Study: NCT00129389

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 31 affected / 974 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 6 affected / 974 at risk

Adverse event: Infection with grade 3 or 4 neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3 or 4
Frequency: 5 affected / 974 at risk

Adverse event: Infection without neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 2 affected / 974 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 3 affected / 974 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 2 affected / 974 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 974 at risk

Adverse event: Catheter-related infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 1 affected / 974 at risk

Adverse event: Wound-infectious
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 974 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 1 affected / 974 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 4
Frequency: 1 affected / 974 at risk

Adverse event: Fistula-rectal/anal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 4
Frequency: 1 affected / 974 at risk

Adverse event: Hepatic - Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Grade 3
Frequency: 1 affected / 974 at risk

Adverse event: Injection site reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 1 affected / 974 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Grade 1
Frequency: 2 affected / 974 at risk

Adverse event: Leukocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 4 and Fever grade 1
Frequency: 1 affected / 974 at risk

Adverse event: Neutrophils/Granulocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3-4
Frequency: 250 affected / 974 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: General disorders
Notes: Grade 3-4
Frequency: 36 affected / 974 at risk

Adverse event: Infection without neutropenia
Serious: no
Organ System: Infections and infestations
Notes: Grade 3-4
Frequency: 3 affected / 974 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Notes: Grade 3-4
Frequency: 3 affected / 974 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3-4
Frequency: 10 affected / 974 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3-4
Frequency: 93 affected / 974 at risk

Adverse event: SGPT (ALT)
Serious: no
Organ System: Investigations
Notes: Grade 3-4
Frequency: 10 affected / 974 at risk

Adverse event: Irregular Menses
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 3-4
Frequency: 105 affected / 974 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 3-4
Frequency: 34 affected / 974 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3-4
Frequency: 40 affected / 974 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3-4
Frequency: 25 affected / 974 at risk

Adverse event: STOMATITIS/PHARYNGITIS (ORAL/PHARYNGEAL MUCOSITIS)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3-4
Frequency: 17 affected / 974 at risk

Adverse event: Myalgia
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3-4
Frequency: 2 affected / 974 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3-4
Frequency: 1 affected / 974 at risk

Adverse event: Thrombosis/embolism
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3-4
Frequency: 1 affected / 974 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3-4
Frequency: 1 affected / 974 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3-4
Frequency: 3 affected / 974 at risk

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3-4
Frequency: 2 affected / 974 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: Grade 3-4
Frequency: 5 affected / 974 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3-4
Frequency: 5 affected / 974 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 3-4
Frequency: 3 affected / 974 at risk

Adverse event: INFECTION WITH NEUTROPENIA
Serious: no
Organ System: Infections and infestations
Notes: Grade 3-4
Frequency: 9 affected / 974 at risk

Adverse event: PLATELETS
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3-4
Frequency: 5 affected / 974 at risk

Adverse event: SGOT (AST)
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 3-4
Frequency: 4 affected / 974 at risk

Adverse event: Bone pain
Serious: no
Organ System: Investigations
Notes: Grade 3-4
Frequency: 2 affected / 974 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3-4
Frequency: 4 affected / 974 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3-4
Frequency: 4 affected / 974 at risk

Adverse event: MOOD ALTERATION-ANXIETY, AGITATION
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3-4
Frequency: 1 affected / 974 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3-4
Frequency: 4 affected / 974 at risk

Adverse event: DYSPEPSIA/HEARTBURN
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3-4
Frequency: 3 affected / 974 at risk

Adverse event: SYNCOPE (FAINTING)
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3-4
Frequency: 2 affected / 974 at risk

Adverse event: VASOVAGAL EPISODE
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3-4
Frequency: 1 affected / 974 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Notes: Grade 3-4
Frequency: 1 affected / 974 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Notes: Grade 3-4
Frequency: 2 affected / 974 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3-4
Frequency: 1 affected / 974 at risk

Adverse event: HOT FLASHES/FLUSHES
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 3-4
Frequency: 1 affected / 974 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Grade 3-4
Frequency: 1 affected / 974 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 18 affected / 951 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 1 affected / 951 at risk

Adverse event: Infection with grade 3 or 4 neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3 or 4
Frequency: 3 affected / 951 at risk

Adverse event: Infection without neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 6 affected / 951 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 951 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 1 affected / 951 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 2 affected / 951 at risk

Adverse event: Catheter-related infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 1 affected / 951 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 3 affected / 951 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 2 affected / 951 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 951 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 951 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 951 at risk

Adverse event: Gastrointestinal - appendicitis surgery
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 951 at risk

Adverse event: Bone Fracture
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 951 at risk

Adverse event: Pneumonitis, refractory septic shock
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 4
Frequency: 1 affected / 951 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 2
Frequency: 1 affected / 951 at risk

Adverse event: Neurotoxicity
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 951 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 4
Frequency: 3 affected / 951 at risk

Adverse event: Musculoskeletal - Right Essential Coxoartrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 951 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3
Frequency: 1 affected / 951 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 951 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Grade 1
Frequency: 2 affected / 951 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 4
Frequency: 1 affected / 951 at risk

Adverse event: Bradycardia and dyspnea
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 2
Frequency: 1 affected / 951 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 951 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 951 at risk

Adverse event: SGOT (AST) and SGPT (ALT)
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Grade 4
Frequency: 1 affected / 951 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 951 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grade 2
Frequency: 2 affected / 951 at risk

Adverse event: Neutrophils/Granulocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3-4
Frequency: 203 affected / 951 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: General disorders
Notes: Grade 3-4
Frequency: 25 affected / 951 at risk

Adverse event: Infection without neutropenia
Serious: no
Organ System: Infections and infestations
Notes: Grade 3-4
Frequency: 13 affected / 951 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Notes: Grade 3-4
Frequency: 11 affected / 951 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3-4
Frequency: 8 affected / 951 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3-4
Frequency: 78 affected / 951 at risk

Adverse event: SGPT (ALT)
Serious: no
Organ System: Investigations
Notes: Grade 3-4
Frequency: 22 affected / 951 at risk

Adverse event: Irregular Menses
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 3-4
Frequency: 148 affected / 951 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 3-4
Frequency: 74 affected / 951 at risk

Adverse event: Neurophaty-sensory
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3-4
Frequency: 51 affected / 951 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3-4
Frequency: 40 affected / 951 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3-4
Frequency: 25 affected / 951 at risk

Adverse event: STOMATITIS/PHARYNGITIS (ORAL/PHARYNGEAL MUCOSITIS)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3-4
Frequency: 16 affected / 951 at risk

Adverse event: Myalgia
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3-4
Frequency: 14 affected / 951 at risk

Adverse event: Thrombosis/embolism
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3-4
Frequency: 10 affected / 951 at risk

Adverse event: Cardiac Function
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3-4
Frequency: 1 affected / 951 at risk

Adverse event: Cardiac Left Ventricular
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3-4
Frequency: 1 affected / 951 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3-4
Frequency: 1 affected / 951 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3-4
Frequency: 9 affected / 951 at risk

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3-4
Frequency: 9 affected / 951 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3-4
Frequency: 7 affected / 951 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: Grade 3-4
Frequency: 4 affected / 951 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3-4
Frequency: 6 affected / 951 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 3-4
Frequency: 5 affected / 951 at risk

Adverse event: INFECTION WITH NEUTROPENIA
Serious: no
Organ System: Infections and infestations
Notes: Grade 3-4
Frequency: 6 affected / 951 at risk

Adverse event: PLATELETS
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3-4
Frequency: 3 affected / 951 at risk

Adverse event: SGOT (AST)
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 3-4
Frequency: 7 affected / 951 at risk

Adverse event: ALLERGIC REACTION/HYPERSENSITIVITY
Serious: no
Organ System: Immune system disorders
Notes: Grade 3-4
Frequency: 3 affected / 951 at risk

Adverse event: Bone pain
Serious: no
Organ System: Investigations
Notes: Grade 3-4
Frequency: 3 affected / 951 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3-4
Frequency: 6 affected / 951 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3-4
Frequency: 5 affected / 951 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3-4
Frequency: 2 affected / 951 at risk

Adverse event: MOOD ALTERATION-ANXIETY, AGITATION
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3-4
Frequency: 4 affected / 951 at risk

Adverse event: HAND FOOT SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3-4
Frequency: 5 affected / 951 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3-4
Frequency: 2 affected / 951 at risk

Adverse event: DYSPEPSIA/HEARTBURN
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3-4
Frequency: 1 affected / 951 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3-4
Frequency: 9 affected / 951 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3-4
Frequency: 2 affected / 951 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3-4
Frequency: 2 affected / 951 at risk

Adverse event: PNEUMONITIS/PULMONARY INFILTRATES
Serious: no
Organ System: Infections and infestations
Notes: Grade 3-4
Frequency: 2 affected / 951 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3-4
Frequency: 2 affected / 951 at risk

Adverse event: PULMONARY
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3-4
Frequency: 2 affected / 951 at risk

Adverse event: SYNCOPE (FAINTING)
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3-4
Frequency: 1 affected / 951 at risk

Adverse event: VASOVAGAL EPISODE
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3-4
Frequency: 3 affected / 951 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Notes: Grade 3-4
Frequency: 6 affected / 951 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Notes: Grade 3-4
Frequency: 1 affected / 951 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3-4
Frequency: 1 affected / 951 at risk

Adverse event: HOT FLASHES/FLUSHES
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 3-4
Frequency: 1 affected / 951 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Grade 3-4
Frequency: 1 affected / 951 at risk