Study: NCT00505375

Adverse event: Insomnia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 77 at risk

Adverse event: Death not associated with CTCAE term
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 77 at risk

Adverse event: Dermatology/Skin - Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Endocrine - Other
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 77 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 77 at risk

Adverse event: Gastrointestinal - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 77 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 77 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 77 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 77 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 77 at risk

Adverse event: Secondary Malignancy - possibly related to cancer treatment
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 77 at risk

Adverse event: Intra-operative Injury - Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 77 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 77 at risk

Adverse event: Constitutional Symptoms - Other
Serious: no
Organ System: General disorders
Frequency: 5 affected / 77 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 77 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 77 at risk

Adverse event: Endocrine - Other
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 77 at risk

Adverse event: Dental: teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 77 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 77 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 77 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 77 at risk

Adverse event: Infection with unknown ANC- Pharynx
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 77 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 77 at risk

Adverse event: Other AE
Serious: no
Organ System: General disorders
Frequency: 4 affected / 77 at risk

Adverse event: Pain- Head/headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 77 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 77 at risk

Adverse event: Bronchospasm, wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Pulmonary/Upper Respiratory - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 77 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 7 affected / 77 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Dermatology/Skin - Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: Gastrointestinal - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 35 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 35 at risk

Adverse event: Mood alteration- Agitation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Pain- Head/headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Syndromes - Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 35 at risk

Adverse event: Constitutional Symptoms - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: Endocrine - Other
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 35 at risk

Adverse event: Dental: teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 35 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 35 at risk

Adverse event: Infection with unknown ANC- Pharynx
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 35 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 35 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 35 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 35 at risk

Adverse event: Other AE
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Pain- Head/headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 35 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 35 at risk

Adverse event: Bronchospasm, wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Pulmonary/Upper Respiratory - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 4 affected / 35 at risk