Study: NCT02696564

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 108 at risk

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

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

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

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

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

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 108 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 108 at risk

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

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

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

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 108 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 108 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 108 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 108 at risk

Adverse event: Skin rash or hives
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 108 at risk

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

Adverse event: Heartburn/indigestion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 108 at risk

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

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 33 affected / 108 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 28 affected / 108 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 108 at risk

Adverse event: Asthenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 108 at risk

Adverse event: Dizziness/lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 108 at risk

Adverse event: Headache/ head pain
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 108 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 38 affected / 108 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 108 at risk

Adverse event: Sleep problems
Serious: no
Organ System: General disorders
Frequency: 30 affected / 108 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 108 at risk

Adverse event: Congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 42 affected / 108 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 108 at risk

Adverse event: Mild COPD exacerbation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 108 at risk

Adverse event: Moderate COPD exacerbation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 108 at risk

Adverse event: Severe COPD exacerbation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 108 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 112 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 112 at risk

Adverse event: Acute respiratory failure secondary to end stage COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 112 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 112 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 112 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 112 at risk

Adverse event: Falls
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 112 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 112 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 112 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Chondrocalcinosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: Panic attack
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 112 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 112 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 112 at risk

Adverse event: Skin rash or hives
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 112 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 112 at risk

Adverse event: Heartburn/indigestion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 112 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 112 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 112 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 112 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 112 at risk

Adverse event: Asthenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 112 at risk

Adverse event: Dizziness/lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 112 at risk

Adverse event: Headache/ head pain
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 112 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 41 affected / 112 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 112 at risk

Adverse event: Sleep problems
Serious: no
Organ System: General disorders
Frequency: 34 affected / 112 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 18 affected / 112 at risk

Adverse event: Congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 47 affected / 112 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 112 at risk

Adverse event: Mild COPD exacerbation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 112 at risk

Adverse event: Moderate COPD exacerbation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 112 at risk

Adverse event: Severe COPD exacerbation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 112 at risk