Study: NCT00578461

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 26 at risk

Adverse event: Coagulation - Other: Severe coagulopathy
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Fever in the absence of neutropenia, where neutropenia is defined as ANC \<1.0 x 10e9/L
Frequency: 1 affected / 26 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death is not associated with CTCAE term - Multi-organ failure
Frequency: 1 affected / 26 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Liver dysfunction/failure (clinical)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 26 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, fever \>=38.5 degrees C.
Frequency: 1 affected / 26 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - Catheter-related
Serious: yes
Organ System: Infections and infestations
Notes: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L) - Catheter-related
Frequency: 1 affected / 26 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - Vein
Serious: yes
Organ System: Infections and infestations
Notes: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L) - Vein
Frequency: 1 affected / 26 at risk

Adverse event: Infection - Other: only clinical signs of infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 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 / 26 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 26 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Nose
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: AST, SGOT
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SGOT: serum glutamic oxaloacetic transaminase
Frequency: 1 affected / 26 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pain - Head/headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 26 at risk

Adverse event: Portal vein flow
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 26 at risk

Adverse event: PTT
Serious: no
Organ System: Vascular disorders
Notes: PTT: Partial Thromboplastin Time
Frequency: 2 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 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 / 26 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: SGPT: serum glutamic pyruvic transaminase
Frequency: 2 affected / 26 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: SGOT: serum glutamic oxaloacetic transaminase
Frequency: 4 affected / 26 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: GGT: gamma-Glutamyl transpeptidase
Frequency: 2 affected / 26 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk