Study: NCT03434028

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Definitely not study related
Frequency: 1 affected / 782 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Definitely not study related
Frequency: 1 affected / 782 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Definitely not study related
Frequency: 1 affected / 782 at risk

Adverse event: Polymorphic Vt
Serious: yes
Organ System: Cardiac disorders
Notes: Probably not study related
Frequency: 1 affected / 782 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Probably or possibly study related
Frequency: 1 affected / 782 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Definitely not study related
Frequency: 2 affected / 782 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Probably not study related
Frequency: 1 affected / 782 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Notes: Definitely not study related
Frequency: 1 affected / 782 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Definitely not study related
Frequency: 1 affected / 782 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Definitely not study related
Frequency: 1 affected / 782 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Notes: Probably not study related
Frequency: 1 affected / 782 at risk

Adverse event: Lactic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Probably not study related
Frequency: 1 affected / 782 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Notes: Probably not study related
Frequency: 1 affected / 782 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Definitely not study related
Frequency: 1 affected / 782 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: Definitely not study related
Frequency: 1 affected / 782 at risk

Adverse event: Worsening Kidney Failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Probably not study related
Frequency: 1 affected / 782 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Probably not study related
Frequency: 1 affected / 782 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Definitely not study related
Frequency: 1 affected / 782 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Notes: Probably or possibly study related/ Probably not study related
Frequency: 2 affected / 782 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: Probably or possibly study related
Frequency: 1 affected / 782 at risk

Adverse event: Rhabdomyolysis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Probably or possibly study related
Frequency: 1 affected / 782 at risk

Adverse event: Seizure Vs Syncope Vasovagal
Serious: no
Organ System: Nervous system disorders
Notes: Probably not study related
Frequency: 1 affected / 782 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Notes: Definitely not study related
Frequency: 1 affected / 782 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Definitely not study related
Frequency: 2 affected / 781 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Cardiac disorders
Notes: Probably or possibly study related
Frequency: 2 affected / 781 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Cardiac disorders
Notes: Probably not study related
Frequency: 1 affected / 781 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Cardiac disorders
Notes: Probably not study related/Probably or possibly study related
Frequency: 3 affected / 781 at risk

Adverse event: Myocardial Ischemia, Elevated Troponin
Serious: yes
Organ System: Cardiac disorders
Notes: Probably not study related
Frequency: 1 affected / 781 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Probably not study related
Frequency: 1 affected / 781 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Definitely not study related
Frequency: 4 affected / 781 at risk

Adverse event: Readmit
Serious: yes
Organ System: General disorders
Notes: Definitely not study related
Frequency: 1 affected / 781 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: Probably not study related
Frequency: 1 affected / 781 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Probably not study related
Frequency: 2 affected / 781 at risk

Adverse event: Blister
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Probably not study related
Frequency: 1 affected / 781 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Probably or possibly study related
Frequency: 2 affected / 781 at risk

Adverse event: Coagulopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Definitely not study related
Frequency: 1 affected / 781 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Probably not study related
Frequency: 1 affected / 781 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Cardiac disorders
Notes: Probably or possibly study related/Probably not study related
Frequency: 3 affected / 781 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Cardiac disorders
Notes: Probably or possibly study related
Frequency: 1 affected / 781 at risk

Adverse event: Transfusion Associated Circulatory Overload
Serious: no
Organ System: Cardiac disorders
Notes: Probably or possibly study related
Frequency: 1 affected / 781 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Notes: Definitely not study related
Frequency: 1 affected / 781 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Probably or possibly study related
Frequency: 1 affected / 781 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Probably or possibly study related
Frequency: 1 affected / 781 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Probably or possibly study related
Frequency: 1 affected / 781 at risk

Adverse event: Worsening Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Probably or possibly study related
Frequency: 1 affected / 781 at risk