Study: NCT02780869

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 175 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 175 at risk

Adverse event: Ascites
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 175 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 175 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 175 at risk

Adverse event: Nausea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Aortic dissection
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 175 at risk

Adverse event: Right bronchopleural fistula
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 175 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 175 at risk

Adverse event: Skin rash/hives
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 175 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Vomiting
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Dehisence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 175 at risk

Adverse event: Seroma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 175 at risk

Adverse event: Abnormal bloodwork
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 175 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 175 at risk

Adverse event: Constipation/ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 175 at risk

Adverse event: Arrythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 175 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 175 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Non wound-related
Frequency: 7 affected / 175 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 15 affected / 175 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 25 affected / 175 at risk

Adverse event: Wound related
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 175 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 83 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 83 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 83 at risk

Adverse event: Delirium
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 83 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 83 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 83 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 83 at risk

Adverse event: Melaena
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 83 at risk

Adverse event: RA lead dislodgement
Serious: yes
Organ System: Product Issues
Notes: RA lead dislodgement
Frequency: 1 affected / 83 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 83 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 83 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 83 at risk

Adverse event: Dehisence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 83 at risk

Adverse event: Abnormal bloodwork
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 83 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 83 at risk

Adverse event: Constipation/ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 83 at risk

Adverse event: Arrythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 83 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 83 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Non wound-related
Frequency: 6 affected / 83 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 3 affected / 83 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 11 affected / 83 at risk

Adverse event: Wound related
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 83 at risk