Study: NCT00063999

Adverse event: Allergic Reaction/Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 647 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 647 at risk

Adverse event: Transfusion: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 647 at risk

Adverse event: Transfusion: Prbcs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 647 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 647 at risk

Adverse event: Neutrophils/Granulocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 647 at risk

Adverse event: Leukocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 647 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 647 at risk

Adverse event: Circulatory Or Cardiac-Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 647 at risk

Adverse event: Cardiac Left Ventricular Function
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 647 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 647 at risk

Adverse event: Phlebitis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 647 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 647 at risk

Adverse event: Thrombosis/Embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 33 affected / 647 at risk

Adverse event: Cardiac-Ischemia/Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 647 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 647 at risk

Adverse event: Prothrombin time
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 647 at risk

Adverse event: Constitutional Symptoms-Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 647 at risk

Adverse event: Fever In The Absence Of Neutropenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 647 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 647 at risk

Adverse event: Wound-Infectious
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 647 at risk

Adverse event: Skin-Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 647 at risk

Adverse event: Wound-Non-Infectious
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 647 at risk

Adverse event: Stomatitis/Pharyngitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 647 at risk

Adverse event: Gi-Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 647 at risk

Adverse event: Fistula-Intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 647 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 647 at risk

Adverse event: Fistula-Rectal/Anal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 647 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 647 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 647 at risk

Adverse event: Diarrhea (Without Colostomy)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 647 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 647 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 647 at risk

Adverse event: Melena/Gi Bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 647 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 647 at risk

Adverse event: Rectal Bleeding/Hematochezia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 647 at risk

Adverse event: Hemorrhage/Bleeding Without Grade 3 Or 4
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 647 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 647 at risk

Adverse event: Infection, Other
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 647 at risk

Adverse event: Catheter-Related Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 647 at risk

Adverse event: Infection With Unknown Anc
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 647 at risk

Adverse event: Infection Documented W Grd 3/4 Neutropn.
Serious: yes
Organ System: Infections and infestations
Frequency: 18 affected / 647 at risk

Adverse event: Infection Without Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 17 affected / 647 at risk

Adverse event: Febrile Neutropenia-Fuo Infect Not Docum
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 647 at risk

Adverse event: Lymphatics-Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 647 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 647 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 647 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 647 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 647 at risk

Adverse event: Hypomagnesmia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 647 at risk

Adverse event: Muscle Weakness Not Due To Neuropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 647 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 647 at risk

Adverse event: Neurologic-Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 647 at risk

Adverse event: Seizure(S)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 647 at risk

Adverse event: Cns Cerebrovascular Ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 647 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 647 at risk

Adverse event: Mood Alteration-Depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 647 at risk

Adverse event: Neuropathy-Sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 647 at risk

Adverse event: Chest Pain Non-Cardiac Or Non-Pleuritic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 647 at risk

Adverse event: Abdominal Pain Or Cramping
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 647 at risk

Adverse event: Pneumonitis/Pulmonary Infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 647 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 647 at risk

Adverse event: Pulmonary-Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 647 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 647 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 647 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 647 at risk

Adverse event: Renal/Gu-Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 647 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 418 affected / 647 at risk

Adverse event: Neutrophils/Granulocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 402 affected / 647 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 244 affected / 647 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 445 affected / 647 at risk

Adverse event: Hematologic-Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 202 affected / 647 at risk

Adverse event: Allergic Reaction/Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 18 affected / 647 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 26 affected / 647 at risk

Adverse event: Cardiac Left Ventricular Function
Serious: no
Organ System: Cardiac disorders
Frequency: 50 affected / 647 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 55 affected / 647 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 647 at risk

Adverse event: Constitutional
Serious: no
Organ System: General disorders
Frequency: 37 affected / 647 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 473 affected / 647 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 647 at risk

Adverse event: Endocrine disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 11 affected / 647 at risk

Adverse event: All other GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 163 affected / 647 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 218 affected / 647 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 165 affected / 647 at risk

Adverse event: Stomatitis/Pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 647 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 647 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 647 at risk

Adverse event: Hepatobiliary disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 647 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 647 at risk

Adverse event: Febrile Neutropenia-Fuo Infect Not Docum
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 647 at risk

Adverse event: Infection Without Neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 54 affected / 647 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 647 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 140 affected / 647 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 647 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 67 affected / 647 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 163 affected / 647 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 46 affected / 647 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 91 affected / 647 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 95 affected / 647 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 90 affected / 647 at risk

Adverse event: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 647 at risk

Adverse event: Allergic Reaction/Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 665 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 665 at risk

Adverse event: Hematologic-Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 665 at risk

Adverse event: Transfusion: Prbcs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 665 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 665 at risk

Adverse event: Neutrophils/Granulocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 665 at risk

Adverse event: Cardiac Left Ventricular Function
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 665 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 665 at risk

Adverse event: Vasovagal Episode
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 665 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 665 at risk

Adverse event: Thrombosis/Embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 665 at risk

Adverse event: Constitutional Symptoms-Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 665 at risk

Adverse event: Fever In The Absence Of Neutropenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 665 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 665 at risk

Adverse event: Wound-Infectious
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 665 at risk

Adverse event: Gi-Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 665 at risk

Adverse event: Fistula-Intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 665 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 665 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 665 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 665 at risk

Adverse event: Mucositis Due To Radiation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 665 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 665 at risk

Adverse event: Fistula-Rectal/Anal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 665 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 665 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 665 at risk

Adverse event: Diarrhea (Without Colostomy)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 665 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 665 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 665 at risk

Adverse event: Melena/Gi Bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 665 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 665 at risk

Adverse event: Hepatic-Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 665 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 665 at risk

Adverse event: Catheter-Related Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 665 at risk

Adverse event: Infection With Unknown Anc
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 665 at risk

Adverse event: Infection Documented W Grd 3/4 Neutropn.
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 665 at risk

Adverse event: Infection Without Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 665 at risk

Adverse event: Febrile Neutropenia-Fuo Infect Not Docum
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 665 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 665 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 665 at risk

Adverse event: Muscle Weakness Not Due To Neuropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 665 at risk

Adverse event: Neurologic-Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 665 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 665 at risk

Adverse event: Cns Cerebrovascular Ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 665 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 665 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 665 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 665 at risk

Adverse event: Mood Alteration-Anxiety Agitation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 665 at risk

Adverse event: Neuropathy-Sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 665 at risk

Adverse event: Neuropathy Motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 665 at risk

Adverse event: Ocular-Other
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 665 at risk

Adverse event: Chest Pain Non-Cardiac Or Non-Pleuritic
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 665 at risk

Adverse event: Rectal Or Perirectal Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 665 at risk

Adverse event: Abdominal Pain Or Cramping
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 665 at risk

Adverse event: Pain-Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 665 at risk

Adverse event: Pleural Effusion (Non-Malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 665 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 665 at risk

Adverse event: Pulmonary-Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 665 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 665 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 665 at risk

Adverse event: Ureteral Obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 665 at risk

Adverse event: Fistula Or Gu Fistula
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 665 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 665 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 665 at risk

Adverse event: Renal/Gu-Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 665 at risk

Adverse event: Syndromes-Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 665 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 556 affected / 665 at risk

Adverse event: Neutrophils/Granulocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 590 affected / 665 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 172 affected / 665 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 410 affected / 665 at risk

Adverse event: Hematologic-Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 156 affected / 665 at risk

Adverse event: Allergic Reaction/Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 29 affected / 665 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 13 affected / 665 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 40 affected / 665 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 665 at risk

Adverse event: Constitutional
Serious: no
Organ System: General disorders
Frequency: 26 affected / 665 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 486 affected / 665 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 665 at risk

Adverse event: Endocrine disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 7 affected / 665 at risk

Adverse event: All other GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 125 affected / 665 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 122 affected / 665 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 82 affected / 665 at risk

Adverse event: Stomatitis/Pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 665 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 20 affected / 665 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 665 at risk

Adverse event: Hepatobiliary disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 665 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 665 at risk

Adverse event: Febrile Neutropenia-Fuo Infect Not Docum
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 665 at risk

Adverse event: Infection Without Neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 665 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 665 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 96 affected / 665 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 665 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 47 affected / 665 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 128 affected / 665 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 34 affected / 665 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 89 affected / 665 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 97 affected / 665 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 82 affected / 665 at risk

Adverse event: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 665 at risk