Study: NCT00412542

Adverse event: Thrombus pulmonary embolus
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 75 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Patient was admitted overnight for Grade 3 seizure, unlikely related
Frequency: 8 affected / 75 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient was admitted for Grade 2 nausea, possibly related
Frequency: 3 affected / 75 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient admitted for Grade 2 vomiting, possibly related
Frequency: 3 affected / 75 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient admitted for Grade 2 diarrhea, possibly related
Frequency: 9 affected / 75 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 75 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 75 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 75 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 75 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Of the 6 deaths reported, 3 were directly related to disease progression of malignant gliomas. The other 3 were due to complications of other events
Frequency: 6 affected / 75 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 75 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Thrombus - deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 75 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 75 at risk

Adverse event: Elevated ALT
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 75 at risk

Adverse event: Elevated Creatinine
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 75 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 75 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Anal incontinence
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 75 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 75 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 75 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 75 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 75 at risk

Adverse event: Musculo-skeletal leg cramps
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 75 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 75 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 75 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 75 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 75 at risk

Adverse event: Subdural fluid collection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 75 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 75 at risk

Adverse event: Asthenia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 75 at risk

Adverse event: Abdominal cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 75 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 75 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 75 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 75 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 75 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 75 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 75 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 75 at risk

Adverse event: AST elevated
Serious: no
Organ System: Investigations
Frequency: 12 affected / 75 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 75 at risk

Adverse event: Bicarbonate sodium, low
Serious: no
Organ System: Investigations
Frequency: 16 affected / 75 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 75 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 75 at risk

Adverse event: Bruising (without thrombocytopenia)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 75 at risk

Adverse event: BUN elevated
Serious: no
Organ System: Investigations
Frequency: 12 affected / 75 at risk

Adverse event: Cholesterol elevated
Serious: no
Organ System: Investigations
Frequency: 11 affected / 75 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 75 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 75 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 75 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 75 at risk

Adverse event: CPK elevated
Serious: no
Organ System: Investigations
Frequency: 4 affected / 75 at risk

Adverse event: Creatinine elevated
Serious: no
Organ System: Investigations
Frequency: 9 affected / 75 at risk

Adverse event: Cushingoid
Serious: no
Organ System: Endocrine disorders
Frequency: 11 affected / 75 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 75 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 75 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 75 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 9 affected / 75 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 75 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 75 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 75 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 31 affected / 75 at risk

Adverse event: Elevated chloride
Serious: no
Organ System: Investigations
Frequency: 18 affected / 75 at risk

Adverse event: Elevated CO2
Serious: no
Organ System: Investigations
Frequency: 14 affected / 75 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Investigations
Frequency: 6 affected / 75 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 63 affected / 75 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 75 at risk

Adverse event: Gait/walking
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 75 at risk

Adverse event: Anemia/decreased hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 57 affected / 75 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 49 affected / 75 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 75 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 75 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 75 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 24 affected / 75 at risk

Adverse event: Hypomagnesium
Serious: no
Organ System: Investigations
Frequency: 13 affected / 75 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 19 affected / 75 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 24 affected / 75 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 75 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 75 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 75 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 75 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 65 affected / 75 at risk

Adverse event: Low protein
Serious: no
Organ System: Investigations
Frequency: 15 affected / 75 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 52 affected / 75 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 75 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 75 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 75 at risk

Adverse event: Muscle weakness lower extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 75 at risk

Adverse event: Muscle weakness facial
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 75 at risk

Adverse event: Muscle weakness left or right sides
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 75 at risk

Adverse event: Muscle weakness generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 75 at risk

Adverse event: Nasal/paranasal reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 75 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 75 at risk

Adverse event: Neuropathy motor
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 75 at risk

Adverse event: Neuropathy sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 75 at risk

Adverse event: Neutrophils, absolute count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 55 affected / 75 at risk

Adverse event: Pain, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 75 at risk

Adverse event: Pain, back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 75 at risk

Adverse event: Pain, chest (non cardiac)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 75 at risk

Adverse event: Pain, extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 75 at risk

Adverse event: Pain, headache
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 75 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 75 at risk

Adverse event: Pyramidal tract dysfunction
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 75 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 75 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 75 at risk

Adverse event: Speech impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 75 at risk

Adverse event: Tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 75 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 75 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 75 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 75 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 75 at risk