Study: NCT00006011

Adverse event: Cns Cerebrovascular Ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Abdominal Pain or Cramping
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 261 at risk

Adverse event: Wound-Infectious
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 261 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Infection, Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Infection without Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 261 at risk

Adverse event: Osteonecrosis (Avascular Necrosis)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 261 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 190 affected / 261 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 158 affected / 261 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 55 affected / 261 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 137 affected / 261 at risk

Adverse event: Other Hematologic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 44 affected / 261 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 261 at risk

Adverse event: Auditory
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 16 affected / 261 at risk

Adverse event: Cardiac left ventricular function
Serious: no
Organ System: Cardiac disorders
Frequency: 28 affected / 261 at risk

Adverse event: Other Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 261 at risk

Adverse event: Constitutional
Serious: no
Organ System: General disorders
Frequency: 105 affected / 261 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 185 affected / 261 at risk

Adverse event: Other Dermatologic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 261 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 17 affected / 261 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 89 affected / 261 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 75 affected / 261 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 261 at risk

Adverse event: Other Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 73 affected / 261 at risk

Adverse event: Genitourinary/Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 18 affected / 261 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 261 at risk

Adverse event: Hepatic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 261 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Infection Without Neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 261 at risk

Adverse event: Other Infection/Fever
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 261 at risk

Adverse event: Lymphatics
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 261 at risk

Adverse event: Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 46 affected / 261 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 261 at risk

Adverse event: Peripheral Sensory Neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 261 at risk

Adverse event: Other Neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 261 at risk

Adverse event: Ocular/Visual
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 261 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 261 at risk

Adverse event: Other Pain
Serious: no
Organ System: General disorders
Frequency: 63 affected / 261 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 261 at risk

Adverse event: Sexual
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 261 at risk

Adverse event: 2nd Primary
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: 2nd primary is not necessarily secondary malignancy and may have been reported any time after randomization including the follow-up period.
Frequency: 14 affected / 261 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 278 at risk

Adverse event: Cns Cerebrovascular Ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 278 at risk

Adverse event: Neutrophils/Granulocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 278 at risk

Adverse event: Circulatory or Cardia, Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 278 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 278 at risk

Adverse event: Vasovagal Episode
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 278 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 278 at risk

Adverse event: Cardia-Ischemia/Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 278 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 278 at risk

Adverse event: Abdominal Pain or Cramping
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 278 at risk

Adverse event: Pain, Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 278 at risk

Adverse event: Diarrhea (without Colostomy)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 278 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 278 at risk

Adverse event: Infection Documented with Grade 3/4 Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 278 at risk

Adverse event: Febrile Neutropenia-Fuo Infection Not Documented
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 278 at risk

Adverse event: Neuropathy-Sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 278 at risk

Adverse event: Thrombosis/Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 278 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 250 affected / 278 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 236 affected / 278 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 116 affected / 278 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 205 affected / 278 at risk

Adverse event: Other Hematologic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 71 affected / 278 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 8 affected / 278 at risk

Adverse event: Auditory
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 278 at risk

Adverse event: Cardiac left ventricular function
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 278 at risk

Adverse event: Other Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 44 affected / 278 at risk

Adverse event: Coagulation
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 278 at risk

Adverse event: Constitutional
Serious: no
Organ System: General disorders
Frequency: 133 affected / 278 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 179 affected / 278 at risk

Adverse event: Other Dermatologic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 278 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 14 affected / 278 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 95 affected / 278 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 79 affected / 278 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 278 at risk

Adverse event: Other Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 88 affected / 278 at risk

Adverse event: Genitourinary/Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 27 affected / 278 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 278 at risk

Adverse event: Hepatic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 278 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 278 at risk

Adverse event: Infection Without Neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 278 at risk

Adverse event: Other Infection/Fever
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 278 at risk

Adverse event: Lymphatics
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 278 at risk

Adverse event: Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 55 affected / 278 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 278 at risk

Adverse event: Peripheral Sensory Neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 76 affected / 278 at risk

Adverse event: Other Neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 52 affected / 278 at risk

Adverse event: Ocular/Visual
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 278 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 52 affected / 278 at risk

Adverse event: Other Pain
Serious: no
Organ System: General disorders
Frequency: 101 affected / 278 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 39 affected / 278 at risk

Adverse event: Sexual
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 278 at risk

Adverse event: 2nd Primary
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: 2nd primary is not necessarily secondary malignancy and may have been reported any time after randomization including the follow-up period.
Frequency: 18 affected / 278 at risk