Study: NCT00187096

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Febrile neutropenia-fever of unknown origin without clinically or microbiologically documented infe
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Typhlitis (cecal inflammation)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hemorrhage, GI, Oral cavity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory, Nose
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hemorrhage/Bleeding - Other (Specify, __)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Febrile neutropenia-fever of unknown origin without clinically or microbiologically documented infe
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Infection - Other (Specify, __)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

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

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hepatobiliary/Pancreas - Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils, Rectum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Febrile neutropenia-fever of unknown origin without clinically or microbiologically documented infe
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 12 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils, Blood
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 12 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 12 at risk

Adverse event: Phosphate, serum-low (hypokalemia)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 12 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils, Lip/perioral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils, Rectum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk