Study: NCT00041132

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Infection with 3-4 neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Second primary
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 49 at risk

Adverse event: Ataxia (incoordination)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 45 affected / 49 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 49 at risk

Adverse event: PRBC transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 49 at risk

Adverse event: Platelet transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 49 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 49 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 49 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 49 at risk

Adverse event: Abdominal pain/cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Constipation/bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 49 at risk

Adverse event: Diarrhea without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 49 at risk

Adverse event: Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 49 at risk

Adverse event: Esophagitis/dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 49 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 49 at risk

Adverse event: Stomatitis/pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 49 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 49 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 23 affected / 49 at risk

Adverse event: Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 43 affected / 49 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 49 at risk

Adverse event: Hemorrhage w/ 3-4 thrombocyt
Serious: no
Organ System: General disorders
Frequency: 5 affected / 49 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 49 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 8 affected / 49 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 49 at risk

Adverse event: Infection w/o 3-4 neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 49 at risk

Adverse event: Infection with 3-4 neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 49 at risk

Adverse event: Respiratory infect w/ neutrop
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 49 at risk

Adverse event: Respiratory infect w/o neutrop
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 49 at risk

Adverse event: Alkaline phosphatase increase
Serious: no
Organ System: Investigations
Frequency: 8 affected / 49 at risk

Adverse event: Bilirubin increase
Serious: no
Organ System: Investigations
Frequency: 7 affected / 49 at risk

Adverse event: Creatinine increase
Serious: no
Organ System: Investigations
Frequency: 6 affected / 49 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 44 affected / 49 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 31 affected / 49 at risk

Adverse event: Neutropenia/granulocytopenia
Serious: no
Organ System: Investigations
Frequency: 45 affected / 49 at risk

Adverse event: SGOT (AST) increase
Serious: no
Organ System: Investigations
Frequency: 18 affected / 49 at risk

Adverse event: SGPT (ALT) increase
Serious: no
Organ System: Investigations
Frequency: 10 affected / 49 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 43 affected / 49 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 49 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 49 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 49 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 49 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 49 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 49 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 49 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 49 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 49 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 49 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 49 at risk

Adverse event: Muscle weakness (not neuro)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 49 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 49 at risk

Adverse event: Myalgia/arthralgia, NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 49 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 49 at risk

Adverse event: Dizziness/vertigo, NOS
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 49 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 49 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 49 at risk

Adverse event: Anxiety/agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 49 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 49 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 49 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 49 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 49 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 49 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Pneumonitis/infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 49 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 49 at risk

Adverse event: Petechiae/purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 49 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 49 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 49 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 49 at risk

Adverse event: Thrombosis/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 49 at risk