Study: NCT03451045

Adverse event: Tachcardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 165 at risk

Adverse event: Distal intestinal obstruction syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 165 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 165 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 165 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 165 at risk

Adverse event: Fungal disease carrier
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 165 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 165 at risk

Adverse event: Forced expiratory volume decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 165 at risk

Adverse event: Human rhinovirus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 165 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 165 at risk

Adverse event: Testicular torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 165 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 165 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 165 at risk

Adverse event: Infective pulmonary exacerbation of cystic fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 42 affected / 165 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 165 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 39 affected / 165 at risk

Adverse event: Immune system disorders
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 165 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 75 affected / 165 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 35 affected / 165 at risk

Adverse event: Musculoskeletal and connective tissues
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 165 at risk

Adverse event: Nervous system
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 165 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 165 at risk

Adverse event: Renal and urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 165 at risk

Adverse event: Respiratory, thoracic and mediastinal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 120 affected / 165 at risk

Adverse event: Skin and subcutaneous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 165 at risk

Adverse event: Distal intestinal obstruction syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 89 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 89 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 89 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Infective pulmonary exacerbation of cystic fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 89 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 89 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 22 affected / 89 at risk

Adverse event: Immune system disorders
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 89 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 89 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 22 affected / 89 at risk

Adverse event: Musculoskeletal and connective tissues
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 89 at risk

Adverse event: Nervous system
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 89 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 89 at risk

Adverse event: Renal and urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 89 at risk

Adverse event: Respiratory, thoracic and mediastinal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 65 affected / 89 at risk

Adverse event: Skin and subcutaneous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 89 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 171 at risk

Adverse event: Non-compaction cardiomyopathy
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 171 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 171 at risk

Adverse event: Distal intestinal obstruction syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 171 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 171 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 171 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 171 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 171 at risk

Adverse event: Rhinovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 171 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 171 at risk

Adverse event: Forced expiratory volume decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 171 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 171 at risk

Adverse event: Pulmonary function test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 171 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 171 at risk

Adverse event: Cystitis haemorrhagic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 171 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 171 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 171 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 171 at risk

Adverse event: Infective pulmonary exacerbation of cystic fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 41 affected / 171 at risk

Adverse event: Pleuritic pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 171 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 171 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 33 affected / 171 at risk

Adverse event: Immune system disorders
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 171 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 72 affected / 171 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 30 affected / 171 at risk

Adverse event: Musculoskeletal and connective tissues
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 171 at risk

Adverse event: Nervous system
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 171 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 171 at risk

Adverse event: Renal and urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 171 at risk

Adverse event: Respiratory, thoracic and mediastinal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 122 affected / 171 at risk

Adverse event: Skin and subcutaneous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 171 at risk