Study: NCT00461734

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 120 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 120 at risk

Adverse event: diabets
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 120 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 120 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 120 at risk

Adverse event: bile duct
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 120 at risk

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

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 120 at risk

Adverse event: Angiogram
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 120 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 120 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 120 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 120 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 120 at risk

Adverse event: prostate
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 120 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 120 at risk

Adverse event: Dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 120 at risk

Adverse event: bypass
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 120 at risk

Adverse event: Raynaud's phenomenon
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 120 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 19 affected / 120 at risk

Adverse event: product issue
Serious: yes
Organ System: Cardiac disorders
Notes: Adverse events related to the pacemaker (e.g., lead dislodgment or changing in threshold values). The term 'product issue' is taken from MedDRA 19.0 classification.
Frequency: 9 affected / 120 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 120 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 120 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 29 affected / 120 at risk

Adverse event: diabets
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 120 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 120 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 120 at risk

Adverse event: bile duct
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 120 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 120 at risk

Adverse event: Angiogram
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 120 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 120 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 120 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 120 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 120 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 120 at risk

Adverse event: prostate
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 120 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 120 at risk

Adverse event: Dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: bypass
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 120 at risk

Adverse event: Raynaud's phenomenon
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 120 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 120 at risk

Adverse event: product issue
Serious: yes
Organ System: Cardiac disorders
Notes: Adverse events related to the pacemaker (e.g., lead dislodgment or changing in threshold values). The term 'product issue' is taken from MedDRA 19.0 classification.
Frequency: 11 affected / 120 at risk