Study: NCT01392625

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: 1-month sae
Frequency: 1 affected / 18 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: 6-month SAE
Frequency: 2 affected / 18 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: 6-month SAE
Frequency: 1 affected / 18 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: 6-month SAE
Frequency: 1 affected / 18 at risk

Adverse event: Subdural heamatoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: 6-month SAE
Frequency: 1 affected / 18 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: 6-month SAE
Frequency: 1 affected / 18 at risk

Adverse event: Mitral valve incompetence
Serious: no
Organ System: Cardiac disorders
Notes: Treatment Emergent AE at 1-month
Frequency: 1 affected / 18 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Treatment emergent adverse event at 1 month
Frequency: 1 affected / 18 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: Treatment emergent adverse event at 1 month
Frequency: 2 affected / 18 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Treatment emergent adverse event at 1 month
Frequency: 1 affected / 18 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Treatment emergent adverse event at 1 month
Frequency: 1 affected / 18 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: 1-month SAE
Frequency: 1 affected / 19 at risk

Adverse event: Device pacing issue
Serious: yes
Organ System: Product Issues
Notes: 1-month SAE
Frequency: 1 affected / 19 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: 6-month SAE
Frequency: 1 affected / 19 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: 6-month SAE
Frequency: 1 affected / 19 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: 6-month SAE
Frequency: 1 affected / 19 at risk

Adverse event: Gatrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 6-month SAE
Frequency: 1 affected / 19 at risk

Adverse event: Device pacing issues
Serious: yes
Organ System: Product Issues
Notes: 6-month SAE
Frequency: 1 affected / 19 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 6-month SAE
Frequency: 1 affected / 19 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: 6-month SAE
Frequency: 1 affected / 19 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Treatment Emergent Adverse event at one-month
Frequency: 1 affected / 19 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Treatment emergent adverse event at 1 month
Frequency: 1 affected / 19 at risk

Adverse event: Adverse drug reaction
Serious: no
Organ System: General disorders
Notes: Treatment emergent adverse event at 1 month
Frequency: 1 affected / 19 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Notes: Treatment emergent adverse event at 1 month
Frequency: 1 affected / 19 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Treatment emergent adverse event at 1 month
Frequency: 1 affected / 19 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Notes: Treatment emergent adverse event at 1 month
Frequency: 1 affected / 19 at risk

Adverse event: Electrocardiogram abnormal
Serious: no
Organ System: Investigations
Notes: Treatment emergent adverse event at 1 month
Frequency: 1 affected / 19 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Treatment emergent adverse event at 1 month
Frequency: 1 affected / 19 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: Treatment emergent adverse event at 1 month
Frequency: 1 affected / 19 at risk

Adverse event: Device pacing issue
Serious: no
Organ System: Product Issues
Notes: Treatment emergent adverse event at 1 month
Frequency: 1 affected / 19 at risk

Adverse event: Implantable defibrillator insertion
Serious: no
Organ System: Surgical and medical procedures
Notes: Treatment emergent adverse event at 1 month
Frequency: 1 affected / 19 at risk