Study: NCT00234052

Adverse event: Puesdogout
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Acute and Chronic Cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Experienced before protocol amended to exclude patients with a history of diverticulitis
Frequency: 4 affected / 50 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient also with Nausea, Constipation and anemia
Frequency: 1 affected / 50 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 50 at risk

Adverse event: Osteomylitis of the right great toe
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Viral Pneumonitis resulting in Death
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Pneumonia/death
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Neutrophils (Neutropenia)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 50 at risk

Adverse event: Hemoglobin (Anemia)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 50 at risk

Adverse event: Leukocytes (Total white blood cells)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 50 at risk

Adverse event: Platelets (Thrombocytopenia)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 50 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 50 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 43 affected / 50 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 50 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 50 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 10 affected / 50 at risk

Adverse event: Hair loss/Alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 50 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 50 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 50 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 50 at risk

Adverse event: Mucositis/Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 50 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 50 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 50 at risk

Adverse event: Epistaxis (Nosebleed)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 50 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 50 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 50 at risk

Adverse event: Alkaline Phosphastase Increase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 50 at risk

Adverse event: Transaminase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 50 at risk

Adverse event: ALT Increase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 50 at risk

Adverse event: AST Increase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 50 at risk

Adverse event: Albumin Decrease
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 50 at risk

Adverse event: Creatinine, Serum-high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 50 at risk

Adverse event: Calcium, Serum-low (Hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 50 at risk

Adverse event: Glucose, Serum-high (Hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 50 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 50 at risk

Adverse event: Neuropathy: Sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 50 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 50 at risk

Adverse event: Mood Alteration - Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 50 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 50 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 25 affected / 50 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 50 at risk

Adverse event: Dyspnea (Shortness of Breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 50 at risk

Adverse event: Watery Eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 50 at risk