Study: NCT01186692

Adverse event: Anaemias NEC
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Haematological disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Cardiac disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 120 at risk

Adverse event: Coronary artery disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 120 at risk

Adverse event: Pulmonary valvular disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 120 at risk

Adverse event: Rate and rhythm disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 120 at risk

Adverse event: Supraventricular arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 120 at risk

Adverse event: Ventricular arrhythmias and cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 120 at risk

Adverse event: Gastrointestinal disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 120 at risk

Adverse event: Nausea and vomiting symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: diarrhoea (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Device issues NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 120 at risk

Adverse event: Device physical property and chemical issues
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 120 at risk

Adverse event: Febrile disorders
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 120 at risk

Adverse event: Therapeutic and nontherapeutic responses
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 120 at risk

Adverse event: Cardiac infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 120 at risk

Adverse event: Lower respiratory tract and lung infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Sepsis, bacteraemia, viraemia and fungaemia NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Cardiac and vascular procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Non-site specific procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 120 at risk

Adverse event: Nervous system disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Neurological signs and symptoms NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Pneumothorax and pleural effusions NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Pulmonary thrombotic and embolic conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Respiratory tract disorders NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 120 at risk

Adverse event: Non-site specific embolism and thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 120 at risk

Adverse event: Vascular injuries NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 120 at risk

Adverse event: Pain and discomfort NEC
Serious: no
Organ System: General disorders
Frequency: 8 affected / 120 at risk

Adverse event: Therapeutic and nontherapeutic responses
Serious: no
Organ System: General disorders
Frequency: 8 affected / 120 at risk

Adverse event: Infections NEC
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 120 at risk

Adverse event: Non-site specific procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 120 at risk