Study: NCT00308516

Adverse event: Infection - Pelvis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Infection - NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 35 at risk

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

Adverse event: Obstruction - GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

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

Adverse event: Liver Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 35 at risk

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

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

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

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

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Infection - Skin
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Surgery/Intraoperative Injury - Prostate
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 35 at risk

Adverse event: Infection - Postoperative
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Infection - Renal/Genitourinary
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Thrombosis/Thrombus/Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 35 at risk

Adverse event: Pollakiuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 35 at risk

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

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 35 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 35 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 35 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 35 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 35 at risk

Adverse event: Rigor/Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 35 at risk

Adverse event: Thrombosis/Thrombus/Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 35 at risk

Adverse event: Cold Sensitivity
Serious: no
Organ System: General disorders
Frequency: 2 affected / 35 at risk

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 35 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 35 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 35 at risk

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

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 29 affected / 35 at risk

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

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

Adverse event: Hand-Foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 35 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 35 at risk

Adverse event: Hemorrhage - Hematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 35 at risk

Adverse event: Hemorrhage - Nose
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 35 at risk

Adverse event: Hemorrhage - GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 35 at risk

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

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 35 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 35 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 35 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 35 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 35 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 35 at risk

Adverse event: Infection - Postoperative
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 35 at risk

Adverse event: Infection - Skin
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 35 at risk

Adverse event: Infection - Upper Respiratory
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 35 at risk

Adverse event: Infection - Renal/Genitourinary
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 35 at risk

Adverse event: Infection with Normal ANC
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 35 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 35 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Immune system disorders
Frequency: 22 affected / 35 at risk

Adverse event: Mood Alteration - Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 35 at risk

Adverse event: Mood Alteration - Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 35 at risk

Adverse event: Mucositis/Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 35 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 35 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Immune system disorders
Frequency: 14 affected / 35 at risk

Adverse event: Pain - NOS
Serious: no
Organ System: General disorders
Frequency: 25 affected / 35 at risk

Adverse event: Pain - Abdomen
Serious: no
Organ System: General disorders
Frequency: 5 affected / 35 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 35 at risk

Adverse event: Pain - Back
Serious: no
Organ System: General disorders
Frequency: 4 affected / 35 at risk

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

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

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 35 at risk

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

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 35 at risk

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

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 35 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 35 at risk

Adverse event: Rash/Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 35 at risk

Adverse event: Neuropathy - Sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 35 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 35 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 35 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 35 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 35 at risk

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 35 at risk

Adverse event: Watery Eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 35 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 35 at risk

Adverse event: Wound complication
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 35 at risk

Adverse event: Pain - Rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Fistula, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Perforation, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hemorrhage - Nose
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pain - Abdomen
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 31 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Cardiac Ischemia/Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 31 at risk

Adverse event: Infection - GI
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Mental Status
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 31 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 31 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Wound complication
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Thrombosis/Thrombus/Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 31 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 31 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 31 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 31 at risk

Adverse event: Thrombosis/Thrombus/Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 31 at risk

Adverse event: Congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 31 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 31 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 31 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 31 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Edema - Limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 22 affected / 31 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 31 at risk

Adverse event: Rectal Drainage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hand-Foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 31 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 31 at risk

Adverse event: Hemorrhage - Gums
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hemorrhage - Nose
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 31 at risk

Adverse event: Hemorrhage - GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 31 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 31 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 31 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 31 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 31 at risk

Adverse event: Infection - GI
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 31 at risk

Adverse event: Infection - Skin
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Infection - Upper Respiratory
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 31 at risk

Adverse event: Infection - Renal/Genitourinary
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 31 at risk

Adverse event: Infection with Normal ANC
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 31 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 31 at risk

Adverse event: Irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Immune system disorders
Frequency: 21 affected / 31 at risk

Adverse event: Mental Status
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 31 at risk

Adverse event: Mood Alteration - Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 31 at risk

Adverse event: Mood Alteration - Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 31 at risk

Adverse event: Mucositis/Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 31 at risk

Adverse event: Neuropathy - Motor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Immune system disorders
Frequency: 15 affected / 31 at risk

Adverse event: Pain - NOS
Serious: no
Organ System: General disorders
Frequency: 26 affected / 31 at risk

Adverse event: Pain - Abdomen
Serious: no
Organ System: General disorders
Frequency: 10 affected / 31 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 31 at risk

Adverse event: Pain - Head
Serious: no
Organ System: General disorders
Frequency: 3 affected / 31 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 31 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 31 at risk

Adverse event: Pain - Rectum
Serious: no
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 31 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 31 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Rash/Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 31 at risk

Adverse event: Neuropathy - Sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 31 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 31 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 31 at risk

Adverse event: Wound complication
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 31 at risk