 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Open Label Phase
Frequency: 2 affected / 45 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Open Label Phase
Frequency: 2 affected / 45 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Head discomfort
Serious: no
Organ System: Nervous system disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Open Label Phase
Frequency: 3 affected / 45 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Loss of consciousness
Serious: no
Organ System: Nervous system disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 3 affected / 45 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Open Label Phase
Frequency: 2 affected / 45 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Notes: Open Label Phase
Frequency: 1 affected / 45 at risk