Study: NCT00973752

Adverse event: Infection w/ gr. 3/4 neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 30 at risk

Adverse event: Infection - other
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 30 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Hypertransaminasaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 30 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 30 at risk

Adverse event: Azotaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Tumour lysis syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 30 at risk

Adverse event: Grade 2 Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 12 affected / 30 at risk

Adverse event: Grade 2 Allergic reaction
Serious: no
Organ System: Immune system disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 1 affected / 30 at risk

Adverse event: Grade 2 Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 1 affected / 30 at risk

Adverse event: Grade 2 hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 6 affected / 30 at risk

Adverse event: Grade 2 fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 18 affected / 30 at risk

Adverse event: Grade 2 Insomnia
Serious: no
Organ System: General disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 2 affected / 30 at risk

Adverse event: Grade 2 weight loss
Serious: no
Organ System: General disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 1 affected / 30 at risk

Adverse event: Grade 2 erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 1 affected / 30 at risk

Adverse event: Grade 2 pruritis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 1 affected / 30 at risk

Adverse event: Grade 2 rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 1 affected / 30 at risk

Adverse event: Grade 2 decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 1 affected / 30 at risk

Adverse event: Grade 2 anorexia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 4 affected / 30 at risk

Adverse event: Grade 2 colitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 2 affected / 30 at risk

Adverse event: Grade 2 constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 3 affected / 30 at risk

Adverse event: Grade 2 diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 4 affected / 30 at risk

Adverse event: Grade 2 stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 4 affected / 30 at risk

Adverse event: Grade 2 nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 11 affected / 30 at risk

Adverse event: Grade 2 taste alteration
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 1 affected / 30 at risk

Adverse event: Grade 2 vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 4 affected / 30 at risk

Adverse event: Grade 2 febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 4 affected / 30 at risk

Adverse event: Grade 2 Infection
Serious: no
Organ System: Infections and infestations
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 9 affected / 30 at risk

Adverse event: Grade 2 Edema
Serious: no
Organ System: General disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 9 affected / 30 at risk

Adverse event: Grade 2 transaminitis
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 7 affected / 30 at risk

Adverse event: Grade 2 Elevated alkaline phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 2 affected / 30 at risk

Adverse event: Grade 2 Hyperbilirubinemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 3 affected / 30 at risk

Adverse event: Grade 2 azotemia
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 3 affected / 30 at risk

Adverse event: Grade 2 hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 3 affected / 30 at risk

Adverse event: Grade 2 hypoalbuminemia
Serious: no
Organ System: General disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 4 affected / 30 at risk

Adverse event: Grade 2 hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 4 affected / 30 at risk

Adverse event: Grade 2 weakness
Serious: no
Organ System: General disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 4 affected / 30 at risk

Adverse event: Grade 2 mental status change
Serious: no
Organ System: General disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 3 affected / 30 at risk

Adverse event: Grade 2 neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 1 affected / 30 at risk

Adverse event: Grade 2 Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 5 affected / 30 at risk

Adverse event: Grade 2 back pain
Serious: no
Organ System: General disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 2 affected / 30 at risk

Adverse event: Grade 2 pain, other
Serious: no
Organ System: General disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 3 affected / 30 at risk

Adverse event: Grade 2 dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 1 affected / 30 at risk

Adverse event: Grade 2 hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 1 affected / 30 at risk

Adverse event: Grade 2 ureteral obstruction
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1 toxicities were not required to be reported per protocol
Frequency: 1 affected / 30 at risk