Study: NCT00323739

Adverse event: Ventricular arrhythmia - left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 80 at risk

Adverse event: Mood alteration - depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 80 at risk

Adverse event: Thrombus/thrombosis/embolism - lung
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 80 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 80 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 80 at risk

Adverse event: Inflammation - small bowel
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Fracture - right hip
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 80 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 80 at risk

Adverse event: Obstruction - small bowel
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Altered mental status
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Obstruction - bowel
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Disease progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 80 at risk

Adverse event: Infection - pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 80 at risk

Adverse event: Abcess - lung
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 80 at risk

Adverse event: Pneumonitis (non-infectious)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 80 at risk

Adverse event: Infection, not otherwise specified
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 80 at risk

Adverse event: Infectious pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Pain - abdomen
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 80 at risk

Adverse event: Injury - compression of right mainstem bronchus
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 80 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Infection - urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 80 at risk

Adverse event: Perforation - rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 80 at risk

Adverse event: Hemmorhage - rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 80 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 80 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Alk Phosphate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 80 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 80 at risk

Adverse event: AST,SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 80 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 80 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 7 affected / 80 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 80 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 80 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 80 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 80 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 80 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 80 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 80 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 80 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 80 at risk

Adverse event: Edema (limb)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 80 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 62 affected / 80 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 80 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 80 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 51 affected / 80 at risk

Adverse event: Hemorrhage (nose)
Serious: no
Organ System: Vascular disorders
Frequency: 25 affected / 80 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 80 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 80 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 80 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 80 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 80 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 34 affected / 80 at risk

Adverse event: Hypoalubminemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 80 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 80 at risk

Adverse event: Hypokakalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 80 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 80 at risk

Adverse event: Infection (NOS)
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 80 at risk

Adverse event: Infection (sinus)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 80 at risk

Adverse event: Infection (URI)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 80 at risk

Adverse event: Infection (UTI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 80 at risk

Adverse event: Leukocytes (WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 80 at risk

Adverse event: Mental Status Change
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 80 at risk

Adverse event: Mood alteration (anxiety)
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 80 at risk

Adverse event: Mood alteration (depression)
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 80 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 80 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 80 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 80 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 80 at risk

Adverse event: Neuropathy (sensory)
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 80 at risk

Adverse event: Neutrophils (ANC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 80 at risk

Adverse event: Pain (abdominal)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 80 at risk

Adverse event: Pain (back)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 80 at risk

Adverse event: Pain (bone)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 80 at risk

Adverse event: Pain (chest)
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 80 at risk

Adverse event: Pain (headache)
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 80 at risk

Adverse event: Pain (jaw)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 80 at risk

Adverse event: Pain (joint)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 80 at risk

Adverse event: Pain (limb)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 80 at risk

Adverse event: Pain (myalgia)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 80 at risk

Adverse event: Pain (neck)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 80 at risk

Adverse event: Pain (NOS)
Serious: no
Organ System: General disorders
Frequency: 16 affected / 80 at risk

Adverse event: Pain (oral)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 80 at risk

Adverse event: Pain (throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 80 at risk

Adverse event: Phosphorous
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 80 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 32 affected / 80 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 80 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 80 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 37 affected / 80 at risk

Adverse event: Reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 80 at risk

Adverse event: Skin (erythema)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 80 at risk

Adverse event: Skin (lesion)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 80 at risk

Adverse event: Sore (mouth)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 80 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 80 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 80 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 80 at risk

Adverse event: Blood triglycerides
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 80 at risk

Adverse event: Blood uric acid
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 80 at risk

Adverse event: Voice change
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 80 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 80 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 80 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 13 affected / 80 at risk

Adverse event: Infection (pneumonia)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 80 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 80 at risk