Study: NCT01996254

Adverse event: Car accident
Serious: yes
Organ System: Social circumstances
Notes: Not study-related
Frequency: 1 affected / 5 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not study-related
Frequency: 1 affected / 14 at risk

Adverse event: Leg Pain/Neuropathy
Serious: yes
Organ System: Nervous system disorders
Notes: Not study-related
Frequency: 1 affected / 14 at risk

Adverse event: Pleuritic pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not study-related
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not study related
Frequency: 1 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not study related
Frequency: 1 affected / 14 at risk

Adverse event: Tiredness/Fatigue
Serious: no
Organ System: General disorders
Notes: One event was study related, and the other was not
Frequency: 1 affected / 14 at risk

Adverse event: Cold/Flu/Sinus infection
Serious: no
Organ System: General disorders
Notes: Not study related
Frequency: 1 affected / 14 at risk

Adverse event: Unpleasant painful stimulation
Serious: no
Organ System: Product Issues
Notes: Study related
Frequency: 2 affected / 14 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not study related
Frequency: 1 affected / 14 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not study related
Frequency: 2 affected / 14 at risk

Adverse event: Itching irritation or bruising from SPRINT pads
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study related
Frequency: 1 affected / 14 at risk

Adverse event: Skin irritation/redness at Lead exit site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study related
Frequency: 3 affected / 14 at risk

Adverse event: Itching or irritation from bandages and/or belt
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study related
Frequency: 1 affected / 14 at risk

Adverse event: Non-specified skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: One event was study related, and the other was not
Frequency: 1 affected / 14 at risk

Adverse event: Blister/abcess
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not study related
Frequency: 1 affected / 14 at risk

Adverse event: Surgery
Serious: no
Organ System: Surgical and medical procedures
Notes: Not study related
Frequency: 1 affected / 14 at risk

Adverse event: Fall
Serious: no
Organ System: Social circumstances
Notes: Not study related
Frequency: 1 affected / 14 at risk

Adverse event: Patellar Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not study-related
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not study related
Frequency: 1 affected / 14 at risk

Adverse event: Cold/Flu/Sinus infection
Serious: no
Organ System: General disorders
Notes: Not study related
Frequency: 1 affected / 14 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Unable to determine relationship
Frequency: 1 affected / 14 at risk

Adverse event: Broken bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not study related
Frequency: 1 affected / 14 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not study related
Frequency: 1 affected / 14 at risk

Adverse event: Pain and tenderness from procedure
Serious: no
Organ System: Product Issues
Notes: Study related
Frequency: 3 affected / 14 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Not study related
Frequency: 1 affected / 14 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not study related
Frequency: 1 affected / 14 at risk

Adverse event: Itching irritation or bruising from SPRINT pads
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study related
Frequency: 2 affected / 14 at risk

Adverse event: Skin irritation/redness at Lead exit site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study related
Frequency: 3 affected / 14 at risk

Adverse event: Itching or irritation from bandages and/or belt
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study related
Frequency: 3 affected / 14 at risk

Adverse event: Non-specified skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: One event was study related, and the other was not
Frequency: 1 affected / 14 at risk

Adverse event: Blister/abcess
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not study related
Frequency: 1 affected / 14 at risk

Adverse event: Surgery
Serious: no
Organ System: Surgical and medical procedures
Notes: Not study related
Frequency: 1 affected / 14 at risk

Adverse event: Fall
Serious: no
Organ System: Social circumstances
Notes: Not study related
Frequency: 1 affected / 14 at risk