Study: NCT00711412

Adverse event: Supraventricular and nodal arrhythmia:Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: Cardiac general:Congestive heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: CARDIAC ARRHYTHMIA: Cardiac arrest (Supraventricular and nodal arrhythmia: Atrial fibrillation)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Cellulitis (skin infection)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 43 at risk

Adverse event: Hemoglobin (Anemia)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 43 at risk

Adverse event: Neutrophils (Neutropenia)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 43 at risk

Adverse event: Leukocytes (total white blood count)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 43 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 43 at risk

Adverse event: Platelets (Thrombocytopenia)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 43 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 43 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: Supraventricular and nodal arrhythmia: multifocal atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: Supraventricular and nodal arrhythmia:Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 33 affected / 43 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 43 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 43 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 43 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 14 affected / 43 at risk

Adverse event: cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: (International Normalized Ratio of prothrombin time)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 43 at risk

Adverse event: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 43 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 43 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 43 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 43 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 43 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 43 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 43 at risk

Adverse event: Mucositis/Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 43 at risk

Adverse event: Heartburn (dyspepsia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 43 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 43 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Difficulty swallowing (dysphagia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 43 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 43 at risk

Adverse event: Infection (not otherwise specified)
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 43 at risk

Adverse event: Colitis, infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Pulmonary infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Upper airway infection (not otherwise specified)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Infection (Sepsis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Alkaline phosphatase (increase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 43 at risk

Adverse event: ALT/SGPT - serum glutamic pyruvic transaminase (increase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 43 at risk

Adverse event: AST/SGOT -serum glutamic oxaloacetic transaminase (increase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 43 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 43 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 43 at risk

Adverse event: Creatinine (increase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 43 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 43 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 43 at risk

Adverse event: Potassium, serum-low(hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 43 at risk

Adverse event: Sodium, serum-low(hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 43 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 43 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 43 at risk

Adverse event: Dizziness
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 43 at risk

Adverse event: Cold sensitivity
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Mood alteration - Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 43 at risk

Adverse event: Esophagus pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 43 at risk

Adverse event: Abdomen pain (Not otherwise specified)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 43 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 43 at risk

Adverse event: Pain swallowing (Odynophagia)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 43 at risk

Adverse event: Shortness of breath (dyspnea)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 43 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 43 at risk