Study: NCT00802880

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 80 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 80 at risk

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

Adverse event: Death
Serious: yes
Organ System: General 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: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 80 at risk

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

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

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

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

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

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 80 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 80 at risk

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

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

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 80 at risk

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

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

Adverse event: Abodominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 80 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 80 at risk

Adverse event: Acneiform rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Albumin - low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 80 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 19 affected / 80 at risk

Adverse event: Allergic reaction/hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 80 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 80 at risk

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

Adverse event: Anisocoria
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 80 at risk

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

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 80 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Frequency: 4 affected / 80 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 80 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 80 at risk

Adverse event: Brachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 80 at risk

Adverse event: Bronchospasm: wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 80 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 80 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 80 at risk

Adverse event: Calcium - high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 80 at risk

Adverse event: Calcium - low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 80 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 80 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Cold sore
Serious: no
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 80 at risk

Adverse event: Congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 80 at risk

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

Adverse event: Muscle contracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 80 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 11 affected / 80 at risk

Adverse event: Cyst
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 80 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 80 at risk

Adverse event: Delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 80 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 80 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 80 at risk

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

Adverse event: Disease pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 17 affected / 80 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 80 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 80 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 80 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 22 affected / 80 at risk

Adverse event: Elevated PTT
Serious: no
Organ System: Investigations
Frequency: 6 affected / 80 at risk

Adverse event: Elevated troponin I
Serious: no
Organ System: Investigations
Frequency: 1 affected / 80 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Oesophageal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Extremity pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 80 at risk

Adverse event: Face pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 80 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 43 affected / 80 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 80 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 80 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 80 at risk

Adverse event: Flu like syndrome
Serious: no
Organ System: General disorders
Frequency: 2 affected / 80 at risk

Adverse event: Frothy urine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 80 at risk

Adverse event: GI abdominal hemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 80 at risk

Adverse event: Glucose - high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 80 at risk

Adverse event: Glucose - low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 80 at risk

Adverse event: Gout
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 80 at risk

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

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 80 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 80 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 57 affected / 80 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 80 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 80 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 80 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 80 at risk

Adverse event: International normalised ratio
Serious: no
Organ System: Investigations
Frequency: 9 affected / 80 at risk

Adverse event: Inferior vena cava thrombus
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 80 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 80 at risk

Adverse event: Intraspinal hematoma
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 80 at risk

Adverse event: Leukocytes (WBC)
Serious: no
Organ System: Investigations
Frequency: 24 affected / 80 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 54 affected / 80 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Mood alteration - agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 80 at risk

Adverse event: Mood alteration - anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 80 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 80 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 80 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 80 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Neuropathy (sensory)
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 80 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 80 at risk

Adverse event: Neutrophils (ANC)
Serious: no
Organ System: Investigations
Frequency: 15 affected / 80 at risk

Adverse event: Nose hemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 80 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Phosphorus - low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 80 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 80 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 33 affected / 80 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 80 at risk

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

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Portal vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 80 at risk

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

Adverse event: Potassium - low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 80 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 80 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 80 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 80 at risk

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

Adverse event: Reflux gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: SGOT (AST)
Serious: no
Organ System: Investigations
Frequency: 16 affected / 80 at risk

Adverse event: SGPT (ALT)
Serious: no
Organ System: Investigations
Frequency: 15 affected / 80 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 80 at risk

Adverse event: Shoulder/back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 80 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 80 at risk

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

Adverse event: Sodium - low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 80 at risk

Adverse event: Speech impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Swelling - face
Serious: no
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 80 at risk

Adverse event: Taste alterations
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 80 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 80 at risk

Adverse event: Ulcer: GI duodenum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 80 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 80 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 80 at risk

Adverse event: Urine color change
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 80 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

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

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 80 at risk