Study: NCT02465450

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 26 at risk

Adverse event: Infective pulmonary exacerbation of cystic fibrosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Haemoptysia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Gastroeosophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Hand fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 26 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Sweat discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Infective pulmonary exacerbation of cystic fibrosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 24 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 24 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Sputum increased
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Haemoptysia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Wrist fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 24 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Infective pulmonary exacerbation of cystic fibrosis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 37 at risk

Adverse event: Infective pulmonary exacerbation of cystic fibrosis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 35 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 35 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 35 at risk

Adverse event: Sputum increased
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Haemoptysia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 35 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 35 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Nervous system disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 35 at risk

Adverse event: Initial insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 35 at risk

Adverse event: Gastrostomy
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 35 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Infective pulmonary exacerbation of cystic fibrosis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 30 at risk

Adverse event: Infective pulmonary exacerbation of cystic fibrosis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 30 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 30 at risk

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

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

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

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Haemoptysia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 30 at risk

Adverse event: Nervous system disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 30 at risk

Adverse event: Disorientation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 30 at risk

Adverse event: Paranasal sinus hypersecretion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Rales
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Bradykinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Stupor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Feeling abnormal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Thrombosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 30 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 30 at risk

Adverse event: Infective pulmonary exacerbation of cystic fibrosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Thrombosis in device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Infective pulmonary exacerbation of cystic fibrosis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 28 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 28 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: Sputum increased
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

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

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

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 28 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Haemoptysia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Nervous system disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Apathy
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 28 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 28 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 28 at risk

Adverse event: Sputum discoloured
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Feeling abnormal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Thrombosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Bone contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 28 at risk

Adverse event: Infective pulmonary exacerbation of cystic fibrosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Infective pulmonary exacerbation of cystic fibrosis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 23 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 23 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 23 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 23 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 23 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 23 at risk