Study: NCT00310050

Adverse event: ALT, SGPT
Serious: no
Organ System: Gastrointestinal disorders
Notes: serum glutamic pyruvic transaminase
Frequency: 1 affected / 4 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Calcium, serum-high
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: hypercalcemia
Frequency: 1 affected / 4 at risk

Adverse event: Calcium, serum-low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: hypocalcemia
Frequency: 1 affected / 4 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Dehydration
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: limb
Frequency: 1 affected / 4 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: trunk/genital
Frequency: 1 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: asthenia, lethargy, malaise
Frequency: 1 affected / 4 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
Notes: in the absence of neutropenia, where neutropenia is defined as ANC \<1.0 x 10e9/L
Frequency: 1 affected / 4 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Glucose, serum-high
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: hyperglycemia
Frequency: 2 affected / 4 at risk

Adverse event: Glucose, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: hypoglycemia
Frequency: 1 affected / 4 at risk

Adverse event: Hemoglobin (gender based)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 4 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: Penis
Frequency: 1 affected / 4 at risk

Adverse event: Leukocytes (total WBC) (4.8-10.8)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Neurology - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: sensory
Frequency: 1 affected / 4 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC) 1.6-7.3
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 4 at risk

Adverse event: Ocular/Visual - Other
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Stomach
Frequency: 1 affected / 4 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (160-360)
Frequency: 1 affected / 4 at risk

Adverse event: Potassium, serum-high
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hyperkalemia) (3.5-5.3)
Frequency: 1 affected / 4 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: dermatitis associated with radiation
Frequency: 1 affected / 4 at risk

Adverse event: Renal/Genitourinary - Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Sodium, serum-high
Serious: no
Organ System: Renal and urinary disorders
Notes: (hypernatremia) (135-146)
Frequency: 1 affected / 4 at risk

Adverse event: Watery eye
Serious: no
Organ System: Eye disorders
Notes: (epiphora, tearing)
Frequency: 1 affected / 4 at risk