Study: NCT00101413

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Cardiac arrythmia - other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: Cardiac general - other
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 52 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: Death not associated with ctcae term, disease progression nos
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 52 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 52 at risk

Adverse event: Constitutional symptoms - other
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 52 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Fistula, GI, esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: GI - other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Stricture, GI,
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hemorrhage, GI, upper GI nos
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hemorrhage pulmonary, respiratory tract nos
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hepatobiliary -other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 52 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 52 at risk

Adverse event: Infection (documented clinically), lung pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 52 at risk

Adverse event: Dermal change
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Edema: limb
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Blood bilirubin
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 52 at risk

Adverse event: Amylase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 52 at risk

Adverse event: Lipase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 52 at risk

Adverse event: Metabolic/lab - other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 52 at risk

Adverse event: CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Mental status
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Neurology - other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pain, abdomen nos
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Pain, chest/thorax nos
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pain, head/headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pain, other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pain, neck
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pain, stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 52 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Fistula, pulmonary, bronchus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 52 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 32 affected / 52 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 16 affected / 52 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 52 at risk

Adverse event: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 52 at risk

Adverse event: Dermatology - other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 52 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 52 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 52 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 52 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 52 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 52 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 52 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 52 at risk

Adverse event: Infection - other
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 52 at risk

Adverse event: Dermal change
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 52 at risk

Adverse event: Pain, other
Serious: no
Organ System: General disorders
Frequency: 19 affected / 52 at risk

Adverse event: Pain, chest/thorax nos
Serious: no
Organ System: General disorders
Frequency: 14 affected / 52 at risk

Adverse event: Pain, head/headache
Serious: no
Organ System: General disorders
Frequency: 14 affected / 52 at risk

Adverse event: Pain, back
Serious: no
Organ System: General disorders
Frequency: 11 affected / 52 at risk

Adverse event: Pain, abdomen nos
Serious: no
Organ System: General disorders
Frequency: 11 affected / 52 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 52 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 52 at risk

Adverse event: Pulmonary - other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 52 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 52 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 52 at risk

Adverse event: Cardiac general - other
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 52 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 52 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 52 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 52 at risk

Adverse event: Constitutional symptoms - other
Serious: no
Organ System: General disorders
Frequency: 10 affected / 52 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 52 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 7 affected / 52 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 52 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 52 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 52 at risk

Adverse event: Mucositis (clinical exam), oral cavitiy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 52 at risk

Adverse event: GI - other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 52 at risk

Adverse event: Hemorrhage - other
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 52 at risk

Adverse event: Hemorrhage pulmonary, bronchopulmonary NOS
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 52 at risk

Adverse event: Hemorrhage pulmonary, nose
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 52 at risk

Adverse event: Musculoskeletal - other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 52 at risk

Adverse event: Gait/walking
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 52 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 52 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 52 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 52 at risk

Adverse event: Lipase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 52 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 52 at risk

Adverse event: Metabolic/lab - other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 52 at risk

Adverse event: Mood alteration, anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 52 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 52 at risk

Adverse event: Mood alteration, depression
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 52 at risk

Adverse event: Neurology - other
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 52 at risk

Adverse event: Neuropathy - sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 52 at risk

Adverse event: Ocular - other
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 52 at risk

Adverse event: Pain, chest wall
Serious: no
Organ System: General disorders
Frequency: 5 affected / 52 at risk

Adverse event: Pain, extremity - limb
Serious: no
Organ System: General disorders
Frequency: 10 affected / 52 at risk

Adverse event: Pain, tumor pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 52 at risk

Adverse event: Pain, joint
Serious: no
Organ System: General disorders
Frequency: 6 affected / 52 at risk

Adverse event: Pain, muscle
Serious: no
Organ System: General disorders
Frequency: 5 affected / 52 at risk

Adverse event: Pain, bone
Serious: no
Organ System: General disorders
Frequency: 3 affected / 52 at risk

Adverse event: Pain, neck
Serious: no
Organ System: General disorders
Frequency: 8 affected / 52 at risk

Adverse event: Pain, stomach
Serious: no
Organ System: General disorders
Frequency: 9 affected / 52 at risk

Adverse event: Pain, throat/pharynx/larynx
Serious: no
Organ System: General disorders
Frequency: 4 affected / 52 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 52 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 52 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 52 at risk

Adverse event: Renal - other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 52 at risk