Study: NCT00064077

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 103 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 103 at risk

Adverse event: Thrombosis Embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 103 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 103 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 103 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 103 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 103 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 103 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 103 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Diarrhea With Colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Fistula Intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 103 at risk

Adverse event: Pain Rectal/Perirectal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 103 at risk

Adverse event: Pain Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 103 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 103 at risk

Adverse event: Febrile With Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 103 at risk

Adverse event: Infection Without Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 103 at risk

Adverse event: Infection With Grade 3/4 Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Infection No Anc
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 103 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 103 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Ataxia(Incoordination)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Cns Cerebrovascular Ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 103 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 103 at risk

Adverse event: Ureteral Obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 103 at risk

Adverse event: Renal/Gu Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 103 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Wound Infectious
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Melena/Gi Bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 103 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 92 affected / 103 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 94 affected / 103 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 36 affected / 103 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 92 affected / 103 at risk

Adverse event: Otherhematologic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 38 affected / 103 at risk

Adverse event: Lymphatics
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Thrombosis Embolism
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 103 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 103 at risk

Adverse event: Cardiac Left Ventricular Function
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 103 at risk

Adverse event: Other Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 22 affected / 103 at risk

Adverse event: Inner Ear/Hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 10 affected / 103 at risk

Adverse event: Other Hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 103 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 9 affected / 103 at risk

Adverse event: Ocular
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 103 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 62 affected / 103 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 103 at risk

Adverse event: Stomatitis/Pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 103 at risk

Adverse event: Other Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 65 affected / 103 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 74 affected / 103 at risk

Adverse event: Other Constitutional
Serious: no
Organ System: General disorders
Frequency: 17 affected / 103 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 103 at risk

Adverse event: Other Pain
Serious: no
Organ System: General disorders
Frequency: 33 affected / 103 at risk

Adverse event: Hepatic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 103 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 10 affected / 103 at risk

Adverse event: Other Allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Febrile With Neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 103 at risk

Adverse event: Infection Without Neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 103 at risk

Adverse event: Other Infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 103 at risk

Adverse event: Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 50 affected / 103 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 103 at risk

Adverse event: Neuropathy Sensor
Serious: no
Organ System: Nervous system disorders
Frequency: 37 affected / 103 at risk

Adverse event: Otherneurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 103 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 103 at risk

Adverse event: Other Genitourinary/Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 103 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 103 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 65 affected / 103 at risk

Adverse event: Rash Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 103 at risk

Adverse event: Other Dermatologic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 103 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 103 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 108 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 108 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 108 at risk

Adverse event: Transfusion Prbc's
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 108 at risk

Adverse event: Thrombosis Embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 108 at risk

Adverse event: Ischemia/Cardiac Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 108 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Diarrhea Without Colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 108 at risk

Adverse event: Fistula Rectal/Anal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Fever(No Neutropenia)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 108 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 108 at risk

Adverse event: Pain Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 108 at risk

Adverse event: Febrile With Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 108 at risk

Adverse event: Infection Without Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 108 at risk

Adverse event: Infection With Grade 3/4 Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 108 at risk

Adverse event: Infection Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Other Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 108 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 108 at risk

Adverse event: Musculoskeletal Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 108 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 108 at risk

Adverse event: Fistula
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 108 at risk

Adverse event: Ureteral Obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 108 at risk

Adverse event: Other Genitourinary/Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 108 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 108 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 98 affected / 108 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 100 affected / 108 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 32 affected / 108 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 94 affected / 108 at risk

Adverse event: Otherhematologic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 53 affected / 108 at risk

Adverse event: Lymphatics
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 108 at risk

Adverse event: Thrombosis Embolism
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 108 at risk

Adverse event: Other Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 108 at risk

Adverse event: Inner Ear/Hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 14 affected / 108 at risk

Adverse event: Other Hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 108 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 108 at risk

Adverse event: Ocular
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 108 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 64 affected / 108 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 108 at risk

Adverse event: Stomatitis/Pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 108 at risk

Adverse event: Other Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 67 affected / 108 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 82 affected / 108 at risk

Adverse event: Other Constitutional
Serious: no
Organ System: General disorders
Frequency: 23 affected / 108 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 108 at risk

Adverse event: Other Pain
Serious: no
Organ System: General disorders
Frequency: 47 affected / 108 at risk

Adverse event: Hepatic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 13 affected / 108 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 108 at risk

Adverse event: Other Allergy
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 108 at risk

Adverse event: Febrile With Neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 108 at risk

Adverse event: Infection Without Neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 108 at risk

Adverse event: Other Infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 108 at risk

Adverse event: Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 50 affected / 108 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 108 at risk

Adverse event: Neuropathy Sensor
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 108 at risk

Adverse event: Otherneurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 108 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 18 affected / 108 at risk

Adverse event: Other Genitourinary/Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 108 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 108 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 108 at risk

Adverse event: Rash Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 108 at risk

Adverse event: Other Dermatologic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 108 at risk

Adverse event: Coagulation
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 108 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 108 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 112 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 112 at risk

Adverse event: Transfusion Prbc's
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Thrombosis Embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 112 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 112 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 112 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 112 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 112 at risk

Adverse event: Fever(No Neutropenia)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 112 at risk

Adverse event: Bone pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 112 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 112 at risk

Adverse event: Pain Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 112 at risk

Adverse event: Febrile With Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 112 at risk

Adverse event: Infection Without Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 112 at risk

Adverse event: Catheter-Related Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 112 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 112 at risk

Adverse event: Metabolic Other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 112 at risk

Adverse event: Speech Impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 112 at risk

Adverse event: Ureteral Obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 112 at risk

Adverse event: Pulmonary Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Skin Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: Hemorrhage With Grade 3/4 Thrombocytopenia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 112 at risk

Adverse event: Melena/Gi Bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 112 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 112 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 112 at risk

Adverse event: Rectal Bleeding/Hematochezia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 112 at risk

Adverse event: Other Hemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 112 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 90 affected / 112 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 104 affected / 112 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 88 affected / 112 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 76 affected / 112 at risk

Adverse event: Otherhematologic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 57 affected / 112 at risk

Adverse event: Lymphatics
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 112 at risk

Adverse event: Thrombosis Embolism
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 112 at risk

Adverse event: Cardiac Left Ventricular Function
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 112 at risk

Adverse event: Other Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 112 at risk

Adverse event: Inner Ear/Hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 17 affected / 112 at risk

Adverse event: Other Hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 112 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 112 at risk

Adverse event: Ocular
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 112 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 112 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 112 at risk

Adverse event: Stomatitis/Pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 112 at risk

Adverse event: Other Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 75 affected / 112 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 90 affected / 112 at risk

Adverse event: Other Constitutional
Serious: no
Organ System: General disorders
Frequency: 27 affected / 112 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 112 at risk

Adverse event: Other Pain
Serious: no
Organ System: General disorders
Frequency: 40 affected / 112 at risk

Adverse event: Hepatic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 16 affected / 112 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 112 at risk

Adverse event: Other Allergy
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 112 at risk

Adverse event: Febrile With Neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 112 at risk

Adverse event: Infection Without Neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 112 at risk

Adverse event: Other Infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 112 at risk

Adverse event: Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 49 affected / 112 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 112 at risk

Adverse event: Neuropathy Sensor
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 112 at risk

Adverse event: Otherneurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 112 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 20 affected / 112 at risk

Adverse event: Other Genitourinary/Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 112 at risk

Adverse event: Sexual/Reproductive
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 112 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 112 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 112 at risk

Adverse event: Rash Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 112 at risk

Adverse event: Other Dermatologic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 112 at risk

Adverse event: Coagulation
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 112 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 112 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 111 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 111 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 111 at risk

Adverse event: Thrombosis Embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 111 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 111 at risk

Adverse event: Cardiac Left Ventricular Function
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 111 at risk

Adverse event: Other Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 111 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 111 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 111 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 111 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 111 at risk

Adverse event: Fistula Intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 111 at risk

Adverse event: Gi Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 111 at risk

Adverse event: Bone pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 111 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 111 at risk

Adverse event: Pain Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 111 at risk

Adverse event: Febrile With Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 111 at risk

Adverse event: Infection Without Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 111 at risk

Adverse event: Infection With Grade 3/4 Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 111 at risk

Adverse event: Infection No Anc
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 111 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 111 at risk

Adverse event: Musculoskeletal Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 111 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 111 at risk

Adverse event: Ureteral Obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 111 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 111 at risk

Adverse event: Prothrombin time
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 111 at risk

Adverse event: Melena/Gi Bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 111 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 111 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 102 affected / 111 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 106 affected / 111 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 87 affected / 111 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 102 affected / 111 at risk

Adverse event: Otherhematologic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 57 affected / 111 at risk

Adverse event: Lymphatics
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 111 at risk

Adverse event: Thrombosis Embolism
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 111 at risk

Adverse event: Cardiac Left Ventricular Function
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 111 at risk

Adverse event: Other Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 111 at risk

Adverse event: Inner Ear/Hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 11 affected / 111 at risk

Adverse event: Other Hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 111 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 111 at risk

Adverse event: Ocular
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 111 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 111 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 111 at risk

Adverse event: Stomatitis/Pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 111 at risk

Adverse event: Other Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 111 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 85 affected / 111 at risk

Adverse event: Other Constitutional
Serious: no
Organ System: General disorders
Frequency: 28 affected / 111 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 111 at risk

Adverse event: Other Pain
Serious: no
Organ System: General disorders
Frequency: 40 affected / 111 at risk

Adverse event: Hepatic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 20 affected / 111 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 9 affected / 111 at risk

Adverse event: Other Allergy
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 111 at risk

Adverse event: Febrile With Neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 111 at risk

Adverse event: Infection Without Neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 111 at risk

Adverse event: Other Infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 111 at risk

Adverse event: Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 48 affected / 111 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 111 at risk

Adverse event: Neuropathy Sensor
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 111 at risk

Adverse event: Otherneurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 111 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 111 at risk

Adverse event: Other Genitourinary/Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 111 at risk

Adverse event: Sexual/Reproductive
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 111 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 111 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 48 affected / 111 at risk

Adverse event: Rash Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 111 at risk

Adverse event: Other Dermatologic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 111 at risk

Adverse event: Coagulation
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 111 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 111 at risk