Study: NCT00293462

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Mucositis Oral:Hypersensitivity Reaction from Salt and Soda Mouthwash
Frequency: 1 affected / 29 at risk

Adverse event: Transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Sinus tachycardia due to Acetaminophen-codeine medication.
Frequency: 1 affected / 29 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: (bicycle accident)
Frequency: 1 affected / 29 at risk

Adverse event: Radiation dermatitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 29 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: (hydrated at doctor's office during/after radiation treatment)
Frequency: 5 affected / 29 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (chest congestion)
Frequency: 1 affected / 29 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: (due to fentanyl patch)
Frequency: 1 affected / 29 at risk

Adverse event: Other
Serious: no
Organ System: Surgical and medical procedures
Notes: (lung biopsy)
Frequency: 1 affected / 29 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Reactive oral mucositis : Due to the timing of the adverse event (AE), the study team determined that the reactive oral mucositis is unlikely to be related to radiation therapy and was part of the salt and soda group.
Frequency: 1 affected / 28 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Radiation dermatitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 28 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: (hydrated at doctor's office during/after radiation treatment)
Frequency: 13 affected / 28 at risk

Adverse event: Exostosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Had the potential to have bone growth and had previous history. Based on physician's decision. Patient was in Salt and Soda group. This was not related to the mouth wash medication.
Frequency: 1 affected / 28 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 28 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Laryngeal obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (mucous)
Frequency: 1 affected / 28 at risk

Adverse event: Laryngeal oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (Asymptomatic; clinical observations only; intervention not indicated; tracheostomy area)
Frequency: 1 affected / 28 at risk

Adverse event: Rash acne form
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Other
Serious: no
Organ System: Surgical and medical procedures
Notes: (basal cell carcinoma remove from thumb)
Frequency: 1 affected / 28 at risk

Adverse event: Other
Serious: no
Organ System: Surgical and medical procedures
Notes: (facial reconstruction)
Frequency: 1 affected / 28 at risk

Adverse event: Other
Serious: no
Organ System: Surgical and medical procedures
Notes: (Septoplasty)
Frequency: 1 affected / 28 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: Other (withdrawal symptoms-opioid)
Frequency: 1 affected / 28 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 28 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: (Shoulder and neck area)
Frequency: 1 affected / 28 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Notes: (Withdraweal symptoms-opioid)
Frequency: 1 affected / 28 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Notes: (Right foot)
Frequency: 1 affected / 28 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (left parotid gland)
Frequency: 1 affected / 28 at risk

Adverse event: Radiation dermatitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 28 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: (\>15 lbs; more than 10%)
Frequency: 1 affected / 28 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: (hydrated at doctor's office during/after radiation treatment)
Frequency: 10 affected / 28 at risk

Adverse event: Cerebral ischaemia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Laryngopharyngeal Dyesthesia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Rash acne form
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Other
Serious: no
Organ System: Surgical and medical procedures
Notes: (Percutaneous endoscopic gastrostomy tube insertion)
Frequency: 2 affected / 28 at risk

Adverse event: Other
Serious: no
Organ System: Surgical and medical procedures
Notes: (PEG tube removal)
Frequency: 1 affected / 28 at risk

Adverse event: Other
Serious: no
Organ System: Surgical and medical procedures
Notes: (facial reconstruction)
Frequency: 1 affected / 28 at risk