Study: NCT01758731

Adverse event: Feed tube placement pain
Serious: yes
Organ System: General disorders
Notes: Subject had an extended hospital stay after his SOC feeding tube placement due to uncontrolled pain that was caused by overeating the morning after the procedure. Not related to study drug.
Frequency: 1 affected / 16 at risk

Adverse event: Confusion, somnolence, disorientation, hypoxia
Serious: yes
Organ System: General disorders
Notes: Subject experienced confusion, somnolence, disorientation and hypoxia on Day 10 of radiation therapy and was admitted through the Emergency Department and discharged the following day. Not related to study drug.
Frequency: 1 affected / 16 at risk

Adverse event: Grade 3 mucositis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject developed sloughing and necrosis of the left pharyngeal wall 6 months post Tx. Feeding tube placed for nutritional support and tube removed at 10 months post-treatment and was able to resume normal food intake. Possibly related to study drug.
Frequency: 1 affected / 1 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Notes: Subject hospitalized for dehydration caused secondarily by nausea and vomiting and also diabetic ketoacidosis, acute kidney injury, anemia, hyperkalemia and hypomagnesemia. Not related to study drug.
Frequency: 1 affected / 16 at risk

Adverse event: Acneform rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 16 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 6 affected / 16 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 16 at risk

Adverse event: Dysphagia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 16 at risk

Adverse event: Elevated TSH
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 16 at risk

Adverse event: Erythema
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 16 at risk

Adverse event: Swelling face
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 16 at risk

Adverse event: Flatulence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dysphonia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 16 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Infection of G-tube site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Insomnia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Intermittent hypocalcemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Laryngeal oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Low albumin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Low T4
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 16 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 16 at risk

Adverse event: Malnutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 16 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 8 affected / 16 at risk

Adverse event: Neck pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 16 at risk

Adverse event: Neck/Face Skin Infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Non-healing Wound
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Odyophagia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 16 at risk

Adverse event: Oral pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Ear pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pharynx Ulceration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 16 at risk

Adverse event: Reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Sinus disorder
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Candida infection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 7 affected / 16 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 9 affected / 16 at risk

Adverse event: Xerosis/dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 16 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 16 at risk