Study: NCT01888640

Adverse event: Pain with testing
Serious: no
Organ System: Nervous system disorders
Notes: Increase in pain with testing at clinic visit
Frequency: 12 affected / 103 at risk

Adverse event: Upper Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Report of upper respiratory infection or difficulty during the study
Frequency: 7 affected / 103 at risk

Adverse event: Pain with TENS; At home, unspecified
Serious: no
Organ System: General disorders
Frequency: 4 affected / 103 at risk

Adverse event: Skin Irritation from actigraph band
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 103 at risk

Adverse event: Skin Irritation with Electrodes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 103 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 103 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 103 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 103 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 103 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 4 affected / 103 at risk

Adverse event: Headache or Migraine
Serious: no
Organ System: General disorders
Frequency: 3 affected / 103 at risk

Adverse event: Dental Procedures
Serious: no
Organ System: General disorders
Frequency: 2 affected / 103 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Subject with chest pain between visits with emergency department visit and hospitalization; non-study related, recovered with treatment
Frequency: 1 affected / 99 at risk

Adverse event: Pain with testing
Serious: no
Organ System: Nervous system disorders
Notes: Increase in pain with testing at clinic visit
Frequency: 10 affected / 99 at risk

Adverse event: Upper Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Report of upper respiratory infection or difficulty during the study
Frequency: 7 affected / 99 at risk

Adverse event: Pain with TENS; At home, unspecified
Serious: no
Organ System: General disorders
Frequency: 4 affected / 99 at risk

Adverse event: Skin Irritation from actigraph band
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 99 at risk

Adverse event: Skin Irritation with Electrodes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 99 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 99 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 99 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 3 affected / 99 at risk

Adverse event: Headache or Migraine
Serious: no
Organ System: General disorders
Frequency: 3 affected / 99 at risk

Adverse event: Dental Procedures
Serious: no
Organ System: General disorders
Frequency: 2 affected / 99 at risk

Adverse event: Dehydration and gastrointestinal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Participant admitted to hospital for complaint of dehydration
Frequency: 1 affected / 99 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Hospitalization for depression
Frequency: 1 affected / 99 at risk

Adverse event: Pain with testing
Serious: no
Organ System: Nervous system disorders
Notes: Increase in pain with testing at clinic visit
Frequency: 15 affected / 99 at risk

Adverse event: Upper Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Report of upper respiratory infection or difficulty during the study
Frequency: 3 affected / 99 at risk

Adverse event: Pain with TENS; At home, unspecified
Serious: no
Organ System: General disorders
Frequency: 3 affected / 99 at risk

Adverse event: Skin Irritation from actigraph band
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 99 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 99 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 2 affected / 99 at risk

Adverse event: Headache or Migraine
Serious: no
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Dental Procedures
Serious: no
Organ System: General disorders
Frequency: 3 affected / 99 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 352 at risk