Study: NCT00170157

Adverse event: Ischemia/Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 110 at risk

Adverse event: Vision-Blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 110 at risk

Adverse event: Diarrhea-No Colostom
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Pain-Abdominal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Hepatic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 110 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 110 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 110 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 110 at risk

Adverse event: Amylase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 110 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 110 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 110 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 110 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 110 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 110 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 110 at risk

Adverse event: Rash/Desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 110 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 110 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 110 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 110 at risk

Adverse event: Lymph node pain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 110 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 110 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 110 at risk

Adverse event: Vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 110 at risk

Adverse event: Vision-Blurred
Serious: no
Organ System: Eye disorders
Frequency: 24 affected / 110 at risk

Adverse event: Anal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 110 at risk

Adverse event: Large intestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 110 at risk

Adverse event: Diarrhea-No Colostom
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 110 at risk

Adverse event: Duodenal ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 110 at risk

Adverse event: Pain-Abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Constitutional Symptoms
Serious: no
Organ System: General disorders
Frequency: 5 affected / 110 at risk

Adverse event: Edema: Limb
Serious: no
Organ System: General disorders
Frequency: 3 affected / 110 at risk

Adverse event: Facial pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 79 affected / 110 at risk

Adverse event: Pain-Chest
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 110 at risk

Adverse event: Hepatic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 110 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 110 at risk

Adverse event: Abdominal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 110 at risk

Adverse event: Colon infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 110 at risk

Adverse event: Lung (pneumonia) infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 110 at risk

Adverse event: Penis infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 110 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 110 at risk

Adverse event: Skin (cellulites) infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 110 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 110 at risk

Adverse event: Bruising (in absence of grade 3 or 4 thrombocytopenia)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 32 affected / 110 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 28 affected / 110 at risk

Adverse event: Amylase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 110 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 31 affected / 110 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 110 at risk

Adverse event: Coagulation
Serious: no
Organ System: Investigations
Frequency: 1 affected / 110 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 14 affected / 110 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 110 at risk

Adverse event: Metabolic/Lab
Serious: no
Organ System: Investigations
Frequency: 10 affected / 110 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 110 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 110 at risk

Adverse event: Blood bicarbonate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 110 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 110 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 110 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 87 affected / 110 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 110 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 110 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 110 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 110 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 110 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 110 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 110 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 110 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 110 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 110 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 28 affected / 110 at risk

Adverse event: Extremity-lower necrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 110 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 110 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 110 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Ischemia-Cerebral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Neuro
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 110 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 110 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 110 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 75 affected / 110 at risk

Adverse event: Ureteral Obstruction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 110 at risk

Adverse event: Urinary bladder haemorrhage
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 110 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 24 affected / 110 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 110 at risk

Adverse event: Prostatic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 110 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Sinus Reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 110 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 110 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 110 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 110 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 110 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 110 at risk

Adverse event: Rash/Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 110 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 110 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 110 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 88 affected / 110 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 110 at risk