Study: NCT00823459

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonitis/pulmonary infiltrates
Frequency: 2 affected / 58 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Seizure
Frequency: 2 affected / 58 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Fever (in the absence of neutropenia, where neutropenia is defined as ANC \<1.0 x 10e9/L)
Frequency: 1 affected / 58 at risk

Adverse event: Pain
Serious: yes
Organ System: Nervous system disorders
Notes: Pain-Head/headache
Frequency: 1 affected / 58 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Infection with normal ANC or Grade 1 or 2 neutrophils

- Meninges (meningitis)
Frequency: 1 affected / 58 at risk

Adverse event: Renal/Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Notes: Malilgnancy
Frequency: 1 affected / 58 at risk

Adverse event: Renal/Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Notes: Renal/Genitourinary malignancy, Urinary frequency/urgency
Frequency: 1 affected / 58 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 58 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 58 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 58 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 58 at risk

Adverse event: mucositis/stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Oral cavity
Frequency: 3 affected / 58 at risk

Adverse event: mucosititis/stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Anus
Frequency: 2 affected / 58 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 58 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 58 at risk

Adverse event: Dizzness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 58 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Motor
Frequency: 2 affected / 58 at risk

Adverse event: mood alteration
Serious: no
Organ System: Nervous system disorders
Notes: Agitation
Frequency: 1 affected / 58 at risk

Adverse event: Mood Alteration
Serious: no
Organ System: Nervous system disorders
Notes: Depression
Frequency: 1 affected / 58 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Sensory
Frequency: 1 affected / 58 at risk

Adverse event: Speech Impairment
Serious: no
Organ System: Nervous system disorders
Notes: dysphasia or aphasia
Frequency: 1 affected / 58 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: Fainting
Frequency: 1 affected / 58 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 6 affected / 58 at risk

Adverse event: Pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal NOS
Frequency: 1 affected / 58 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Back
Frequency: 1 affected / 58 at risk

Adverse event: Pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Chest/Thorax
Frequency: 1 affected / 58 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: with Grade III or IV neurtophils (ANC \< 1.0x 10e9/L) - Lung
Frequency: 1 affected / 58 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: With normal ANC or Grade 1 or 2 neurtrophils - meninges (meningitis)
Frequency: 1 affected / 58 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 58 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 58 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: In absence of neutropenia,where neutropenia is defined as ANC \< 1.0 x 10e9/L
Frequency: 1 affected / 58 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 58 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: desquamation
Frequency: 1 affected / 58 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: acne/acneiform
Frequency: 1 affected / 58 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Generalized
Frequency: 1 affected / 58 at risk

Adverse event: Musculoskeletal/soft Tissue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Other
Frequency: 1 affected / 58 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 58 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath
Frequency: 3 affected / 58 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary Infiltrates
Frequency: 2 affected / 58 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 58 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 58 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 58 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: ANC
Frequency: 2 affected / 58 at risk

Adverse event: Increased ALT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 58 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Triglyceride, serum-high
Frequency: 6 affected / 58 at risk

Adverse event: Hypophosephatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Phosphate, serum - low
Frequency: 4 affected / 58 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cholesterol, serum-high
Frequency: 3 affected / 58 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Glucose, Serum - high
Frequency: 3 affected / 58 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Potassium, serum - high
Frequency: 1 affected / 58 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Sodium, serum - high
Frequency: 1 affected / 58 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum glutamic pyruvic transaminase - serum high
Frequency: 2 affected / 58 at risk