Study: NCT00570232

Adverse event: pneumonia leading to respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pt hospitalized for respiratory failure and pneumonia felt releated to disease recurrence
Frequency: 1 affected / 31 at risk

Adverse event: bleeding from throat
Serious: yes
Organ System: Surgical and medical procedures
Notes: Pt hospitalized for throat bleeding felt related to disease progress
Frequency: 1 affected / 31 at risk

Adverse event: Stridor
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pt hospitalized for stridor and trach debulking, felt unrelated to study drug
Frequency: 1 affected / 31 at risk

Adverse event: Bell's palsy
Serious: yes
Organ System: Nervous system disorders
Notes: Pt hospitalized and diagnosed with Bell's Palsy
Frequency: 1 affected / 31 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pt hospitalized for pneumonia
Frequency: 1 affected / 31 at risk

Adverse event: cardiac stents placed
Serious: yes
Organ System: Cardiac disorders
Notes: Pt had cardiac stents placed; event deemed unrelated to protocol therapy
Frequency: 1 affected / 31 at risk

Adverse event: H pylori infection
Serious: yes
Organ System: Infections and infestations
Notes: Pt hospitalized for nausea and vomiting felt related to inadequate PEG and H pylori infection
Frequency: 1 affected / 31 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Pt hospitalized for MI felt possibly related to study drug
Frequency: 1 affected / 31 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pt hospitalized for septic shock and ARDS related to pneumonia; unrelated to study drug
Frequency: 1 affected / 31 at risk

Adverse event: acniform rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 31 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 22 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 31 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 31 at risk

Adverse event: Anaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 31 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 31 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 31 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 31 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 31 at risk

Adverse event: decreased platelet count
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 31 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 31 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 31 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 31 at risk

Adverse event: Hirsutism
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 31 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 31 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 31 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 31 at risk