Study: NCT01969409

Adverse event: Infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonia
Frequency: 1 affected / 28 at risk

Adverse event: Worsening respiratory function
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Increased dyspnea without acute exacerbation
Frequency: 1 affected / 28 at risk

Adverse event: cerebral vascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: stroke
Frequency: 1 affected / 28 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: syncope
Frequency: 1 affected / 28 at risk

Adverse event: Acute exacerbation of idiopathic pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Acute exacerbation
Frequency: 1 affected / 28 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Notes: Right heart failure
Frequency: 2 affected / 28 at risk

Adverse event: Flushing
Serious: no
Organ System: General disorders
Notes: flushing
Frequency: 2 affected / 28 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: fever self reported
Frequency: 1 affected / 28 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: dry mouth
Frequency: 4 affected / 28 at risk

Adverse event: Infection unspecified (mild)
Serious: no
Organ System: Infections and infestations
Notes: infection
Frequency: 2 affected / 28 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Cardiac disorders
Notes: chest tightness, Not Otherwise Specified (NOS)
Frequency: 2 affected / 28 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: mild, NOS
Frequency: 3 affected / 28 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: blood pressure elevated greater than usual
Frequency: 2 affected / 28 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: pruritis
Frequency: 2 affected / 28 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: skin rash NOS
Frequency: 1 affected / 28 at risk

Adverse event: Brusing
Serious: no
Organ System: Surgical and medical procedures
Notes: Ecchymosis
Frequency: 2 affected / 28 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: abdominal pain self limited and NOS
Frequency: 1 affected / 28 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: loss of appetite
Frequency: 2 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: diarrhea
Frequency: 4 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea with or without vomiting
Frequency: 4 affected / 28 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: elevated blood sugar greater than baseline
Frequency: 2 affected / 28 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Notes: anxiety
Frequency: 2 affected / 28 at risk

Adverse event: Dizzyness
Serious: no
Organ System: Nervous system disorders
Notes: dizziness self reported
Frequency: 3 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Notes: self reported fatigue NOS
Frequency: 4 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: headache
Frequency: 3 affected / 28 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: trouble sleeping
Frequency: 4 affected / 28 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough greater than baseline
Frequency: 7 affected / 28 at risk

Adverse event: Post-nasal drip
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: post-nasal discharge
Frequency: 1 affected / 28 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath greater than baseline not attributable to acute exacerbations, pneumonia, or causes other than idiopathic pulmonary fibrosis
Frequency: 8 affected / 28 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: dry eyes, self-limited
Frequency: 2 affected / 28 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Muscle pain other than backache (self limited)
Frequency: 2 affected / 28 at risk

Adverse event: Joint stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self limited joint stiffness
Frequency: 2 affected / 28 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: urinary tract infection documented by culture or suspected
Frequency: 1 affected / 28 at risk

Adverse event: Infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonia
Frequency: 1 affected / 30 at risk

Adverse event: Infection
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Appendicitis Colitis
Frequency: 2 affected / 30 at risk

Adverse event: Worsening respiratory function
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Increased dyspnea without acute exacerbation
Frequency: 2 affected / 30 at risk

Adverse event: Acute exacerbation of idiopathic pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Acute exacerbation
Frequency: 2 affected / 30 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: myocardial infarct
Frequency: 2 affected / 30 at risk

Adverse event: Carotid revascularisation
Serious: yes
Organ System: Nervous system disorders
Notes: carotid artery stint
Frequency: 1 affected / 30 at risk

Adverse event: Flushing
Serious: no
Organ System: General disorders
Notes: flushing
Frequency: 2 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: fever self reported
Frequency: 2 affected / 30 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: dry mouth
Frequency: 3 affected / 30 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: blood pressure elevated greater than usual
Frequency: 2 affected / 30 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: self reported palpitations NOS
Frequency: 2 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: pruritis
Frequency: 3 affected / 30 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: skin rash NOS
Frequency: 7 affected / 30 at risk

Adverse event: Brusing
Serious: no
Organ System: Surgical and medical procedures
Notes: Ecchymosis
Frequency: 1 affected / 30 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: abdominal pain self limited and NOS
Frequency: 2 affected / 30 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: loss of appetite
Frequency: 3 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: diarrhea
Frequency: 5 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea with or without vomiting
Frequency: 6 affected / 30 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: elevated blood sugar greater than baseline
Frequency: 2 affected / 30 at risk

Adverse event: Dizzyness
Serious: no
Organ System: Nervous system disorders
Notes: dizziness self reported
Frequency: 2 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Notes: self reported fatigue NOS
Frequency: 3 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: headache
Frequency: 5 affected / 30 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: trouble sleeping
Frequency: 5 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough greater than baseline
Frequency: 10 affected / 30 at risk

Adverse event: Post-nasal drip
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: post-nasal discharge
Frequency: 3 affected / 30 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath greater than baseline not attributable to acute exacerbations, pneumonia, or causes other than idiopathic pulmonary fibrosis
Frequency: 5 affected / 30 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: back pain, self limited
Frequency: 4 affected / 30 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Muscle pain other than backache (self limited)
Frequency: 1 affected / 30 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: urinary tract infection documented by culture or suspected
Frequency: 2 affected / 30 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Notes: tooth infection self-reported
Frequency: 2 affected / 30 at risk