Study: NCT00307736

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 32 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Abdomen pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 32 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 32 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 32 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 32 at risk

Adverse event: ALT- SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 32 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 32 at risk

Adverse event: Anus- pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 32 at risk

Adverse event: AST- SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 32 at risk

Adverse event: Back- pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Blood bicarbonate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 32 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 32 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 32 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 32 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 32 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 32 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 32 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 32 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 32 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 32 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Extremity-limb- pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 29 affected / 32 at risk

Adverse event: Fever w/o neutropenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 32 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: GI-other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 32 at risk

Adverse event: Hand-foot reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 32 at risk

Adverse event: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 32 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 32 at risk

Adverse event: Hemorrhage-other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 32 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 32 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 32 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 32 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 32 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 32 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 32 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 32 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 32 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 32 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 32 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 32 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 32 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 29 affected / 32 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Mucositis/stomatitis (symptom) oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 32 at risk

Adverse event: Mucositis/stomatitis by exam- oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 32 at risk

Adverse event: Muscle- pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 32 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 32 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Nose- hemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 32 at risk

Adverse event: Oral cavity- pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Oral gums- pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Pelvic- pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 32 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Proctitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 32 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 32 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 32 at risk

Adverse event: Radiation dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 32 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 32 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 32 at risk

Adverse event: Rectum- hemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 32 at risk

Adverse event: Rectum- pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 32 at risk

Adverse event: Renal/GU-other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 32 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 7 affected / 32 at risk

Adverse event: Skin-other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 32 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Throat/pharynx/larynx- pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 32 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 32 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Vagina- pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 32 at risk

Adverse event: Vision-blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 32 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 14 affected / 32 at risk