Study: NCT00085202

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 269 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 269 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 269 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Fever of unknown origin without clinically or microbiologically documented infection (ANC \<1.0 x 10e9/L).
Frequency: 2 affected / 269 at risk

Adverse event: Infection, blood
Serious: yes
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 1 affected / 269 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 269 at risk

Adverse event: Infection with unknown ANC, meninges (meningitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 269 at risk

Adverse event: Acidosis (metabolic or respiratory)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 269 at risk

Adverse event: Musculoskeletal/soft tissue - other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 269 at risk

Adverse event: CNS necrosis/cystic progression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 269 at risk

Adverse event: Personality/behavioral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 269 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 269 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 269 at risk

Adverse event: Adult Respiratory Distress Syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 269 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 269 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 269 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 269 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 269 at risk

Adverse event: Pulmonary fibrosis (radiographic changes)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 269 at risk

Adverse event: Pulmonary/upper respiratory - other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 269 at risk

Adverse event: Syndromes - other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 269 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: Fever of unknown origin without clinically or microbiologically documented infection (ANC \<1.0 x 10e9/L).
Frequency: 172 affected / 269 at risk

Adverse event: Infection, blood
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 55 affected / 269 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 269 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 39 affected / 269 at risk

Adverse event: Pain, abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 33 affected / 269 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 269 at risk

Adverse event: Infection - other
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 269 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 269 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 269 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, blood
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 269 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 269 at risk

Adverse event: Infection with unknown ANC, blood
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 269 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, catheter-related
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 269 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 269 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 269 at risk

Adverse event: Infection, catheter-related
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 14 affected / 269 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory, nose
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 269 at risk

Adverse event: Pain, head/headache
Serious: no
Organ System: General disorders
Frequency: 13 affected / 269 at risk

Adverse event: Hearing: patients with/without baseline audiogram and enrolled in a monitoring program
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 11 affected / 269 at risk

Adverse event: Supraventricular and nodal arrhythmia - sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 144 at risk

Adverse event: Cardiac general - other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 144 at risk

Adverse event: Thrombotic microangiopathy
Serious: yes
Organ System: Vascular disorders
Notes: e.g., thrombotic thrombocytopenic purpura (TTP) or hemolytic uremic syndrome (HUS)
Frequency: 1 affected / 144 at risk

Adverse event: Death not associated with CTCAE term, death NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 144 at risk

Adverse event: Hemorrhage/bleeding - other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 144 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 144 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 144 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, meninges (meningitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Infection with unknown ANC, wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 144 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 144 at risk

Adverse event: CNS necrosis/cystic progression
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 144 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 144 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 144 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 144 at risk

Adverse event: Leak, cerebrospinal fluid (CSF)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 144 at risk

Adverse event: Leukoencephalopathy (radiographic findings)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 144 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 144 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 144 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 144 at risk

Adverse event: Pulmonary/upper respiratory - other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 144 at risk

Adverse event: Syndromes - other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 144 at risk

Adverse event: Pain - other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 144 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: Fever of unknown origin without clinically or microbiologically documented infection (ANC \<1.0 x 10e9/L).
Frequency: 77 affected / 144 at risk

Adverse event: Infection, blood
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 24 affected / 144 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 144 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 23 affected / 144 at risk

Adverse event: Pain, abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 17 affected / 144 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 144 at risk

Adverse event: Infection - other
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 144 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 144 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 144 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, blood
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 144 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 144 at risk

Adverse event: Infection with unknown ANC, blood
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 144 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, catheter-related
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 144 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 144 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 144 at risk

Adverse event: Infection, catheter-related
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
Frequency: 5 affected / 144 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory, nose
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 144 at risk

Adverse event: Pain, head/headache
Serious: no
Organ System: General disorders
Frequency: 10 affected / 144 at risk

Adverse event: Hearing: patients with/without baseline audiogram and enrolled in a monitoring program
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 9 affected / 144 at risk