Study: NCT03399604

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Acute on Chronic Hypoxic Respiratory Failure
Frequency: 1 affected / 121 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Worsening Volume Overload
Frequency: 1 affected / 121 at risk

Adverse event: Pulmonary arterial hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Worsening of PAH
Frequency: 1 affected / 121 at risk

Adverse event: Ovarian neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Struma Ovarii
Frequency: 1 affected / 121 at risk

Adverse event: Hypersensitivity pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Possible Hypersensitivity Pneumonitis
Frequency: 1 affected / 121 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Atrial Fibrillation Exacerbation
Frequency: 1 affected / 121 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Fever
Frequency: 1 affected / 121 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Worsening Hypoxia
Frequency: 1 affected / 121 at risk

Adverse event: Diaphragmatic paralysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Left Hemidiaphragmatic Paresis
Frequency: 1 affected / 121 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Possible Pneumonia
Frequency: 2 affected / 121 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Worsening of Shortness of Breath
Frequency: 2 affected / 121 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Syncope
Frequency: 2 affected / 121 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Notes: Hypertensive Urgency
Frequency: 1 affected / 121 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Notes: Viral Illness
Frequency: 1 affected / 121 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Sepsis
Frequency: 1 affected / 121 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Acute Kidney Injury
Frequency: 1 affected / 121 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Possible Seizure Activity
Frequency: 1 affected / 121 at risk

Adverse event: Parainfluenzae virus infection
Serious: yes
Organ System: Infections and infestations
Notes: Parainfluenzae
Frequency: 1 affected / 121 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Acute on Chronic Hypoxic Respiratory Failure
Frequency: 1 affected / 121 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Non ST Elevation Myocardial Infarction
Frequency: 1 affected / 121 at risk

Adverse event: Open fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Compound Fracture of Lower Leg
Frequency: 1 affected / 121 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Notes: Worsening Lower Extremity Edema
Frequency: 1 affected / 121 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Notes: Worsening Left Internal Carotid Stenosis
Frequency: 1 affected / 121 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Fluid Overload
Frequency: 1 affected / 121 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough
Frequency: 41 affected / 121 at risk

Adverse event: Dysponea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 121 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 121 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 121 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 121 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 121 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 121 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 121 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 121 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 7 affected / 121 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 121 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 121 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 121 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 121 at risk

Adverse event: Diahrrea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea
Frequency: 15 affected / 121 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea
Frequency: 6 affected / 121 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Acute on Chronic Hypoxic Respiratory Failure
Frequency: 1 affected / 121 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Worsening Volume Overload
Frequency: 1 affected / 121 at risk

Adverse event: Pulmonary arterial hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Worsening of PAH
Frequency: 1 affected / 121 at risk

Adverse event: Overgrowth bacterial
Serious: yes
Organ System: Infections and infestations
Notes: Exacerbation of Chronic Bacterial Overgrowth
Frequency: 1 affected / 121 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary Embolism
Frequency: 2 affected / 121 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: GI Bleed
Frequency: 1 affected / 121 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough
Frequency: 23 affected / 121 at risk

Adverse event: Dysponea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 121 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 121 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 121 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 121 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 121 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 121 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 121 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 121 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 11 affected / 121 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 121 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 121 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 121 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 121 at risk

Adverse event: Diahrrea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea
Frequency: 7 affected / 121 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea
Frequency: 6 affected / 121 at risk