Study: NCT00521079

Adverse event: Incision pain incision site
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 192 at risk

Adverse event: Infection neuroregulator site
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 192 at risk

Adverse event: Neuroregulator malfunction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 192 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 192 at risk

Adverse event: Pain neuroregulator site
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 192 at risk

Adverse event: Bleeding other
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 192 at risk

Adverse event: Cardiac abnormality
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 192 at risk

Adverse event: Cold/flu/respiratory tract infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 192 at risk

Adverse event: Gallbladder disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 192 at risk

Adverse event: Infection other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 192 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 192 at risk

Adverse event: Pain other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 192 at risk

Adverse event: Reaction to medicines
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 192 at risk

Adverse event: Bloating Abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 192 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: Primarily related to the sensation of therapy.

Generally occurred early with mild to moderate severity.
Frequency: 19 affected / 192 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 192 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 192 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 192 at risk

Adverse event: Heartburn/Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 192 at risk

Adverse event: Incision pain incision site
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 192 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 192 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 192 at risk

Adverse event: Pain neuroregulator site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 42 affected / 192 at risk

Adverse event: Skin reaction to coil/coil adhesion method
Serious: no
Organ System: General disorders
Frequency: 18 affected / 192 at risk

Adverse event: Wound redness or irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 192 at risk

Adverse event: Cold/flu/respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 93 affected / 192 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 24 affected / 192 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 192 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 20 affected / 192 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 192 at risk

Adverse event: Emesis (vomiting)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 192 at risk

Adverse event: Out of range lab values
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 192 at risk

Adverse event: Vitamin or mineral insufficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 192 at risk

Adverse event: Cramps abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 192 at risk

Adverse event: Reaction to medicines
Serious: no
Organ System: General disorders
Frequency: 9 affected / 192 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 192 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 192 at risk

Adverse event: Injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 192 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 192 at risk

Adverse event: Infection neuroregulator site
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Lead impedance high
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 102 at risk

Adverse event: Pain neuroregulator site
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 102 at risk

Adverse event: Infection other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Large bowel dysfunction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 102 at risk

Adverse event: Bloating Abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 102 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: Primarily related to the sensation of therapy.

Generally occurred early with mild to moderate severity.
Frequency: 2 affected / 102 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 102 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 102 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 102 at risk

Adverse event: Heartburn/Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 102 at risk

Adverse event: Incision pain incision site
Serious: no
Organ System: Surgical and medical procedures
Frequency: 8 affected / 102 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 102 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 102 at risk

Adverse event: Pain neuroregulator site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 102 at risk

Adverse event: Skin reaction to coil/coil adhesion method
Serious: no
Organ System: General disorders
Frequency: 8 affected / 102 at risk

Adverse event: Wound redness or irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 102 at risk

Adverse event: Cold/flu/respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 102 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 102 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 102 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 102 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 102 at risk

Adverse event: Emesis (vomiting)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 102 at risk

Adverse event: Out of range lab values
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 102 at risk

Adverse event: Vitamin or mineral insufficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 102 at risk

Adverse event: Cramps abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 102 at risk

Adverse event: Reaction to medicines
Serious: no
Organ System: General disorders
Frequency: 5 affected / 102 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 102 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 102 at risk

Adverse event: Injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 102 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 102 at risk