Study: NCT00113360

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 64 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 64 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Investigations
Notes: Alanine aminotransferase (ALT or SGPT)
Frequency: 24 affected / 64 at risk

Adverse event: AST,SGOT
Serious: no
Organ System: Investigations
Notes: Aspartate aminotransferase (AST or SGOT)
Frequency: 40 affected / 64 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 6 affected / 64 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 64 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Frequency: 4 affected / 64 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 64 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 64 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 64 at risk

Adverse event: Edema, limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 64 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 40 affected / 64 at risk

Adverse event: Fever (in the absence of neutropenia)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 64 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 64 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Investigations
Frequency: 45 affected / 64 at risk

Adverse event: Glucose, serum-low (Hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 64 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 37 affected / 64 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 64 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: White Blood Count (WBC)
Frequency: 21 affected / 64 at risk

Adverse event: Magnesium, serum-low (Hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 64 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 64 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 64 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 64 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Absolute neutrophil count (ANC)/Absolute granulocytes count (AGC)
Frequency: 25 affected / 64 at risk

Adverse event: Pain (Abdomen NOS)
Serious: no
Organ System: General disorders
Notes: Not otherwise specified (NOS)
Frequency: 4 affected / 64 at risk

Adverse event: Pain (Head/Headache
Serious: no
Organ System: General disorders
Frequency: 17 affected / 64 at risk

Adverse event: Pain (other)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 64 at risk

Adverse event: Pain - Other (injection site)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 64 at risk

Adverse event: Pain-Other (Buttock)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 64 at risk

Adverse event: Phosphate, serum-low (Hypophosphatemia)
Serious: no
Organ System: Investigations
Frequency: 20 affected / 64 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 64 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 64 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 64 at risk

Adverse event: Potassium, serum-low (Hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 64 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 64 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 64 at risk

Adverse event: Rash: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 64 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 64 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 64 at risk

Adverse event: Thyroid function, low (hypothyroidism)
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 64 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: no
Organ System: Investigations
Frequency: 29 affected / 64 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 64 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 5 affected / 64 at risk