Study: NCT00629265

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 116 at risk

Adverse event: Cancer Recurrence in Head & Neck
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Two were base of tongue recurrances and one was a begnign vocal polyp
Frequency: 3 affected / 116 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 116 at risk

Adverse event: Excision of Necrotic Mass
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 116 at risk

Adverse event: Lung biopsy for suspicious mass
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 116 at risk

Adverse event: PEG Complications
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 1 patient had an infection at PEG site and another had a blocked PEG
Frequency: 2 affected / 116 at risk

Adverse event: Blood pressure complications
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Dehydration requiring hospitilization
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 116 at risk

Adverse event: Exacerbation of COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Progressive shortness of breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Laryngeal edema had been getting worse since end of RT and progressed to critical stage while in the study.
Frequency: 1 affected / 116 at risk

Adverse event: Tongue tingling / edema
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 116 at risk

Adverse event: Pain / discomfort in neck / throat
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 116 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 116 at risk

Adverse event: Blood in sputum
Serious: no
Organ System: General disorders
Frequency: 1 affected / 116 at risk

Adverse event: Common Cold / Fever / Not Feeling Well
Serious: no
Organ System: General disorders
Frequency: 2 affected / 116 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Bronchoscopy for RLL infiltrate
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 116 at risk

Adverse event: Patient over-medicated
Serious: no
Organ System: General disorders
Frequency: 1 affected / 116 at risk

Adverse event: Pain related to oral biopsy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 116 at risk

Adverse event: Lung biopsy for suspicious mass
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 116 at risk

Adverse event: Worstening of swallow - more difficult
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: New Cancer / METs (other than Head & Neck)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 54 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Airway obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Acute allergic reaction to cat
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Severe Heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Pain / discomfort in neck / throat
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 54 at risk

Adverse event: Common Cold / Fever / Not Feeling Well
Serious: no
Organ System: General disorders
Frequency: 3 affected / 54 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Unable to tolerate electrode placement it c/o dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 54 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Difficulty breathing d/t glottic stenosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 54 at risk