Study: NCT01070069

Adverse event: Blood and Lymph Disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 50 at risk

Adverse event: GI Disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 50 at risk

Adverse event: General Disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Injury and Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 50 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 50 at risk

Adverse event: Metabolism/Nutrition Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 50 at risk

Adverse event: Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 50 at risk

Adverse event: Renal and Urinary Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 50 at risk

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

Adverse event: Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 50 at risk

Adverse event: Surgical/Medical procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 50 at risk

Adverse event: Blood and Lymph Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 50 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 50 at risk

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

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Frequency: 20 affected / 50 at risk

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

Adverse event: injury and Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 50 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 23 affected / 50 at risk

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

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

Adverse event: Psychiatric Disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 50 at risk

Adverse event: Renal and Urinary Disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 50 at risk

Adverse event: Respiratory/Thoracic Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 50 at risk

Adverse event: Skin Disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 50 at risk

Adverse event: Surgical/Medical Procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 50 at risk

Adverse event: Vascular Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 50 at risk

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

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

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 50 at risk

Adverse event: GI Disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: General Disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 50 at risk

Adverse event: Injury and Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 50 at risk

Adverse event: Metabolism/Nutrition Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 50 at risk

Adverse event: Neoplasms
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 50 at risk

Adverse event: Renal and Urinary Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 50 at risk

Adverse event: Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Blood and Lymph Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 50 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 50 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 50 at risk

Adverse event: GI Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 50 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Frequency: 12 affected / 50 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 50 at risk

Adverse event: injury and Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 50 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 31 affected / 50 at risk

Adverse event: Metabolism/Nutritional Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 50 at risk

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

Adverse event: Psychiatric Disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 50 at risk

Adverse event: Renal and Urinary Disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 50 at risk

Adverse event: Reproductive Disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 50 at risk

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

Adverse event: Skin Disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 50 at risk

Adverse event: Surgical/Medical Procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 50 at risk

Adverse event: Vascular Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 50 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Blood and Lymph Disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 51 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 51 at risk

Adverse event: GI Disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 51 at risk

Adverse event: General Disorder
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 51 at risk

Adverse event: Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 51 at risk

Adverse event: Injury and Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 51 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 51 at risk

Adverse event: Metabolism/Nutrition Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 51 at risk

Adverse event: Neoplasms
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 51 at risk

Adverse event: Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Renal and Urinary Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 51 at risk

Adverse event: Respiratory/Thoracic Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 51 at risk

Adverse event: Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 51 at risk

Adverse event: Surgical/Medical procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 51 at risk

Adverse event: Blood and Lymph Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 51 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 51 at risk

Adverse event: GI Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 51 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Frequency: 12 affected / 51 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 51 at risk

Adverse event: injury and Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 51 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 24 affected / 51 at risk

Adverse event: Metabolism/Nutritional Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 51 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 51 at risk

Adverse event: Reproductive Disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 51 at risk

Adverse event: Respiratory/Thoracic Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 51 at risk

Adverse event: Surgical/Medical Procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 51 at risk

Adverse event: Vascular Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 51 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 51 at risk

Adverse event: Congenital anomaly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 51 at risk

Adverse event: Blood and Lymph Disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 19 at risk

Adverse event: General Disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Injury and Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 19 at risk

Adverse event: Metabolism/Nutrition Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Respiratory/Thoracic Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 19 at risk

Adverse event: Blood and Lymph Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 19 at risk

Adverse event: GI Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 19 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Frequency: 9 affected / 19 at risk

Adverse event: injury and Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 19 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 5 affected / 19 at risk

Adverse event: Metabolism/Nutritional Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 19 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Renal and Urinary Disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 19 at risk

Adverse event: Reproductive Disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 19 at risk

Adverse event: Respiratory/Thoracic Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Vascular Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 19 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: GI Disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: General Disorder
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Metabolism/Nutrition Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 22 at risk

Adverse event: Respiratory/Thoracic Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 22 at risk

Adverse event: Blood and Lymph Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 22 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: GI Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Frequency: 13 affected / 22 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: injury and Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 22 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 11 affected / 22 at risk

Adverse event: Metabolism/Nutritional Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 22 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Psychiatric Disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 22 at risk

Adverse event: Skin Disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Vascular Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 22 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk