Study: NCT00671437

Adverse event: Allergic reaction/hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Grade 4
Frequency: 1 affected / 42 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Investigations
Notes: Grade 4
Frequency: 1 affected / 42 at risk

Adverse event: Brachial plexopathy
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 4 Due to radiographically proven tumor progression
Frequency: 1 affected / 42 at risk

Adverse event: Bronchospasm/Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 5 Chronic obstructive pulmonary disease (COPD)
Frequency: 1 affected / 42 at risk

Adverse event: Death - Disease Progression
Serious: yes
Organ System: General disorders
Notes: Grade 5
Frequency: 1 affected / 42 at risk

Adverse event: Infection lung - pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 5
Frequency: 1 affected / 42 at risk

Adverse event: Lymphocytes (decreased)
Serious: yes
Organ System: Investigations
Notes: Grade 4

Occurred in the setting of concurrent administration of dexamethasone for head and neck lymph edema occurring due to the patient's disease.
Frequency: 1 affected / 42 at risk

Adverse event: Albumin (low)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 42 at risk

Adverse event: Alkaline phosphatase (high)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 42 at risk

Adverse event: Allergic reaction/hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 42 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 42 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 42 at risk

Adverse event: Calcium (high)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 42 at risk

Adverse event: Calcium (low)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 42 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 42 at risk

Adverse event: Creatinine (high)
Serious: no
Organ System: Investigations
Frequency: 9 affected / 42 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 42 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 42 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 42 at risk

Adverse event: Edema - head and neck
Serious: no
Organ System: General disorders
Frequency: 2 affected / 42 at risk

Adverse event: Edema - limb
Serious: no
Organ System: General disorders
Frequency: 4 affected / 42 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 42 at risk

Adverse event: Glucose (high)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 42 at risk

Adverse event: Glucose (low)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 42 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 42 at risk

Adverse event: Hemoglobin (low)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 42 at risk

Adverse event: Hemorrhage: Tumor Site
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 42 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 42 at risk

Adverse event: INR (high)
Serious: no
Organ System: Investigations
Frequency: 9 affected / 42 at risk

Adverse event: Infection normal ANC - cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 42 at risk

Adverse event: Infection normal ANC - skin
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 42 at risk

Adverse event: Infection normal ANC - upper respiratory
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 42 at risk

Adverse event: Infection skin - ungual
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 42 at risk

Adverse event: Leukocytes (low)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 42 at risk

Adverse event: Lymphocytes (low)
Serious: no
Organ System: Investigations
Frequency: 26 affected / 42 at risk

Adverse event: Magnesium (high)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 42 at risk

Adverse event: Magnesium (low)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 42 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 42 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 42 at risk

Adverse event: PTT (high)
Serious: no
Organ System: Investigations
Frequency: 8 affected / 42 at risk

Adverse event: Pain - back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 42 at risk

Adverse event: Pain - musculoskeletal - neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 42 at risk

Adverse event: Phosphate (low)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 42 at risk

Adverse event: Platelets (low)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 42 at risk

Adverse event: Potassium (low)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 42 at risk

Adverse event: Rach - acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 42 at risk

Adverse event: Rash - trach site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 42 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 42 at risk

Adverse event: SGOT (AST - high)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 42 at risk

Adverse event: SGPT (ALT-high)
Serious: no
Organ System: Investigations
Frequency: 9 affected / 42 at risk

Adverse event: Sodium (high)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 42 at risk

Adverse event: Sodium (low)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 42 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 42 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 42 at risk

Adverse event: Potassium (high)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 42 at risk

Adverse event: Pain - tumor
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 42 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 42 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 42 at risk