Study: NCT00413959

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Cerebral Vascular Accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Anxiety Grade 1 & 2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Abdominal Pain Grade 1 & 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Appetite Decreased Grade 1 & 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Bilirubin Increased Grade 1 & 2
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Alopecia Grade 1 & 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Creatinine Increased Grade 1 & 2
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Constipation Grade 1 & 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Cough Grade 1 & 2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Chills Grade 1 & 2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Edema Grade 1 & 2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Fever Grade 1 & 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue Grade 1 & 2
Serious: no
Organ System: General disorders
Frequency: 4 affected / 12 at risk

Adverse event: Hyponatremia Grade 1 & 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypertension Grade 1 & 2
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hyperglycemia Grade 1 & 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Insomnia Grade 1 & 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Leukopenia Grade 1 & 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Rash Grade 1 & 2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Nausea Grade 1 & 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 12 at risk

Adverse event: Mucositis Grade 1 & 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pulmonary Edema Grade 1 & 2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Nail Changes Grade 1 & 2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Sweats Grade 1 & 2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Dry Skin Grade 1 & 2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Stomatitis Grade 1 & 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Sinus Congestion Grade 1 & 2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Tronopin Increased Grade 1 & 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Triglyceride Increased Grade 1 & 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Tongue Swelling Grade 1 & 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Weight Decreased Grade 1 & 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Tooth Abcess Grade 1 & 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Vomiting Grade 1 & 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Difficulty Walking Grade 1 & 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 12 at risk

Adverse event: Chest Pain Grade 3 & 4
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hyperglycemia Grade 3 & 4
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Leukopenia Grade 3 & 4
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 12 at risk

Adverse event: Neutropenia Grade 3 & 4
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 12 at risk

Adverse event: Orthopnea Grade 3 & 4
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pulmonary Edema Grade 3 & 4
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pulmonary Emboli Grade 3 & 4
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Shortness of Breath Grade 3 & 4
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache Grade 1 & 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pain Grade 1 & 2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk