Study: NCT00004031

Adverse event: LVEF decrease/CHF
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 123 at risk

Adverse event: Reportable adverse event, NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 123 at risk

Adverse event: Infection with 3-4 neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Infection with grade 3-4 neutropenia \[present or life-threatening sepsis (e.g., septic shock)\]
Frequency: 1 affected / 123 at risk

Adverse event: Second primary
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 123 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 57 affected / 123 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 123 at risk

Adverse event: PRBC transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 123 at risk

Adverse event: Platelet transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 123 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 123 at risk

Adverse event: Abdominal pain/cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 123 at risk

Adverse event: Constipation/bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 123 at risk

Adverse event: Diarrhea without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 123 at risk

Adverse event: Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 123 at risk

Adverse event: Esophagitis/dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 123 at risk

Adverse event: GI Mucositis, NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Mouth dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 123 at risk

Adverse event: Stomatitis/pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 123 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 123 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 9 affected / 123 at risk

Adverse event: Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 47 affected / 123 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 123 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 15 affected / 123 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 123 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 9 affected / 123 at risk

Adverse event: Infection w/o 3-4 neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 123 at risk

Adverse event: Infection with 3-4 neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 123 at risk

Adverse event: Device related infection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 123 at risk

Adverse event: Alkaline phosphatase increase
Serious: no
Organ System: Investigations
Frequency: 9 affected / 123 at risk

Adverse event: Bilirubin increase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 123 at risk

Adverse event: Creatinine increase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 123 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 68 affected / 123 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 59 affected / 123 at risk

Adverse event: Neutropenia/granulocytopenia
Serious: no
Organ System: Investigations
Frequency: 60 affected / 123 at risk

Adverse event: SGOT (AST) increase
Serious: no
Organ System: Investigations
Frequency: 9 affected / 123 at risk

Adverse event: SGPT (ALT) increase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 123 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 15 affected / 123 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 123 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 123 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 123 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 123 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 123 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 123 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 123 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 123 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 123 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 123 at risk

Adverse event: Chest pain,not cardio or pleur
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 123 at risk

Adverse event: Muscle weakness (not neuro)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 123 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 123 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 123 at risk

Adverse event: Dizziness/light headedness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 123 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 123 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 123 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 123 at risk

Adverse event: Weakness (motor neuropathy)
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 123 at risk

Adverse event: Anxiety/agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 123 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 123 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 123 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 123 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 123 at risk

Adverse event: Pneumonitis/infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 123 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 43 affected / 123 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 123 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 123 at risk

Adverse event: Skin-other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 123 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 123 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 123 at risk

Adverse event: Stomatitis/pharyngitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Syndrome-other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 113 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Pneumonitis/infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 113 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 89 affected / 113 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 44 affected / 113 at risk

Adverse event: PRBC transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 32 affected / 113 at risk

Adverse event: Platelet transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 37 affected / 113 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 113 at risk

Adverse event: Abdominal pain/cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 113 at risk

Adverse event: Constipation/bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 113 at risk

Adverse event: Diarrhea without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 113 at risk

Adverse event: Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 113 at risk

Adverse event: Esophagitis/dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 113 at risk

Adverse event: GI Mucositis, NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 113 at risk

Adverse event: Mouth dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 113 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 113 at risk

Adverse event: Stomatitis/pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 113 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 113 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 32 affected / 113 at risk

Adverse event: Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 67 affected / 113 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 17 affected / 113 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 17 affected / 113 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 15 affected / 113 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 11 affected / 113 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 8 affected / 113 at risk

Adverse event: Infection w/o 3-4 neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 113 at risk

Adverse event: Infection with 3-4 neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 113 at risk

Adverse event: Device related infection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 113 at risk

Adverse event: Alkaline phosphatase increase
Serious: no
Organ System: Investigations
Frequency: 15 affected / 113 at risk

Adverse event: Bilirubin increase
Serious: no
Organ System: Investigations
Frequency: 6 affected / 113 at risk

Adverse event: Creatinine increase
Serious: no
Organ System: Investigations
Frequency: 7 affected / 113 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 81 affected / 113 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 80 affected / 113 at risk

Adverse event: Neutropenia/granulocytopenia
Serious: no
Organ System: Investigations
Frequency: 89 affected / 113 at risk

Adverse event: SGOT (AST) increase
Serious: no
Organ System: Investigations
Frequency: 15 affected / 113 at risk

Adverse event: SGPT (ALT) increase
Serious: no
Organ System: Investigations
Frequency: 9 affected / 113 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 61 affected / 113 at risk

Adverse event: Transplant-leukopenia
Serious: no
Organ System: Investigations
Frequency: 11 affected / 113 at risk

Adverse event: Transplant-thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 13 affected / 113 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 113 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 113 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 113 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 113 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 113 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 113 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 113 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 113 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 113 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 113 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 113 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 113 at risk

Adverse event: Chest pain,not cardio or pleur
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 113 at risk

Adverse event: Muscle weakness (not neuro)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 113 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 113 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 113 at risk

Adverse event: Dizziness/light headedness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 113 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 113 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 40 affected / 113 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 113 at risk

Adverse event: Weakness (motor neuropathy)
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 113 at risk

Adverse event: Anxiety/agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 113 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 113 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 113 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 113 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 113 at risk

Adverse event: Hiccoughs
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 113 at risk

Adverse event: Pneumonitis/infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 113 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 36 affected / 113 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 113 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 113 at risk

Adverse event: Skin-other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 113 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 113 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 113 at risk